chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb injury, SARS-CoV-2 test
Clinical narrative: little finger in the air thing is 98; 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.  An 85-year-old female 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, Lot number- unknown), for Covid-19 Immunization; Bnt162b2 (Dose 2, single, Lot number- unknown), for Covid-19 Immunization. The following information was reported: LIMB INJURY (non-serious), outcome "unknown", described as "little finger in the air thing is 98". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient called in to ask if she needed PAXLOVID since she tested positive for COVID. Patient symptoms were minimal. Patient stated her little finger in the air thing is 98 and feels fine. patient was with somebody that had COVID a few days ago. Patient was in excellent health and physically at 77 years old. Patient walks the golf course, carries her golf clubs, runs and does everything. patient stated she had been around a lot and her husband, daughter, and son are doctors and did all the Pfizer shots and boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Impaired work ability, Pyrexia
Clinical narrative: headaches; off from her work for 2 months; chills; little bit of a fever; 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 62-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "COVID", start date: 2021 (unspecified if ongoing), notes: caller had Covid, which was two weeks before caller got the first shot. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization; Bnt162b2 (Second dose), for COVID-19 Immunization.The following information was reported: HEADACHE (hospitalization), outcome "recovered", described as "headaches"; IMPAIRED WORK ABILITY (non-serious), outcome "recovered", described as "off from her work for 2 months"; CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "little bit of a fever". The patient was hospitalized for headache (hospitalization duration: 6 day(s)).   Additional  information: The reporter mentioned that before caller got her very first primary shot of the Pfizer Covid 19 vaccine, caller had Covid, which was two weeks before caller got the first shot. Reporter also mentioned that she experienced headaches and felt like she had Covid again, transfer agent not able to specify if this occurred with the first, second, or third shot. Reporter also mentioned that she ended up in the hospital for 6 days and this caused her to be off work for 2 months. Also mentioned that her sister who also got the Pfizer COVID-19 shot did not experience the same side effects as caller's side effects. The caller believed that caller's sister did not experience any side effects, but transfer agent is not sure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: headaches; off from her work for 2 months; chills; little bit of a fever; 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 62-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "COVID", start date: 2021 (unspecified if ongoing), notes: caller had Covid, which was two weeks before caller got the first shot. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization; Bnt162b2 (Second dose), for COVID-19 Immunization.The following information was reported: HEADACHE (hospitalization), outcome "recovered", described as "headaches"; IMPAIRED WORK ABILITY (non-serious), outcome "recovered", described as "off from her work for 2 months"; CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "little bit of a fever". The patient was hospitalized for headache (hospitalization duration: 6 day(s)).   Additional  information: The reporter mentioned that before caller got her very first primary shot of the Pfizer Covid 19 vaccine, caller had Covid, which was two weeks before caller got the first shot. Reporter also mentioned that she experienced headaches and felt like she had Covid again, transfer agent not able to specify if this occurred with the first, second, or third shot. Reporter also mentioned that she ended up in the hospital for 6 days and this caused her to be off work for 2 months. Also mentioned that her sister who also got the Pfizer COVID-19 shot did not experience the same side effects as caller's side effects. The caller believed that caller's sister did not experience any side effects, but transfer agent is not sure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: lost my sense of smell and taste for about 11 months; lost my sense of smell and taste for about 11 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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: ANOSMIA (non-serious), AGEUSIA (non-serious), outcome "unknown" and all described as "lost my sense of smell and taste for about 11 months". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received 2 Pfizer vaccines for Covid 19 + 2 Booster shots. I have lost my sense of smell and taste for about 11 months. Was this a side effect of the vaccine? I have never tested positive for Covid 19. I have been tested 8 times in the past 2 years.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I received the shot in left arm and in two weeks later I'm in hospital with an blood clot .; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 at 13:00 as dose 1, single (Lot number: Eu6208) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: THROMBOSIS (caused and prolonged hospitalization, medically significant) with onset 26Mar2021, outcome "not recovered", described as "I received the shot in left arm and in two weeks later I'm in hospital with an blood clot .". The patient was hospitalized and prolonged hospitalization for thrombosis (hospitalization duration: 7 day(s)). The events "i received the shot in left arm and in two weeks later i'm in hospital with an blood clot ." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of thrombosis and treatment included blood thinners.  