chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: the vaccine is active against the cancer he currently have; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "the vaccine is active against the cancer he currently have".  Additional Information: The reporter (Patient) said he would like to inform Pfizer that he didn't had any problem with the Pfizer Covid 19 vaccine. He received letters from Pfizer asking if he had problems with the vaccine. He said he previously work on a cancer research institution and now he was suffering from Kaposi sarcoma cancer. He said he would like to inform Pfizer the vaccine is active against the cancer he currently have and would like to talk to a scientist. He was requesting to receive an email stating that we understand him.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: COVID vaccine seemed to make Crohn's disease worsening; MARKETING PROGRAM NAME NOT AVAILBALE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4510259-00.  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "COVID vaccine seemed to make Crohn's disease worsening". The action taken for adalimumab was unknown.  The reporter considered "covid vaccine seemed to make crohn's disease worsening" related to BNT162b2. Causality for Humira (Adalimumab)The reporter causality for the event(s) of COVID vaccine seemed to make Crohn's disease worsening was not provided.  Clinical Course: Describe reaction (include relevant test/lab data): Crohn's disease aggravated (Crohn's disease): Not recovered/not resolved. Solicited report by a consumer of an adult female with an event of non-serious COVID vaccine seemed to make Crohn's disease worsening with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced COVID vaccine seemed to make Crohn's disease worsening. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. Did event abate after stopping drug was NA. Concomitant drugs and dates of administration: Not reported, Other relevant history: Not reported. Study No: Facilitated collect. Report source: study Causality: Drug: HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB)                     Causality: Crohn's disease aggravated (Crohn's disease)                     Causality as per reporter (Drug/Vaccine): Not Reported                 Drug: Pfizer BioNTech COVID-19 vaccine (Tozinameran), unknown, unknown, unknown                     Causality: Crohn's disease aggravated (Crohn's disease)                     Causality as per reporter (Drug/Vaccine): Probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of  crohn's disease worsening cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack on the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 19Aug2022, outcome "unknown", described as "heart attack on the vaccine".  Clinical course: Patient stated that, he understand the ad but scared to take because he had a heart attack on the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-000002896. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". Additional information: On 05Aug2022, it was reported that a patient started treatment on an unreported date with mRNA vaccine at an unreported dose/frequency for an unreported indication. It was reported the patient had an allergic reaction and was seeing an immunologist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy in feet and legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002895 (Novavax).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy in feet and legs".  Clinical information: On 05Aug2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine with an unspecified dose/frequency and unspecified indication. It was reported the patient experienced Neuropathy in feet and legs.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: Since then I've had COVID twice; Since then I've had COVID twice; Since then I've had COVID twice; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "Since then I've had COVID twice".  Clinical course: Patient information age 64 (unit not reported). Patient was curious about the booster portion. Patient have only had one booster. Since then patient had COVID twice. patient was curious if it would say something about the timeframe to get next booster after having COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I was double vaccinated and got covid 4 and a half months later; I was double vaccinated and got covid 4 and a half months later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I was double vaccinated and got covid 4 and a half months later". Clinical information: Patient stated getting vaccinated was better than getting COVID. But he (patient) was double vaccinated and got COVID 4 and a half months later.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid relapse; Covid replase; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Gastric Ulcer" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension, start date: 2012; HYDROCHLOROTHIAZIDE taken for hypertension, start date: 2017; PROTONIX [OMEPRAZOLE] taken for gastric ulcer, start date: 13Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Covid relapse"; COVID-19 (medically significant), outcome "unknown", described as "Covid replase". