chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Menorrhagia, Platelet count decreased, Ultrasound scan vagina
Clinical narrative: Bruising all over body 10/24/19 Bloody Gums 10/28/19 Heavy Menses 11/1/19 Hospital 11/4/19 Platelets decreased 15,000 (ITP) Multiple doctor visits to rule out cause of symptoms Platelets IV - Reaction had to be medicated with Benadryl, antihistamines, steroids. Has to get weekly lab to monitor platelets count. Been on reduction Prednisone (since hospitalization) Dr - Rheumatologist Dr - Hematologist/Oncologist Dr - GI/Family Practice Dr - GYN office visit after event.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; the patient was administered an improperly stored dose of PEDVAXHIB; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 13-DEC-2019, the patient was vaccinated with a dose of improperly stored Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, with lot number S006471, which was confirmed to be a valid lot number for Haemophilus b conjugate vaccine (meningococcal protein conjugate) (therapy type: digital data logger), and expiration date reported and established as 22-JAN-2022 for prophylaxis (strength, exact dose, frequency, and anatomical location were not reported).  Temperature excursion (product storage error) was reported as follows: temperature of 48.5 degrees Fahrenheit for a timeframe of 1 hour. There was no previous temperature excursion and the product storage error was identified via a data logger. No additional adverse event information was provided. No product quality complaint was reported.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site pain, Nausea, Pyrexia
Clinical narrative: Moderate pain on injection site that started several hours after injection.  Fever of 101 with mild nausea that started approximately 24 hours after injection.  Lasted for approximately 12 hours but did cause loss of work for one day.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Approximately 7 hours after injection pt experience painful movement of arm used cold compress, pain greatly reduced next morning. By day 3 pt was not experiencing pain.  She asked Pharmacy to file and incident report.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Insomnia, Musculoskeletal pain
Clinical narrative: Pain everywhere overnight. Mild shivering. Pain to touch. Didn't get much sleep. Took tylenol. Pain calmed down in about1-2 hours. Still aching when I got up at 9:10 a.m. Headache, pain in neck, shoulders, arms, hands, feet, toes, knees. Joints hurt as well as all muscles when touched.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pain, Pain in extremity, Tenderness
Clinical narrative: Pain everywhere overnight. Mild shivering. Pain to touch. Didn't get much sleep. Took tylenol. Pain calmed down in about1-2 hours. Still aching when I got up at 9:10 a.m. Headache, pain in neck, shoulders, arms, hands, feet, toes, knees. Joints hurt as well as all muscles when touched.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a full dose of Fluzone  0.5mg. Provider was notified immediately after injection given. Poison control was called as well as Agency. Both were notified that the patient was 2 months old and received a full dose of Flu. We kept the patient in office for 45 minutes after vaccine administered and patient had no reaction. Pt's mother was advised to watch for flu-like symptoms for the next 24-48 hours.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: currently patient has NOT suffered any reaction.  The above mentioned vaccine was given before time frame had lapsed for MMR (given on 12/30/19)
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: HIVES, UNSURE PARENTS RESPONSE, DID NOT TELL MD UNTIL 15 MONTH VISIT
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Breast mass, Decreased appetite, Injection site discolouration, Injection site pain
Clinical narrative: Fever (temperature 3 degrees above my normal temperature) Soreness and stiffness at site of injection and eventually extending to all muscles and joints Mild nausea, loss of appetite Discoloration (non-itchy rash?) from injection site extending up arm and down chest and across half of my left breast. (It looked like one of those magenta birth marks.) Swollen, tender, bluish lump in left armpit and lumpiness in left breast in left third of breast closest to injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Joint stiffness, Musculoskeletal stiffness, Nausea, Oedema peripheral
Clinical narrative: Fever (temperature 3 degrees above my normal temperature) Soreness and stiffness at site of injection and eventually extending to all muscles and joints Mild nausea, loss of appetite Discoloration (non-itchy rash?) from injection site extending up arm and down chest and across half of my left breast. (It looked like one of those magenta birth marks.) Swollen, tender, bluish lump in left armpit and lumpiness in left breast in left third of breast closest to injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin discolouration, Tenderness