Clinical course: Patient did not received other vaccine within 4 weeks of Covid vaccine. Patient did not have covid prior to vaccination. Patient did not tested for Covid post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID symptoms are not severe and only had a cold; COVID symptoms are not severe and only had a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  An 82-year-old female 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 complete, Manufacturer-unknown, Dose no- 1 and 2), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID symptoms are not severe and only had a cold". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Severe shaking (flailing of arms and legs) about 8 hours after the 2nd shot that lasted for 30 minutes.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 10:00 as dose 2, single (Lot number: EK9231) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergy: Sulfa drugs" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing). Concomitant medication(s) included: HCTZ; BENAZEPRIL; ARMOUR THYROID; VIT C; VIT E [TOCOPHEROL]; VIT B6; VIT B12; FLU VACCINE VII, in Sep2021 as dose 1, single. Past drug history included: Morphine for Known allergies: morphine. Vaccination history included: BNT162b2 (lot number=ET1685,, administration date=20Dec2020,, administration time=10:00 AM, dose number=1,, vaccine location=Right arm}]), administration date: 20Dec2020, when the patient was 79-year-old, for Covid-19 immunization. The following information was reported: TREMOR (medically significant) with onset 21Jan2021 at 19:00, outcome "recovered", described as "Severe shaking (flailing of arms and legs) about 8 hours after the 2nd shot that lasted for 30 minutes.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2021) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of tremor.; Sender's Comments: Based on the available reported information, the causal association between the event tremor 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: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: gets sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (002591). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), at 11 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "gets sick". The action taken for tofacitinib citrate was unknown.  Additional information: Offered to transfer patient to the Inquiry line she declined and will contact her doctor. Patient called to inquire about the Pfizer vaccine. She stated that she got the Pfizer shot and has been receiving the booster shots. She advised she is on her fifth month without the booster and every time she takes it she gets sick. Patient was prescribed Xeljanz XR 11mg. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid  start on 14Apr2022 Treatment of COVID-19; Paxlovid  start on 14Apr2022 Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 at 09:00 as dose 3 [booster], single (Lot number: FE3592) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Primary immunization series complete manufacturer unknown.), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Paxlovid  start on 14Apr2022 Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood glucose
Clinical narrative: asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 2, single (Lot number: EL9262) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: She says she has a history of asthma, she has had it all her life, but hadn't been to the hospital for it for the last 25 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, LOT: EL3246), administration date: 12Jan2021, when the patient was 73-year-old, for Covid-19 Immunization. The following information was reported: ASTHMA (hospitalization) with onset Feb2021, outcome "not recovered". The patient was hospitalized for asthma (start date: Feb2021, hospitalization duration: 7 day(s)). The event "asthma" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood glucose: 462.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test 17Apr2022; Positive COVID test 17Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6203), in right arm, on 23Mar2021 as dose 2, single (Lot number: EN6203), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Apr2022, outcome "recovering" and all described as "Positive COVID test 17Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: Nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination and was positive.  Follow up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Fatigue, Headache, Nasal congestion
Clinical narrative: Congestion; cough; headache; scratchy throat; backache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Lot number: EN6205) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: morphone for Known allergies: morphone. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 11Feb2021, when the patient was 51-year-old, for Covid-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 17Apr2022, outcome "recovering", described as "Congestion"; BACK PAIN (non-serious) with onset 17Apr2022, outcome "recovering", described as "backache"; COUGH (non-serious) with onset 17Apr2022, outcome "recovering"; FATIGUE (non-serious) with onset 17Apr2022, outcome "recovering"; HEADACHE (non-serious) with onset 17Apr2022, outcome "recovering"; THROAT IRRITATION (non-serious) with onset 17Apr2022, outcome "recovering", described as "scratchy throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion, cough, headache, throat irritation, back pain, fatigue. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat irritation
