chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain in extremity
Clinical narrative: Patient called stating her arm is still extremely sore, inflamed and red. She did state it is getting better. She is icing it to help with inflammation.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dyspnoea
Clinical narrative: Extreme gasping for breath, extreme weakness, sudden onset. NO pain, vomit or nausea Called Doctors emergency number. Saw GP the next day.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Pallor, Presyncope
Clinical narrative: After vaccination, the father of the patient who was with her at the time said she wasn't feeling well. He said she feels squeamish from needles. At the time of the vaccine she was sitting down during the vaccination. She did not mention any issues with vaccines prior to vaccination. She walked to the bathroom. I approached the patient who said she wasn't feeling well. Her face looked very light in color compared to the rest of her body. I asked if she thought she was going to pass out. She said yes. She was sitting on the floor. I told her to lay down and got her a cold compress to put on her forehead. She laid down for about five minutes and then proceeded to feel better. Ten minutes later she.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue, headache, shivering, then fever, 100.4.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site swelling, Swelling face
Clinical narrative: Facial swelling approximately 20-30 minutes after vaccination, which subsided during an unknown amount of time but had subsided by 1:30 pm (1.5 hours after vaccination). At approximately 1.5 hours after vaccination, the patient reported the reaction and was also beginning to develop some itching and swelling at the injection site. It was recommended to the patient to visit urgent care for evaluation and to take BENADRYL. The patient stated that she took BENADRYL (but decided not to visit urgent care). Resolution of symptoms occurred by 7:00 pm on 12/1.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying, Hypertonia, Pyrexia, Selective eating disorder
Clinical narrative: Started uncontrollable crying for hours hour 4-5 days following vaccines. Began about 3-4 hours after vaccines. Mild low grade fever 99.5. Began having trouble nursing approximately 3 days following. Developed high tone and increased hip tightness. Went to emergency on 7/8/18 for non stop crying.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised
Clinical narrative: Systemic itching ongoing.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiac arrest, Electrocardiogram abnormal, Troponin increased, Ventricular fibrillation
Clinical narrative: Sudden cardiac arrest 21 days s/p small pox vaccine.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema, Pruritus
Clinical narrative: Redness, itching, swelling (seen day after vaccination - 11/30; some edema near lower portion of swollen red site. Site size approximately 5" by 3-4"...patient used BENADRYL. Was counseled regarding use of hydrocortisone topically as well as 24  hour ALLEGRA.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Swelling
Clinical narrative: Redness, itching, swelling (seen day after vaccination - 11/30; some edema near lower portion of swollen red site. Site size approximately 5" by 3-4"...patient used BENADRYL. Was counseled regarding use of hydrocortisone topically as well as 24  hour ALLEGRA.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness, Nerve conduction studies, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Left arm became numb with electric shocks running down to my hand. Middle, ring and pinkie fingers folded down into the palm of my hand and would not open up. I could not use my hand which made it extremely difficult as I am left-handed. It has been two months and I still cannot use my hand. My fingers have opened up a bit and will not completely open up. I still have no strength in the hand. I have been going to physical therapy since November 3, 2018.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13, VARCEL
Symptoms: Eyelid function disorder, Lethargy, Swelling face, Wrong product administered
Clinical narrative: My baby was NOT supposed to receive the PEDIARIX, however the nurse who was "in a hurry" accidentally grabbed the wrong vaccination and gave it. My daughter woke up with half of her face completely swollen and was unable to open one eye and was very lethargic. The nurse told me this was "due to a cold". And told me NOT to take her to the ER.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Rash erythematous
Clinical narrative: Patient reports a very large red rash, spanning most of her upper arm that persisted for over 1 week. She also states that about 1 or 2 weeks after the vaccination that she is having difficulty twisting her wrist and some arm movements.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Soreness and Rash adjacent to injection site with light itching, redness and some heat to the touch - about one inch in circumference. Applied zinc oxide (self determined) at night and morning after shower. Size of rash area somewhat reduced as result. Still sore to touch.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Insomnia, Pyrexia