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Negative, notes: The antigen test was negative 04Jul2022 and 05Jul2022; (05Jul2022) Negative, notes: The antigen test was negative 04Jul2022 and 05Jul2022; (06Jul2022) Positive, notes: positive COVID antigen test on 06Jul2022 and 08Jul2022; (08Jul2022) Positive, notes: positive COVID antigen test on 06Jul2022 and 08Jul2022; (13Jul2022) Negative, notes: antigen test was negative on 13Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The Relapse was documented by a positive COVID antigen test on 06Jul2022 and 08Jul2022. The antigen test was negative 04Jul2022 and 05Jul2022. Patient was asymptomatic on 05Jul2022 but became symptomatic on 06Jul2022. symptoms resolved and antigen test was negative on 13Jul2022. Patient was fully vaccinated and had 2 booster shots, all of which were Pfizer vaccine. The most recent booster was 04May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided and known drug safety profile, the causality between the suspect drug  BNT162B2 in the occurrence of the event cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Sneezing
Clinical narrative: COVID-19; COVID-19; Sneezing; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4497527-00 (Agency).  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19"; SNEEZING (non-serious), outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Unknown date covid test: positive. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of drug ineffective, covid-19, sneezing.  Clinical course: The patient was treated with Paxlovid. Solicited report from a consumer of an elderly female with events of non-serious Sneezing and Covid-19 with Humira (Adalimumab). The patient experienced Sneezing and Covid-19. On an unknown date, Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. There was no reported medical history. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. On 16Aug2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information, treatment drug information and narrative description. The event of "tested positive for covid" was amended to "covid-19". The event of "sore throat" was removed.  Reporter's causality of events Sneezing, COVID-19 with suspect Pfizer BioNTech COVID-19 vaccine (Tozinameran) was reported as possible. Causality of events Sneezing, COVID-19 with suspect HUMIRA was not reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective, covid-19, sneezing and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Erythema multiforme, Oesophagogastroduodenoscopy
Clinical narrative: ERYTHEMA MULTIFORME MAJOR; This is a literature report for the following literature source(s).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastroesophageal reflux" (unspecified if ongoing); "Hypertension" (ongoing); "gastrostomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ERYTHEMA MULTIFORME (medically significant, life threatening), 36 hrs after the suspect product(s) administration, outcome "unknown", described as "ERYTHEMA MULTIFORME MAJOR". The patient underwent the following laboratory tests and procedures: Endoscopy: removed a 34 cm section, notes: esophageal tissue was removed from the airway; Oesophagogastroduodenoscopy: noting extensive Grade D, notes: erosive esophagitis and gastric ulcerations with friability. Therapeutic measures were taken as a result of erythema multiforme.   Clinical course: 36 hours after receiving the second Pfizer COVID-19 vaccine, she developed lip and tongue swelling, mucosal ulcerations, and respiratory distress. There was no conjunctivitis or genital involvement. She denied taking any new medications, supplements, or food that might have led to the reactions. She initially presented to an outside hospital and required intubation prior to transfer to our facility. A bedside esophagogastroduodenoscopy (EGD) was performed noting extensive Grade D erosive esophagitis and gastric ulcerations with friability. When the endoscope was removed a 34cm section of necrotic esophageal tissue was removed from the airway. Despite intravenous steroid treatment, she continued to have esophageal scarring and was unable to tolerate food by mouth. Therefore, a gastrostomy tube was placed. Since that time, she has required several recurrent EGDs for esophageal dilation due to scarring. It has now been six months from her initial injury, and unfortunately, the patient is still unable to take PO and is dependent on tube feedings.; Sender's Comments: Based on the available reported information, the causal association between the event erythema multiforme and the suspect drug BNT162B2 cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: vaccine-associated EM; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown.), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; manufacturer unknown.), for COVID-19 immunisation. The following information was reported: ERYTHEMA MULTIFORME (medically significant), outcome "unknown", described as "vaccine-associated EM".; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Erythema Multiforme and the suspect drug BNT162B2 cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Erythema, Infection, Pleural effusion
