chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; a 30 year old patient received a dose of PROQUAD; This spontaneous report was received from a pharmacist and refers to a 30-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 02-AUG-2019, the patient was vaccinated with a dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot # S002924, expiration date: 28-JUL-2020 (exact dose, site and route of administration were not reported) for prophylaxis (inappropriate age at vaccine administration). There were no known adverse effects reported.
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Papule, Pruritus, Skin lesion
Clinical narrative: Primary varicella infection; vaccine strain virus was the most likely etiology; This literature marketed report has been received from the authors of a published literature article and refers to a 61-year-old female patient with cirrhosis. The patient had been hospitalized the month previous for decompensated cirrhosis and underwent liver transplantation evaluation. She was found to have an undetectable varicella IgG antibody titer during routine pre-transplantation screening.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) first dose, (dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date, about 3 weeks later, the patient developed pruritic skin lesions involving her chest, back, arms, and legs. Dermatologic evaluation revealed disseminated vesicles and eroded papules on an erythematous base, without ocular or mucosal involvement. Direct fluorescent antibody (DFA) testing of a vesicle for varicella zoster virus (VZV) returned positive. The patient's classic skin lesions in multiple stages of evolution and positive DFA, were felt to be consistent with primary varicella infection, with which the patient presented 3 weeks after vaccination (also reported as 1 moth after the first dose of the vaccination). Based on the temporal relation of the patient's rash with the vaccination with varicella virus vaccine live (oka/merck) (manufacturer unknown), the authors felt that vaccine strain virus, rather than wild type, was the most likely etiology. The patient was started on intravenous acyclovir and was transitioned to oral valacyclovir for a total 10-day course. The event of the rash diagnosed as primary varicella infection resolved without complication on an unknown date. The outcome of the event of vaccination failure was unknown. The causality between the events and varicella virus vaccine live (oka/merck) (manufacturer unknown) was assessed to be related.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: Primary varicella infection; vaccine strain virus was the most likely etiology; This literature marketed report has been received from the authors of a published literature article and refers to a 61-year-old female patient with cirrhosis. The patient had been hospitalized the month previous for decompensated cirrhosis and underwent liver transplantation evaluation. She was found to have an undetectable varicella IgG antibody titer during routine pre-transplantation screening.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) first dose, (dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date, about 3 weeks later, the patient developed pruritic skin lesions involving her chest, back, arms, and legs. Dermatologic evaluation revealed disseminated vesicles and eroded papules on an erythematous base, without ocular or mucosal involvement. Direct fluorescent antibody (DFA) testing of a vesicle for varicella zoster virus (VZV) returned positive. The patient's classic skin lesions in multiple stages of evolution and positive DFA, were felt to be consistent with primary varicella infection, with which the patient presented 3 weeks after vaccination (also reported as 1 moth after the first dose of the vaccination). Based on the temporal relation of the patient's rash with the vaccination with varicella virus vaccine live (oka/merck) (manufacturer unknown), the authors felt that vaccine strain virus, rather than wild type, was the most likely etiology. The patient was started on intravenous acyclovir and was transitioned to oral valacyclovir for a total 10-day course. The event of the rash diagnosed as primary varicella infection resolved without complication on an unknown date. The outcome of the event of vaccination failure was unknown. The causality between the events and varicella virus vaccine live (oka/merck) (manufacturer unknown) was assessed to be related.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one dose of improperly stored vaccine, Gardasil 9, has been administered to one patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-AUG-2019, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (lot # R032766 has been verified to be a valid lot number and expiration date reported as 14-AUG-2019 but upon internal validation established as 31-AUG-2021) (dose and route of administration were not reported) for prophylaxis. The temperature was 29.3 F (units not reported) for 7 hours and 57 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster/ shingles; This spontaneous report was received from a lawyer and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 24-AUG-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On 28-AUG-2017 (reported as four days after receiving the vaccine), the patient suffered herpes zoster/shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using vaccine. The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's 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, 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 of zoster vaccine live (ZOSTAVAX) use, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered herpes zoster/ shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster/ shingles was considered to be disabling.