chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Pain
Clinical narrative: Left knee became swollen and very stiff; Left knee became swollen and very stiff; Painful to walk; knee is still tender and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2022 at 18:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing), notes: Osteoarthritis all over my body, but my knees have it more mildly. The patient took concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose lot number: FC3180,, Prev dose administration time: 05:30 PM, Prev dose dose number: 2,, Prev dose vaccine location: Left arm), administration date: 13Aug2021, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose lot number: FA7484,, Prev dose administration time: 05:30 PM, Prev dose dose number: 1,, Prev dose vaccine location: Left arm), administration date: 23Jul2021, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: JOINT SWELLING (non-serious), JOINT STIFFNESS (non-serious) all with onset 25Feb2022 at 22:00, outcome "recovered with sequelae" (2022) and all described as "Left knee became swollen and very stiff"; PAIN (non-serious) with onset 25Feb2022 at 22:00, outcome "recovered with sequelae" (2022), described as "Painful to walk"; ARTHRALGIA (non-serious) with onset 25Feb2022 at 22:00, outcome "not recovered", described as "knee is still tender and sore". Therapeutic measures were not taken as a result of joint swelling, joint stiffness, pain, arthralgia.  Additional information: It was reported that about four hours after the 3rd dose of the COVID vaccine was received, my left knee became swollen and very stiff. It felt like my knee had been stuffed with cotton. I was unable to bend it fully, and it was painful to walk and go up and down stairs. It took about 10 days for the worst of it to go away, but it never completely resolved. It has been two months now, and the knee is still tender and sore, and quickly becomes painful when going for a walk. I do have osteoarthritis all over my body, but my knees have it more mildly and were not an issue before the booster dose. I plan on consulting an ortho doctor about it in the near future. Patient had No COVID prior vaccination and neither tested post vaccination. Patient did not have any Known allergies. Patient received unspecified medications in two weeks of vaccination.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Facial pain, Lethargy
Clinical narrative: Rebound COVID; Rebound COVID; lethargy; Shortness of breath; Post-nasal drip; Facial pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2021 at 09:00 as dose 3 (booster), single (Lot number: 33025BD) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "WPW" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series, unknown manufacturer), for Covid-19 immunization. The following information was reported: FACIAL PAIN (non-serious) with onset 25Apr2022 at 20:00, outcome "recovering"; RHINORRHOEA (non-serious) with onset 25Apr2022 at 20:00, outcome "recovering", described as "Post-nasal drip"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 25Apr2022 at 20:00, outcome "recovering" and all described as "Rebound COVID"; DYSPNOEA (non-serious) with onset 25Apr2022 at 20:00, outcome "recovering", described as "Shortness of breath"; LETHARGY (non-serious) with onset 25Apr2022 at 20:00, outcome "recovering". Therapeutic measures were not taken as a result of covid-19, drug ineffective, lethargy, dyspnoea, rhinorrhoea, facial pain.  Clinical Course:Adverse event: "Rebound COVID". Redevelopment of symptoms (lethargy, shortness of breath, post-nasal drip, facial pain) 5 days following completion of treatment course; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Rebound COVID; Rebound COVID; lethargy; Shortness of breath; Post-nasal drip; Facial pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2021 at 09:00 as dose 3 (booster), single (Lot number: 33025BD) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "WPW" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series, unknown manufacturer), for Covid-19 immunization. The following information was reported: FACIAL PAIN (non-serious) with onset 25Apr2022 at 20:00, outcome "recovering"; RHINORRHOEA (non-serious) with onset 25Apr2022 at 20:00, outcome "recovering", described as "Post-nasal drip"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 25Apr2022 at 20:00, outcome "recovering" and all described as "Rebound COVID"; DYSPNOEA (non-serious) with onset 25Apr2022 at 20:00, outcome "recovering", described as "Shortness of breath"; LETHARGY (non-serious) with onset 25Apr2022 at 20:00, outcome "recovering". Therapeutic measures were not taken as a result of covid-19, drug ineffective, lethargy, dyspnoea, rhinorrhoea, facial pain.  Clinical Course:Adverse event: "Rebound COVID". Redevelopment of symptoms (lethargy, shortness of breath, post-nasal drip, facial pain) 5 days following completion of treatment course; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: a PCR positive case of COVID; a PCR positive case of COVID; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CIDP" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 04Dec2019; IVIGLOB-EX, start date: 01Sep2014, stop date: 26Apr2022.  The following information was reported: VACCINATION FAILURE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (Apr2022) and all described as "a PCR positive case of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (Apr2022) Positive; SARS-CoV-2 test: (Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  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 available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination Failure and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: I was exposed alot during the past week to a person that has tested POS. for Covid19. And i now have a sore throat.; I was exposed alot during the past week to a person that has tested POS. for Covid19. And i now have a sore throat.; I was exposed alot during the past week to a person that has tested POS. for Covid19. And i now have a sore throat.