chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: Genital herpes once or twice a year during stressful time / gotten the vaccine she has had 1 to 2 episodes a month; Bruising, raised area and soreness at the sight right away; Raised area and soreness at the sight right away; discoloation; soreness; fatigue; headache; Shot was given on the backside of her left arm in the fatty part below her shoulder; she was taking just 1 a day,   but then was told by her doctor to take valacyclovir twice a da; the herpes rersolved but then returns; This case was reported by a consumer via call center representative and described the occurrence of genital herpes in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included valaciclovir hydrochloride (Valacyclovir) tablet for genital herpes.  The patient's past medical history included genital herpes (once or twice a year during stressful time).   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Valacyclovir 1 g once daily (1 g daily). On an unknown date, the dose was changed to 1 g twice daily (2 g daily). On an unknown date, less than 6 months after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced genital herpes, contusion, swelling, skin discoloration, pain, fatigue, headache, vaccine administered at inappropriate site, underdose and lack of drug effect. The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the genital herpes, contusion, swelling, skin discoloration, pain, fatigue, headache, vaccine administered at inappropriate site, underdose and lack of drug effect were unknown.   It was unknown if the reporter considered the genital herpes, contusion, swelling, skin discoloration, pain, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the pharmacist did not seem to be aware of where to give the shot, so it was given on the backside of her left arm in the fatty part below her shoulder, which led to inappropriate site of vaccine administration. She stated that she was told this could help with her genital herpes, which she stated was once or twice a year during stressful time. She noted she had gotten the vaccine she has had 1 to 2 episodes a month. She was being treated with Valacylovir (manufacturer unknown). She reported that she was taking just 1 a day, but then was told by her doctor to take valacyclovir twice a day, which led to underdose.  She stated that the herpes resolves, but then returns, which led to lack of drug effect. The prescribing information was reviewed for indications and dosage and administration and common adverse events seen.  She was referred to her doctor. The doctor noted she had bruising, raised area and soreness at the sight right away. She noted she also had fatigue and headache after the vaccine.   Follow up information received from physician on 23rd April 2020: The patient was under care and no longer with the practice. Called to reviewer and officer but unable to add patient discovery.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness and warmth at the injection site; redness and warmth at the injection site; her arm felt sore at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 7L27G, expiry date 27th February 2022) for prophylaxis.  On 16th March 2020, the patient received Shingrix (intramuscular). On 16th March 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 17th March 2020, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in right deltoid. In evening, the patient's arm felt sore at the injection site.  One day after receiving Shingrix, the patient had redness and warmth at the injection site.  The redness was 3x5 inches.   Follow up information received other health professional on 23rd April 2020: The patient demographics details were updated. Previously administered products included LISINOPRIL COMP received on 24th December 2019.  Concurrent drug included naproxen and tizanidine received on 23th March 2020. The outcome of the injection site erythema, injection site warmth and injection site pain were recovered. The reporter considered the injection site erythema, injection site warmth and injection site pain to be related to Shingrix. The VAERS details were updated.
Sex: F
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: May have been given her second dose of Trumenba in the wrong location; Area of redness is well below the deltoid muscle, in the bicep area; This is a spontaneous report from a contactable physician reporting for her daughter via a Pfizer sales representative. A female patient of an unspecified age received the 2nd dose of meningococcal group b rlp2086 (TRUMENBA), intramuscular possibly in the bicep area, in Apr2020, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. Previously the patient receive the 1st dose of Trumenba for immunization in Jun2019. In Apr2020, the patient may have been given her second dose of Trumenba in the wrong location. The area of redness was well below the deltoid muscle, in the bicep area.    No follow-up attempts are needed. No further information is expected.
