chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9, MMR, VARCEL, HPV9, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is 22 2/7 inadvertently received 0.5ml of MMR, Varicella and HPV vaccines.
Age: 17.0
Sex: F
Vaccine: HPV9, MMR, VARCEL, HPV9, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient is 22 2/7 inadvertently received 0.5ml of MMR, Varicella and HPV vaccines.
Age: 91.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Urinary retention
Clinical narrative: Patient presented to pharmacy the day following vaccination with chief complaint of not being able to urinate after receiving vaccinations.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient woke up with redness and swelling on the entire upper arm from elbow to shoulder. Treated with Hydrocortisone 1% Cream OTC and then received an Rx for Prednisone tablets. Pt reports swelling and itching had subsided, but still very red.
Age: 29.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No actual adverse event known at this time but patient was pregnant at the time that this vaccine was administered. Patients EDC is 8/28/19. This vaccine was not administered by our office but our provider (Dr.) requested that this form be completed. The vaccine was administered by Agency to the patient as one of their employees. Dr. is the medical director for that center.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Mom presented to clinic for EPSDT, Immunizations, and Nutritional Education appointment. EPSDT and Immunizations were done as per protocol and when entering the Immunizations into the registry it was found that the immunizations had already been given at Clinic on 12/26/2018.  Dr., medical director and, VAERS coordinator were contacted and the mother was attempted to contact numerous times with messages left to call back. Mother returned call on 1/7/2019 and was informed that vaccines were given too soon as per schedule. Mother reported there had been no adverse reactions with the infant since the immunizations, no redness, no swelling, and that the infant was doing fine.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site vesicles, Local reaction, Rash
Clinical narrative: The patient presents with rash. He is not having fever. Other comments include: was to get SYNAGIS today; however just today at sight of varicella imm: a 1.5 cm sts with many teeny vesicals on it appeared  imm was done 12.26.18 (within the 10 day window for a varicella imm reaction the more usual one with a few scattered vesicals with temp < 102/ lack of ++ discomfort) site in question is nontender. Outcome >>> for the local allergic reaction: observation and reporting only; defer SYNAGIS x 72 h
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Injection site warmth, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Approximately 3 hours after receiving the shot, my arm suddenly was in excruciating pain. On a scale of 1-10, I would put it at 9+. I could not lift my arm. Because of circumstances, it was an hour after the pain began that I went back to the Doctor's office. My shoulder was swollen and hot. He had never seen a reaction like this and neither had his nurse. It took 2 people to get my sweater off (over my head) so he could look at the arm. He gave me an injection of a high dose of a form of MOTRIN. Told me to take 1000mg of TYLENOL every 6 hours starting later that night.  TYLENOL did not touch the pain. Could not sleep. Could not eat with right arm. After a week, the pain level dropped to maybe 7. Arm was still useless. 5 Weeks after the injection, arm is still hurting. Pain level is still above pre-vaccination level of discomfort. Area of pain expanded much wider that pre-vacination area. Have visited my orthopedic doctor to discuss my options. Arm hurts all the time. Impacts my sleep. Impacts my ability to perform normal daily functions (getting dressed, bathing). I am definitely the worse for having taken that shot.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Approximately 3 hours after receiving the shot, my arm suddenly was in excruciating pain. On a scale of 1-10, I would put it at 9+. I could not lift my arm. Because of circumstances, it was an hour after the pain began that I went back to the Doctor's office. My shoulder was swollen and hot. He had never seen a reaction like this and neither had his nurse. It took 2 people to get my sweater off (over my head) so he could look at the arm. He gave me an injection of a high dose of a form of MOTRIN. Told me to take 1000mg of TYLENOL every 6 hours starting later that night.  TYLENOL did not touch the pain. Could not sleep. Could not eat with right arm. After a week, the pain level dropped to maybe 7. Arm was still useless. 5 Weeks after the injection, arm is still hurting. Pain level is still above pre-vaccination level of discomfort. Area of pain expanded much wider that pre-vacination area. Have visited my orthopedic doctor to discuss my options. Arm hurts all the time. Impacts my sleep. Impacts my ability to perform normal daily functions (getting dressed, bathing). I am definitely the worse for having taken that shot.