chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Electrocardiogram normal, Pallor, Syncope, Vomiting
Clinical narrative: Approximately 5 minutes after vaccines were given patient was in waiting room with mom and siblings when she had witnessed collapse by medical staff, ma. Episode lasting less than 30 seconds. Mom reports patient was pale and vomited clear liquid. Mom and patient brought back to exam room with provider present when patient again had another syncopal episode lasting 15-30 seconds. Patient pale in color. Respirations 20 clear, HR 74 RRR, BP 88/64, Sp02 98%. Patient responding to loud voice and shaking by mom. Patient talking and responding to mom/provider. Mom denies patient having any similar reaction prior to vaccines. Mom reporting she is going to drive patient to ED. Mother very frantic and upset. Discussed with mother patient being transported via EMS over mother driving due to mother's state and incase patient were to have another syncopal episode. Mother reports concern as patient's sister has seizure disorder. Mother agreeable to transport via EMS. EMS notified. Repeat vitals 88/48, 84, 24, 97%. EMS arrived and confirmed with mother her desire for patient to be transported to hospital and patient/parent left with EMS. **documented by CRNP on 11/12/2020 immediately after visit**
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Initially, there was normal pain in my upper arm and shoulder that got better after a few days.  Then, sharp pain began in my shoulder a few days after and has lasted since then.  This pain has been persistent and limits mobility in my left shoulder.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Flushing, Laboratory test normal, Myocardial necrosis marker normal, Oxygen therapy
Clinical narrative: Patient had developed tightness in his face and trouble swallowing  while he was driving home 30 minutes after receiving the vaccination. Patient came back to clinic and was noted to have flushed face without obvious rashes.  Treatment: patient was placed on oxygen, 2 L/min via nasal cannula. Saline lock was placed and solumedrol 125 mg IVP was given followed by saline flush (10 ml).  Outcome: Patient was taken to for evaluation. He was given IVP Benadryl and discharged with: Benadryl 25 mg every 4-6 hours as needed and Prednisone 50 mg once daily for 4 days. Patients feels a lot better now and denies any tightness in face or throat or shortness of breath.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin tightness
Clinical narrative: Patient had developed tightness in his face and trouble swallowing  while he was driving home 30 minutes after receiving the vaccination. Patient came back to clinic and was noted to have flushed face without obvious rashes.  Treatment: patient was placed on oxygen, 2 L/min via nasal cannula. Saline lock was placed and solumedrol 125 mg IVP was given followed by saline flush (10 ml).  Outcome: Patient was taken to for evaluation. He was given IVP Benadryl and discharged with: Benadryl 25 mg every 4-6 hours as needed and Prednisone 50 mg once daily for 4 days. Patients feels a lot better now and denies any tightness in face or throat or shortness of breath.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Pain, Pneumonia
Clinical narrative: pneumonia; This spontaneous report was received from a lawyer referring to a female patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not provided. On or about 15-JUN-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, route, dose number, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sharp intermittent left-sided chest pain radiating to her left shoulder and back and was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of pneumonia was considered as not recovered. The reporter considered pneumonia to be related to zoster vaccine live (ZOSTAVAX).   Pneumonia was considered as disabling. Upon internal review, pneumonia was considered as medically significant.
Sex: F
Vaccine: VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: an HCP reported to her a patient "recently received the Varicella vaccine" and "later" told the office that "she thought that she might have experienced some kind of 'anaphylactic reaction' after receiving the vaccine; This spontaneous report was received from a registered nurse via a company representative, referring to a female patient of unknown age. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), and recently she received another dose of varicella virus vaccine live (oka/merck)(VARIVAX) (formulations, strengths, doses, vaccination schemes, routes of administration, anatomical sites of vaccination, lot numbers and expiration dates were not reported, for any of the vaccines), both vaccines were administered as prophylaxis, however; after the vaccination, she notified that, she thought that she might have experienced some kind of "anaphylactic reaction" after received the vaccine, as she had previously done before when she received the vaccine as an infant.    The health care professional, was currently asking if it was ok for the patient to receive the influenza vaccination.   The outcome and the causality assessment between varicella virus vaccine live (oka/merck)(VARIVAX) with anaphylactic reaction was not provided.   Upon internal review, anaphylactic reaction was determined to be medically significant.