Age: 6.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt received the polio vaccine and the Hep A vaccine in her R. deltoid on 04/29/2020 per IR. The parent pointed out that the pt's R. upper arm/deltoid is red when the pt came back to have her PPD skin test read. There is a red area that measures 65 mm long and 75 mm wide that is warm to touch which, per the pt's parent,  appeared after receiving the vaccines. The parent stated that there has been no other symptoms. The parent was encouraged to seek care from a provider for an assessment of this red and warm area on the pt's arm. She was also encouraged to consult with a provider before getting those vaccines again. Parent was informed about which vaccines were given in the R. deltoid on 04/29/2020.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Bacterial test, Incisional drainage, Injection site abscess, Injection site cellulitis, Injection site dryness
Clinical narrative: Patient is a now 6 month old male who was seen at the Pediatric Clinic at Family Health Center on February 25, 2020 for his 4 month old well visit during which time he received immunizations. Per documentation, he received his oral Rotavirus immunization along with intramuscular administration of Pediarix (DTap-Hep B-IPV) in the left thigh, PedVaxHib in left thigh, and Prevnar in right thigh.  On April 17, 2020, a virtual appointment was scheduled for the patient due to COVID-19 pandemic restrictions. During that visit, the mother of patient reported that he was having left thigh redness and swelling. She reported that after his immunizations on February 25, patient did have swelling in both thighs at the sites of the injections. Mother of patient reported that although the right thigh swelling resolved, the left thigh remained slightly red. She noticed that the left thigh progressively became more red and indurated/hard then began to have some dryness of the skin.   Within the week of April 17th leading up to patient's appointment, mom reported that the same area on Patient's left thigh started to become purple/red with what looked like an overlying scab.  She also stated that there appeared to be some pus underneath the skin in the center of the hardened area, almost like a boil or abscess. The swollen area is between pea and marble sized. Not painful to touch.  There was no associated fever reported in relation to this event.   The provider that conducted the April 17th visit, advised mother of patient that the patient needed to be seen by a physician for further evaluation and management of likely abscess and cellulitis of left thigh. Due to the current COVID-19 restrictions during that time and mother's location from clinic, it was advised for her to take the child to urgent care for in-person evaluation.  Patient was seen at Urgent care on April 27, 2020 and diagnosed with an abscess of the left thigh. It was incised and drained with a sample of the drainage sent for bacterial culture. Patient was started on a 2 week course of Amoxicillin. A follow up Telephone Consult was conducted on April 21, 2020 and documentation shows improvement of lesion and symptoms.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pustule, Injection site scab, Injection site swelling
Clinical narrative: Patient is a now 6 month old male who was seen at the Pediatric Clinic at Family Health Center on February 25, 2020 for his 4 month old well visit during which time he received immunizations. Per documentation, he received his oral Rotavirus immunization along with intramuscular administration of Pediarix (DTap-Hep B-IPV) in the left thigh, PedVaxHib in left thigh, and Prevnar in right thigh.  On April 17, 2020, a virtual appointment was scheduled for the patient due to COVID-19 pandemic restrictions. During that visit, the mother of patient reported that he was having left thigh redness and swelling. She reported that after his immunizations on February 25, patient did have swelling in both thighs at the sites of the injections. Mother of patient reported that although the right thigh swelling resolved, the left thigh remained slightly red. She noticed that the left thigh progressively became more red and indurated/hard then began to have some dryness of the skin.   Within the week of April 17th leading up to patient's appointment, mom reported that the same area on Patient's left thigh started to become purple/red with what looked like an overlying scab.  She also stated that there appeared to be some pus underneath the skin in the center of the hardened area, almost like a boil or abscess. The swollen area is between pea and marble sized. Not painful to touch.  There was no associated fever reported in relation to this event.   The provider that conducted the April 17th visit, advised mother of patient that the patient needed to be seen by a physician for further evaluation and management of likely abscess and cellulitis of left thigh. Due to the current COVID-19 restrictions during that time and mother's location from clinic, it was advised for her to take the child to urgent care for in-person evaluation.  Patient was seen at Urgent care on April 27, 2020 and diagnosed with an abscess of the left thigh. It was incised and drained with a sample of the drainage sent for bacterial culture. Patient was started on a 2 week course of Amoxicillin. A follow up Telephone Consult was conducted on April 21, 2020 and documentation shows improvement of lesion and symptoms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Scab, Skin exfoliation, Tenderness
Clinical narrative: PATIENT STATES THEY WERE HAVING AN ADVERSE REACTION IMMEDIATELY AFTER THE VACCINE WAS GIVEN. SHE STATES IT WELTED UP AND WAS VERY SORE AND TENDER TO THE TOUCH. SHE STATED IT FORMED  SCAB AT THE AREA AND STARTED TO PEEL. SHE ASSUMED IT WOULD GO AWAY. NOW, THE WELT HAS GOTTEN SMALLER AND THE SCAB IS SMALLER BUT STILL VISIBLE. THE AREA IS STILL TENDER/PAINFUL TO THE TOUCH.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: PATIENT STATES THEY WERE HAVING AN ADVERSE REACTION IMMEDIATELY AFTER THE VACCINE WAS GIVEN. SHE STATES IT WELTED UP AND WAS VERY SORE AND TENDER TO THE TOUCH. SHE STATED IT FORMED  SCAB AT THE AREA AND STARTED TO PEEL. SHE ASSUMED IT WOULD GO AWAY. NOW, THE WELT HAS GOTTEN SMALLER AND THE SCAB IS SMALLER BUT STILL VISIBLE. THE AREA IS STILL TENDER/PAINFUL TO THE TOUCH.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site urticaria
Clinical narrative: Patient experience extreme fatigue, arthralgias and a welt at the injection site.  Treated with Tylenol and antihistamines with resolution.