Clinical narrative: Congestion; cough; headache; scratchy throat; backache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Lot number: EN6205) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: morphone for Known allergies: morphone. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 11Feb2021, when the patient was 51-year-old, for Covid-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 17Apr2022, outcome "recovering", described as "Congestion"; BACK PAIN (non-serious) with onset 17Apr2022, outcome "recovering", described as "backache"; COUGH (non-serious) with onset 17Apr2022, outcome "recovering"; FATIGUE (non-serious) with onset 17Apr2022, outcome "recovering"; HEADACHE (non-serious) with onset 17Apr2022, outcome "recovering"; THROAT IRRITATION (non-serious) with onset 17Apr2022, outcome "recovering", described as "scratchy throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion, cough, headache, throat irritation, back pain, fatigue. No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: he had all the shots and the covid booster and still got covid.; he had all the shots and the covid booster and still got covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8734), in arm, on 30Apr2021 as dose 2, single (Lot number: ER20170), in arm and on 14Jan2022 as dose 3 (booster), single (Lot number: PJ6369) at the age of 84 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma States she is an asthmatic and does not remember when that was diagnosed but she was a kid. The patient did not begin any new medications within 2 weeks prior to testing positive for COVID. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 29Mar2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "he had all the shots and the covid booster and still got covid.". The events "he had all the shots and the covid booster and still got covid." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Mar2022) positive. Therapeutic measures were taken as a result of covid-19.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Dyspnoea, Illness, Sinusitis
Clinical narrative: he had all the shots and the covid booster and still got covid.; he had all the shots and the covid booster and still got covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8734), in arm, on 30Apr2021 as dose 2, single (Lot number: ER20170), in arm and on 14Jan2022 as dose 3 (booster), single (Lot number: PJ6369) at the age of 84 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma States she is an asthmatic and does not remember when that was diagnosed but she was a kid. The patient did not begin any new medications within 2 weeks prior to testing positive for COVID. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 29Mar2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "he had all the shots and the covid booster and still got covid.". The events "he had all the shots and the covid booster and still got covid." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Mar2022) positive. Therapeutic measures were taken as a result of covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Has tested positive; Has tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  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 included: "Diabetic" (unspecified if ongoing), notes: Husband is diabetic and has a heart condition; "Heart condition" (unspecified if ongoing), notes: Husband is diabetic and has a heart condition. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Apr2022, outcome "unknown" and all described as "Has tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: She and her husband both tested postive. Patient and his wife both tested positive the husband (patient) was diabetic and had a heart condition. The receptionist offered monoclonal antibody without considering that they had received the booster dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200591001 Same reporter/ drug/ event for different patients.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: intermittent itching that comes for 10-30 minutes at a time. It migrates from different parts of the body. He woke up 3 times itching in the middle of the night, he itches for 10- 20 minutes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-011537 (Moderna).  A 61-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: moderna coviD-19 vaccine (First dose), administration date: 04Mar2021, when the patient was 60-year-old, for COVID-19 Immunization; moderna coviD-19 vaccine (Second dose), administration date: 01Apr2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "intermittent itching that comes for 10-30 minutes at a time. It migrates from different parts of the body. He woke up 3 times itching in the middle of the night, he itches for 10- 20 minutes". Therapeutic measures were not taken as a result of pruritus.  Additional information: Consumer calling to report adverse reactions he experienced after the 3rd booster dose of the Moderna COVID-19 vaccine. He mentions he owns 1700 shares of Moderna that he bought in Apr2020. He reports he received an extra booster of COVID-19 vaccine on 01Apr2022. A few days later, he started to experience intermittent itching that comes for 10-30 minutes at a time. It migrates from different parts of the body. He woke up 3 times itching in the middle of the night, he itches for 10- 20 minutes. He has an appointment with a dermatologist in a few days. He reports in total he has received 5 total doses of COVID-19 vaccines. He mentions he searched itching, he found a bunch of people who report itching with the vaccine. He reports he read dozens of people who receive Moderna and Pfizer COVID-19 vaccines report the same symptoms of itching he has. He mentions he thinks Moderna should factor in all the data of people reporting these problems, and Moderna should be responsible. He reports he is on no concomitant medication  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hemiplegia
Clinical narrative: paralysis of right side arm, hand, leg, foot, hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 at 09:00 as dose 2, single (Lot number: FK9894) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive any other vaccine in four weeks and other medications in two weeks. The patient had no known allergies. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FK9894, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 11Mar2022, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: HEMIPLEGIA (medically significant) with onset 02Apr2022 at 04:00, outcome "not recovered", described as "paralysis of right side arm, hand, leg, foot, hip". Therapeutic measures were not taken as a result of hemiplegia.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Investigation, Pain in extremity, Platelet factor 4, Thrombosis