Age: 21.0
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: never been sicker in; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The patient received the flu shot once, required for work and never been sicker in patient's life. The patient stated no vaccine. No other information was provided. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Acne
Clinical narrative: face Acne/ooszing acne on my face; This case was reported by a consumer via call center representative and described the occurrence of acne in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced acne. On an unknown date, the outcome of the acne was unknown.   It was unknown if the reporter considered the acne to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had acne on face and three months later still struggling with oozing acne on face.  The patient supposed to get 2nd dose at time of reporting. The reporter asked was shot 2 like shot 1 or was it weaker. The reporter asked was acne a symptom of Shingles.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Musculoskeletal discomfort, Nervous system disorder
Clinical narrative: left side of his face went numb. / numbness started above his left ear and migrated down the neck to his shoulder blade; felt like burning when hand was rubbed over the left side of his neck; felt also like water trickling down his neck; Shingrix triggered something in the nerve of the neck; This case was reported by a consumer via call center representative and described the occurrence of numbness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2020).   In July 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced numbness, burning sensation, neck discomfort and neurological disorder nos. The patient was treated with gabapentin and valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the numbness was not recovered/not resolved and the outcome of the burning sensation, neck discomfort and neurological disorder nos were unknown.   It was unknown if the reporter considered the numbness, burning sensation, neck discomfort and neurological disorder nos to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left arm.  The patient reported the left side of his face went numb. The numbness started above his left ear and migrated down the neck to his shoulder blade. It felt like burning when hand was rubbed over the left side of his neck, it felt also like water trickling down his neck. The patient's family physician thought the patient had a stroke and had him go to the emergency room. A neurologist determined getting Shingrix triggered something in the nerve of the neck. The patient was treated with Gabapentin and (possibly) Valacyclovir, the numbness went away but now it was coming back. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fever /  low grade fever; aches / pains; fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain and fatigue. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the fever, pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced fever, pain, aches and fatigue. The symptoms lasted for 24 hours and then resolved. Lot number was not provided. The reporter consented to follow up. For tolerance of 2nd dose, refer case; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223946:same reporter US-GLAXOSMITHKLINE-US2020223956:same reporter US-GLAXOSMITHKLINE-US2020AMR224583:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: Tingling in the mouth; This case was reported by a pharmacist via call center representative and described the occurrence of tingling mouth in a adult female patient who received Herpes zoster (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 tingling mouth. On an unknown date, the outcome of the tingling mouth was recovered/resolved.   It was unknown if the reporter considered the tingling mouth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced tingling in mouth. The event resolved after an unknown period of time. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Herpes zoster, Injection site pain
Clinical narrative: Severe pain in the left armpit; Shingles; Pain around the injection site which became more painful; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th October 2020, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced injection site pain. On 7th November 2020, the patient experienced axillary pain and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the axillary pain and shingles were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, axillary pain and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and on the same day experienced pain around the injection site, which lasted for few days and then resolved. On 7th November 2020, patient was diagnosed with shingles and had pain in left armpit. The patient was treated with valacyclovir for shingles 3 tabs once daily for 7 days. The o lot number and expiration date.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th September 2020, no adverse events reported).   On 11th November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, headache and chills. On an unknown date, the outcome of the fever, headache and chills were unknown.   It was unknown if the reporter considered the fever, headache and chills to be related to Shingrix.  Additional information was provided as follows: The patient experienced fever, headache and chills after receiving the 2nd dose of Shingrix. The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a consumer over the age of 65 years was in error not given the ordered dose of Fluzone Quadrivalent High Dose but was administered Fluzone Quadrivalent Standard dose with no adverse event; Initial information regarding this unsolicited valid non-serious case via The Agency (reference number: 00309763) was received from a pharmacist and transmitted to Sanofi 12-Oct-2020.  This case involved 89 years old female who was over the age of 65 years was in error not given the ordered dose of Fluzone quadrivalent high dose but was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringes standard dose of 0.5 mL (lot number and expiry date: not reported) (wrong product administered), on 09-Oct-2020, via unknown route in in unknown administration site for prophylactic vaccination. No other vaccines were administered.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  No adverse event was reported at the time of reporting.  It was a case of actual medical error due to wrong vaccine administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: the patient gets very sick every year after receiving her flu vaccine; Initial information regarding this unsolicited valid non-serious case via the agency (reference number: 00311644) was received from a consumer and transmitted to Sanofi 12-Oct-2020.  This case involved a female patient of unknown age who experienced gets very sick every year after receiving her INFLUENZA VACCINE (flu vaccine) (Illness).  Relevant medical history, past medical treatment, vaccination details and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient became very sick every year after receiving her flu vaccine (illness), unknown latency following the administration of INFLUENZA VACCINE.  Final diagnosis was the patient gets very sick every year after receiving her flu vaccine.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Pain, Pain in extremity, Tenderness