Age: 53.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia
Clinical narrative: The adverse event did not occur for around 2 weeks after the injection. Patient complains of muscle pain. STates it does NOT feel like nerve pain.  No redness but feels warm to the touch. Had telemed appointment with physician on 4/29/20 He told her that he wasn't sure the cause but gave her some possibilities. From what patient told me the doctor said it could possibly be an immune response,  a hematoma, or nerve damage. Doctor did give her an antibiotic in case there is an infection.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: When I got the vaccine, my arm was very sore.  It remained sore when I returned 14 days later and I told NP  that the pain had not subsided. I explained that my arm hurt terribly with the range of motion.  Therefore, she injected my Hep B in my right arm instead of my left, which was closes to her.  She said she would do that due to me having pain in my left arm.  She said that it should have only hurt for a couple of days and not this long. However, I just received my medical records, because I wanted to verify if it was documented or not and IT WAS NOT.  I called the customer service department of pharmacy to have my medical records amended, because I am very well aware of all medical professionals are supposed to document subjective and objective information and it was not documented.  I can only assume that it is because she is the same person who gave me the flu shot that caused the issue.  My arm is weaker due to the pain. I was on hold for 25 min, so I discontinued the call.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Ophthalmological examination, Paraesthesia, Rash, Swelling
Clinical narrative: Vaccines administered, localized swelling, tingling and rash developed one day after administration.  Patient retuned to clinic 2 days after receiving vaccines.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: redness, inflammation on left arm
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Fatigue, Flushing
Clinical narrative: Severe headaches- continues to present; head feels like a pressure of a balloon expanding; lightheaded; chest rash, pain on left arm-still tender; unable to walk very far due to weakness in legs- lasted 2.5 days; face flushed, tiredness, diarrhea upset stomach.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Head discomfort, Headache, Muscular weakness, Pain in extremity
Clinical narrative: Severe headaches- continues to present; head feels like a pressure of a balloon expanding; lightheaded; chest rash, pain on left arm-still tender; unable to walk very far due to weakness in legs- lasted 2.5 days; face flushed, tiredness, diarrhea upset stomach.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: Severe headaches- continues to present; head feels like a pressure of a balloon expanding; lightheaded; chest rash, pain on left arm-still tender; unable to walk very far due to weakness in legs- lasted 2.5 days; face flushed, tiredness, diarrhea upset stomach.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Chills headache fatigue soreness at injection site muscle sched
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Fall, Feeling hot, Hyperhidrosis, Vomiting
Clinical narrative: 15 minutes after immunization the patient became dizzy, hot and sweaty, fell down. the patient then began to vomit. the patient then sat down and drank water for about 30 minutes and felt better. the patient did not have any problems breathing. After filling out a report the patient then left with a caregiver.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Dyskinesia, Loss of consciousness
Clinical narrative: Lose of consciousness and jerking, Stethoscopes was used to check breathing, happened right after injection. Was told symptoms were normal and was told we were okay to leave.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose fluctuation, Depressed level of consciousness, Vomiting
Clinical narrative: Patients caregiver said about 3-4 hours after vaccine, patient started vomiting uncontrollably. Also mentioned that patients blood sugar was fluctuating and the patient was barely conscious
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: On day 10 after child had varicella vaccine child had red welt on the upper left tricep that was swollen and tender to the touch. Child had a fever of 101.1 for 2 days. On day 12 after vaccination child presented with a mild varicella/chickenpox type rash.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash vesicular, Urticaria
Clinical narrative: On day 10 after child had varicella vaccine child had red welt on the upper left tricep that was swollen and tender to the touch. Child had a fever of 101.1 for 2 days. On day 12 after vaccination child presented with a mild varicella/chickenpox type rash.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain in extremity, Rash erythematous
Clinical narrative: Starting on 4/27/2020 (12 days after vaccine was given), he started having burning type pain in left mid posteriormedial thigh.  On 4/29/2020, he started to have a rash that consisted of a cluster of red bumps later turning into vesicles in the same area as the pain..  The rash and pain combination was clinically consistent with shingles.  On 5/2/2020 there was spread of rash to left mid posteriorolateral shin.  He was started on Valtrex 1000 mg tid for 7 days on 5/2/2020.