Clinical narrative: I had a slight fever (99.6) and I had extreme chills starting at approximately 1:00 a.m. I just couldn't seem to warm up, which made it difficult to fall asleep. I got up and took 2 TYLENOL. I eventually fell asleep between 3:30-4:00 a.m. I woke up around 10:00 a.m. and by 11:00 a.m. I had the chills again. I went back to bed for about another hour and woke up and the chills were gone.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient presented to the pharmacy 12/1/18 indicating that her left upper arm had started hurting within the past week. She states that her arm is sore to sleep on within the past week and hurt when reaching to grab an item in her home.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient's wife, presented to the pharmacy on 12/1/18 indicating that patient's left upper arm has been hurting him since his flu shot. She described soreness and pain - when prompted, she did not indicate any loss of range of motion, numbness/tingling, no pain shooting down arm. I advised the use of pain relievers such as TYLENOL or NSAIDs as well as a heat pack to help with the pain. I advised he follow up with his PCP if pain continues.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus
Clinical narrative: A few days after the vaccine was administered I started to get horrible read itching patches on my face, hands, head, and neck and arms. No matter what I did I couldn't get them to go away. I never formed a physical reaction from the smallpox vaccine itself in terms of a bump on my arm or anything, but I did get some pretty horrible itchy patches that I am still having on my scalp that I'm slowly getting rid of a year later.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Bed rest, Pyrexia, Swelling
Clinical narrative: Friday AM swelling and febrile with 103 degree fever and unable to get out of bed. Worsened Saturday so she presented to ER Sunday at 2:00 AM.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient experienced red, warm to the touch, itchy spots on the arm directly below the injection site and on the bicep. She also felt very tired, lethargic, and cold. It started the day after the injection around noon and she took BENADRYL to help with the itching. I spoke with her on Friday and also recommended placing ice on the warm injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy
Clinical narrative: Patient experienced red, warm to the touch, itchy spots on the arm directly below the injection site and on the bicep. She also felt very tired, lethargic, and cold. It started the day after the injection around noon and she took BENADRYL to help with the itching. I spoke with her on Friday and also recommended placing ice on the warm injection site.
Age: 17.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient received FLUZONE QUAD and BOOSTRIX vaccine today. After less than 2 minutes patient fainted and fell on the floor from the standing position. Called 911 right away. Patient regained consciousness in less than 30 seconds. Patient was instructed to stay flat back position on the floor. After approximately 10 minutes, patient got up and sat on the chair in the waiting area while waiting for paramedic to arrive. Patient was given water and pharmacist pressed back bleeding head while mom and patient was talking. Patient wanted cold water to be poured over his head. Patient was doing well and paramedic arrived. Paramedic checked patient's vital sign and patient was taken to the emergency room.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Shortness of breath and chest pain upon exercise but unusal for patient, prescriber aware and following up with care.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Injection site swelling, Pyrexia
Clinical narrative: Severe weakness/ severe swelling at site of injection/fever/admission to hospital for reaction.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: 11 hours after injection got a fever (101 degrees), shivering, muscular aches; I felt like I had the flu; I had to stay in bed all next day.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had painful, warm and swelling at the site of injection for 4 days. No MD follow up as patient is feeling better.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia, Vaccination complication
Clinical narrative: Patient reported a high fever of 103 degrees F, stingy, intense all-over body pain, and a very bad headache the day following the vaccination. She contacted her doctor and they conculded that her symptoms were due to the vaccination and instructed patient to take over-the-counter pain and fever reducer. However her doctor also said she will still need to get the second dose.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: PATIENT EXPERIENCED TIGHTNESS IN THE THROAT AND WAS HAVING PROBLEMS BREATHING WHEN AT HOME. HE USED HIS EPIPEN AND IT ALLEVIATED THE SYMPTOMS. THE PATIENT NEVER WENT TO THE ER OR TOLD ANYONE UNTIL I CALLED HIM TO TELL HIM HE WAS DUE FOR HIS 2ND DOSE ON 12/2/18.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Eye pain, Influenza like illness, Injection site bruising, Injection site discomfort
Clinical narrative: Swelling, redness near injection site 5 inches by 5 inches, bruising and injection site discomfort, flu-like symptoms, joint aches, eye pain.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness near injection site 5 inches by 5 inches, bruising and injection site discomfort, flu-like symptoms, joint aches, eye pain.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient described arm as red, swollen and hot arm at vaccine area.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: 10 minutes after receiving vaccine, patient had throbbing pain in arms, legs and buttocks, lasted about 5 minutes then stopped.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash erythematous