Clinical narrative: By Sunday night we took him to hospital due to fluid build up around his chest and severe pain.; By Sunday night we took him to hospital due to fluid build up around his chest and severe pain.; Complained of arm soreness on Saturday but not at injection site, under armpit.; He started oral antibiotics due to a perceived infection/ reaction.; mild swelling at infection site but mostly the fluid build up is at lymph node under arm.; redness and swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: AXILLARY PAIN (medically significant), outcome "unknown", described as "Complained of arm soreness on Saturday but not at injection site, under armpit."; PLEURAL EFFUSION (hospitalization, medically significant), CHEST PAIN (hospitalization, medically significant), outcome "unknown" and all described as "By Sunday night we took him to hospital due to fluid build up around his chest and severe pain."; INFECTION (medically significant), outcome "unknown", described as "He started oral antibiotics due to a perceived infection/ reaction."; SWELLING (medically significant), outcome "unknown", described as "mild swelling at infection site but mostly the fluid build up is at lymph node under arm."; ERYTHEMA (medically significant), outcome "unknown", described as "redness and swelling". Therapeutic measures were taken as a result of pleural effusion, chest pain, infection.  Clinical course: Patient received booster shot on Friday at 2pm. Complained of arm soreness on Saturday but not at injection site, under armpit. By Sunday night we took him to hospital due to fluid build up around his chest and severe pain. He started oral antibiotics due to a perceived infection/ reaction. No underlying conditions. Did not react this way with first two doses. He does have mild swelling at infection site but mostly the fluid build up is at lymph node under arm. The redness and swelling is about 8 inches wide.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: By Sunday night we took him to hospital due to fluid build up around his chest and severe pain.; By Sunday night we took him to hospital due to fluid build up around his chest and severe pain.; Complained of arm soreness on Saturday but not at injection site, under armpit.; He started oral antibiotics due to a perceived infection/ reaction.; mild swelling at infection site but mostly the fluid build up is at lymph node under arm.; redness and swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: AXILLARY PAIN (medically significant), outcome "unknown", described as "Complained of arm soreness on Saturday but not at injection site, under armpit."; PLEURAL EFFUSION (hospitalization, medically significant), CHEST PAIN (hospitalization, medically significant), outcome "unknown" and all described as "By Sunday night we took him to hospital due to fluid build up around his chest and severe pain."; INFECTION (medically significant), outcome "unknown", described as "He started oral antibiotics due to a perceived infection/ reaction."; SWELLING (medically significant), outcome "unknown", described as "mild swelling at infection site but mostly the fluid build up is at lymph node under arm."; ERYTHEMA (medically significant), outcome "unknown", described as "redness and swelling". Therapeutic measures were taken as a result of pleural effusion, chest pain, infection.  Clinical course: Patient received booster shot on Friday at 2pm. Complained of arm soreness on Saturday but not at injection site, under armpit. By Sunday night we took him to hospital due to fluid build up around his chest and severe pain. He started oral antibiotics due to a perceived infection/ reaction. No underlying conditions. Did not react this way with first two doses. He does have mild swelling at infection site but mostly the fluid build up is at lymph node under arm. The redness and swelling is about 8 inches wide.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4509739-00 (Company). A 52-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), on 13May2021 as dose 2, single (Batch/Lot number: unknown) and on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) till Jul2022, subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Moderate to severe chronic plaque psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was dosage permanently withdrawn in Jul2022. Additional information: Reported causality for adalimumab by reporter: Not related. Reported causality for BNT162B2 by reporter: Possible. The reporter considered "covid-19" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, SARS-CoV-2 test, Sleep disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  62-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 at 16:30 as dose 