Age: 0.75
Sex: F
Vaccine: UNK
Symptoms: Abdominal distension, Allergy test, Biopsy, Blood immunoglobulin A decreased, Colonoscopy abnormal
Clinical narrative: Patient started to cry about 4 hours after shot.  About 6 hours after shot, she spiked a fever of 101.5, turned red, started vomiting and had bouts of diarrhea.  She stopped crying and became listless bordering unresponsive.  When I tried to rouse her, she made weird moaning sounds and her eyes would open and roll back in her head.  I called the 24 hour nurse who said if her fever didn't go above 102, to keep her home and hydrated.  I stayed up all night to make sure she kept breathing because her body was so limp and lifeless.  She didn't turn or do anything throughout the night.  She moved a little when she vomited.  She didn't nurse for 14 hours after symptoms first appeared.  I reported all these symptoms to Dr her next appt and she said they were all normal reactions and she should have two more booster vaccines.  I asked if she could have them individually to see what she reacted to so severely, and she said that wasn't cost effective.  I declined the boosters out of concern that future reactions could have more severe outcomes.   After the vaccine, patient developed numerous food sensitivities.  She gained weight more slowly and was diagnosed failure to thrive at 2 yo by gastroenterologist.  She had an endoscopy and colonoscopy a year later, and they found chronic inflammation from her esophagus to her colon.  They rules out chrohn's, celiac, and every other inflammatory bowel disease.  Her immunologist said her immune system was malfunctioning and "always" on.  She had chronic stomach bloat and diarrhea.  She was sick about 7 months a year.  Her sensitivity to some foods resulted her pink eye which she got about twice a month, every month. This was her new life post her one and only pentacel vaccine.
Age: 0.75
Sex: F
Vaccine: UNK
Symptoms: Conjunctivitis, Crying, Decreased appetite, Diarrhoea, Endoscopy abnormal
Clinical narrative: Patient started to cry about 4 hours after shot.  About 6 hours after shot, she spiked a fever of 101.5, turned red, started vomiting and had bouts of diarrhea.  She stopped crying and became listless bordering unresponsive.  When I tried to rouse her, she made weird moaning sounds and her eyes would open and roll back in her head.  I called the 24 hour nurse who said if her fever didn't go above 102, to keep her home and hydrated.  I stayed up all night to make sure she kept breathing because her body was so limp and lifeless.  She didn't turn or do anything throughout the night.  She moved a little when she vomited.  She didn't nurse for 14 hours after symptoms first appeared.  I reported all these symptoms to Dr her next appt and she said they were all normal reactions and she should have two more booster vaccines.  I asked if she could have them individually to see what she reacted to so severely, and she said that wasn't cost effective.  I declined the boosters out of concern that future reactions could have more severe outcomes.   After the vaccine, patient developed numerous food sensitivities.  She gained weight more slowly and was diagnosed failure to thrive at 2 yo by gastroenterologist.  She had an endoscopy and colonoscopy a year later, and they found chronic inflammation from her esophagus to her colon.  They rules out chrohn's, celiac, and every other inflammatory bowel disease.  Her immunologist said her immune system was malfunctioning and "always" on.  She had chronic stomach bloat and diarrhea.  She was sick about 7 months a year.  Her sensitivity to some foods resulted her pink eye which she got about twice a month, every month. This was her new life post her one and only pentacel vaccine.
Age: 0.75
Sex: F
Vaccine: UNK
Symptoms: Erythema, Eye movement disorder, Failure to thrive, Food allergy, Gastrointestinal inflammation
Clinical narrative: Patient started to cry about 4 hours after shot.  About 6 hours after shot, she spiked a fever of 101.5, turned red, started vomiting and had bouts of diarrhea.  She stopped crying and became listless bordering unresponsive.  When I tried to rouse her, she made weird moaning sounds and her eyes would open and roll back in her head.  I called the 24 hour nurse who said if her fever didn't go above 102, to keep her home and hydrated.  I stayed up all night to make sure she kept breathing because her body was so limp and lifeless.  She didn't turn or do anything throughout the night.  She moved a little when she vomited.  She didn't nurse for 14 hours after symptoms first appeared.  I reported all these symptoms to Dr her next appt and she said they were all normal reactions and she should have two more booster vaccines.  I asked if she could have them individually to see what she reacted to so severely, and she said that wasn't cost effective.  I declined the boosters out of concern that future reactions could have more severe outcomes.   After the vaccine, patient developed numerous food sensitivities.  She gained weight more slowly and was diagnosed failure to thrive at 2 yo by gastroenterologist.  She had an endoscopy and colonoscopy a year later, and they found chronic inflammation from her esophagus to her colon.  They rules out chrohn's, celiac, and every other inflammatory bowel disease.  Her immunologist said her immune system was malfunctioning and "always" on.  She had chronic stomach bloat and diarrhea.  She was sick about 7 months a year.  Her sensitivity to some foods resulted her pink eye which she got about twice a month, every month. This was her new life post her one and only pentacel vaccine.