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a dose of VARIVAX following a temperature excursion; no adverse effects reported; This spontaneous report as received from an office manager refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 16-AUG-2019, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # N034553, expiration date 05-DEC-2019, for prophylaxis (route of administration, anatomical location, dose and frequency were not reported), following a temperature excursion. The vaccine was exposed to a temperature 15 degrees Fahrenheit to 46 degrees Fahrenheit for 30 days. The call was made because of digital data logger. There were no previous temperature excursion. There were no adverse effects reported. The outcome of the events was unknown.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; one female patient was administered improperly stored M-M-R II; This spontaneous report was received from an office manager and refers to a 26-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 31-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031628 has been verified to be a valid lot number, expiration date 01-NOV-2020, recombinant Human albumin (exact dose, dose number, route and site of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  Administered doses of vaccine were exposed to the temperature excursion above (also reported as the highest temperature) 47 degrees Fahrenheit (51.1 degrees Fahrenheit, multiple) total time for 29 hours. Data logger was involved. There was no previous temperature excursions. There was no adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Depressed level of consciousness, Dizziness
Clinical narrative: got dizzy, was close to passing out, and went back into the office; This spontaneous report was received from a Licensed Practical Nurse and refers to a female patient of unknown age. No information regarding her pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 20-AUG-2019, the patient was vaccinated with the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), route of administration reported as injection (exact dose, lot # and expiration date were not reported) for cancer prevention. On 20-AUG-2019, the patient refused to wait in the office after receiving her dose of the vaccine and went outside to her car. She got dizzy, was close to passing out and went back into the office. The outcome of the event was reported as recovered on 20-AUG-2019. The reported stated that, the event was an adverse effect after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Therefore, the event was considered to be related to suspected vaccine.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA008206:
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: did pass out; This spontaneous report was received from a Licensed Practical Nurse and refers to a 15-year-old male patient. No information regarding his pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date in January 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot # and expiration date were not reported) for cancer prevention. It was reported that he "was OK" after vaccination. On 02-AUG-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) route of administration reported as injection (exact dose, lot # and expiration date were not reported) for cancer prevention. On 02-AUG-2019, the patient passed out after receiving his second dose of the vaccine. He did not eat any food prior to receiving the vaccine. As soon as the office personnel gave him food, he was fine. The outcome of the event was reported as recovered on 02-AUG-2019. The reported stated that, the passing out was an adverse effect after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Therefore, the event was considered to be related to suspected vaccine.   Upon internal review the event of pass out was considered to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA008190:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored; This spontaneous report was received from a nurse regarding a patient of unknown demographics. The patient's medical history, concurrent conditions and drug allergies were unknown. On 14-AUG-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection lot # R031681, expiry date: 01-NOV-2020 (dose number, anatomical location and route of administration unknown) for prophylaxis which was reconstituted with a properly stored sterile diluent (product storage error). No adverse effects were reported.  The vaccine underwent temperature excursion of above 47-degree Fahrenheit (48.1 F) for a time frame of 7 hours without a previous temperature excursion. A digital data logger was involved. No product quality complaints (PQC) were involved.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 5544H, expiry date 15th May 2021) for prophylaxis.   On 18th February 2019, the patient received the 1st dose of Shingrix. On 18th February 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On 19th February 2019, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had flu-like symptoms within 8 hours. The symptoms resolved the following day.  He also reported that he had a similar reaction to the 2nd shot.  No additional details were available as the patient's cell phone disconnected in a remote location.  The reporter can follow up directly with the patient. The reporter called back and provided additional information. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019149401. This case linked with US2019149405, reported by same reporter.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash, Rash macular, Rash pruritic