Clinical narrative: Rash red and sore.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: She developed a red spot about the size of a 3x5 note card. It was itchy, warm to the touch, and very tender to the touch.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient called on 11/26/18 (11:30 AM), she reported hives, redness, and being very itchy a few hours after her vaccine. Patient stated she will follow up with doctor and she did not try any treatment remedies.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Pt stated that she noticed within 30 minutes of the shot, as she'd headed back to work, that the shot was higher up on her arm than what she was used to. It hurt for about 2 days (typical soreness), but then in the weeks that followed, she continued to notice pain in a specific spot near the shoulder that feels more localized to where the injection was...especially upon lifting arm at shoulder.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced redness, warmth, pain, and swelling at site of injection. Patient was instructed to take ibuprofen and BENADRYL for treatment. Also recommended to see doctor in case symptoms worsen.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Fatigue, Full blood count normal, Mononucleosis heterophile test negative, Myalgia, Urine analysis normal
Clinical narrative: Patient states he developed severe fatigue & myalgias approximately 2 weeks after receiving the BEXSERO vaccine. The myalgias have resolved but the fatigue is persistent. Denies any localized site reactions.
Sex: U
Vaccine: FLUA3
Symptoms: Back pain, Pain
Clinical narrative: Had pain going down her back soon after getting High Dose flu shot - hurt all over gave her 1 Dose of EPI-PEN and symptoms subsided. Ambulance came to attend.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-SEP-2016, a healthcare provider at a county health department administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 26-SEP-2016, the patient was treated by a healthcare provider at a county health department for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd July 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site induration and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX in left arm. The patient planned to follow-up with her physician on an unknown date.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd July 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site induration and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX in left arm. The patient planned to follow-up with her physician on an unknown date.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd July 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site induration and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX in left arm. The patient planned to follow-up with her physician on an unknown date.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cyst, Neuralgia, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. On 18th October 2018, the patient experienced cyst. On an unknown date, the patient experienced injected limb mobility decreased. The patient was treated with Steroid (Not Specified). On an unknown date, the outcome of the injection site swelling, injection site pain, injected limb mobility decreased and cyst were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site pain, injected limb mobility decreased and cyst to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in left arm and presented with pain and swelling in the left arm shortly after vaccination with SHINGRIX. The patient stated that the pain and swelling lingered for approximately 1 week and she went to saw her physician. The patient was prescribed steroids and states that the steroids were helping with the swelling and once she stopped taking the steroids, the pain and swelling came back. On 18th October 2018, the patient done ultrasound and found out that the patient had fatty cyst in the area in which she received the SHINGRIX vaccine. The patient stated that the physician was not sure if the cyst was there before or after the SHINGRIX injection and that the cyst could be the cause for the pain and swelling. The patient states that if the cyst was there before vaccination, the vaccine could have been injected into the cyst. The patient was in the physical therapy because she had limited use of her left arm. The patient had consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ultrasound scan abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. On 18th October 2018, the patient experienced cyst. On an unknown date, the patient experienced injected limb mobility decreased. The patient was treated with Steroid (Not Specified). On an unknown date, the outcome of the injection site swelling, injection site pain, injected limb mobility decreased and cyst were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site pain, injected limb mobility decreased and cyst to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in left arm and presented with pain and swelling in the left arm shortly after vaccination with SHINGRIX. The patient stated that the pain and swelling lingered for approximately 1 week and she went to saw her physician. The patient was prescribed steroids and states that the steroids were helping with the swelling and once she stopped taking the steroids, the pain and swelling came back. On 18th October 2018, the patient done ultrasound and found out that the patient had fatty cyst in the area in which she received the SHINGRIX vaccine. The patient stated that the physician was not sure if the cyst was there before or after the SHINGRIX injection and that the cyst could be the cause for the pain and swelling. The patient states that if the cyst was there before vaccination, the vaccine could have been injected into the cyst. The patient was in the physical therapy because she had limited use of her left arm. The patient had consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site cyst, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. On 18th October 2018, the patient experienced cyst. On an unknown date, the patient experienced injected limb mobility decreased. The patient was treated with Steroid (Not Specified). On an unknown date, the outcome of the injection site swelling, injection site