Clinical narrative: Fever (temperature 3 degrees above my normal temperature) Soreness and stiffness at site of injection and eventually extending to all muscles and joints Mild nausea, loss of appetite Discoloration (non-itchy rash?) from injection site extending up arm and down chest and across half of my left breast. (It looked like one of those magenta birth marks.) Swollen, tender, bluish lump in left armpit and lumpiness in left breast in left third of breast closest to injection site.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray, Chills, Computerised tomogram head, Electrocardiogram, Headache
Clinical narrative: Received the first dose of the shingrix vaccine 2.5 months prior with no issues other than body aches and a sore arm. Evening after recieving the second dose of the shingrix vaccine (1/3/20),  pt presented with body aches, fever of >101, headache, chills, and vomitting. Took one dose of imitrex and threw it up. Went to ER that night at 4am (1/4/20)and there they took tests (see below)- CT of head, chest XRay, EKG twice to rule out all possible scenerios. They admitted pt to Hospital for severe migraine. Gave dose of Depakote, Benadryl, and Dilaudid to try to help with migraine pain. At hospital gave a migraine cocktail and IV fluids, which then ended up helping. Discharged on Sunday afternoon with a prescription for Topamax. Patient has had a history of severe headaches/migraines, gets headaches 2-3 times a week and had only been taking the OTC Excedrin-Migraine. Patient has also had a history of a severe migraine that had caused him to go to the ER in the past.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Migraine, Pain, Pyrexia, Vomiting
Clinical narrative: Received the first dose of the shingrix vaccine 2.5 months prior with no issues other than body aches and a sore arm. Evening after recieving the second dose of the shingrix vaccine (1/3/20),  pt presented with body aches, fever of >101, headache, chills, and vomitting. Took one dose of imitrex and threw it up. Went to ER that night at 4am (1/4/20)and there they took tests (see below)- CT of head, chest XRay, EKG twice to rule out all possible scenerios. They admitted pt to Hospital for severe migraine. Gave dose of Depakote, Benadryl, and Dilaudid to try to help with migraine pain. At hospital gave a migraine cocktail and IV fluids, which then ended up helping. Discharged on Sunday afternoon with a prescription for Topamax. Patient has had a history of severe headaches/migraines, gets headaches 2-3 times a week and had only been taking the OTC Excedrin-Migraine. Patient has also had a history of a severe migraine that had caused him to go to the ER in the past.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Nausea
Clinical narrative: Currently on dose 3 of 4. Taking in the morning before eating and waiting 90 min to eat or drink anything. Since first dose, near-constant nausea (without vomiting) and appetite loss. Intermittent abdominal cramping (2-3x daily, lasting 2-15 minutes) of varying severity (typically moderate, ie distracting but not entirely disabling), generally in the lower abdomen. Looser stool than usual, but no diarrhea.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: (Statement from Patient) "Injection was very painful and my arm was very painful and couldn't more the arm easily for the first week. The pain has continued going down the arm. Saw my doctor who prescribed naproxen and exercises but it has not improved.  Will follow up with my doctor."
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever started on the evening of the day of the shot and continued for the whole next day. It peaked at 102 degrees.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Tremor
Clinical narrative: Patient came to receive the first shingles vaccine. Patient also received a flu shot the same day as the shingles vaccine. Upon receiving the second vaccine patient reported that she felt ill with chills and shakes after receiving the first vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Tremor
Clinical narrative: Patient's wife describes that he has had chills with shakes and diarrhea
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Immediate post-injection reaction
Clinical narrative: Patient started to bruise immediately after administration of vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hyperhidrosis, Malaise, Pain, Sensitive skin
Clinical narrative: body aches, joint aches, skin sensitivity, sweating, malaise, possible fever but did not check temperature
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient states that she has difficulty lifting her arm and is in pain every since she received the Shingrix vaccintation on 10/16/2019.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: As per physician's documentation on 01/07/2020: "Got flu vaccine in November and still has 'bruise' around it on left thigh. Hyperpigmented/brown somewhat reticular pattern in an oval, does not blanch, about 5 cm x 4 cm in diameter. Painless. Not itchy or bothersome. Will ask RN to report as adverse reaction, but not dangerous, no treatment needed."