Age: 0.75
Sex: F
Vaccine: UNK
Symptoms: Hyporesponsive to stimuli, Hypotonia, Immune system disorder, Immunodeficiency, Immunology test
Clinical narrative: Patient started to cry about 4 hours after shot.  About 6 hours after shot, she spiked a fever of 101.5, turned red, started vomiting and had bouts of diarrhea.  She stopped crying and became listless bordering unresponsive.  When I tried to rouse her, she made weird moaning sounds and her eyes would open and roll back in her head.  I called the 24 hour nurse who said if her fever didn't go above 102, to keep her home and hydrated.  I stayed up all night to make sure she kept breathing because her body was so limp and lifeless.  She didn't turn or do anything throughout the night.  She moved a little when she vomited.  She didn't nurse for 14 hours after symptoms first appeared.  I reported all these symptoms to Dr her next appt and she said they were all normal reactions and she should have two more booster vaccines.  I asked if she could have them individually to see what she reacted to so severely, and she said that wasn't cost effective.  I declined the boosters out of concern that future reactions could have more severe outcomes.   After the vaccine, patient developed numerous food sensitivities.  She gained weight more slowly and was diagnosed failure to thrive at 2 yo by gastroenterologist.  She had an endoscopy and colonoscopy a year later, and they found chronic inflammation from her esophagus to her colon.  They rules out chrohn's, celiac, and every other inflammatory bowel disease.  Her immunologist said her immune system was malfunctioning and "always" on.  She had chronic stomach bloat and diarrhea.  She was sick about 7 months a year.  Her sensitivity to some foods resulted her pink eye which she got about twice a month, every month. This was her new life post her one and only pentacel vaccine.
Age: 0.75
Sex: F
Vaccine: UNK
Symptoms: Listless, Malaise, Mannose-binding lectin deficiency, Moaning, Oesophagitis
Clinical narrative: Patient started to cry about 4 hours after shot.  About 6 hours after shot, she spiked a fever of 101.5, turned red, started vomiting and had bouts of diarrhea.  She stopped crying and became listless bordering unresponsive.  When I tried to rouse her, she made weird moaning sounds and her eyes would open and roll back in her head.  I called the 24 hour nurse who said if her fever didn't go above 102, to keep her home and hydrated.  I stayed up all night to make sure she kept breathing because her body was so limp and lifeless.  She didn't turn or do anything throughout the night.  She moved a little when she vomited.  She didn't nurse for 14 hours after symptoms first appeared.  I reported all these symptoms to Dr her next appt and she said they were all normal reactions and she should have two more booster vaccines.  I asked if she could have them individually to see what she reacted to so severely, and she said that wasn't cost effective.  I declined the boosters out of concern that future reactions could have more severe outcomes.   After the vaccine, patient developed numerous food sensitivities.  She gained weight more slowly and was diagnosed failure to thrive at 2 yo by gastroenterologist.  She had an endoscopy and colonoscopy a year later, and they found chronic inflammation from her esophagus to her colon.  They rules out chrohn's, celiac, and every other inflammatory bowel disease.  Her immunologist said her immune system was malfunctioning and "always" on.  She had chronic stomach bloat and diarrhea.  She was sick about 7 months a year.  Her sensitivity to some foods resulted her pink eye which she got about twice a month, every month. This was her new life post her one and only pentacel vaccine.
Age: 0.75
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Vomiting, Weight gain poor
Clinical narrative: Patient started to cry about 4 hours after shot.  About 6 hours after shot, she spiked a fever of 101.5, turned red, started vomiting and had bouts of diarrhea.  She stopped crying and became listless bordering unresponsive.  When I tried to rouse her, she made weird moaning sounds and her eyes would open and roll back in her head.  I called the 24 hour nurse who said if her fever didn't go above 102, to keep her home and hydrated.  I stayed up all night to make sure she kept breathing because her body was so limp and lifeless.  She didn't turn or do anything throughout the night.  She moved a little when she vomited.  She didn't nurse for 14 hours after symptoms first appeared.  I reported all these symptoms to Dr her next appt and she said they were all normal reactions and she should have two more booster vaccines.  I asked if she could have them individually to see what she reacted to so severely, and she said that wasn't cost effective.  I declined the boosters out of concern that future reactions could have more severe outcomes.   After the vaccine, patient developed numerous food sensitivities.  She gained weight more slowly and was diagnosed failure to thrive at 2 yo by gastroenterologist.  She had an endoscopy and colonoscopy a year later, and they found chronic inflammation from her esophagus to her colon.  They rules out chrohn's, celiac, and every other inflammatory bowel disease.  Her immunologist said her immune system was malfunctioning and "always" on.  She had chronic stomach bloat and diarrhea.  She was sick about 7 months a year.  Her sensitivity to some foods resulted her pink eye which she got about twice a month, every month. This was her new life post her one and only pentacel vaccine.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Dehydration, Diarrhoea, Incontinence, Vomiting projectile