Clinical narrative: Shingles; Condition aggravated; rash appear across his chest, down his arms and onto his stomach; little red whelps, splotches; Itchy splotches; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 20th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd June 2019, 3 days after receiving Shingrix, the patient experienced shingles (serious criteria clinically significant/intervention required), condition aggravated (serious criteria clinically significant/intervention required), erythromacular rash (serious criteria clinically significant/intervention required), welts (serious criteria clinically significant/intervention required) and itchy rash (serious criteria clinically significant/intervention required). The patient was treated with prednisone, antihistamine (Antihistamines) and dexamethasone. On an unknown date, the outcome of the shingles, condition aggravated, erythromacular rash, welts and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, condition aggravated, erythromacular rash, welts and itchy rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix while he still had active shingles. The patient experienced shingles outbreak.  Rash appeared across his chest, spread down to his arms and onto his stomach. He noted it was also down his left leg at the time of reporting. He described the rash as little red whelps, splotches that are slightly itchy that started where his shingles were on her right side of chest, spread to left chest, down both arms and down onto stomach. The patient stated his shingles began on his back and came around his right side. The patient saw his primary care physician on 1st July 2019, who recommended to see a dermatologist. He saw the dermatologist on 18th July 2019. The patient was given a Prednisone shot and that did calm the itch and rash but didn't resolve.  The patient was also given a Prednisone dose pack and told to take an antihistamine, but noted the antihistamine didn't help.  The patient was using dexamethasone cream at the time of reporting, which did help but the rash was still not resolved.  The patient stated the dermatologist stated she did not think this rash was related to dose 1 of Shingrix. The reporter consented for follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Shingles; Condition aggravated; rash appear across his chest, down his arms and onto his stomach; little red whelps, splotches; Itchy splotches; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 20th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd June 2019, 3 days after receiving Shingrix, the patient experienced shingles (serious criteria clinically significant/intervention required), condition aggravated (serious criteria clinically significant/intervention required), erythromacular rash (serious criteria clinically significant/intervention required), welts (serious criteria clinically significant/intervention required) and itchy rash (serious criteria clinically significant/intervention required). The patient was treated with prednisone, antihistamine (Antihistamines) and dexamethasone. On an unknown date, the outcome of the shingles, condition aggravated, erythromacular rash, welts and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, condition aggravated, erythromacular rash, welts and itchy rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix while he still had active shingles. The patient experienced shingles outbreak.  Rash appeared across his chest, spread down to his arms and onto his stomach. He noted it was also down his left leg at the time of reporting. He described the rash as little red whelps, splotches that are slightly itchy that started where his shingles were on her right side of chest, spread to left chest, down both arms and down onto stomach. The patient stated his shingles began on his back and came around his right side. The patient saw his primary care physician on 1st July 2019, who recommended to see a dermatologist. He saw the dermatologist on 18th July 2019. The patient was given a Prednisone shot and that did calm the itch and rash but didn't resolve.  The patient was also given a Prednisone dose pack and told to take an antihistamine, but noted the antihistamine didn't help.  The patient was using dexamethasone cream at the time of reporting, which did help but the rash was still not resolved.  The patient stated the dermatologist stated she did not think this rash was related to dose 1 of Shingrix. The reporter consented for follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Immediate post-injection reaction, Injection site extravasation
Clinical narrative: vaccine was observed leaking down the patient's arm; underdose; accidental exposure to vaccine; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RR52, expiry date unknown) for prophylaxis.   On 13th August 2019, the patient received Shingrix. On 13th August 2019, immediately after receiving Shingrix, the patient experienced injection site leaking, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site leaking, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were provided as follows: The patient received an unknown amount of Shingrix after the vaccine was observed leaking down the patient's arm, which led to underdose, injection site leaking, inadvertent exposure to vaccine, exposure via skin contact. It was not known whether it leaked from the syringe or the injection site. The reporter did not consent to follow-up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: low grade fever; tiredness; severe injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2019, the patient received Shingrix (intramuscular). On 9th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and tiredness. On 10th August 2019, the patient experienced low grade fever. On 10th August 2019, the outcome of the low grade fever and tiredness were recovered/resolved. In August 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, low grade fever and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The reporter did not give permission to follow up. In the document outcome of events was reported as unknown, but in date of end of reaction/event was reported, so events outcome was captured as recovered/resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Pain; Swelling; This case was reported by a physician via call center representative and described the occurrence of pain in a 91-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, less than 2 years after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were unknown.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain and swelling. The reporter did not have lot or expiration date, as the 1st dose was given elsewhere. The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Blood sodium decreased, Facial paralysis, Hypoaesthesia, Injection site pain, Pain