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 02-JAN-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. In January 2017, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In February 2017, the patient was treated by a physician at a family medicine 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 not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 02-JAN-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. In 2016, a physician at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2017, the patient was treated by a physician at a physician's office 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 not recovered. The causality of the events is related. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Concussion, Dizziness, Fall, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 72-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX and PNEUMOVAX. In September 2018, immediately after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), syncope vasovagal (serious criteria GSK medically significant) and dizziness. On an unknown date, the patient experienced fall and concussion. On an unknown date, the outcome of the passed out, syncope vasovagal and dizziness were recovered/resolved and the outcome of the fall was not recovered/not resolved and the outcome of the concussion was recovering/resolving. It was unknown if the reporter considered the passed out, syncope vasovagal, fall, concussion and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm and PNEUMOVAX in the right arm. Shortly after receiving the vaccines, she felt dizzy and had to sit down for a little while. When she tried to walk to her car, she passed out and had to go to the emergency room. The patient was not admitted to the hospital and states that she was told she had a vasovagal syncope reaction. Approximately 1 month after receiving the vaccine, she fell and got a concussion. The patient was still recovering from the concussion. It was unknown if the reporter considered the passed out, syncope vasovagal, fall, concussion and dizziness to be related to PNEUMOVAX as well. The patient would like to get the next shot at her doctor's office so she could lie down. She has never had vaccine available. She was halfway through the 6 month time period. She asked what could you do to make the vaccine available to me at her office. Consent to follow up was provided.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 72-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX and PNEUMOVAX. In September 2018, immediately after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), syncope vasovagal (serious criteria GSK medically significant) and dizziness. On an unknown date, the patient experienced fall and concussion. On an unknown date, the outcome of the passed out, syncope vasovagal and dizziness were recovered/resolved and the outcome of the fall was not recovered/not resolved and the outcome of the concussion was recovering/resolving. It was unknown if the reporter considered the passed out, syncope vasovagal, fall, concussion and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm and PNEUMOVAX in the right arm. Shortly after receiving the vaccines, she felt dizzy and had to sit down for a little while. When she tried to walk to her car, she passed out and had to go to the emergency room. The patient was not admitted to the hospital and states that she was told she had a vasovagal syncope reaction. Approximately 1 month after receiving the vaccine, she fell and got a concussion. The patient was still recovering from the concussion. It was unknown if the reporter considered the passed out, syncope vasovagal, fall, concussion and dizziness to be related to PNEUMOVAX as well. The patient would like to get the next shot at her doctor's office so she could lie down. She has never had vaccine available. She was halfway through the 6 month time period. She asked what could you do to make the vaccine available to me at her office. Consent to follow up was provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Injection site pain, Injection site rash, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 76-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included polymyalgia rheumatica (had about 8 years ago before the date of reporting, it lasted about a year). In August 2018, the patient received SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), stiffness, shoulder pain, injection site pain, injection site rash and pain in hip. On an unknown date, the outcome of the polymyalgia rheumatica and stiffness were not recovered/not resolved and the outcome of the shoulder pain and pain in hip were unknown and the outcome of the injection site pain and injection site rash were recovered/resolved. It was unknown if the reporter considered the polymyalgia rheumatica, stiffness, shoulder pain, injection site pain, injection site rash and pain in hip to be related to SHINGRIX. Additional details were provided as follows: On 30th or 31st August, the patient received the SHINGRIX vaccine. Since patient had the vaccine, she has experienced a relapse of polymyalgia rheumatica. The patient has been experiencing stiffness and pain in  her shoulders and hip joint. The patient started having the symptoms about a week or 2 weeks since getting the vaccine. Less than a week after receiving SHINGRIX, the patient did not notice that immediately because she also experienced a sore arm and a large rash at the injection site. The rash was about 4 inches long by 2 to 3 inches wide on her arm at the site of injection. It took a while for that to go away. The patient reported this to her rheumatologist and he reported that to the the Center for disease control and prevention (CDC). The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Polymyalgia rheumatica