Clinical narrative: Feb2021: blood clot in Lt leg.; Lt leg pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer", start date: May2001, stop date: 2010, notes: 91 seeds placed in grown around CT scan, Start date: summer 2010; "Heart attack", start date: Sep2005 (ongoing), notes: Install 3 stents, under withheld. The patient took concomitant medications. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset Feb2021, outcome "not recovered", described as "Feb2021: blood clot in Lt leg."; PAIN IN EXTREMITY (hospitalization) with onset Feb2021, outcome "recovered with sequelae", described as "Lt leg pain". The patient was hospitalized for pain in extremity (hospitalization duration: 3 day(s)). The events "feb2021: blood clot in lt leg." and "lt leg pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Unknown, notes: Many times; INC (2-3): (unspecified date) 1.7 - 4.4, notes: Every 2 weeks - 1/month; Platelet factor 4: (Feb2021) Factor V, notes: Ultrasound to check for clots in legs; Ultrasound scan: (unspecified date) Yes, notes: Tet for blood clots. Therapeutic measures were taken as a result of thrombosis, pain in extremity.  Clinical course: Patient was factor V on warfarin and for leg pain took Warfarin.   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: Ultrasound scan
Clinical narrative: Feb2021: blood clot in Lt leg.; Lt leg pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer", start date: May2001, stop date: 2010, notes: 91 seeds placed in grown around CT scan, Start date: summer 2010; "Heart attack", start date: Sep2005 (ongoing), notes: Install 3 stents, under withheld. The patient took concomitant medications. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset Feb2021, outcome "not recovered", described as "Feb2021: blood clot in Lt leg."; PAIN IN EXTREMITY (hospitalization) with onset Feb2021, outcome "recovered with sequelae", described as "Lt leg pain". The patient was hospitalized for pain in extremity (hospitalization duration: 3 day(s)). The events "feb2021: blood clot in lt leg." and "lt leg pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Unknown, notes: Many times; INC (2-3): (unspecified date) 1.7 - 4.4, notes: Every 2 weeks - 1/month; Platelet factor 4: (Feb2021) Factor V, notes: Ultrasound to check for clots in legs; Ultrasound scan: (unspecified date) Yes, notes: Tet for blood clots. Therapeutic measures were taken as a result of thrombosis, pain in extremity.  Clinical course: Patient was factor V on warfarin and for leg pain took Warfarin.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: After receiving your Covid-19 vaccine my taste buds and smell have change and has not gone back to normal.; After receiving your Covid-19 vaccine my taste buds and smell have change and has not gone back to normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAROSMIA (non-serious), TASTE DISORDER (non-serious), outcome "unknown" and all described as "After receiving your Covid-19 vaccine my taste buds and smell have change and has not gone back to normal".  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: Body mass index, Cerebrovascular accident, Thrombosis
Clinical narrative: she experienced a blood clot; caused a stroke which killed her.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female 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 (Manufacturer Unknown, Booster: 1), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer Unknown, Primary series of vaccination completed), for Covid-19 Immunization. The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "she experienced a blood clot"; CEREBROVASCULAR ACCIDENT (death, medically significant), outcome "fatal", described as "caused a stroke which killed her.". The patient underwent the following laboratory tests and procedures: Body mass index: Low, notes: a low bmi. The patient date of death was unknown. Reported cause of death: "caused a stroke which killed her.", "she experienced a blood clot". It was not reported if an autopsy was performed.  Clinical course: Reporter mother was a healthy woman who maintained a low bmi and a healthy vegetable focused diet. However, 4 days after second booster patient experienced a blood clot which caused a stroke which killed her. Reporter was interested in getting pfizer data on the situation if it can help to improve vaccination efficacy and reduce side effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: caused a stroke which killed her.; she experienced a blood clot
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset Jan2022, outcome "not recovered", described as "Ringing in left ear". The event "ringing in left ear" required physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Ae treatment was reported as various allergy medicines and steroids. It was reported that patient had ringing in left ear started shortly after getting the vaccine. It had not stopped and was constant in his left ear only. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.   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: Antibody test, Dry mouth, Thirst