Clinical narrative: Within 2 hours of getting the vaccine, my arm was sore. It got more and more tender as the hours went by. Approximately 8 hours after the injection, I started to feel very tired and achy. I remained achy all night and couldn't sleep or get comfortable. It's now 24 hours since getting the vaccine and I feel a bit better, but still achy and my arm is extremely sore and tender.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Nausea, Pruritus, Swelling face
Clinical narrative: Face swelling, itching, dizzy, nausea. No medical treatment
Age: 61.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Back pain
Clinical narrative: I got the injection shots at 9:50 am.  One shot in each arm but I cant remember exactly which shot was given in which arm but about 25 minutes to a half hour after the injections I got severe pain in my lower back and the pain is so severe and excruciating.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration
Clinical narrative: Patient woke up with palm size red spot on leg. There is a knot in it.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain at injection site; pain radiated to shoulder and arm; decrease shoulder movement range
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: Injection site pain, muscle aches, headache
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain, Pain in extremity, Paraesthesia oral, Peripheral swelling
Clinical narrative: After 2nd injection, within 5 minutes had tingling in upper and lower lip.  Within half hour arm was sore, mild swelling. Approximately 5 hours later, moderate shooting pain down arms and legs, happening infrequently.  At bedtime, starting shivering and had a 101.5 temp. Continued for 6 hours, fever then broke. Was groggy the next day with no effects lingering
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: After 2nd injection, within 5 minutes had tingling in upper and lower lip.  Within half hour arm was sore, mild swelling. Approximately 5 hours later, moderate shooting pain down arms and legs, happening infrequently.  At bedtime, starting shivering and had a 101.5 temp. Continued for 6 hours, fever then broke. Was groggy the next day with no effects lingering
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: This was a revaccination as #1 was given 12/5/19 and was stored at improper storage and handling at facility. The pt called and came into the clinic 2 days after the vaccine was given . She had mild redness the day after and progressed greatly today. no fever but pain in the rt deltoid. Pt did say that this did happen with the previous dose.   10cm by 15 cm erythematous patch , it is warm .  She was given Triamcinolone Acetonide 0.5% cr to  apply BID to affected area.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Dysstasia, Musculoskeletal stiffness, Myositis
Clinical narrative: Severe lower back pain and stiffness.  Could not play golf for over a week.  Difficulty and pain standing and sitting.  As bad as 8 of 10 pain.  Seemed to be located around spine at belt level.  Lateral stretch most painful/difficult.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: experienced profound fatigue, headache, and muscle and joint pain ? mostly across my upper torso, shoulder to shoulder and from neck to mid-chest. This continued for over 48 hours, making activity impossible
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure, Syncope
Clinical narrative: Patient had a syncopal event with mini seizure lasting approximately 15 seconds. Patient has fainted in the past with vaccines.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Pain at point of injection, shivering, low grade fever
Age: 1.25
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Fatigue, Gait disturbance, Hyperhidrosis, Magnetic resonance imaging, Pallor
Clinical narrative: WITNESSED BY MATERNAL GRANDMOTHER WHILE PLAYING OUTSIDE SUDDENLY STARING WITHOUT RESPONSE, LIMP, PALE AND SWEATING FOR 3-7 MINUTES TIRED FOR HOURS AFTERWARDS
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site dermatitis, Injection site erythema, Injection site haemorrhage, Injection site irritation, Injection site pain
Clinical narrative: Received the flu shot on 10/23/20. Had localized irritation at the time of injection (redness, some muscle pain, bleeding). The muscle pain / pain at site of injection lasted for approximately 24- 36 hours. When bandaid was removed, was able to see puncture site. approximately 4 days later began having itching at the site and sloughing of skin accompanied with redness. Skin would continue sloughing until tissue was "raw", at which time the skin would then begin to form a scab. After a few days this area would be completely scabbed over. After a few days the scab fell off and the process would repeat. This has occurred approximately 3 times by this time point. The area appears to be scarring at this time, however, it is still giving the sensation of itching so it is believed the cycle will occur again
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site scab
Clinical narrative: Received the flu shot on 10/23/20. Had localized irritation at the time of injection (redness, some muscle pain, bleeding). The muscle pain / pain at site of injection lasted for approximately 24- 36 hours. When bandaid was removed, was able to see puncture site. approximately 4 days later began having itching at the site and sloughing of skin accompanied with redness. Skin would continue sloughing until tissue was "raw", at which time the skin would then begin to form a scab. After a few days this area would be completely scabbed over. After a few days the scab fell off and the process would repeat. This has occurred approximately 3 times by this time point. The area appears to be scarring at this time, however, it is still giving the sensation of itching so it is believed the cycle will occur again