1, single (Lot number: ER8732) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (ongoing), notes: Onset date: Since childhood, Stop date: Ongoing, Pertinent details: no meds taken for many years.; "Osteoporosis", start date: 2012 (ongoing), notes: Diagnosed in 2012 during screening test. No fractures no medication yet.; "Prior post fever rashes after some illness", start date: 1990 (ongoing), notes: Onset date: 1990, Stop date: Ongoing, intermittent may be once every few years. Concomitant medication(s) included: CITRACAL [CALCIUM CITRATE] oral taken for osteoporosis (ongoing); VITAMIN D [VITAMIN D NOS] oral taken for osteoporosis (ongoing). Past drug history included: Thimerosal, start date: 1980, reaction(s): "Thimerosal allergy", notes: Onset date: Since early 1980, Stop date: Ongoing, Diagnosed by eye doctor due to thimerosal in contact lens solution. The following information was reported: RASH (non-serious) with onset 27Mar2021, outcome "recovered", described as "Each time I got a Covid vaccine (2 initial doses and 2 boosters), I got a 'torso' rash over my whole front and back after a few days"; PRURITUS (non-serious), outcome "unknown", described as "very uncomfortable itching for several days"; ERYTHEMA (non-serious), outcome "unknown", described as "redness"; SLEEP DISORDER (non-serious), outcome "unknown", described as "disrupting sleep"; SOCIAL PROBLEM (non-serious), outcome "unknown", described as "making it difficult to socialize or plan activities". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash. Additional information: Each lime I got a Covid vaccine (2 initial doses and 2 boosters), I got a 'torso' rash over my whole front and bark after a few days. When the redness occurred, it felt like a minor sunburn, a little warm and uncomfortable. After the red went away, there was very uncomfortable itching for several days, even disrupting sleep, and making it difficult to socialize or plan activities (due to discomfort wearing regular clothing). This effect happened after Pfizer and Moderna doses. After the 4"' shot (20' booster, Moderna), I decided to report it, because I cannot take this anymore every months or each time we get a booster.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Social problem
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  62-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 at 16:30 as dose 1, single (Lot number: ER8732) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (ongoing), notes: Onset date: Since childhood, Stop date: Ongoing, Pertinent details: no meds taken for many years.; "Osteoporosis", start date: 2012 (ongoing), notes: Diagnosed in 2012 during screening test. No fractures no medication yet.; "Prior post fever rashes after some illness", start date: 1990 (ongoing), notes: Onset date: 1990, Stop date: Ongoing, intermittent may be once every few years. Concomitant medication(s) included: CITRACAL [CALCIUM CITRATE] oral taken for osteoporosis (ongoing); VITAMIN D [VITAMIN D NOS] oral taken for osteoporosis (ongoing). Past drug history included: Thimerosal, start date: 1980, reaction(s): "Thimerosal allergy", notes: Onset date: Since early 1980, Stop date: Ongoing, Diagnosed by eye doctor due to thimerosal in contact lens solution. The following information was reported: RASH (non-serious) with onset 27Mar2021, outcome "recovered", described as "Each time I got a Covid vaccine (2 initial doses and 2 boosters), I got a 'torso' rash over my whole front and back after a few days"; PRURITUS (non-serious), outcome "unknown", described as "very uncomfortable itching for several days"; ERYTHEMA (non-serious), outcome "unknown", described as "redness"; SLEEP DISORDER (non-serious), outcome "unknown", described as "disrupting sleep"; SOCIAL PROBLEM (non-serious), outcome "unknown", described as "making it difficult to socialize or plan activities". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash. Additional information: Each lime I got a Covid vaccine (2 initial doses and 2 boosters), I got a 'torso' rash over my whole front and bark after a few days. When the redness occurred, it felt like a minor sunburn, a little warm and uncomfortable. After the red went away, there was very uncomfortable itching for several days, even disrupting sleep, and making it difficult to socialize or plan activities (due to discomfort wearing regular clothing). This effect happened after Pfizer and Moderna doses. After the 4"' shot (20' booster, Moderna), I decided to report it, because I cannot take this anymore every months or each time we get a booster.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Autoimmune neuropathy, Biopsy skin, Electromyogram, Heart rate