Age: 4.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Swelling, rash/redness that covered half of his upper arm and the inside of his arm near the armpit.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Muscle spasms, Paraesthesia, Tachycardia
Clinical narrative: Tachycardia,  arms and hands tingling, and flu-like symptoms. Wide spread muscle cramping (arches, hamstrings, chest)
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Injection site reaction. Pain. Hot to touch. Redness. Horseshoe shape rash continuing down arm, below injection site. Slight itch. Resolved in ~2 weeks. No doctor visit required.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Injection site reaction. Pain. Hot to touch. Redness. Horseshoe shape rash continuing down arm, below injection site. Slight itch. Resolved in ~2 weeks. No doctor visit required.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently given Pentacel vaccine at age 5 years 3 months. Patient suffered no side effects as of this reporting.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states that she felt fine after the vaccine was administered at ~6:10pm on 1/6/20.  She went home and states that symptoms began around 2:00am 1/7/20.  States that at this time she experienced arm pain and inflammation.  She said that basically the entire arm was hurting from shoulder to fingers.  States that swelling was present as well.  Patient also says that her temperature was 100 degrees Fahrenheit and that she was experiencing general weakness.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS 2 WEEKS EXPIRED WHEN GIVEN TO THE PATIENT.  MANUFACTURER RECOMMENDATION IS TO REVACCINATE
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Injection site erythema, Irritability, Pyrexia
Clinical narrative: Very tired, slept longer than normal. A little out of sorts. Big red spot around where injection occurred, about 1 or 2 inches by 3 or 4 inches. (not a wet). Very Slight fever.
Age: 80.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Back pain
Clinical narrative: She received the vaccines and moved to another chair at the pharmacy.  Within five minutes, she began complaining of lower back pain.  She didn't have any pain at the inject site nor any other adverse events.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: I spoke with patient on 1/6/2020 regarding getting his second shingrix shot.  Patient then explained that he has a rash on the side of the stomach since 10/29/19 shingrix shot.   It has not fully resolved.  Patient did not go see his physician.  I advised him to get it looked at to rule out if he got shingles and why he is getting a rash.  He only took benadryl to help with the itching.
Age: 22.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Injection site bruising
Clinical narrative: Pt called in with bruising appearing in right shoulder, pt was counseled on the ADR and response. pt stated no longer growing
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Vomiting
Clinical narrative: Vomiting, extreme dizziness lasting roughly the day of january 3rd
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: PATIENT STATES THAT HER ARM HURT FOR 3 WEEKS AFTER RECEIVING THE VACCINATION AND WHEN SHE SAW A DOCTOR, DOCTOR STATED SHE HAD FROZEN SHOULDER AND IS IN NEED OF THERAPY TREATMENT
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Crying, Eyelid ptosis, Food refusal, Gait disturbance, Influenza virus test negative
Clinical narrative: 1/6/2020 irritability, refusing to walk, crying, food refusal, disturbed sleep, insomnia, irritability  1/7/2020 lethargic, food refusal, refusing to walk, crying, dropping eyes, irritability fever from 98.9 F at 1:10pm to 102.2F at 1:46pm.  Treated with Motrin 5.5ml of 100mg/5ml at 845am Treated with Tylenol 5ml of 160mg/5ml at 2:10pm Pediatrician visit 1/7/2020 at 345pm fever was 100.4 Rapid Flu negative Negative for URI symptoms and negative for ear infections
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Insomnia, Irritability, Lethargy, Pyrexia, Sleep disorder
Clinical narrative: 1/6/2020 irritability, refusing to walk, crying, food refusal, disturbed sleep, insomnia, irritability  1/7/2020 lethargic, food refusal, refusing to walk, crying, dropping eyes, irritability fever from 98.9 F at 1:10pm to 102.2F at 1:46pm.  Treated with Motrin 5.5ml of 100mg/5ml at 845am Treated with Tylenol 5ml of 160mg/5ml at 2:10pm Pediatrician visit 1/7/2020 at 345pm fever was 100.4 Rapid Flu negative Negative for URI symptoms and negative for ear infections