Clinical narrative: Projectile vomiting & severe diarrhea causing incontinence & dehydration. Oral rehydration successful & patient recovered
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: I already have aches and pains from a car accident but they were about 5 x worse than usual and even my hands were aching badly along with  nausea and a headache, couldn't sleep at all.  Obviously, today I feel extremely fatigued but the aches and pains have already improved quite a bit (it's now noon, the following day of the vaccination).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: I already have aches and pains from a car accident but they were about 5 x worse than usual and even my hands were aching badly along with  nausea and a headache, couldn't sleep at all.  Obviously, today I feel extremely fatigued but the aches and pains have already improved quite a bit (it's now noon, the following day of the vaccination).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Husband stated that 6 days following her shingrix shot on 11/25/2019, she went to the emergency room and was diagnosed with Guillain - Barre  syndrome. She is still at the rehab facility as of 5/3/2020.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's arm became swollen, red and warm to the touch.  This reaction occurred at the injection site and went up to the top of the arm and down to just before the elbow.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient she her arm was sore and achy and she thought she had a fever the last night.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Inflammation, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient's arm was swelling and painful from shoulder to elbow and experienced this on Tuesday night. She woke up without a fever yet, was told to contact her doctor. She then went to Emergency room Wednesday afternoon because she still had pain, inflammation and fever. She was admitted overnight for observation in the hospital. Doctor said it was cellulitis and she has an increase WBC count. She was given Ceftriaxone IV and was released on Thursday. She is currently taking oral cephalexin for 7 days. She said she felt better, no more fever but arms are still with pain and swelling . ( as of 5/03/2020 3pm).
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Patient's arm was swelling and painful from shoulder to elbow and experienced this on Tuesday night. She woke up without a fever yet, was told to contact her doctor. She then went to Emergency room Wednesday afternoon because she still had pain, inflammation and fever. She was admitted overnight for observation in the hospital. Doctor said it was cellulitis and she has an increase WBC count. She was given Ceftriaxone IV and was released on Thursday. She is currently taking oral cephalexin for 7 days. She said she felt better, no more fever but arms are still with pain and swelling . ( as of 5/03/2020 3pm).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Cervical radiculopathy, Feeling hot, Hypersensitivity, Hypoaesthesia
Clinical narrative: still having pain at the site with pain shooting from the neck to the hand ? local heat weakness, pain numbness in the L arm partially responding to NSAIDS affecting sleep now having arrythmias patient seeing a Cardiologist general malaise because of ? lack of sleep
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Magnetic resonance imaging abnormal, Malaise, Muscular weakness
Clinical narrative: still having pain at the site with pain shooting from the neck to the hand ? local heat weakness, pain numbness in the L arm partially responding to NSAIDS affecting sleep now having arrythmias patient seeing a Cardiologist general malaise because of ? lack of sleep
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neuropathy peripheral, Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: still having pain at the site with pain shooting from the neck to the hand ? local heat weakness, pain numbness in the L arm partially responding to NSAIDS affecting sleep now having arrythmias patient seeing a Cardiologist general malaise because of ? lack of sleep
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tendon disorder
Clinical narrative: still having pain at the site with pain shooting from the neck to the hand ? local heat weakness, pain numbness in the L arm partially responding to NSAIDS affecting sleep now having arrythmias patient seeing a Cardiologist general malaise because of ? lack of sleep
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Injection site pain, Lethargy, Lymphadenopathy, Pain in extremity
Clinical narrative: Soreness right arm; Fever; fatigue; swollen lymph nodes under the right armpit; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2020, the patient received the 1st dose of Shingrix. On 8th January 2020, 2 days after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the patient experienced pain in arm, fever and fatigue. On an unknown date, the outcome of the enlargement of lymph nodes, pain in arm, fever and fatigue were resolved with sequelae.   It was unknown if the reporter considered the enlargement of lymph nodes, pain in arm, fever and fatigue to be related to Shingrix.  Additional case details were reported as follows: The patient developed fever, fatigue and soreness in the right arm after receiving the vaccine. The patient stated that approximately 2 days after receiving the vaccine, he developed swollen lymph nodes under the right armpit. The patient consented to follow up.      Lab Comments: on an unknown date ultrasound was done
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Ultrasound scan abnormal
