chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Muscle was sore/Muscle ache; Chills; Fever; Arm pain that I can hardly lift my arm up; Arm pain that I can hardly lift my arm up; Joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received bnt162b2 (BNT162B2 formulation: solution for injection), dose 1 via an unspecified route of administration, administer in left arm on 03May2021 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE (at the age of 61-year-old) for covid-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), arthritis, gout, ongoing GERD (gastrooesophageal reflux disease), ongoing psoriasis, ongoing pain (pain for foot because patient had fungus on foot) ongoing sinuses. The patient stated medical conditions deigned 7 or 8 years ago maybe 10. Concomitant medication included nifedipine taken for GERD, triamcinolone acetonide (1 percent) taken for psoriasis, ibuprofen taken for pain (pain for foot because patient had fungus on foot), famotidine, salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) (inhaler) taken for sinuses and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, all concomitant start and stop date were not reported. The patient experienced muscle was sore/muscle ache, chills, fever, arm pain that the patient can hardly lift arm up, joint pain on an unspecified date. The patient asking if she need to go emergency room for this side effects. The patient stated that "feels like its gone into my arm in my armpit I am still freeze. Its kind of say in that progressing little bit". The second dose was scheduled on 23May2021. No treatment taken for the events. The outcome of event arm pain that I can hardly lift my arm up reported as not recovered and outcome other events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscle was sore/Muscle ache; Chills; Fever; Arm pain that I can hardly lift my arm up; Arm pain that I can hardly lift my arm up; Joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received bnt162b2 (BNT162B2 formulation: solution for injection), dose 1 via an unspecified route of administration, administer in left arm on 03May2021 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE (at the age of 61-year-old) for covid-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), arthritis, gout, ongoing GERD (gastrooesophageal reflux disease), ongoing psoriasis, ongoing pain (pain for foot because patient had fungus on foot) ongoing sinuses. The patient stated medical conditions deigned 7 or 8 years ago maybe 10. Concomitant medication included nifedipine taken for GERD, triamcinolone acetonide (1 percent) taken for psoriasis, ibuprofen taken for pain (pain for foot because patient had fungus on foot), famotidine, salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) (inhaler) taken for sinuses and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, all concomitant start and stop date were not reported. The patient experienced muscle was sore/muscle ache, chills, fever, arm pain that the patient can hardly lift arm up, joint pain on an unspecified date. The patient asking if she need to go emergency room for this side effects. The patient stated that "feels like its gone into my arm in my armpit I am still freeze. Its kind of say in that progressing little bit". The second dose was scheduled on 23May2021. No treatment taken for the events. The outcome of event arm pain that I can hardly lift my arm up reported as not recovered and outcome other events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pain, Pain in extremity
Clinical narrative: Muscle was sore/Muscle ache; Chills; Fever; Arm pain that I can hardly lift my arm up; Arm pain that I can hardly lift my arm up; Joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received bnt162b2 (BNT162B2 formulation: solution for injection), dose 1 via an unspecified route of administration, administer in left arm on 03May2021 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE (at the age of 61-year-old) for covid-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), arthritis, gout, ongoing GERD (gastrooesophageal reflux disease), ongoing psoriasis, ongoing pain (pain for foot because patient had fungus on foot) ongoing sinuses. The patient stated medical conditions deigned 7 or 8 years ago maybe 10. Concomitant medication included nifedipine taken for GERD, triamcinolone acetonide (1 percent) taken for psoriasis, ibuprofen taken for pain (pain for foot because patient had fungus on foot), famotidine, salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) (inhaler) taken for sinuses and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, all concomitant start and stop date were not reported. The patient experienced muscle was sore/muscle ache, chills, fever, arm pain that the patient can hardly lift arm up, joint pain on an unspecified date. The patient asking if she need to go emergency room for this side effects. The patient stated that "feels like its gone into my arm in my armpit I am still freeze. Its kind of say in that progressing little bit". The second dose was scheduled on 23May2021. No treatment taken for the events. The outcome of event arm pain that I can hardly lift my arm up reported as not recovered and outcome other events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Muscle