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71-year-old male patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOW (BOOSTER), SINGLE, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), OROPHARYNGEAL PAIN (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "I was exposed alot during the past week to a person that has tested POS. for Covid19. And i now have a sore throat.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was exposed alot during the past week to a person that has tested POS. for Covid19. Therapeutic measures were not taken as a result of drug ineffective, covid-19. It was reported that patient had not received any Other Medication in 2weeks. Patient had no known allergies. It was reported that patient was exposed a lot during the past week to a person that has tested POS. for Covid19. And now had a sore throat The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 at 12:00 as dose 3 (booster), single (Lot number: EW0175) at the age of 35 years, in right arm 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. The patient's relevant medical history was not reported. Concomitant medication(s) included: CEFALEXIN, start date: 31Mar2022, stop date: 10Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Clinical Course: Anti viral details, Paxlovid treatment start date was on 18Apr2022, and treatment stop date was on 22Apr2022, adverse event: Sore throat & coughing returned 5 days after taking last dose of Paxlovid. Fatigue returned 4 days after taking last dose of Paxlovid. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Nasopharyngitis, Pyrexia
Clinical narrative: Postive test on a Sunday; PCR positive; Postive test on a Sunday; PCR positive; exhausted; head cold; fever lifted almost miraculously; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 at 17:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 10Sep2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Haemochromatosis" (unspecified if ongoing); "Food allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022 at 01:00, outcome "recovered" and all described as "Postive test on a Sunday; PCR positive"; FATIGUE (non-serious) with onset 26Apr2022 at 01:00, outcome "recovered", described as "exhausted"; PYREXIA (non-serious) with onset 26Apr2022 at 01:00, outcome "recovered", described as "fever lifted almost miraculously"; NASOPHARYNGITIS (non-serious) with onset 26Apr2022 at 01:00, outcome "recovered", described as "head cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) faintest pink, notes: 4 days later Binax test faintest pink; (unspecified date) solid pink, notes: 6 days later cold symptoms coming on Binax sold pink; (06Apr2022) Positive, notes: PCR positive with 38 viral load; (07Apr2022) Negative, notes: Negative on binax. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had rebound effect. Positive test on a Sunday. Started Paxlovid Sunday night. Within 5 hours she was 50% better, by the next day 80 % better, just exhausted. head cold, fever lifted almost miraculously. 4 days later, Binax test faintest pink, 6days later cold symptoms coming on. Binax solid pink. terrible cold. On 04April still testing positive. 06Apr PCR positive with 38 viral loads. Positive on Binax, Negative on Clear Vue, on 07Apr negative on Binax. Patient was allergic to Some food.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Postive test on a Sunday; PCR positive; Postive test on a Sunday; PCR positive; exhausted; head cold; fever lifted almost miraculously; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 at 17:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 10Sep2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Haemochromatosis" (unspecified if ongoing); "Food allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022 at 01:00, outcome "recovered" and all described as "Postive test on a Sunday; PCR positive"; FATIGUE (non-serious) with onset 26Apr2022 at 01:00, outcome "recovered", described as "exhausted"; PYREXIA (non-serious) with onset 26Apr2022 at 01:00, outcome "recovered", described as "fever lifted almost miraculously"; NASOPHARYNGITIS (non-serious) with onset 26Apr2022 at 01:00, outcome "recovered", described as "head cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) faintest pink, notes: 4 days later Binax test faintest pink; (unspecified date) solid pink, notes: 6 days later cold symptoms coming on Binax sold pink; (06Apr2022) Positive, notes: PCR positive with 38 viral load; (07Apr2022) Negative, notes: Negative on binax. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had rebound effect. Positive test on a Sunday. Started Paxlovid Sunday night. Within 5 hours she was 50% better, by the next day 80 % better, just exhausted. head cold, fever lifted almost miraculously. 4 days later, Binax test faintest pink, 6days later cold symptoms coming on. Binax solid pink. terrible cold. On 04April still testing positive. 06Apr PCR positive with 38 viral loads. Positive on Binax, Negative on Clear Vue, on 07Apr negative on Binax. Patient was allergic to Some food.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Symptoms returned 27Apr. Rapid test positive on evening of 27Apr.; Symptoms returned 27Apr. Rapid test positive on evening of 27Apr.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Covid-19 vaccine ("Primary Immunization series complete; unknown manufacturer"), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Apr2022 at 06:45, outcome "not recovered" and all described as "Symptoms returned 27Apr. Rapid test positive on evening of 27Apr.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2022) Negative; (27Apr2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: It was reported that COVID. Symptoms resolved on 20Apr2022. Tested negative on 22Apr2022. Symptoms returned 27Apr2022. Rapid test positive on evening of 27Apr2022. Treatment Paxlovid start date was 16Apr2022 and treatment stop date was 20Apr2022.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Therapeutic product effect decreased