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling abnormal, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Sore throat, chills, muscle soreness, headache, fuzzy headed, swollen neck glands Symptoms began approx. 7:30p.m. until 3:30 a.m. on Oct. 24, 2020
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat, chills, muscle soreness, headache, fuzzy headed, swollen neck glands Symptoms began approx. 7:30p.m. until 3:30 a.m. on Oct. 24, 2020
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Musculoskeletal stiffness, Rash erythematous
Clinical narrative: Received vaccine on Sunday 11/15/20.  Patient complained for muscle stiffness and redness at injection site that started the next day.  The rash is just red, not warm, no fever, no open sore or blisters.  Recommended acetaminophen or ibuprofen and benadryl.  Counseled for signs of possible infection and when to contact physician for further treatment.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Vomiting
Clinical narrative: Pain,tiredness,headache,and vomiting
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion for Varivax; no additional AE reported; This spontaneous report was received from a medical assistant and refers to a currently 18-year-old male patient. No information regarding his pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S002395, expiry date: 23-JAN-2021, for prophylaxis (dose number, route of administration were not provided). No adverse events were reported.      Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit for 1 hour. There were no previous excursions related. Data logger was involved.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: without any residual effects experienced by the consumer; inadvertently administered 2 Pneumovax23 vaccines; This spontaneous report was received from a 67 year old patient reporting on her/him self. No information was given regarding the patient's concurrent conditions, concomitant medication or medical history.  On 09-JUN-2020 the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T007790 for prophylaxis. On 05-OCT-2020, the patient was inadvertently administered a second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) without any residual effects experienced. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Ear hissing; This case was reported by a consumer via interactive digital media and described the occurrence of ear hissing in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced ear hissing. On an unknown date, the outcome of the ear hissing was unknown.   It was unknown if the reporter considered the ear hissing to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced ear hissing after vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Computerised tomogram normal, Herpes zoster, Nerve injury
Clinical narrative: red rash on my stomach and back / internal and external rash; shingles. It was affecting the nerve endings in my back and abdomen; Wednesday night I woke several times in severe pain.; internal and external rash were in fact shingles; lower back pain / pain in my back was like a knife stabbed me and kept pushing up; sharp abdominal pain on my right side; This case was reported by a consumer and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, 2 days after receiving Shingrix, the patient experienced shingles, low back pain and abdominal pain. On 4th November 2020, the patient experienced poor sleep. On 5th November 2020, the patient experienced red rash and nerve injury. On an unknown date, the outcome of the shingles, low back pain, abdominal pain, poor sleep, red rash and nerve injury were unknown.   It was unknown if the reporter considered the shingles, low back pain, abdominal pain, poor sleep, red rash and nerve injury to be related to Shingrix.  Additional details were received as follows: The patient started experiencing lower back pain and started experiencing sharp abdominal pain on right side.  The pain level increased until Wednesday night and woke several times in severe pain.  Thursday  woke with a red rash on stomach and back.  The pain in back was like a knife stabbed and kept pushing up. The patient went to ER where a cat scan was done that showed that my internal organs were good, ruled out kidney stones, appendicitis, liver or pancreas issues, and gallbladder problems.  The diagnosis was the internal and external rash were in fact shingles. It was affecting the nerve endings in my back and abdomen.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Rash erythematous
Clinical narrative: red rash on my stomach and back / internal and external rash; shingles. It was affecting the nerve endings in my back and abdomen; Wednesday night I woke several times in severe pain.; internal and external rash were in fact shingles; lower back pain / pain in my back was like a knife stabbed me and kept pushing up; sharp abdominal pain on my right side; This case was reported by a consumer and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, 2 days after receiving Shingrix, the patient experienced shingles, low back pain and abdominal pain. On 4th November 2020, the patient experienced poor sleep. On 5th November 2020, the patient experienced red rash and nerve injury. On an unknown date, the outcome of the shingles, low back pain, abdominal pain, poor sleep, red rash and nerve injury were unknown.   It was unknown if the reporter considered the shingles, low back pain, abdominal pain, poor sleep, red rash and nerve injury to be related to Shingrix.  Additional details were received as follows: The patient started experiencing lower back pain and started experiencing sharp abdominal pain on right side.  The pain level increased until Wednesday night and woke several times in severe pain.  Thursday  woke with a red rash on stomach and back.  The pain in back was like a knife stabbed and kept pushing up. The patient went to ER where a cat scan was done that showed that my internal organs were good, ruled out kidney stones, appendicitis, liver or pancreas issues, and gallbladder problems.  