Clinical narrative: Severe pain at location of injection and all over body; Severe pain at location of injection and all over body; Sodium  low; Bell's Palsy; Numbness and tingling in feet and coming up legs; Numbness and tingling in feet and coming up legs; Numbness and tingling in feet and coming up legs; This is a spontaneous report from a contactable consumer (patient).   This 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot. W81747) on an unspecified date, in Apr2019, at single dose, for immunization (Pneumococcal prevention). Relevant medical history included high cholesterol from an unspecified date. Concomitant medication included oral simvastatin 20 mg, once daily, from an unspecified date (ongoing), for high cholesterol. On an unspecified date, in Apr2019, after the shot, the patient experienced severe pain at location of injection and all over body. Hospitalization was required for severe pain at location of injection and all over body from an unspecified date, in Apr2019. She was in hospital for 4 days and when she got out, 4 days later experienced Bell's palsy (onset date Apr2019). On an unspecified date, in Apr2019, about a week later went to emergency room and was diagnosed with low sodium. On an unspecified date, in 2019, the patient developed also numbness and tingling in feet and coming up legs. Laboratory test included blood sodium low on an unspecified date, in Apr2019, and an unspecified result on an unknown date, in May2019. The patient recovered completely from pain at location of injection and all over body on an unspecified date, in 2019, recovered from sodium low on an unspecified date, in Apr2019. Clinical outcome of bell's palsy was recovering while clinical outcome of the event numbness and tingling in feet was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia
Clinical narrative: Severe pain at location of injection and all over body; Severe pain at location of injection and all over body; Sodium  low; Bell's Palsy; Numbness and tingling in feet and coming up legs; Numbness and tingling in feet and coming up legs; Numbness and tingling in feet and coming up legs; This is a spontaneous report from a contactable consumer (patient).   This 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot. W81747) on an unspecified date, in Apr2019, at single dose, for immunization (Pneumococcal prevention). Relevant medical history included high cholesterol from an unspecified date. Concomitant medication included oral simvastatin 20 mg, once daily, from an unspecified date (ongoing), for high cholesterol. On an unspecified date, in Apr2019, after the shot, the patient experienced severe pain at location of injection and all over body. Hospitalization was required for severe pain at location of injection and all over body from an unspecified date, in Apr2019. She was in hospital for 4 days and when she got out, 4 days later experienced Bell's palsy (onset date Apr2019). On an unspecified date, in Apr2019, about a week later went to emergency room and was diagnosed with low sodium. On an unspecified date, in 2019, the patient developed also numbness and tingling in feet and coming up legs. Laboratory test included blood sodium low on an unspecified date, in Apr2019, and an unspecified result on an unknown date, in May2019. The patient recovered completely from pain at location of injection and all over body on an unspecified date, in 2019, recovered from sodium low on an unspecified date, in Apr2019. Clinical outcome of bell's palsy was recovering while clinical outcome of the event numbness and tingling in feet was unknown.
Age: 12.0
Sex: F
Vaccine: MMRV
Symptoms: Blood immunoglobulin G normal, Clumsiness, Crying, Decreased appetite, Depressed mood
Clinical narrative: fever, swelling of face, eye pain and pressure in eyes, blood shot eyes, daily sneezing (1-4 times a day), nose stuffed, labored breathing noticed during sleep, sleepwalking (twice), speaking during dreams,loss of appetite, more clumsy, thinking more cloudy, thoughts of hopelessness, daily crying, profound sadness (only in the evening).     My daughter continues to have hopeless thoughts and sadness every evening that is relieved with crying and lasts from 30 min to one hour. It occurs when the sun is coming down. She still sneezes, but less.  Her eyes are bloodshot at night.
Age: 12.0
Sex: F
Vaccine: MMRV
Symptoms: Dyspnoea, Eye pain, Feeling of despair, Laboratory test, Measles antibody positive
Clinical narrative: fever, swelling of face, eye pain and pressure in eyes, blood shot eyes, daily sneezing (1-4 times a day), nose stuffed, labored breathing noticed during sleep, sleepwalking (twice), speaking during dreams,loss of appetite, more clumsy, thinking more cloudy, thoughts of hopelessness, daily crying, profound sadness (only in the evening).     My daughter continues to have hopeless thoughts and sadness every evening that is relieved with crying and lasts from 30 min to one hour. It occurs when the sun is coming down. She still sneezes, but less.  Her eyes are bloodshot at night.