Clinical narrative: AUTOIMMUNE SMALL FIBER POLYNEUROPATHY AFTER COVID-19 VACCINATION; POTS; This is a literature report for the following literature source(s).  A previously healthy 27-year-old woman who presented with several months of progressive weakness, neuropathy, and tachycardia that began shortly after her second dose of the Pfizer COVID-19 vaccine. Initially, she noticed fatigue followed by occipital neuralgia and paresthesia. Weeks later, she was febrile with extremity tremors and neuralgia. She went to the ED where she was lymphopenic, group A strep positive (GAS+), and had unremarkable imaging; she was given antibiotics and gabapentin. Her fever resolved, but her pain/tremor continued. Occipital nerve blocks provided temporary relief; acyclovir and duloxetine had no effect. On two subsequent ED visits, she was again GAS+ and was given additional antibiotics. Later, she developed non-pruritic rash, dermatographia, and blepharitis; skin biopsy showed non-vasculitic progressive pigmented purpura. An extensive rheumatologic, post-infectious, and paraneoplastic workup was unrevealing. Notably, she had high anti-COVID-19 spike antibody on qualitative assay. During workup, her symptoms rapidly worsened, leading to admission. On exam, she had intact sensation, profound gait imbalance, and HR to 150s with standing. LP was negative; EMG ruled out large fiber polyneuropathy (LFPN). She was diagnosed with autoimmune small fiber polyneuropathy (SFPN) and POTS. She improved rapidly with IVIG and steroids. Given her negative workup, the COVID-19 vaccine was identified as the likely trigger.; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Autoimmune Polyneuropathy and the suspect drug cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202200048823 Same article, different patient, drug and events;US-PFIZER INC-202201087490 Same article and patient, different drug and event;
Sex: F
Vaccine: COVID19
Symptoms: Imaging procedure, Investigation, Lumbar puncture, Postural orthostatic tachycardia syndrome, Rheumatological examination
Clinical narrative: AUTOIMMUNE SMALL FIBER POLYNEUROPATHY AFTER COVID-19 VACCINATION; POTS; This is a literature report for the following literature source(s).  A previously healthy 27-year-old woman who presented with several months of progressive weakness, neuropathy, and tachycardia that began shortly after her second dose of the Pfizer COVID-19 vaccine. Initially, she noticed fatigue followed by occipital neuralgia and paresthesia. Weeks later, she was febrile with extremity tremors and neuralgia. She went to the ED where she was lymphopenic, group A strep positive (GAS+), and had unremarkable imaging; she was given antibiotics and gabapentin. Her fever resolved, but her pain/tremor continued. Occipital nerve blocks provided temporary relief; acyclovir and duloxetine had no effect. On two subsequent ED visits, she was again GAS+ and was given additional antibiotics. Later, she developed non-pruritic rash, dermatographia, and blepharitis; skin biopsy showed non-vasculitic progressive pigmented purpura. An extensive rheumatologic, post-infectious, and paraneoplastic workup was unrevealing. Notably, she had high anti-COVID-19 spike antibody on qualitative assay. During workup, her symptoms rapidly worsened, leading to admission. On exam, she had intact sensation, profound gait imbalance, and HR to 150s with standing. LP was negative; EMG ruled out large fiber polyneuropathy (LFPN). She was diagnosed with autoimmune small fiber polyneuropathy (SFPN) and POTS. She improved rapidly with IVIG and steroids. Given her negative workup, the COVID-19 vaccine was identified as the likely trigger.; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Autoimmune Polyneuropathy and the suspect drug cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202200048823 Same article, different patient, drug and events;US-PFIZER INC-202201087490 Same article and patient, different drug and event;
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test
Clinical narrative: AUTOIMMUNE SMALL FIBER POLYNEUROPATHY AFTER COVID-19 VACCINATION; POTS; This is a literature report for the following literature source(s).  A previously healthy 27-year-old woman who presented with several months of progressive weakness, neuropathy, and tachycardia that began shortly after her second dose of the Pfizer COVID-19 vaccine. Initially, she noticed fatigue followed by occipital neuralgia and paresthesia. Weeks later, she was febrile with extremity tremors and neuralgia. She went to the ED where she was lymphopenic, group A strep positive (GAS+), and had unremarkable imaging; she was given antibiotics and gabapentin. Her fever resolved, but her pain/tremor continued. Occipital nerve blocks provided temporary relief; acyclovir and duloxetine had no effect. On two subsequent ED visits, she was again GAS+ and was given additional antibiotics. Later, she developed non-pruritic rash, dermatographia, and blepharitis; skin biopsy showed non-vasculitic progressive pigmented purpura. An extensive rheumatologic, post-infectious, and paraneoplastic workup was unrevealing. Notably, she had high anti-COVID-19 spike antibody on qualitative assay. During workup, her symptoms rapidly worsened, leading to admission. On exam, she had intact sensation, profound gait imbalance, and HR to 150s with standing. LP was negative; EMG ruled out large fiber polyneuropathy (LFPN). She was diagnosed with autoimmune small fiber polyneuropathy (SFPN) and POTS. She improved rapidly with IVIG and steroids. Given her negative workup, the COVID-19 vaccine was identified as the likely trigger.; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Autoimmune Polyneuropathy and the suspect drug cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202200048823 Same article, different patient, drug and events;US-PFIZER INC-202201087490 Same article and patient, different drug and event;