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 76-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included polymyalgia rheumatica (had about 8 years ago before the date of reporting, it lasted about a year). In August 2018, the patient received SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), stiffness, shoulder pain, injection site pain, injection site rash and pain in hip. On an unknown date, the outcome of the polymyalgia rheumatica and stiffness were not recovered/not resolved and the outcome of the shoulder pain and pain in hip were unknown and the outcome of the injection site pain and injection site rash were recovered/resolved. It was unknown if the reporter considered the polymyalgia rheumatica, stiffness, shoulder pain, injection site pain, injection site rash and pain in hip to be related to SHINGRIX. Additional details were provided as follows: On 30th or 31st August, the patient received the SHINGRIX vaccine. Since patient had the vaccine, she has experienced a relapse of polymyalgia rheumatica. The patient has been experiencing stiffness and pain in  her shoulders and hip joint. The patient started having the symptoms about a week or 2 weeks since getting the vaccine. Less than a week after receiving SHINGRIX, the patient did not notice that immediately because she also experienced a sore arm and a large rash at the injection site. The rash was about 4 inches long by 2 to 3 inches wide on her arm at the site of injection. It took a while for that to go away. The patient reported this to her rheumatologist and he reported that to the the Center for disease control and prevention (CDC). The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a reaction with the first dose of the vaccine and was told that she could not get the second dose. The reporter did not provide the healthcare provider's information. She did not go into detail of what the reaction was, just stated she had a reaction to the first dose. The reporter did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Severe shivering and chills that came on very suddenly. I was lucky I was at home and I am in good physical condition. I was able to get into my pajamas and get into bed. As soon as I got warm (in about 10-15 minutes), I was fine. If I was in a less fit condition or was driving at the time, I have no idea what kind of outcome there would have been. I think everyone should be advised to go straight home after this shot and if disabled in any way, should have someone stay with them for 24 hours.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received vaccine to soon, should have returned on 11/15/2018.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Pyrexia, Rash generalised
Clinical narrative: Fever of 102 degrees for 1 day, rash all over body for 3 days, and bulging anterior fontanel for 1 day.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness around the area and swelling of the arm.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Red palm-sized mark on arm, hot to touch.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Aphasia, Attention deficit/hyperactivity disorder, Autism spectrum disorder, Decreased eye contact, Stereotypy
Clinical narrative: He stopped talking, avoided eye contact and started rocking. We didn't realize that it meant anything until he was 4 and we got him tested for ADHD. We were told that he couldn't be diagnosed until the age of 5. We just got him tested and diagnosed with ADHD and Autism 3 months ago. We are working to get started with therapy and getting an IEP for him in school.
Age: 39.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Patient complained of having repeated episodes of dizziness and bilateral weakness in arms.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Influenza like illness, Injection site pain, Pain
Clinical narrative: Patient said 2 days after receiving vaccine her arm was still sore at site of injection and she also began to have flu like symptoms. She returned to the pharmacy to see if arm soreness/flu symptoms were normal after the vaccine. She was recommended over the counter cold medicine.  Patient reports as of 1/7/19 her arm is still sore and hurts when she moves it. There is no redness, swelling, or warmth at injection site but sometimes she feels her arm pulsating at injection site.  she went to urgent care and was told to apply warm compresses and monitor for any change.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Urticaria, Vomiting
Clinical narrative: PARENT REPORTED VOMITING A FEW DAYS AFTER VACCINES WERE GIVEN. ALSO HIVES APPEARING ON FRONT AND BACK OF TORSO AFTER VACCINES WERE GIVEN.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Pain and swelling with redness at injection site. Headache, muscle ache, fatigue. All symptoms lasted 3 days, except pain and swollen lump at injection site which lasted 5 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Pain and swelling with redness at injection site. Headache, muscle ache, fatigue. All symptoms lasted 3 days, except pain and swollen lump at injection site which lasted 5 days.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt's arm became swollen and they said it is the size of a baseball. Red and hot to the touch and itches.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Urticaria