pain, injected limb mobility decreased and cyst were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site pain, injected limb mobility decreased and cyst to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in left arm and presented with pain and swelling in the left arm shortly after vaccination with SHINGRIX. The patient stated that the pain and swelling lingered for approximately 1 week and she went to saw her physician. The patient was prescribed steroids and states that the steroids were helping with the swelling and once she stopped taking the steroids, the pain and swelling came back. On 18th October 2018, the patient done ultrasound and found out that the patient had fatty cyst in the area in which she received the SHINGRIX vaccine. The patient stated that the physician was not sure if the cyst was there before or after the SHINGRIX injection and that the cyst could be the cause for the pain and swelling. The patient states that if the cyst was there before vaccination, the vaccine could have been injected into the cyst. The patient was in the physical therapy because she had limited use of her left arm. The patient had consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electromyogram, Hypoaesthesia, Muscle spasms, Muscular weakness, Nerve conduction studies
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cramp of limb in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 22nd June 2018, 7 days after receiving SHINGRIX, the patient experienced cramp of limb, twitching of limbs, hands weakness of and injection site inflammation. On an unknown date, the outcome of the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation were not recovered/not resolved. It was unknown if the reporter considered the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient had not experienced any real pain initially. About a week later after vaccination with SHINGRIX, the patient experienced cramping and twitching in her upper arm. The patient lost control of her arm. The patient had also filed a workers compensation claim. She also went to the neurologist and was diagnosed with inflammation in the upper arm near where the vaccine was given. This case was linked to case US2018214122 (1st dose) reported by the same reporter for the same patient.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nerve injury, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cramp of limb in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 22nd June 2018, 7 days after receiving SHINGRIX, the patient experienced cramp of limb, twitching of limbs, hands weakness of and injection site inflammation. On an unknown date, the outcome of the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation were not recovered/not resolved. It was unknown if the reporter considered the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient had not experienced any real pain initially. About a week later after vaccination with SHINGRIX, the patient experienced cramping and twitching in her upper arm. The patient lost control of her arm. The patient had also filed a workers compensation claim. She also went to the neurologist and was diagnosed with inflammation in the upper arm near where the vaccine was given. This case was linked to case US2018214122 (1st dose) reported by the same reporter for the same patient.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Electromyogram abnormal, Grip strength decreased, Injection site inflammation, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cramp of limb in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 22nd June 2018, 7 days after receiving SHINGRIX, the patient experienced cramp of limb, twitching of limbs, hands weakness of and injection site inflammation. On an unknown date, the outcome of the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation were not recovered/not resolved. It was unknown if the reporter considered the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient had not experienced any real pain initially. About a week later after vaccination with SHINGRIX, the patient experienced cramping and twitching in her upper arm. The patient lost control of her arm. The patient had also filed a workers compensation claim. She also went to the neurologist and was diagnosed with inflammation in the upper arm near where the vaccine was given. This case was linked to case US2018214122 (1st dose) reported by the same reporter for the same patient.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Muscle twitching, Muscular weakness, Neuritis, Neuropathy peripheral, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cramp of limb in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 22nd June 2018, 7 days after receiving SHINGRIX, the patient experienced cramp of limb, twitching of limbs, hands weakness of and injection site inflammation. On an unknown date, the outcome of the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation were not recovered/not resolved. It was unknown if the reporter considered the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient had not experienced any real pain initially. About a week later after vaccination with SHINGRIX, the patient experienced cramping and twitching in her upper arm. The patient lost control of her arm. The patient had also filed a workers compensation claim. She also went to the neurologist and was diagnosed with inflammation in the upper arm near where the vaccine was given. This case was linked to case US2018214122 (1st dose) reported by the same reporter for the same patient.