Clinical narrative: Soreness right arm; Fever; fatigue; swollen lymph nodes under the right armpit; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2020, the patient received the 1st dose of Shingrix. On 8th January 2020, 2 days after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the patient experienced pain in arm, fever and fatigue. On an unknown date, the outcome of the enlargement of lymph nodes, pain in arm, fever and fatigue were resolved with sequelae.   It was unknown if the reporter considered the enlargement of lymph nodes, pain in arm, fever and fatigue to be related to Shingrix.  Additional case details were reported as follows: The patient developed fever, fatigue and soreness in the right arm after receiving the vaccine. The patient stated that approximately 2 days after receiving the vaccine, he developed swollen lymph nodes under the right armpit. The patient consented to follow up.      Lab Comments: on an unknown date ultrasound was done
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity, Pyrexia, Ultrasound scan
Clinical narrative: Soreness right arm; Fever; fatigue; swollen lymph nodes under the right armpit; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2020, the patient received the 1st dose of Shingrix. On 8th January 2020, 2 days after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the patient experienced pain in arm, fever and fatigue. On an unknown date, the outcome of the enlargement of lymph nodes, pain in arm, fever and fatigue were resolved with sequelae.   It was unknown if the reporter considered the enlargement of lymph nodes, pain in arm, fever and fatigue to be related to Shingrix.  Additional case details were reported as follows: The patient developed fever, fatigue and soreness in the right arm after receiving the vaccine. The patient stated that approximately 2 days after receiving the vaccine, he developed swollen lymph nodes under the right armpit. The patient consented to follow up.      Lab Comments: on an unknown date ultrasound was done
Sex: M
Vaccine: VARZOS
Symptoms: Amyotrophic lateral sclerosis, Biopsy muscle abnormal, Gait disturbance, Hypoaesthesia, Motor neurone disease
Clinical narrative: Progressive muscle weakness/Progressive lower extremity muscle weakness; muscle cramps; myalgias; amyotrophic lateral sclerosis (ALS); Moderate to severe neurogenic atrophy; peripheral neuropathy/neuropathy; drop foot on the L side; Limping; toe movement problem; numbness in left leg; Motor neuron disease; This case was reported by a lawyer and described the occurrence of amyotrophic lateral sclerosis in a 58-year-old male patient who received Herpes zoster (Shingrix) for product used for unknown indication.   The following information was received on 23 April 2020 via medical records (case is now medically confirmed). As per the pharmacy record, the patient had shingrix vial kit on 09 June 2018 and 14 August 2018. The patient's past medical history included Former smoker (0.50 pack per day for 10 years, ceased on 02 November 1995). The patient had a Family History of ALS (patient's paternal uncle had ALS) and guillain barre syndrome (The patient's mother had GBS). Concurrent medical conditions included alcohol use (occasional), hepatitis c and essential hypertension. The patient's mother had Guillian Barre Syndrome. As per the pharmacy record, the patient had shingrix vial kit on 09 June 2018 and 14 August 2018. As per medical record dated on 23 October 2018, the patient was present with numbness in left leg with limping. The patient had left toes movement problem. He had progressive muscle weakness in legs since 2018. He has had drop foot on the left side since December 2018. The patient was diagnosed with motor neuron disease in 2018. As per lab report dated on 22 March 2019, He was assess with Neuropathy. On 24 June 2019, he was diagnosed with amyotrophic lateral sclerosis (ALS). On 26 June 2019, during the review of the system, patient was positive for muscle cramps, muscle weakness and myalgias. Left tight muscle biopsy performed on June 2019, Moderate to severe neurogenic atrophy. As per Nerve conduction velocity study 2020, findings was indicative of a sensorimotor peripheral neuropathy in the nerves tested the bilateral lower extremities. It was unknown if the reporter considered the amyotrophic lateral sclerosis, motor neuron disease, neural atrophy, peripheral neuropathy, numbness in leg, foot drop, muscle weakness, muscle cramp and myalgia to be related to Shingrix.      Lab Comments: As per Nerve conduction velocity study 2020, findings was indicative of a sensorimotor peripheral neuropathy in the nerves tested the bilateral lower extremities
Sex: M
Vaccine: VARZOS
Symptoms: Movement disorder, Muscle spasms, Muscular weakness, Myalgia, Nerve conduction studies abnormal
Clinical narrative: Progressive muscle weakness/Progressive lower extremity muscle weakness; muscle cramps; myalgias; amyotrophic lateral sclerosis (ALS); Moderate to severe neurogenic atrophy; peripheral neuropathy/neuropathy; drop foot on the L side; Limping; toe movement problem; numbness in left leg; Motor neuron disease; This case was reported by a lawyer and described the occurrence of amyotrophic lateral sclerosis in a 58-year-old male patient who received Herpes zoster (Shingrix) for product used for unknown indication.   