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Autoimmune thyroiditis, Burning sensation, Lymphadenopathy, Pain
Clinical narrative: 3 miscarriages; Hashimoto's; Arms and legs are burning; I have several swollen lymph nodes that hurt and haven't gone away for over a year and more are appearing; I have several swollen lymph nodes that hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "3 miscarriages"; AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "Hashimoto's"; BURNING SENSATION (non-serious), outcome "unknown", described as "Arms and legs are burning"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "I have several swollen lymph nodes that hurt and haven't gone away for over a year and more are appearing"; PAIN (non-serious), outcome "not recovered", described as "I have several swollen lymph nodes that hurt".  Clinical course: Since receiving 2 COVID-19 Pfizer vaccines and a booster, the patient health has taken a dive, have several swollen lymph nodes that hurt and haven't gone away for over a year and more are appearing. The arms and legs were burning, had 3 miscarriages, and was diagnosed with Hashimoto's. The patient asked is there a way to flush my body of the vaccine? A way to detox from it? A way to reverse all of these negative effects it's been having on my body?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Patient Developed a fever of 103 post Prevnar 13 administration; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 3-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Patient Developed a fever of 103 post Prevnar 13 administration". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient Developed a fever of 103 post Prevnar 13 administration, event took place after use of product.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: After take the vaccines and got a covid-19; After take the vaccines and got a covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After take the vaccines and got a covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: After take the vaccines and got a covid-19. It is insane. You need more researchers  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have recently had COVID; I have recently had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing), notes: Have ITP and MGUS; "MGUS" (unspecified if ongoing), notes: Have ITP and MGUS. Concomitant medication(s) included: DOPTELET. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I have recently had COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Customer verbatim: Patient had recently had COVID. Due to being on Doptelet she could not take the antiviral. patient had 2 COVID vaccines. She was given the monoclonal antibody infusion instead. Due to the shortage of the monoclonal antibodies are there recommendations for what persons in my situation can do.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Penis disorder, Skin warm
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: FLUSHING (non-serious), outcome "unknown", described as "getting flushed"; SKIN WARM (non-serious), outcome "unknown", described as "his skin is in heat"; PENIS DISORDER (non-serious), outcome "unknown", described as "penis went 11 inches and got twice the size". Additional information: A caller had a question about the COVID vaccine. He wants to know if the fourth booster is the third shot. He said he had side effects and he got it from withheld. He started getting flushed and his skin is in heat and his penis went 11 inches and got twice the size. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness
Clinical narrative: hearing deficit / hearing loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,Single), for Covid-19 immunization; Bnt162b2 (Dose 2, Single), for Covid-19 immunization. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing deficit / hearing loss". The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: hearing loss.  Clinical information: I received your Covid "vaccine" in 2 doses, as well as 2 boosters. I have always experienced very acute hearing & have no family history of hearing loss. This past year my grandchildren brought to my attention, I have a hearing deficit. After an ear examination & hearing test by 2 doctors, I am now a prime candidate for hearing aids. In retrospect I believe I may have my hearing loss due to the boosters. No one could be sure. I feel this information is important for your records.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.