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Oedema, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cramp of limb in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 22nd June 2018, 7 days after receiving SHINGRIX, the patient experienced cramp of limb, twitching of limbs, hands weakness of and injection site inflammation. On an unknown date, the outcome of the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation were not recovered/not resolved. It was unknown if the reporter considered the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient had not experienced any real pain initially. About a week later after vaccination with SHINGRIX, the patient experienced cramping and twitching in her upper arm. The patient lost control of her arm. The patient had also filed a workers compensation claim. She also went to the neurologist and was diagnosed with inflammation in the upper arm near where the vaccine was given. This case was linked to case US2018214122 (1st dose) reported by the same reporter for the same patient.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site inflammation, Muscle spasms, Muscle twitching, Muscular weakness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cramp of limb in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 22nd June 2018, 7 days after receiving SHINGRIX, the patient experienced cramp of limb, twitching of limbs, hands weakness of and injection site inflammation. On an unknown date, the outcome of the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation were not recovered/not resolved. It was unknown if the reporter considered the cramp of limb, twitching of limbs, hands weakness of and injection site inflammation to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient had not experienced any real pain initially. About a week later after vaccination with SHINGRIX, the patient experienced cramping and twitching in her upper arm. The patient lost control of her arm. The patient had also filed a workers compensation claim. She also went to the neurologist and was diagnosed with inflammation in the upper arm near where the vaccine was given. This case was linked to case US2018214122 (1st dose) reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Decreased activity, Pain in extremity, Sleep disorder
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included thoracotomy (to have lung mass removed 2 weeks before receiving the vaccine). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, blister and injection site erythema. On an unknown date, the outcome of the pain in arm, blister and injection site erythema were unknown. It was unknown if the reporter considered the pain in arm, blister and injection site erythema to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient was called by the pharmacy to come in and get her 2nd dose of SHINGRIX dose as the pharmacy just received a shipment of doses. The patient was 2 weeks post thoracotomy. After receiving the SHINGRIX, the patient's arm hurts from the shoulder down to her wrist and the pain from the shot reaction hurt more than the incision pain from the surgery. The patient had a linear line of blisters away from the injection site, but reported that the injection site was red in color. The reporter agreed to follow up from GlaxoSmithKline..
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included thoracotomy (to have lung mass removed 2 weeks before receiving the vaccine). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, blister and injection site erythema. On an unknown date, the outcome of the pain in arm, blister and injection site erythema were unknown. It was unknown if the reporter considered the pain in arm, blister and injection site erythema to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient was called by the pharmacy to come in and get her 2nd dose of SHINGRIX dose as the pharmacy just received a shipment of doses. The patient was 2 weeks post thoracotomy. After receiving the SHINGRIX, the patient's arm hurts from the shoulder down to her wrist and the pain from the shot reaction hurt more than the incision pain from the surgery. The patient had a linear line of blisters away from the injection site, but reported that the injection site was red in color. The reporter agreed to follow up from GlaxoSmithKline..
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, Swelling face
Clinical narrative: After I received the flu vaccine in my left arm, my arm became very sore and painful. I also developed swelling in my face, especially around my eyes, which took several days to subside. The pain and soreness in my left arm has not gone away. I have lost range of motion in my left shoulder. I am unable to sleep on my left side because of the pain in my shoulder and the pain wakes me up at night several times. I have decreased strength in my left arm and shoulder as well. I have taken Ibuprofen and Tylenol with no relief.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Seizure
Clinical narrative: 105 Fever, Seizure.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications and drugs reactions or allergies were not reported. On unknown dates, an unspecified number of patients received improperly stored doses of VARIVAX injection, lot # N017395, expiration date 07-JUN-2019, for prophylaxis (dose, dose number, route of administration and anatomical location were not reported). It was reported that sterile diluent used for reconstitution of the vaccine was properly stored. No adverse effects were reported. It was reported that the vaccines were stored in temperature of -9 to 8 (also reported as -8.8) degrees Celsius for 52 minutes (date unspecified). There were no previous temperature excursions recorded. A digital data logger was involved in recording the excursion details. This is a non-valid case due to lack of patients' identifiers. Please add to the end of the narrative: As of 27-NOV-2017, all telephone attempts to obtain follow-up information have been unsuccessful.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from an unknown age female patient referring to herself. The patient's current condition, concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 05-NOV-2018, the patient was given 0.5 milliliter GARDASIL 9 injection (strength,  route, batch/lot # and expiration date were not reported) for prophylaxis at her doctor's office and during this doctor visit, the patient was informed that she was pregnant. The last menstrual period (LMP) was estimated in 2018 and the estimated date of delivery (EDD) was not provided (Vaccine exposure during pregnancy). The outcome of pregnant was pending.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Pain in extremity, Rash erythematous