Clinical narrative: Patient showed technician and pharmacist pictures of whole body rash (hives).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blister rupture, Condition aggravated, Herpes simplex, Rash erythematous
Clinical narrative: Have had HSV2 for 10 years with minimal and minor outbreaks. This was the worst one ever. Had three blisters which merged, broke and scabbed on right buttocks. Immediately took Valtrex. Also had several red bumps appear on 12/8. After 4 weeks there is still a light red scar where the blisters were. Never had blisters before & a scar that is taking forever to go away. I was not under any emotional stress, but am positive that it stressed my system and gave me an outbreak. I have never had a reaction to a vaccine before including the old shingles vaccine 5 years ago. I would suggest that those with HSV2 should be warned to take Valtrex before getting the SHINGRIX shot.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Scar
Clinical narrative: Have had HSV2 for 10 years with minimal and minor outbreaks. This was the worst one ever. Had three blisters which merged, broke and scabbed on right buttocks. Immediately took Valtrex. Also had several red bumps appear on 12/8. After 4 weeks there is still a light red scar where the blisters were. Never had blisters before & a scar that is taking forever to go away. I was not under any emotional stress, but am positive that it stressed my system and gave me an outbreak. I have never had a reaction to a vaccine before including the old shingles vaccine 5 years ago. I would suggest that those with HSV2 should be warned to take Valtrex before getting the SHINGRIX shot.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Lethargy, Malaise, Mobility decreased, Nocturia
Clinical narrative: Patient complains of arm swelling that begin when she got home from the pharmacy to the point she wasn't able to use her arm, flushing, tremors and malaise/lethargy (malaise lasted 2 days). She also complains of nocturnal diuresis - specifically, the night after she got this vaccine, she had to get up in the night to urinate every hour.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Polyuria, Tremor
Clinical narrative: Patient complains of arm swelling that begin when she got home from the pharmacy to the point she wasn't able to use her arm, flushing, tremors and malaise/lethargy (malaise lasted 2 days). She also complains of nocturnal diuresis - specifically, the night after she got this vaccine, she had to get up in the night to urinate every hour.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Patient broke out in hives after receiving SHINGRIX. She said on 1/6/19 she began breaking out, and went to the ER today 1/7/19. The emergency room doctor told her he feels she had an allergic reaction to the vaccine. The patient stated she also broke out in hives after the first dose of SHINGRIX, but had just started another inhalant and her doctor felt it was the other medicine, not the SHINGRIX. After receiving the second dose of SHINGRIX, she once again broke out in hives and the ER doctor told her he feels it is an allergic reaction to the SHINGRIX. She was given ZANTAC (which she already is taking) and a prescription for prednisone. I spoke with her this evening again and she says she is feeling better after starting the prednisone.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Myalgia, Vomiting
Clinical narrative: Woke up about 4 AM on 12/24/18 from very sore, painful muscles in my back (don't have back problems). Took an ALEVE but then about 5 minutes later started vomiting for about 10 minutes. Was able to go back to sleep within a half hour. Thought I had contracted the flu but this was the only event. Then I read all the side effects of the vaccination which prompted this report.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Erythema, Headache, Hyperhidrosis, Mass
Clinical narrative: Large red welt/hive 4"x3" itching,lump,painful,hot to touch,headaches,chills,sweats,itching.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pruritus, Skin warm, Urticaria
Clinical narrative: Large red welt/hive 4"x3" itching,lump,painful,hot to touch,headaches,chills,sweats,itching.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Amnesia, Aphasia, Encephalitis
Clinical narrative: Loss of speech and memory. Encephalitis, emergency room visit and inpatient stay, full recovery.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states, "I felt very bad. Like I didn't have any energy." Patient reports fever the early morning of 1/4/2019, followed by soreness, redness and swelling of right arm. Symptoms continued into 1/5/2019 and began to resolve by 1/6/2019. Patient was instructed by pharmacist to take OTC MOTRIN for pain/swelling of right arm. Currently (1/7/2019), pt feels better with no fever and minimal soreness, redness and swelling.