Age: 12.0
Sex: F
Vaccine: MMRV
Symptoms: Mental impairment, Nasal congestion, Ocular discomfort, Ocular hyperaemia, Pyrexia
Clinical narrative: fever, swelling of face, eye pain and pressure in eyes, blood shot eyes, daily sneezing (1-4 times a day), nose stuffed, labored breathing noticed during sleep, sleepwalking (twice), speaking during dreams,loss of appetite, more clumsy, thinking more cloudy, thoughts of hopelessness, daily crying, profound sadness (only in the evening).     My daughter continues to have hopeless thoughts and sadness every evening that is relieved with crying and lasts from 30 min to one hour. It occurs when the sun is coming down. She still sneezes, but less.  Her eyes are bloodshot at night.
Age: 12.0
Sex: F
Vaccine: MMRV
Symptoms: Rubella antibody positive, Sleep talking, Sneezing, Somnambulism, Swelling face
Clinical narrative: fever, swelling of face, eye pain and pressure in eyes, blood shot eyes, daily sneezing (1-4 times a day), nose stuffed, labored breathing noticed during sleep, sleepwalking (twice), speaking during dreams,loss of appetite, more clumsy, thinking more cloudy, thoughts of hopelessness, daily crying, profound sadness (only in the evening).     My daughter continues to have hopeless thoughts and sadness every evening that is relieved with crying and lasts from 30 min to one hour. It occurs when the sun is coming down. She still sneezes, but less.  Her eyes are bloodshot at night.
Age: 9.0
Sex: F
Vaccine: MNQ
Symptoms: Product administration error
Clinical narrative: THE MEDICAL ASSISTANT DID NOT VERIFY PT'S IDENTITY NOR THE CORRECT VACCINE. RETRAINING OF THE STAFF WILL BE IMPLEMENTED, TO ENSURE BETTER QUALITY AND CORRECT ADMINISTRATION IS DONE.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: 65 yo F presented for annual exam on 8/14/19.  First Prevnar immunization.  Given by CMA in her left arm at 0922.  The same day, patient developed pain and redness at the site of the njection.  Pain resolved within a couple of days but erythema and warmth had gotten worse.  Area of involvement on proximal side of left upper arm is pruritic, red, raised confluent rash.  Due to concern for cellulits, patient was started on 10 day course of Bactrim and a prednisone taper.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 65 yo F presented for annual exam on 8/14/19.  First Prevnar immunization.  Given by CMA in her left arm at 0922.  The same day, patient developed pain and redness at the site of the njection.  Pain resolved within a couple of days but erythema and warmth had gotten worse.  Area of involvement on proximal side of left upper arm is pruritic, red, raised confluent rash.  Due to concern for cellulits, patient was started on 10 day course of Bactrim and a prednisone taper.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: Patient received 1st dose of Shingrix on 8/18 by RPH, patient called Monday to say that her  arm was red and sore, RPH advised that this was a common reaction and to ice, take pain medication, but to watch it and if it progressed to contact her provider as well as us so we can initiate proper treatment. Wed 8/21 patient arrived at the pharmacy in drive thru to pick up an antibiotic rx for confirmed cellulitis by her provider.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Abdominal pain upper, Back pain, Dizziness, Dyspnoea
Clinical narrative: At around 3pm, FLUAD was administered to Patient. At around 3:03 patient stated she was feeling dizzy, back pain, stomach pain and she could not breathe. Pharmacist comforted Patient and asked technicians to call 911, He administered Epi Pen contents and stayed with patient until EMS arrived.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Pruritus, Rash
Clinical narrative: Itching, pain Rash (observed in office 8/23/19, erythematous, vesicular lesions in dermatomal pattern on right side of back, right torso/breast
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: 5th Dtap + 4th Polio.  rash, redness and swelling
Age: 1.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Dysstasia, Ear infection, Gait disturbance, Injection site pain, Pyrexia