Clinical narrative: Dry mouth, off the chart, feels like cannot get enough water, feels like she has to drink every 2 seconds; Dry mouth, off the chart, feels like cannot get enough water, feels like she has to drink every 2 seconds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she donated blood" (unspecified if ongoing), notes: prior to the second booster, she donated blood at the (Institution name withheld). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: DRY MOUTH (non-serious), THIRST (non-serious), outcome "unknown" and all described as "Dry mouth, off the chart, feels like cannot get enough water, feels like she has to drink every 2 seconds". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got the second booster. Prior to the second booster, she donated blood at the (Institution name withheld) and was tested for antibodies after the first booster, but before the second booster. The patient was reactive plus, which means that she has very high levels of antibodies in her blood from the vaccines. After the second booster, she has experienced dry mouth, which feels off the chart, and she feels like she cannot get enough water, and feels like she has to drink every 2 seconds. The patient stated that she should not have gotten the second booster. Her doctor did not know what was going on and she thought it could be a side effect. She asked when this going will stop. She could refer herself to her own doctor. Her doctor did not help her. Pfizer could not advise people to get a second booster if people are going to have side effects. Caller states that she is going to call the CDC and go on Twitter to alert people to these issues and that Pfizer has no idea what was going on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expired dose of Menactra with no reported adverse event; Initial information received on 08-Apr-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient of unknown demographics who had received an expired dose of meningococcal a-c-y-w135 (d conj) vaccine (Menactra) with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (strength, frequency, formulation, lot number and expiry date were unknown) not reported via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date, (latency: unknown) the patient received an expired dose of menactra with no reported adverse event (expired product administered) .  Action taken : not applicable.  Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Appetite disorder, Blepharospasm, Pallor, Vasospasm
Clinical narrative: vaso-vagal spasm type movements; eye fluttering; child turned very pale; change in appetite; Initial information received on 14-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who experienced vaso-vagal spasm type movements, eye fluttering, child turned very pale and change in appetite while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunization; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunization.  On 12-Apr-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown)  lot UJ592AAA via intramuscular route in unknown administration site.  On 12-APR-2022 the patient developed a non-serious events vaso-vagal spasm type movements (vasospasm) eye fluttering (blepharospasm) child turned very pale (pallor) change in appetite (appetite disorder) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the all the events.  At time of reporting, the outcome was Recovered / Resolved in 2022 for all.
Age: 11.0
Sex: F
Vaccine: HPVX, MNQ, TTOX
Symptoms: Vomiting
Clinical narrative: Vomited 5 times at school after receiving Menquadfi; Initial information received on 14-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced vomited 5 times at school after receiving menquadfi while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE); and TETANUS VACCINE (TETANUS VACCINE).  On 14-Apr-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U7249AA (expiry date 03-Nov-2024) via intramuscular route in the right deltoid for Immunization.  On 14-APR-2022 (latency: Same day) the patient developed a non-serious vomited 5 times at school after receiving menquadfi (vomiting) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Vomited 5 times at school after receiving Menquadfi).  At time of reporting, the outcome was Unknown for the event vomited 5 times at school after receiving menquadfi.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: administered Menactra to a patient subcutaneously instead of intramuscularly with no reported adverse event; Initial information received on 14-Apr-2022 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 18 years old female patient who had administered menactra to a patient subcutaneously instead of intramuscularly with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 14-Apr-2022, the patient received 0.5ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (frequency, strength was unknown, lot U6952AA and expiry date: 09-Jun-2022) via subcutaneous route in unknown administration site for prophylactic vaccination.  It was reported that Patient last menstrual period was on 25-Mar-2022. On 14-Apr-2022, (Latency: same day) Nurse administered menactra to a patient subcutaneously instead of intramuscularly with no reported adverse event (incorrect route of product administration) and they just want to know what to do moving forward. Nurse just wants to know if the dose needs to be repeated.   Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: medication error due to reconstituting with the wrong diluent and administering to a patient, with no reported adverse event; Initial information received on 15-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old female patient who experienced medication error due to reconstituting with the wrong diluent and administering to a patient, with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination.  On 14-Apr-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot UJ574AAA via intramuscular route in unknown administration site for prophylactic vaccination.  On 14-APR-2022 the patient developed a non-serious medication error due to reconstituting with the wrong diluent and administering to a patient, with no reported adverse event (medication error) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error due to reconstituting with the wrong diluent and administering to a patient, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event medication error due to reconstituting with the wrong diluent and administering to a patient, with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.