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient developed pain and swelling at the injection site that radiate to her back and find it difficult to move left arm up and pain when turning or coughing.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pain, Tenderness
Clinical narrative: Patient had swelling & redness below injection site. Complained of pain when trying to raise arm. Area sensitive to touch. Patient given Keflex 500mg q 12hrs x 10 days for cellulitis. Outcome pending
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Pyrexia, Tenderness
Clinical narrative: Received vaccine on 27Dec2019. Lymph nodes swelling and pain, Low grade fever, tenderness in shot area and under my arm
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration
Clinical narrative: 1/6/20 Call from patient, she is now away for approx. 1 month received vaccine 1/3/20. States 6" area of redness and hardness, started Friday night patient states better now. She states today having trouble lifting left arm. Advised seek care today.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Headache, Pruritus, Rash
Clinical narrative: Mom state son c/o of RA itching. Redness & rash noted to right arm and c/o of headache 01/06/2020. Benadryl po given, anti-itch cream applied. Requested mom to apply ice pack to area.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Blood glucose increased, Blood lactic acid normal, Febrile convulsion, Influenza A virus test negative, Influenza B virus test
Clinical narrative: presented to ED the evening of 1/3/2020 with fever of 101.6. Diagnosed with a simple Febrile seizure
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Influenza virus test negative, Pyrexia
Clinical narrative: presented to ED the evening of 1/3/2020 with fever of 101.6. Diagnosed with a simple Febrile seizure
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: At around 10:00 P.M shakes & shivering and sore all over body. Spent next day in bed. Drank fluid all day. Took 2 days till he felt better. Felt like he had a fever.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Moments after injection (Thursday evening), complained of what felt like spasms at injection site. Next day (Friday)  achy arm  Saturday  arm was red, hot to the touch and very swollen from injection site to below elbow joint.  evening: Bactrim tablets  prescribed at pharmacy Sunday  redness started subsiding,  Monday swelling was down continuing  pain in upper left arm muscle, pain down to fingers
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Muscle spasms, Pain in extremity, Staphylococcal infection
Clinical narrative: Moments after injection (Thursday evening), complained of what felt like spasms at injection site. Next day (Friday)  achy arm  Saturday  arm was red, hot to the touch and very swollen from injection site to below elbow joint.  evening: Bactrim tablets  prescribed at pharmacy Sunday  redness started subsiding,  Monday swelling was down continuing  pain in upper left arm muscle, pain down to fingers
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Abdominal discomfort, Dyspnoea, Feeling hot, Hyperhidrosis, Influenza like illness
Clinical narrative: fells like flu; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an unknown flu shot a couple of years ago and the patient experienced flu-like symptoms. The reporter unable to obtain additional information. The reporter consented to follow up. This case had been linked to the case US2019AMR225782 and US2019225168 reported for same patient and by reporter. As per narrative it was unclear the patient received trivalent or quadrivalent flu vaccine, so we have captured the Influenza vaccine.
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Malaise, Migraine, Musculoskeletal pain, Palpitations, Tremor
Clinical narrative: fells like flu; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an unknown flu shot a couple of years ago and the patient experienced flu-like symptoms. The reporter unable to obtain additional information. The reporter consented to follow up. This case had been linked to the case US2019AMR225782 and US2019225168 reported for same patient and by reporter. As per narrative it was unclear the patient received trivalent or quadrivalent flu vaccine, so we have captured the Influenza vaccine.