The diagnosis was the internal and external rash were in fact shingles. It was affecting the nerve endings in my back and abdomen.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness / around the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2020, the patient received Shingrix. On 7th November 2020, 4 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient had reported the event for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received vaccine on Tuesday and on the day of reporting in morning he/she developed redness about the size of a softball around the injection site. The consent to follow-up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This case was reported by a consumer via interactive digital media and described the occurrence of tinnitus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced tinnitus from Shingrix shot. The consent to follow-up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous, Skin exfoliation
Clinical narrative: Small breakout of shingles; Red scaly patch; scaly patch; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On 9th November 2020, 4 weeks after receiving Shingles vaccine, the patient experienced shingles, red rash and skin scaly. On an unknown date, the outcome of the shingles, red rash and skin scaly were unknown.   It was unknown if the reporter considered the shingles, red rash and skin scaly to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingles shot about 4 weeks ago and had red scaly patch on my right side.  The reporter asked could a small breakout of shingles occur after a shot.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: large red circle at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (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 injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced a large red circle at the injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: have 99.98 fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 13th November 2020, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had Fever. The reporter asked how long would fever last after getting the shot.
Sex: F
Vaccine: FLU4
Symptoms: Chest pain
Clinical narrative: chest pain; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 75-years-old female patient who experienced chest pain, while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing chest pain and had a similar episode after last years vaccine.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious chest pain unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Patient treated in emergency room.  Laboratory details were not reported.   An unknown corrective treatment was received and had received pre treats before immunization.  On an unknown date, the patient recovered from chest pain.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: the child had a fever of 104 and vomiting the same night she received the vaccine.; the child had a fever of 104 and vomiting the same night she received the vaccine.; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who had a  fever of 104 (pyrexia) and vomiting the same night (vomiting) she received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 19-Sep-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5772BA and expiration date-17-Sep-2022] via intramuscular route in the left arm for prophylactic vaccination.  On same day, the patient had a fever of 104 (pyrexia) and vomiting the same night (vomiting) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Final diagnosis was pyrexia and vomiting.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for both events.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Nodule, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient came in to pharmacy today showing a red knot that she reported is sore and warm to touch. Red knot not on deltoid where shot was given but was on the same arm. Arm had a knot and some swelling.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Please note - pt received Pneumovax 23 same visit - LOT T028093 IM Right Deltoid - could the combo of vaccines caused the following?   Middle of night 11/16-11/17 - woke with chills and diaphoresis - did not measure temp Woke this morning 11/17 - when putting on shoes, she became lightheaded and diaphoretic - woke up on the floor (syncope) not knowing how she got there - was helped to bed - had dizziness for 3 hours - then all symptoms resolved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: On the day following the immunization, patient developed a non-itching rash wrapped around her upper trunk.  Patient stated it was slightly tender on her back if she laid on it, but otherwise very mild, and disappeared completely after two days.  She did not treat it with any oral or topical medications.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Insomnia
Clinical narrative: Started with mild pain at the injection site. As the evening progressed so did the pain to a medium level. When I went to bed I developed chills and uncontrollable shivering for about 1 to 2 minutes. I remained extremely chilled throughout the night despite a heating blanket and several thick blankets over me. I developed a severe headache that lasted until the next day. My joints were extremely painful as well. I didn?t sleep much.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling cold, Headache, Injection site pain, Pain
Clinical narrative: I had the usual side effects: chills, headache, major soreness at the site of injection but I also had sharp pains randomly running down only the left side of my body.  Sharp pains in my rib cage when trying to take a deep breath, jolting pain from my left hip to my ankle (specifically on the outside on my left knee) and the top of my left foot ached for about an hour.  It's now 22 hours after injection and I still have a headache and feel very weak.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Painful respiration
Clinical narrative: I had the usual side effects: chills, headache, major soreness at the site of injection but I also had sharp pains randomly running down only the left side of my body.  Sharp pains in my rib cage when trying to take a deep breath, jolting pain from my left hip to my ankle (specifically on the outside on my left knee) and the top of my left foot ached for about an hour.  It's now 22 hours after injection and I still have a headache and feel very weak.