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history included haemochromatosis. The patient had no concomitant medication or drug reactions/allergies. On 07-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (lot# R012550, expiration date was 20-JAN-2019; strength, dose and route were not reported) for prophylaxis. On 09-NOV-2018, the patient came into the pharmacy stating that her arm really hurt (Pain in arm) and she had a red rash at the injection site (Injection site rash). No treatment had been provided. The patient also stated that the red rash had grown in size from the day before the reporting time. No lab test was performed. The outcome of the events was reported as not recovered. The causality between the events and PNEUMOVAX 23 was not reported.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a medical student (consumer) referring to himself, a 25 year old male patient. Patient's medical history, concurrent condition and concomitant medications were reported as none. On an unknown date, when the patient was a child, he was vaccinated with first dose of VARIVAX (dosing details unknown) for prophylaxis. On an unknown date (reported as 'a couple of years ago'), a titer drawn for varicella was negative (varicella virus test negative). On an unknown date in JUL-2017, the patient was vaccinated with second dose of VARIVAX (dosing details unknown) for prophylaxis. In approximately, on an unknown date in 2017, the patient developed local injection site reaction after vaccination. The patient's arm was red and hard for 2 to 3 days. No treatment for reaction was needed and it went away on its own on an unspecified date. On 12-NOV-2018, another titer was drawn which was also negative for immunity to varicella (varicella virus test negative). The outcome of varicella virus test negative was unknown. The outcome of injection site reaction was reported as recovered/resolved. Causality assessment was not provided. No product quality compliant was present.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 13 year old patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 16-NOV-2018, the patient was vaccinated with GARDASIL 9 lot # 1586749, expiry date: 13-FEB-2021 (dose, frequency and route of administration unknown) for an unknown indication, which was improperly stored (product storage error). The product GARDASIL 9 was reportedly stored at temperature/ time frame of 23.7 Fahrenheit (below 32 degrees Fahrenheit) for 17 hours 41 minutes (3 cycles) and 51.9 Fahrenheit (47 degrees Fahrenheit to 77 degrees Fahrenheit) for 7 hours 30 minutes with multiple excursions. Data logger was reported as yes. No adverse event reported.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. The patient's concurrent conditions, historical conditions, concomitant medications and drug reactions/allergies were unknown. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis. On an unknown date in November 2018, it was discovered that, the patient had titers for mumps and rubella, but not measles. On an unknown date in November 2018, the patient underwent laboratory test for measles titer and the result was negative. The patient was not treated for the event. The event did not cause significant disability to the patient. The outcome of the event measles antibody negative was unknown. The reporters causality assessment was not provided. No product quality complaint involved.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: Information has been received from a physician referring to himself, a male patient of an unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date years ago, the patient was vaccinated with M-M-R II to prophylaxis (strength, dose, route of administration, anatomical injection site, lot number and expiration date were not reported). On an unknown date,(reported as "recently"), an unspecified blood work completed was performed at an unspecified laboratory and the titre results were: "Rubella 4.74, Rubeola 1.56 and Mumps 0.312" (units not provided). (Virus antibody test abnormal). The outcome of the event and its causal relationship between therapy M-M-R II were not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a 65-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 27-NOV-2018, the patient was inadvertently administered a dose of GARDASIL 9 lot # R008164 and expiration date 12-NOV-2020 (dose, frequency and route were not provided) for prophylaxis instead of PNEUMOVAX 23 (dose, frequency, route, lot number and expiration date were not provided). No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 17-JAN-2014, a pharmacist administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot number not provided). On or about 16-JUN-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 2016, a healthcare provider at a physician's office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries and conditions (dose, route, and lot # not provided). In or about 2016, the patient was treated by a healthcare professional at the same medical branch for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.