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Vaccine positive rechallenge
Clinical narrative: fells like flu; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an unknown flu shot a couple of years ago and the patient experienced flu-like symptoms. The reporter unable to obtain additional information. The reporter consented to follow up. This case had been linked to the case US2019AMR225782 and US2019225168 reported for same patient and by reporter. As per narrative it was unclear the patient received trivalent or quadrivalent flu vaccine, so we have captured the Influenza vaccine.
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Cystitis, Feeling abnormal, Hyperhidrosis, Hyperventilation, Nausea
Clinical narrative: fells like flu; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an unknown flu shot a couple of years ago and the patient experienced flu-like symptoms. The reporter unable to obtain additional information. The reporter consented to follow up. This case had been linked to the case US2019AMR225782 and US2019225168 reported for same patient and by reporter. As per narrative it was unclear the patient received trivalent or quadrivalent flu vaccine, so we have captured the Influenza vaccine.
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Influenza like illness
Clinical narrative: fells like flu; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an unknown flu shot a couple of years ago and the patient experienced flu-like symptoms. The reporter unable to obtain additional information. The reporter consented to follow up. This case had been linked to the case US2019AMR225782 and US2019225168 reported for same patient and by reporter. As per narrative it was unclear the patient received trivalent or quadrivalent flu vaccine, so we have captured the Influenza vaccine.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Disorientation, Musculoskeletal stiffness, Seizure like phenomena, Syncope, Tremor
Clinical narrative: Patient received first Afluria 2019-2020 in right arm and was fine.  Then he received Gardasil also in right arm and appeared to have Syncope.  Started to lean over to his left.  I went immediately to patient to assess situation.  Patient then "planked", extending legs shaking his body in a seizure movement.  Patient was disoriented at this time.  Father and I  attempted to converse with patient but he would not respond appeared "out of it".  Then he started to "faint" again and repeated the same pattern of seizure-like movement.  I then asked father to help me lie him on the ground and I placed a jacket under his head to prevent head injury.  Paramedics were called since I was still unsure if patient was having seizures or syncope.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient received first Afluria 2019-2020 in right arm and was fine.  Then he received Gardasil also in right arm and appeared to have Syncope.  Started to lean over to his left.  I went immediately to patient to assess situation.  Patient then "planked", extending legs shaking his body in a seizure movement.  Patient was disoriented at this time.  Father and I  attempted to converse with patient but he would not respond appeared "out of it".  Then he started to "faint" again and repeated the same pattern of seizure-like movement.  I then asked father to help me lie him on the ground and I placed a jacket under his head to prevent head injury.  Paramedics were called since I was still unsure if patient was having seizures or syncope.
Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: severe pain in left arm at injection sight.  pain quite severe for 2 weeks and gradually became less as days passed.  today 1/8/2020, there ix still minor pain but almost gone.  I did not report this to the doctor.........i have had flu shots for the past 8 or 9 years.  this is the first adverse reaction.  i just assumed the person that gave me the injection hit a bone or something.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions.        On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX) vaccine, the pt was treated by a physician for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the pt had and would continue suffering ongoing injuries, including but not limited to mental and physical pain and had medical care and treatment for these injuries, significant medical and related expenses of these injuries, including but not limited to medical losses and cost which included care for hospitalization (on an unspecified date), physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue suffering such losses and damages in the future. The reporter considered the vaccination with zoster vaccine live (ZOSTAVAX) to be related to shingles.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Pain, Rash
Clinical narrative: Within six months of receiving the vaccine, the patient suffered a painful outbreak of shingles and rash in his forehead. Shortly thereafter, patient had multiple outbreaks of shingles including cellulitis of his right upper arm.; Within six months of receiving the vaccine, the patient suffered a painful outbreak of shingles and rash in his forehead. Shortly thereafter, patient had multiple outbreaks of shingles including cellulitis of his right upper arm.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history.   On 01-DEC-2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at an army clinic for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes zoster) (dose, administration route, anatomical location lot # and expiration date were not provided).  Within six months of receiving the vaccine (In June 2016), the patient suffered a painful outbreak of shingles and rash in his forehead. Shortly thereafter, patient had multiple outbreaks of shingles including cellulitis of his right upper arm. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered severe injuries, also reported as serious, progressive and incurable injuries. The reporter considered cellulitis and shingles to be related to Zoster Vaccine Live(ZOSTAVAX).    Upon internal review, the event of cellulitis was considered as medically significant event.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: patient was administered with an improperly stored dose of PEDVAX HIB; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 02-JAN-2020, the patient was vaccinated with a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength and route of administration were not reported) (lot # S007079 and expiration date: 24-JAN-2022) for prophylaxis (product storage error). The suspect vaccine underwent a temperature excursion of 8.64 degree Celsius for a duration of 30 minutes. The digital data logger was involved. There was no previous temperature excursion. The product quality complaint was not involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received a improperly stored dose of VAQTA; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 06-JAN-2020, the patient was vaccinated with an improperly stored dose (also reported as "1 injection") of hepatitis a vaccine, inactivated(VAQTA) lot # S020241 with expiration date 23-AUG-2020, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse effect was reported. It was stated that the vaccine was exposed to a temperature of -5.7 Celsius degrees for 16 minutes. No previous temperature excursion was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse symptoms; the patient was inadvertently administered one dose of MMR II and VARIVAX by intramuscular route, instead of the subcutaneous route; This spontaneous report was received from a pharmacist referring to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 02-JAN-2020 the patient was inadvertently administered one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) with lot # R022423 and expiration date 06-AUG-2020 and varicella virus vaccine live (oka/merck)(VARIVAX) with lot # R029517 and expiration date 14-OCT-2020 (strength, dose, route of administration and anatomical location were unknown) via intramuscular instead of subcutaneous route for prophylaxis (incorrect route of product administration). No additional adverse symptoms were reported. There was no product quality complaint associated with the case.
Sex: M
Vaccine: UNK
Symptoms: Adverse drug reaction, Influenza, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; mimicked the flu; Body pain; Adverse drug reaction; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Shingrix (had 1st dose, 1.5 to 2 years ago, refer case US2019231576). Concurrent medical conditions included epilepsy (had epilepsy) and aneurysm cerebral (had brain aneurysm).   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than 3 weeks after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant), flu symptoms, general body pain and adverse drug reaction. On an unknown date, the outcome of the vaccination failure, flu symptoms, general body pain and adverse drug reaction were unknown.   It was unknown if the reporter considered the vaccination failure, flu symptoms, general body pain and adverse drug reaction to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving flu vaccine, the patient had complete body aches which mimicked the flu.  After days, other symptoms started but he did not elaborate on what those symptoms were. Several days after vaccination, the patient had adverse events The reporter did not conset to follow up. This case was considered as a suspected vaccination failure case since details regarding complete immunization schedule for influenza and the lab test confirmation for influenza were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: intermittent headaches; tiredness; hard lump the size of an egg at the; the injection site is red; injection site is itchy; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (received 1st dose on an unknown date and experienced all the common side effects).   On 31st December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, tiredness, injection site lump, injection site erythema and injection site itching. On an unknown date, the outcome of the headache, tiredness, injection site lump, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the headache, tiredness, injection site lump, injection site erythema and injection site itching to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination had headaches, tiredness, a hard lump the size of an egg at the injection site, and the injection site was red and itchy but not blistered. The patient asked whether it is safe to be around 3 month old grandson who was born a few weeks early weighing just over 4 lbs, but was quite healthy. The patient asked how long expect the side effects to last or if necessary at all remain isolated from infants. This case has been linked to US2019AMR238653, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: experienced all the common side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced all the common side effects after vaccination. This case has been linked to US2019AMR238651, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: during injection, he experienced intense prolonged pain; This case was reported by a consumer via local affiliate and described the occurrence of injection site pain in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter experienced intense prolonged pain and the liquid was pooling under his skin causing the administrator to leave the needle in his arm for a prolonged period of time. The