was sore/Muscle ache; Chills; Fever; Arm pain that I can hardly lift my arm up; Arm pain that I can hardly lift my arm up; Joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received bnt162b2 (BNT162B2 formulation: solution for injection), dose 1 via an unspecified route of administration, administer in left arm on 03May2021 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE (at the age of 61-year-old) for covid-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), arthritis, gout, ongoing GERD (gastrooesophageal reflux disease), ongoing psoriasis, ongoing pain (pain for foot because patient had fungus on foot) ongoing sinuses. The patient stated medical conditions deigned 7 or 8 years ago maybe 10. Concomitant medication included nifedipine taken for GERD, triamcinolone acetonide (1 percent) taken for psoriasis, ibuprofen taken for pain (pain for foot because patient had fungus on foot), famotidine, salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) (inhaler) taken for sinuses and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, all concomitant start and stop date were not reported. The patient experienced muscle was sore/muscle ache, chills, fever, arm pain that the patient can hardly lift arm up, joint pain on an unspecified date. The patient asking if she need to go emergency room for this side effects. The patient stated that "feels like its gone into my arm in my armpit I am still freeze. Its kind of say in that progressing little bit". The second dose was scheduled on 23May2021. No treatment taken for the events. The outcome of event arm pain that I can hardly lift my arm up reported as not recovered and outcome other events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb mass, Lymph node pain, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: upper arm sore; big swollen area on her her upper arm; The area hurts and itches; sore arm at the injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 26Apr2021 (age at vaccination was 71 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On an unspecified date in 2021, after the first dose patient had a sore arm at the injection site for a couple of days, upper arm was sore, a big swollen area on her upper arm, the area hurts and itches. The patient stated that She had a sore arm at the injection site for a couple of days. The soreness went away. Ten days later her upper arm was sore. She did not see any swelling and she was not looking for any. Then two days after that, she had a big swollen area on her upper arm. She called the pharmacist and was told that it could be a lymph node. She applied ice and took Tylenol. This weekend she continued to ice it and it has gone down a little. The area hurts and itches. She was scheduled to get the second dose on 16 May 2021 and asking whether she can get second dose and whether she get it in the same arm or not. The patient received treatment for upper arm was sore and a big swollen area on her upper arm. The outcome of the even sore arm at the injection site was resolved on an unspecified date in 2021and outcome of other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Vaccination site pain
Clinical narrative: upper arm sore; big swollen area on her her upper arm; The area hurts and itches; sore arm at the injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 26Apr2021 (age at vaccination was 71 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On an unspecified date in 2021, after the first dose patient had a sore arm at the injection site for a couple of days, upper arm was sore, a big swollen area on her upper arm, the area hurts and itches. The patient stated that She had a sore arm at the injection site for a couple of days. The soreness went away. Ten days later her upper arm was sore. She did not see any swelling and she was not looking for any. Then two days after that, she had a big swollen area on her upper arm. She called the pharmacist and was told that it could be a lymph node. She applied ice and took Tylenol. This weekend she continued to ice it and it has gone down a little. The area hurts and itches. She was scheduled to get the second dose on 16 May 2021 and asking whether she can get second dose and whether she get it in the same arm or not. The patient received treatment for upper arm was sore and a big swollen area on her upper arm. The outcome of the even sore arm at the injection site was resolved on an unspecified date in 2021and outcome of other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: rash on my upper right arm (the arm where I got the shot).; itchy; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737; Expiration Date: 20Jul2021) via an unspecified route of administration on 19Apr2021 as dose 1, single for covid-19 immunisation. The patient medical his-tory and concomitant medications were not reported. The patient experienced rash on my upper right arm (the arm where i got the shot), itchy on an unspecified date. This week Wednesday, patient developed a rash on his upper right arm (the arm where patient got the shot). yesterday, it was itchy, but it didn't seem to be too bad today. The outcome of events were unknown.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on my upper right arm (the arm where I got the shot).; itchy; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737; Expiration Date: 20Jul2021) via an unspecified route of administration on 19Apr2021 as dose 1, single for covid-19 immunisation. The patient medical his-tory and concomitant medications were not reported. The patient experienced rash on my upper right arm (the arm where i got the shot), itchy on an unspecified date. This week Wednesday, patient developed a rash on his upper right arm (the arm where patient got the shot). yesterday, it was itchy, but it didn't seem to be too bad today. The outcome of events were unknown.  No follow-up attempts are needed. No further information is expected