Age: 16.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Sixteen year old female present to clinic for well child and was to received MENACTRA (MCF4) and Meningitis B (BEXSERO) vaccine. Pt was inadvertently administered MMR, Varicella and Hepatitis A vaccine. Pt did not develop any symptoms of reaction to vaccines. Spoke with mother on 1/5/2019 (4:28) and she reported that Patient was fine with no fever, rash or symptoms.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site reaction, Mobility decreased, Neuralgia
Clinical narrative: Nerve pain to Lt. upper arm (elbow to shoulder) and continuous pain. Could not raise/lift arm. Pain was like having shingles, as I had shingles 4/15 in back.
Age: 53.0
Sex: F
Vaccine: PNC13, VARCEL, VARZOS
Symptoms: Erythema
Clinical narrative: Pt received SHINGRIX Vaccine manufactured by GlaxoSmithKline, the next day she noticed a baseball sized area of redness on that arm, not hot or tender, no other symptoms.
Age: 24.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient received flu vaccine first. Then I gave her the BOOSTRIX vaccine. After pulling out needle. She immediately fainted in chair. She came to w/in approximately 5-7 seconds and had no further incidents.
Age: 2.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Acne
Clinical narrative: Small pimple, no fever, no pain.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Dizziness, Fall, Pain, Pain in extremity
Clinical narrative: Patient received SHINGRIX then worked for 4 hours without incident. On her ride home her legs became extremely painful. She has experience this before with her spinal stenosis but described the pain as more severe. She took a tramadol for the pain. The next morning she awakened at 4am and upon rising, she felt very dizzy and fainted. She fell to the floor and was discovered by her husband. She reports being sore and experiencing some bruising on her finger.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Patient received SHINGRIX then worked for 4 hours without incident. On her ride home her legs became extremely painful. She has experience this before with her spinal stenosis but described the pain as more severe. She took a tramadol for the pain. The next morning she awakened at 4am and upon rising, she felt very dizzy and fainted. She fell to the floor and was discovered by her husband. She reports being sore and experiencing some bruising on her finger.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Partial syncope.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Allergy to vaccine, Communication disorder, Irritability, Pyrexia, Rash
Clinical narrative: Fever 4-5 days after MMR injection. Rashes 10-15 days after MMR injection. Fussiness, loss of communication x15 days with resolvement.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood pressure increased, Pruritus, Rash
Clinical narrative: Pt. received VZV vaccine #1 on 12/17/18 - offered no complaints and stated he felt fine. On 12/31/18 pt noticed a rash starting under (R) arm, additional spots on (L) groin, back of neck, top of (R) foot, (R) abdominal area and (L) arm near antecubital area. No C/O fever 98.4 and 98.5, B/P increased slightly, C/O itching.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Within 24 hrs, (R) upper arm became itchy and within 36 hrs redness, firmness (induration?), swelling. No neuropathy. No fever. Red and firmness 13x14 cm. (R) upper arm circumference 34.5 cm; (L) upper arm circumference 31 cm. Full range of motion.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Parents described, at a subsequent visit, a prolonged rough quarter-sized round pink patch over the site x several weeks w/out other assoc. symptoms-to-date. Then self0resolved.
Age: 49.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Culture, Erythema, Incisional drainage, Pain in extremity, Peripheral swelling
Clinical narrative: Patient is a 49-year-old female who is seen in consultation for Dr. for evaluation of bilateral arm lesions. Patient states she had hep A vaccine injections in her right upper extremity and flu vaccine injection in her left upper extremity on 10/3/18. Patient states she began to notice some erythema and swelling in the right upper extremity after getting the injection in October. States she began to notice some erythema and swelling of the left upper extremity in December. Rates pain in both arms 1/10. States that the lesions were area tender, but that the tenderness has since improved. States that the lesion on her right upper extremity was drained with a needle, and has drained 2-3 other times. Patient states that the lesion on her left arm has drained as well. Denies fever, sweats, chills. States that she was taking an antibiotic and a steroid for a rash elsewhere on her body, which seem to decrease the size of the lesions on her bilateral upper extremities. I&D Rt. arm. Wet-to-dry dressing BID. Cultures obtained.