patient commented to the administrator that she was hurting him, and she replied that this was how the Shingrix vaccine worked. Eventually liquid dissipated into the body and the administrator removed the needle. No local or systemic reactions were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: arm and shoulder are still painful; Shoulder pain; Mobility decreased; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm, shoulder pain and mobility decreased. On an unknown date, the outcome of the pain in arm, shoulder pain and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain and mobility decreased to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be 83 or 84 years. The patient experienced arm and shoulder pain after vaccination. The patient cannot lift arm very far after vaccination. The patient asked whether the event occurred is normal.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2019 16:30, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, 23 hrs 30 min after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. At around 4:30 PM, the patient received a dose of Shingrix. On 23rd December 2019 at 4:00 PM, the patient experienced diarrhea. The reporter stated that her pharmacist told her not to be around any babies for about 2 weeks after the vaccine.   The discussed vaccine not being live and advised caller that her pharmacist could call for more information. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia
Clinical narrative: double vision; This case was reported by a consumer via call center representative and described the occurrence of double vision in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 2nd dose of Shingrix. On 14th November 2019, 14 days after receiving Shingrix, the patient experienced double vision. On an unknown date, the outcome of the double vision was recovering/resolving.   It was unknown if the reporter considered the double vision to be related to Shingrix.  Additional details were provided as follows: The patient had the second dose of Shingrix and experienced double vision and eyes are out of alignment. After closing the one eye she seen ok but both eyes open she seen double, one on top of each other.
Sex: U
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: pain and muscle stiffness in arm after Trumenba injection; pain and muscle stiffness in arm after Trumenba injection; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at the arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain and muscle stiffness in arm after Trumenba injection. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever, nausea, headache, dizziness, painful right arm
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Limb mass, Tenderness
Clinical narrative: Patient state after receiving the flu shot her arm formed a lump. The lump does not hurt, not unless she applies pressure.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ROSTER SAID HIGH DOSE INFLUENZA VACCINE. THIS RN CONFIRMED CLIENT WANTED HIGH DOSE INFLUENZA VACCINE. VACCINE WAS ADMINISTERED TO PATIENT. CLIENT TOLERATED WELL. THIS RN WAS NOTIFIED THAT CLIENT'S INSURANCE WOULD NOT COVER VACCINE INJECTION DUE TO CLIENT IS ONLY 61 AND HIGH DOSE IS FOR 65 YEARS AND OLDER CLIENTS. CLIENT HAS  NOT REPORTED ANY ADVERSE PHYSICAL EFFECTS FROM THE VACCINE INJECTION.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever of 100.8; Tired; Achy; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 2nd dose of Shingrix. On 3rd January 2020, 1 days after receiving Shingrix, the patient experienced fever, tiredness and pain. On an unknown date, the outcome of the fever, tiredness and pain were unknown.   It was unknown if the reporter considered the fever, tiredness and pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the afternoon of day before reporting. In the morning of the day of reporting, the patient had fever of 100.8 degree farenite, achy and tired. The patient asked, if it was ok to take Advil for Shingrix related fever.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache
Clinical narrative: Headache; Chills; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2019, the patient received the 1st dose of Shingrix. On 2nd January 2020, 3 days after receiving Shingrix, the patient experienced headache, chills and upset stomach. On an unknown date, the outcome of the headache, chills and upset stomach were unknown.   It was unknown if the reporter considered the headache, chills and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient experienced headache chills and an upset stomach in the night of 2nd January 2020. The patient asked, did it usually take this long to have a side effect.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Musculoskeletal discomfort
Clinical narrative: debilitating horrible back issues; This case was reported by a other health professional via call center representative and described the occurrence of back discomfort in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced back discomfort. On an unknown date, the outcome of the back discomfort was recovered/resolved.   It was unknown if the reporter considered the back discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The reporter stated that, the patient had debilitating horrible back issues within a couple days of 2nd dose of shingrix for 1 or 2 weeks. Till the time of reporting, the back issue recovered. The patient unsure if the back issue was related to Shingrix vaccine. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Mild rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows:  Three days post vaccination the patient developed a mild rash in a site different than the injection site. The reporter did not consent to follow up.