Sex: M
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Abnormal behaviour, Autism spectrum disorder, Dyskinesia, Fatigue, Febrile convulsion
Clinical narrative: Took my son to get his routine 15 month vaccinations. after he received his vaccinations he immediately started feeling tired and wanted to go to bed. Son had high fever later in the night and started having seizures and convulsions.  Called the on call Nurse for sons PCP 4 times in the night and they stated that all was normal and advised he did not need to be seen at Er. Thought we were talking to the Ped group on call but found out that they were speaking to a sub contracted ped group after hour center and does not know if the enter was professionally staffed. Group will not release the call information.  Convulsions/ tremors lasted for about a month and son started not being himself. 2015 Dr. Dr. diagnosed with sleep seizures (febral seizure activity). temp throughout the night was up to 103. After spoke with on call nurse 4th time. next day started having tremors throughout the day. Spoke with several family members who are MDs and they told me to let him sleep it off. Went in to  MD (Dr.) and he started getting weird with me.Did not preform any tests or report to the VAERS program. few months later he diagnosed him autism. Son was on track with every milestone before the admin of vaccine. Have seen 3 different types of neuro MD psychologists. Placed him in a study at the treatment center. Study.  ( showed remarkable results). to this day he is still nonverbal. still lacking some Muscular control.
Sex: M
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Immediate post-injection reaction, Pyrexia, Seizure, Speech disorder, Transcranial magnetic stimulation
Clinical narrative: Took my son to get his routine 15 month vaccinations. after he received his vaccinations he immediately started feeling tired and wanted to go to bed. Son had high fever later in the night and started having seizures and convulsions.  Called the on call Nurse for sons PCP 4 times in the night and they stated that all was normal and advised he did not need to be seen at Er. Thought we were talking to the Ped group on call but found out that they were speaking to a sub contracted ped group after hour center and does not know if the enter was professionally staffed. Group will not release the call information.  Convulsions/ tremors lasted for about a month and son started not being himself. 2015 Dr. Dr. diagnosed with sleep seizures (febral seizure activity). temp throughout the night was up to 103. After spoke with on call nurse 4th time. next day started having tremors throughout the day. Spoke with several family members who are MDs and they told me to let him sleep it off. Went in to  MD (Dr.) and he started getting weird with me.Did not preform any tests or report to the VAERS program. few months later he diagnosed him autism. Son was on track with every milestone before the admin of vaccine. Have seen 3 different types of neuro MD psychologists. Placed him in a study at the treatment center. Study.  ( showed remarkable results). to this day he is still nonverbal. still lacking some Muscular control.
Sex: M
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Tremor
Clinical narrative: Took my son to get his routine 15 month vaccinations. after he received his vaccinations he immediately started feeling tired and wanted to go to bed. Son had high fever later in the night and started having seizures and convulsions.  Called the on call Nurse for sons PCP 4 times in the night and they stated that all was normal and advised he did not need to be seen at Er. Thought we were talking to the Ped group on call but found out that they were speaking to a sub contracted ped group after hour center and does not know if the enter was professionally staffed. Group will not release the call information.  Convulsions/ tremors lasted for about a month and son started not being himself. 2015 Dr. Dr. diagnosed with sleep seizures (febral seizure activity). temp throughout the night was up to 103. After spoke with on call nurse 4th time. next day started having tremors throughout the day. Spoke with several family members who are MDs and they told me to let him sleep it off. Went in to  MD (Dr.) and he started getting weird with me.Did not preform any tests or report to the VAERS program. few months later he diagnosed him autism. Son was on track with every milestone before the admin of vaccine. Have seen 3 different types of neuro MD psychologists. Placed him in a study at the treatment center. Study.  ( showed remarkable results). to this day he is still nonverbal. still lacking some Muscular control.
Age: 34.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Eye pruritus, Lacrimation increased, Nasal congestion, Ocular hyperaemia
Clinical narrative: Itchy, watery, bloodshot eyes, eyelid swelling and hives around eyes, nasal congestion and swelling, some wheezing and coughing
Age: 34.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria, Wheezing
Clinical narrative: Itchy, watery, bloodshot eyes, eyelid swelling and hives around eyes, nasal congestion and swelling, some wheezing and coughing
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: High fever, chills, joint pain, headache