Age: 49.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Skin lesion, Tenderness
Clinical narrative: Patient is a 49-year-old female who is seen in consultation for Dr. for evaluation of bilateral arm lesions. Patient states she had hep A vaccine injections in her right upper extremity and flu vaccine injection in her left upper extremity on 10/3/18. Patient states she began to notice some erythema and swelling in the right upper extremity after getting the injection in October. States she began to notice some erythema and swelling of the left upper extremity in December. Rates pain in both arms 1/10. States that the lesions were area tender, but that the tenderness has since improved. States that the lesion on her right upper extremity was drained with a needle, and has drained 2-3 other times. Patient states that the lesion on her left arm has drained as well. Denies fever, sweats, chills. States that she was taking an antibiotic and a steroid for a rash elsewhere on her body, which seem to decrease the size of the lesions on her bilateral upper extremities. I&D Rt. arm. Wet-to-dry dressing BID. Cultures obtained.
Age: 44.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Fatigue, Incisional drainage, Injection site swelling, Mycobacterium test positive, Secretion discharge
Clinical narrative: Patient is a 44-year-old male who presents for evaluation of bilateral arm lesions. Patient had injections of vaccines performed on 10/3/18, but unsure of what these vaccinations were. Patient states a couple days after being check shins he noticed swelling of the proximal right and left arm where injection was given. Two weeks ago he noticed another area of swelling in the right arm, distally to the prior area of swelling. Patient reports that the lesion on the left arm drained 3-4 times. Patient states he has been on 2 antibiotics, but is unsure what these are. Patient denies fever, sweats, chills. Does report feeling more tired than usual. I&D of bilateral lesions. Wet-to-dry dressing BID. Cultures obtained.
Age: 44.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Skin lesion
Clinical narrative: Patient is a 44-year-old male who presents for evaluation of bilateral arm lesions. Patient had injections of vaccines performed on 10/3/18, but unsure of what these vaccinations were. Patient states a couple days after being check shins he noticed swelling of the proximal right and left arm where injection was given. Two weeks ago he noticed another area of swelling in the right arm, distally to the prior area of swelling. Patient reports that the lesion on the left arm drained 3-4 times. Patient states he has been on 2 antibiotics, but is unsure what these are. Patient denies fever, sweats, chills. Does report feeling more tired than usual. I&D of bilateral lesions. Wet-to-dry dressing BID. Cultures obtained.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Dyskinesia, Electroencephalogram normal, Gaze palsy, Metabolic function test normal, Neurological examination normal
Clinical narrative: 11/30: Pt. developed repetitive right side head jerk and extension of right arm. Left arm would occasionally extend upward. Episodes increased in frequency on 12/01 prompting ED visit and hospital admission for overnight EEG. No seizure activity noted. Pt. was seen by Ophthamology and no increased ICP was noted. She followed up with Neurology on 12/14/18 and had a normal exam.  Episodes had almost completely resolved. Differential diagnosis by Neurology: paroxysmal torticollis vs benign tonic upgaze without ocular involvement.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Ophthalmological examination normal, Stereotypy, Torticollis
Clinical narrative: 11/30: Pt. developed repetitive right side head jerk and extension of right arm. Left arm would occasionally extend upward. Episodes increased in frequency on 12/01 prompting ED visit and hospital admission for overnight EEG. No seizure activity noted. Pt. was seen by Ophthamology and no increased ICP was noted. She followed up with Neurology on 12/14/18 and had a normal exam.  Episodes had almost completely resolved. Differential diagnosis by Neurology: paroxysmal torticollis vs benign tonic upgaze without ocular involvement.
Age: 0.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Diet refusal, Fatigue, Gastrointestinal tube insertion, Infantile spitting up, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Our daughter received her first HepB immunization 8-18-18. Shortly after, she was extremely tired, nursed infrequently and threw up bright yellow fluid every time she ate. We were in the hospital for the night due to the lack of appetite and amount of vomit. Our daughter nursed within 5 minutes after birth and was great at home in 8-17-18. We are certain her poor appetite and vomiting was directly linked to this unnecessary HepB shot pushed by doctors to profit from the pharmaceutical industry.