Clinical narrative: I may have the brands off for the vaccines, I'm reading off of his past visit report. He had extreme pain in his legs, couldn't stand or walk for hours. He was screaming from around 9pm until 11:30pm from pain, I could not touch his injection site or hold him anywhere but around his chest without him screaming and shaking. he developed and fever of 105* around, we went to the ER and they said it was normal, it went down after Tylenol, but was back up to 105.6* at 5:30am. At 8:30am he had a fever of 104.4* and we went into his doctor, who found he had developed an ear infection "as a result of the vaccines". He had a low level fever until 8/23/19
Age: 1.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Screaming, Tremor
Clinical narrative: I may have the brands off for the vaccines, I'm reading off of his past visit report. He had extreme pain in his legs, couldn't stand or walk for hours. He was screaming from around 9pm until 11:30pm from pain, I could not touch his injection site or hold him anywhere but around his chest without him screaming and shaking. he developed and fever of 105* around, we went to the ER and they said it was normal, it went down after Tylenol, but was back up to 105.6* at 5:30am. At 8:30am he had a fever of 104.4* and we went into his doctor, who found he had developed an ear infection "as a result of the vaccines". He had a low level fever until 8/23/19
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Ataxia, Headache, Herpes zoster, Rash
Clinical narrative: Patient received his second dose of shingrix at another facility on 7/31/19. He reported to our clinic on 8/7/19 with complaints of a rash starting 3 days prior.  The provider determined it was shingles upon their assessment and prescribed the patient acyclovir 800mg 5 times per day x 7 days.  Patient saw his primary provider on 8/13/19 who reports patient continued with typical zoster type rash on left torso as well as headache and some ataxia. Unsure if this is related to the shingles or acyclovir. Patient was advised to DC the medication as he only had 1 day left and report any changes to provider as there is a concern for secondary bacterial infection. Patient was also prescribed lidocaine patches.  The nurse spoke to the patient on 8/19/19 as he continues to report the rash, but the headache and ataxia resolved shortly after stopping acyclovir.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: On July 8, 2019 she was admitted to Hospital and was diagnosed with Kawasaki Disease on 07/10/2019. She received IVIG and is currently taking Aspirin.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient presented in office due to small red bump on left thigh over injection site that was hard to the touch. Per mother she explains that it was present since date vaccine was administered. Provider ruled outcome as Serum reaction due to vaccination. Patient did not present with discomfort and was able to ambulate without problems. Patient will follow up in about 2 weeks.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Lethargy, Sluggishness
Clinical narrative: extreme lethargy, sluggish, chills, felt like the flu. resolved after 24 hours
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: pt developed raised red patch, warm to the touch since the evening of 8/20/19. Instructed potential allergic reaction and to administer ice patch and Ibuprofen
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, swelling around injection site. Hot to the touch.  Patient will take diphenhydramine by mouth and use cold packs. Seek further treatment if condition worsens.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Lethargy, Sluggishness
Clinical narrative: extreme letharge, sluggishness, felt like the flu, very bad headache, resolved after 24 hrs
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Had vaccines on 8/6/19.  Presented back to clinic 8/8/19.  Mom states child did well with vaccines but the next day woke up complaining of soreness on left arm. She looked  and site was red and swollen and hot to touch.  She put ice to area on and off and says it does look better.  Today area on left upper arm is red, raised and hot to touch.  Measures 2.5  x 3 cm.  Advised to continue to apply ice on and off for next 24 hours.  Advised follow up with physician for eval.  today.   8/9/19:  Phoned mother.  She did take child to his physician and they gave him a steroid shot and oral prednisone and it looks much better now.  She states they did not call it allergic .