Age: 64.0
Sex: M
Vaccine: COVID19, UNK, COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: SPOTS ON HEAD LIKE A PIMPLE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced spots on head like a pimple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from spots on head like a pimple. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19, UNK, COVID19, UNK
Symptoms: Skin disorder
Clinical narrative: SPOTS ON HEAD LIKE A PIMPLE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced spots on head like a pimple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from spots on head like a pimple. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Pulmonary embolism
Clinical narrative: Received Pfizer vaccines on 12/22/20, 1/12/21, 10/8/21 Tested positive for COVID 19 by PCR on 10/31/21. Admitted to local Hospital on 10/31/21 d/t Pulmonary embolus from asymptomatic COVID infection.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, COVID-19, Pulmonary embolism, SARS-CoV-2 test positive
Clinical narrative: Received Pfizer vaccines on 12/22/20, 1/12/21, 10/8/21 Tested positive for COVID 19 by PCR on 10/31/21. Admitted to local Hospital on 10/31/21 d/t Pulmonary embolus from asymptomatic COVID infection.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Pain in extremity, Peripheral swelling
Clinical narrative: VARIVAX was administered 7 days outdated; arm  swelling and pain; arm  swelling and pain; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 13-AUG-2021, the patient was vaccinated with a second dose 7 days outdated varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S024364 with an expiration date on 06-AUG-2021) at a dose of 0.5 milliliters (strength, anatomical location, and route of administration were not reported) for prophylaxis (expired product administered). No previous temperature excursions were reported. No additional adverse events were reported.   Follow-up information was received from the director of nursing on 29-OCT-2021. The patient was 33 years old. Concomitant therapies included iron supplement, hepatitis A vaccine and fluticasone propionate (PROAIR). The varicella virus vaccine live (oka/merck)(VARIVAX) was administered to the right arm subcutaneously by medical assistant on 13-AUG-2021. No other vaccinations were given within 4 weeks prior. On 16-AUG-2021, the patient called to into the doctor's office to report arm swelling and pain (unknown which arm; event onset date: unknown date in August 2021). The outcome of the arm swelling and pain was not reported. The causality between the events and varicella virus vaccine live (oka/merck)(VARIVAX) was not reported. Additionally, the patient's details were provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; An MMR-II vaccine which was 2 days expired; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history and concurrent conditions was not provided.    On 12-OCT-2021, the patient was vaccinated with a 2 days expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 0.5 mL, route of administration was not provided (Lot # S032036, expiration date 10-OCT-2021) for prophylaxis. Sterile diluent (Lot #S024969). No adverse event or product quality complaint (PQC) was reported.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody
Clinical narrative: patient has low Hepatitis B antibody titers after receiving unspecified Hepatitis B vaccine; This spontaneous report was received from a pharmacist, referring to a 25-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (dose, strength, lot# and expiration date were not provided) intramuscular for prophylaxis.  On an unknown date, the patient had low Hepatitis B antibody titers. The patient sought medical attention. The patient received revaccination for treatment. The outcome of the event was reported as not recovered.   The causality assessment between the event and hepatitis b vaccine (recombinant)(RECOMBIVAX HB) was not provided.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant referring to a 13-month-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      On 20-SEP-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported; lot # T032317, expiration date: 22-SEP-2022) for prophylaxis (product storage error).         The vaccine underwent temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.5 Fahrenheit) for 18 minutes and 6 degrees Fahrenheit to 14 degrees Fahrenheit (11.9 Fahrenheit) for 1 hour. Cumulative timeframe: 1 hour and 18 minutes. There was no previous temperature excursion. No additional adverse event details was available (no adverse event).