Age: 0.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Decreased appetite, Fatigue, Vomiting
Clinical narrative: Our daughter received her first HepB immunization 8-18-18. Shortly after, she was extremely tired, nursed infrequently and threw up bright yellow fluid every time she ate. We were in the hospital for the night due to the lack of appetite and amount of vomit. Our daughter nursed within 5 minutes after birth and was great at home in 8-17-18. We are certain her poor appetite and vomiting was directly linked to this unnecessary HepB shot pushed by doctors to profit from the pharmaceutical industry.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Eczema, Food allergy, Rash
Clinical narrative: Child developed rash across stomach which was diagnosed as eczema. Child developed an allergic reaction to eggs.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity
Clinical narrative: Headache with a red and sore arm for 5 to 7 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: Intense chills/coldness/ inability to warm up ? temp outside is 46 degrees. Wearing three layers and four blankets and unable to get warm. This has never happened to me before. NO rigors or shaking chills ? just extremely cold.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, HEPA, HPV9, MENB, MNQ
Symptoms: Dyspnoea, Swelling face
Clinical narrative: 4 Hours after vaccines, face began to swell and had difficulty breathing. Parents took client to the ER and he was given a steroid and benadryl and sent home. Continued the benadryl for 3 days and according to parents, swelling down and client no longer having issues with breathing.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 21 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 09-NOV-2018, the patient was vaccinated with the first dose of RECOMBIVAX HB on the right deltoid(lot# reported as U5980DA, dose detail and expiration date were not reported) intramuscularly for prophylaxis. On 10-DEC-2018, the patient was vaccinated with the second dose of RECOMBIVAX HB (therapy type: thimerosal free) 10 microgram /1 milliliter (lot #: M037019, expiration date: 04-NOV-2018, 1 milliliter, once) intramuscularly on the left deltoid  for prophylaxis (expired product administered). No adverse event was reported. The data from Manufacture indicated vaccines was still potent, so the physician decided to not repeat vaccination and order patient to return in one month for final vaccination.
Sex: F
Vaccine: PPV
Symptoms: Decreased immune responsiveness
Clinical narrative: Information has been received from a healthcare business professional via a company representative referring to a 63 year old female patient. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route, lot # and expiration date unknown) for prophylaxis. On an unspecified date after receiving PNEUMOVAX 23, the patient was seen by unspecified immunologist on unspecified date after receiving PNEUMOVAX 23. The patient was "diagnosed with low immune response" on unspecified date. The outcome for low immune response was not provided. The causality between low immune response and PNEUMOVAX 23 was unknown.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Gait disturbance, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a female patient of an unknown age concerning herself. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in 2008, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml (route, anatomical location, lot# and expiry date were not reported) for prophylaxis. On an unspecified date in November 2018, the patient was vaccinated with booster shot of PNEUMOVAX 23, 0.5 ml (route, anatomical location, lot# and expiry date were not reported) for prophylaxis. On an unspecified date in 2018 (reported as the day after the vaccination), the patient's arm hurt at the injection site (Vaccination site pain) and 2 days following the vaccination all of her joints hurt (arthralgia). About a week later, the patient experienced swelling of her legs and her legs (peripheral swelling) hurt so much (pain in extremity) that she could barely walk. She could only take baby steps (gait disturbance). The patient stated that swelling gotten better and she could take slightly bigger steps. The outcome of events was reported as recovering/resolving. No causality assessment with respect to suspect product was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In July 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose of permanent prevention and protection against shingles and zoster related conditions. On or about 04-AUG-2014, the patient was treated by a healthcare provider 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 vaccine, 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 considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In August 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. In September 2013, the patient was treated by a healthcare provider 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 vaccine, 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 considered to be not recovered. Additional information has been requested. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) 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 12-DEC-2009, a healthcare provider at a physician's office administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2011, the patient was treated by a physician/MD at a physician's surgical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.