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Hypersensitivity, Swelling face
Clinical narrative: I woke up this AM with my face especially under my eyes and cheeks extremely swollen I went to the Urgent care facility and the doctor said it was an allergic reaction to something. The diagnosis he gave me was angioneurotic edema.  I got a shot of prednisone, a  prescription for 50mg tablets one tablet per day for 5 days, and a topical cream called Clobetasol propriate 0.05%.   I went to she Shindrex website and it mentioned that a severe reaction to the vaccine could be a swollen face.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Erythematous rash with tenderness of the left arm 48 hours after vaccine
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: vesicular rash right groin
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous ulcer
Clinical narrative: Patient presented approximately 5 days after receiving immunization. He reported what he described as a canker sore that developed about 24-48 hours after receipt of immunization. At the time of his report the symptoms had improved but had not yet fully resolved. He did not consider it serious but wanted to mention as he was picking up a prescription anyhow.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: pt woke up the next morning with a severe migraine and nausea/vomiting
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate to lasting pain, soreness and redness at injection site. Fever within 2 hrs.,  exceeding 101.0 - lasting longer than single course over-the-counter remedy (acetaminophen 8 hr. relief),  abdominal cramps & discomfort, acute neuralgia/sharp muscular aches and pains, headache, nausea.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nausea, Neuralgia, Pyrexia
Clinical narrative: Immediate to lasting pain, soreness and redness at injection site. Fever within 2 hrs.,  exceeding 101.0 - lasting longer than single course over-the-counter remedy (acetaminophen 8 hr. relief),  abdominal cramps & discomfort, acute neuralgia/sharp muscular aches and pains, headache, nausea.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5
Symptoms: Infantile spasms
Clinical narrative: Starting having spasms, got worse over several weeks. Went to ER. Diagnosed with Infant Spasms
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Induration, Pain, Pyrexia, Skin discolouration
Clinical narrative: Pt developed low grade fever and swelling, golf ball size the day after her injection. Swelling was hard, red & painful x 3-4 days. Following with 25¢ size blackened area that is fading. Pt reported reaction 17 days after injection. No discomfort after 4 days.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Swelling
Clinical narrative: Pt developed low grade fever and swelling, golf ball size the day after her injection. Swelling was hard, red & painful x 3-4 days. Following with 25¢ size blackened area that is fading. Pt reported reaction 17 days after injection. No discomfort after 4 days.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Rash from face to arms to trunk within seconds of receiving vaccines. Given Benadryl and resolved within 30 min.
Age: 7.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving Tdap and IPV vaccine.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received one dose of improperly stored MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 15-AUG-2019, the patient received an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031681 with expiration date 01-NOV-2020 (strength, dose, route not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent lot # N029636 with expiration date 29-MAR-2020. The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was exposed to a temperature excursion above 47 degrees Fahrenheit (°F) (48.1 F) during a timeframe of 7 hours, which was detected by a digital data logger. There were no previous temperature excursions. No adverse effects reported.  The therapy type of the lot number R031681 is rHA.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 18th February 2019, for tolerance refer case US2019AMR149954).   On 7th May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient had flu-like symptoms after receiving 2nd shot of Shingrix. The patient consented to follow up and provided contact details of his physician. No additional details were available as the patient's cell phone was disconnected in a remote location. This case is linked with US2019149405, reported by the patient for his wife.
Sex: U
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Malaise, Pain, Swelling
Clinical narrative: Malaise; puffiness/swelling; redness; Pain; This case was reported by a pharmacist via other manufacturer and described the occurrence of malaise in an unknown number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included pneumococcal vaccine (Prevenar 13) for an unknown indication.   On an unknown date, the patient received Shingrix at an unknown dose and Prevenar 13 at an unknown dose and frequency. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise, tissue puffing, erythema and pain. On an unknown date, the outcome of the malaise, tissue puffing, erythema and pain were unknown.   It was unknown if the reporter considered the malaise, tissue puffing, erythema and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The pharmacist reported that with Prevnar a patient experienced puffiness, redness and swelling post vaccination. The pharmacist compared it with Shingrix and most patients experience malaise with Shingrix. The reporter had no patient details to provide.  The reporter added this was the reporter's general experience with the vaccines. No additional details were provided. The reporter stated that the most common side effects were pain, redness and swelling.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on chest; This case was reported by a physician via sales rep and described the occurrence of rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix and developed rash on chest. The reporter did not agree to follow up from GlaxoSmithKline (GSK).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Pyrexia
Clinical narrative: fever; rash at the injection site; red at the injection site; scratchy at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 21st March 2019, refer case US2019149405).   On 7th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced fever, injection site rash, injection site erythema and injection site abrasion. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was unknown and the outcome of the injection site rash, injection site erythema and injection site abrasion were recovered/resolved.   It was unknown if the reporter considered the fever, injection site rash, injection site erythema and injection site abrasion to be related to Shingrix.  Additional details were provided as follows: The husband reported that his wife had Shingrix and experienced a fever of 101 to 101.5, but the symptoms were worse. The reporter Consented to follow up. No additional details were available as the reporter's cell phone died in a remote location. The reporter also added that his wife had a decent rash at the injection site. It was red at the injection site and scratchy at the injection site. The events were gone by time of reporting. This case has been linked with US2019149405, reported by same reporter.      Lab Comments: Lab test performed on an unknown date