The following information was received on 23 April 2020 via medical records (case is now medically confirmed). As per the pharmacy record, the patient had shingrix vial kit on 09 June 2018 and 14 August 2018. The patient's past medical history included Former smoker (0.50 pack per day for 10 years, ceased on 02 November 1995). The patient had a Family History of ALS (patient's paternal uncle had ALS) and guillain barre syndrome (The patient's mother had GBS). Concurrent medical conditions included alcohol use (occasional), hepatitis c and essential hypertension. The patient's mother had Guillian Barre Syndrome. As per the pharmacy record, the patient had shingrix vial kit on 09 June 2018 and 14 August 2018. As per medical record dated on 23 October 2018, the patient was present with numbness in left leg with limping. The patient had left toes movement problem. He had progressive muscle weakness in legs since 2018. He has had drop foot on the left side since December 2018. The patient was diagnosed with motor neuron disease in 2018. As per lab report dated on 22 March 2019, He was assess with Neuropathy. On 24 June 2019, he was diagnosed with amyotrophic lateral sclerosis (ALS). On 26 June 2019, during the review of the system, patient was positive for muscle cramps, muscle weakness and myalgias. Left tight muscle biopsy performed on June 2019, Moderate to severe neurogenic atrophy. As per Nerve conduction velocity study 2020, findings was indicative of a sensorimotor peripheral neuropathy in the nerves tested the bilateral lower extremities. It was unknown if the reporter considered the amyotrophic lateral sclerosis, motor neuron disease, neural atrophy, peripheral neuropathy, numbness in leg, foot drop, muscle weakness, muscle cramp and myalgia to be related to Shingrix.      Lab Comments: As per Nerve conduction velocity study 2020, findings was indicative of a sensorimotor peripheral neuropathy in the nerves tested the bilateral lower extremities
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathic muscular atrophy, Neuropathy peripheral, Peripheral sensorimotor neuropathy, Peroneal nerve palsy
Clinical narrative: Progressive muscle weakness/Progressive lower extremity muscle weakness; muscle cramps; myalgias; amyotrophic lateral sclerosis (ALS); Moderate to severe neurogenic atrophy; peripheral neuropathy/neuropathy; drop foot on the L side; Limping; toe movement problem; numbness in left leg; Motor neuron disease; This case was reported by a lawyer and described the occurrence of amyotrophic lateral sclerosis in a 58-year-old male patient who received Herpes zoster (Shingrix) for product used for unknown indication.   The following information was received on 23 April 2020 via medical records (case is now medically confirmed). As per the pharmacy record, the patient had shingrix vial kit on 09 June 2018 and 14 August 2018. The patient's past medical history included Former smoker (0.50 pack per day for 10 years, ceased on 02 November 1995). The patient had a Family History of ALS (patient's paternal uncle had ALS) and guillain barre syndrome (The patient's mother had GBS). Concurrent medical conditions included alcohol use (occasional), hepatitis c and essential hypertension. The patient's mother had Guillian Barre Syndrome. As per the pharmacy record, the patient had shingrix vial kit on 09 June 2018 and 14 August 2018. As per medical record dated on 23 October 2018, the patient was present with numbness in left leg with limping. The patient had left toes movement problem. He had progressive muscle weakness in legs since 2018. He has had drop foot on the left side since December 2018. The patient was diagnosed with motor neuron disease in 2018. As per lab report dated on 22 March 2019, He was assess with Neuropathy. On 24 June 2019, he was diagnosed with amyotrophic lateral sclerosis (ALS). On 26 June 2019, during the review of the system, patient was positive for muscle cramps, muscle weakness and myalgias. Left tight muscle biopsy performed on June 2019, Moderate to severe neurogenic atrophy. As per Nerve conduction velocity study 2020, findings was indicative of a sensorimotor peripheral neuropathy in the nerves tested the bilateral lower extremities. It was unknown if the reporter considered the amyotrophic lateral sclerosis, motor neuron disease, neural atrophy, peripheral neuropathy, numbness in leg, foot drop, muscle weakness, muscle cramp and myalgia to be related to Shingrix.      Lab Comments: As per Nerve conduction velocity study 2020, findings was indicative of a sensorimotor peripheral neuropathy in the nerves tested the bilateral lower extremities
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Condition aggravated, Confusional state, Memory impairment, Transient ischaemic attack
Clinical narrative: mini transient ischemic attack / mini stroke; mini transient ischemic attack / mini stroke; Confusion; could not remember things; This case was reported by a consumer via call center representative and described the occurrence of transient ischemic attack in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included TIA (transient ischemic attack) and stroke.  On 7th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th March 2020, 1 days after receiving Shingrix, the patient experienced transient ischemic attack (serious criteria GSK medically significant), stroke (serious criteria GSK medically significant), confusion and memory disturbance. On 8th March 2020, the outcome of the transient ischemic attack, stroke, confusion and memory disturbance were recovered/resolved.   It was unknown if the reporter considered the transient ischemic attack, stroke, confusion and memory disturbance to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported the case. The patient received Shingrix in left arm. On the next day, in morning, the patient experienced confusion and could not remember things. This lasted for about 5 hours and then he recovered. The reporter thought, this was a mini transient ischemic attack, a mini stroke that the patient had. The reporter did not consent to follow-up. No other details were provided.