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody increased, Aphasia, Encephalitis autoimmune, Extra dose administered, Hypersomnia
Clinical narrative: almost ended her life after her 48th dose at 4 years old; Our daughter passed out the day of her 4 year vaccines; she was left with brain inflammation or in other words, autoimmune encephalitis; Vaccines caused our daughter seizures after 1 year vaccinations; full loss of words at her 18 month vaccines; slept for 3 days straight; What didn't come back normal were her titers for when she was vaccinated/labs showed greater than 300; This spontaneous report was received from the mother of the patient referring to her daughter a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, strength, route, lot number and expiration date were not reported) and other unspecified vaccines administered for prophylaxis. The reporter mentioned that vaccines caused to her daughter seizure after her 1 year vaccinations, full loss of words at her 18 months vaccines and almost ended her life after her 48th dose at 4 years old (Ill-defined disorder). She also mentioned that her daughter passed out the day of her 4 years vaccines and slept for 3 days straight. She said that doctor tested her for every disease and illness they could think of, but everything came back normal. But what did not come back normal were her titers for when she was vaccinated against. She said that people need a titer of a 1.1 for immunity; however, her daughter's labs showed greater than 300 (units not provided). She did not know if her titer was 3.000 or 300.000 but the test stopped at 300. She also said that her daughter was left with brain inflammation or in other words, autoimmune encephalitis.  At the reporting the outcome of the adverse events was unknown.   The reporter considered Ill-defined disorder as a life-threatening event. Upon internal review the events seizure, encephalitis autoimmune and loss of consciousness were considered as medically significant. The reporter considered all events as related to the vaccines.
Sex: F
Vaccine: MMR
Symptoms: Ill-defined disorder, Laboratory test normal, Loss of consciousness, Noninfective encephalitis, Seizure
Clinical narrative: almost ended her life after her 48th dose at 4 years old; Our daughter passed out the day of her 4 year vaccines; she was left with brain inflammation or in other words, autoimmune encephalitis; Vaccines caused our daughter seizures after 1 year vaccinations; full loss of words at her 18 month vaccines; slept for 3 days straight; What didn't come back normal were her titers for when she was vaccinated/labs showed greater than 300; This spontaneous report was received from the mother of the patient referring to her daughter a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, strength, route, lot number and expiration date were not reported) and other unspecified vaccines administered for prophylaxis. The reporter mentioned that vaccines caused to her daughter seizure after her 1 year vaccinations, full loss of words at her 18 months vaccines and almost ended her life after her 48th dose at 4 years old (Ill-defined disorder). She also mentioned that her daughter passed out the day of her 4 years vaccines and slept for 3 days straight. She said that doctor tested her for every disease and illness they could think of, but everything came back normal. But what did not come back normal were her titers for when she was vaccinated against. She said that people need a titer of a 1.1 for immunity; however, her daughter's labs showed greater than 300 (units not provided). She did not know if her titer was 3.000 or 300.000 but the test stopped at 300. She also said that her daughter was left with brain inflammation or in other words, autoimmune encephalitis.  At the reporting the outcome of the adverse events was unknown.   The reporter considered Ill-defined disorder as a life-threatening event. Upon internal review the events seizure, encephalitis autoimmune and loss of consciousness were considered as medically significant. The reporter considered all events as related to the vaccines.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This is a spontaneous report from a contactable physician based on information received by Pfizer from Amgen, manufacturer control number US-AMGEN-USASP2021163339, license party for etanercept (ENBREL). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via unspecified route of administration as dose number unknown, single on an unspecified date for covid-19 immunisation. Co-suspect medication included etanercept (ENBREL), via unspecified route of administration and dose from an unspecified date to an unspecified date for an unspecified indication. No historical medical condition was reported. No current medical condition was reported. No concomitant medications were provided. The patient began Enbrel on an unknown date. On an unknown date, the patient was taking Enbrel and took the Coronavirus disease 2019 (COVID-19) vaccine which was mandated by the company. The patient received the COVID-19 vaccine while on Enbrel and developed Guillain-Barre syndrome. Subsequently, the patient had been taken off Enbrel by the physician on unspecified date. No treatment information was received. Action taken with Enbrel was withdrawn for the event Guillain-Barre syndrome. The causal relationship between the event Guillain-Barre syndrome and Enbrel was not provided by the physician. At the time of this report, the outcome of event was unknown. Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.; Sender's Comments: Based on the limited information provided the causal association between the event Guillain barre syndrome and the suspected drugs BNT162B2 and Enbrel cannot be meaningfully assessed and excluded. Case will be reassessed if any new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: If I have 1st shingrix and get covid; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 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 covid-19. The patient was treated with MONOCLONAL ANTIBODY (NOS) (MONOCLONAL ANTIBODY). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had 1st shot of Shingrix and experienced Covid. The patient received monoclonal antibodies shot. The patent asked if could get 2nd shingrix shot and how long did have to wait for monoclonal shots.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose increased, Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 68-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of vaccination failure (refer case US2021AMR222494). Concurrent medical conditions included diabetes (Family History) (patient's mother's brother was 4 years old when he died of diabetes), thyroid disorder, blood cholesterol increased, post-traumatic stress disorder and stress.   On 5th September 2021, the patient received the 2nd dose of Influenza vaccine Quadrivalent 2021-2022 season. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: The case was reported by the patient. Relevant tests include blood sugar on July 2021 result: 400. The patient got the flu shot this year on the year of reporting and she had a sore arm onset age 68  This case was 1 of 3 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR221277:same reporter US-GLAXOSMITHKLINE-US2021AMR222494:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Colitis, Incomplete course of vaccination
Clinical narrative: colitis flare; had to miss my second shot; This case was reported by a consumer via call center representative and described the occurrence of colitis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced colitis and incomplete course of vaccination. The patient was treated with prednisone. On an unknown date, the outcome of the colitis and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the colitis to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix and had to miss 2nd dose of Shingrix because the patient was on Prednisone due to colitis flares which led to incomplete course of vaccination.  The reporter did not specify if the colitis was concurrent condition or experienced after receiving 1st dose of Shingrix. The patient asked if he/she should restart the series or just receive the 2nd dose. Follow-up would not be possible as no contact details available. Note: It was not clear if the colitis was the patients current condition and if it was aggravated after vaccination so the event coded as Colitis.
Sex: U
Vaccine: VARZOS
Symptoms: Product availability issue, Social problem
Clinical narrative: first dose on 2019, due to COVID not been able to receive the second; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. The patient was not able to receive second dose of Shingrix due to Covid pandemic. The patient asked if he/she should just get the 2nd dose or should restart the series. Follow-up would not be possible as no contact details available.
Sex: F
Vaccine: VARZOS
Symptoms: Eye patch application, Ophthalmic herpes zoster
Clinical narrative: shingles in her eye; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The reporter stated that he/she had a customer (patient) who said be warned, she had an eye patch and received a Shingles shot and a week later developed herpes zoster in her eye. The doctor said, she was very lucky because she did not get blind. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter US-GLAXOSMITHKLINE-US2021AMR224766:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Original Case : US2021223559 US-GLAXOSMITHKLINE-US2021223559:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Original Case : US2021223559 US-GLAXOSMITHKLINE-US2021223559:same reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Original Case : US2021223559
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: 103 fever; insane head pain; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced fever of 103 degree F and insane head pain. The patient stated that he/she had the worst reaction in his/her life to this vaccine. The patient also stated that but after reading the comments, it sounds like it was worth it. The follow-up would not possible as no contact details were available.