Clinical narrative: Rheumatoid arthritis flare up; Drug effect decreased; 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-163-4255354-00 (RA).  A 58-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious) with onset Dec2021, outcome "unknown", described as "Drug effect decreased"; RHEUMATOID ARTHRITIS (medically significant) with onset Dec2021, outcome "unknown", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" and "drug effect decreased" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Additional Information: The reporter's causality for the event(s) of HUMIRA not effective anymore rheumatoid arthritis symptoms worsened/ Possible increase in arthritic issues following the COVID vaccine onset in Dec2021 and HUMIRA not effective anymore rheumatoid arthritis symptoms worsened/ Possible increase in arthritic issues following the COVID vaccine onset in Dec2021 was not provided. On 22Apr2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of HUMIRA not effective anymore rheumatoid arthritis symptoms worsened/ Possible increase in arthritic issues following the COVID vaccine.  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 available reported information, the causal association between the events rheumatoid arthritis and therapeutic product effect decreased 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Dizziness, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: asthma; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: shellfish. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], start date: 03Jan2022, stop date: 09Apr2022. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer). The following information was reported: NASAL CONGESTION (non-serious) with onset 24Apr2022, outcome "not recovered", described as "Congestion"; COUGH (non-serious) with onset 24Apr2022, outcome "not recovered"; FATIGUE (non-serious) with onset 24Apr2022, outcome "not recovered"; HEADACHE (non-serious) with onset 24Apr2022, outcome "not recovered"; NAUSEA (non-serious) with onset 24Apr2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 24Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 24Apr2022, outcome "not recovered" and all described as "Relapse of Covid-19 symptoms and positive Covid-19 test after two negative tests two days apart"; DIARRHOEA (non-serious) with onset 24Apr2022, outcome "not recovered", described as "diarrhea"; DIZZINESS (non-serious) with onset 24Apr2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 'positive Covid-19 test after two negative tests two days apart'; Negative, notes: two negative tests. Therapeutic measures were not taken as a result of Covid-19, nasal congestion, headache, cough, fatigue, nausea, diarrhoea, dizziness. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Nausea, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: asthma; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: shellfish. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], start date: 03Jan2022, stop date: 09Apr2022. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer). The following information was reported: NASAL CONGESTION (non-serious) with onset 24Apr2022, outcome "not recovered", described as "Congestion"; COUGH (non-serious) with onset 24Apr2022, outcome "not recovered"; FATIGUE (non-serious) with onset 24Apr2022, outcome "not recovered"; HEADACHE (non-serious) with onset 24Apr2022, outcome "not recovered"; NAUSEA (non-serious) with onset 24Apr2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 24Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 24Apr2022, outcome "not recovered" and all described as "Relapse of Covid-19 symptoms and positive Covid-19 test after two negative tests two days apart"; DIARRHOEA (non-serious) with onset 24Apr2022, outcome "not recovered", described as "diarrhea"; DIZZINESS (non-serious) with onset 24Apr2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 'positive Covid-19 test after two negative tests two days apart'; Negative, notes: two negative tests. Therapeutic measures were not taken as a result of Covid-19, nasal congestion, headache, cough, fatigue, nausea, diarrhoea, dizziness. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms; 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 64-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years 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 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: INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms".  Additional information: The caller received the 2nd booster shot of the Pfizer-BioNTech Covid 19 Vaccine and had flu symptoms due to the vaccine. His date of birth is (DOB withheld). However, (Name withheld) called on behalf his girlfriend who also received the 2nd booster dose of the Pfizer-BioNTech Covid 19 Vaccine and has a rash all over her body (both arms and her chest) ever since she received the vaccine. He stated that her girlfriend is in pain. His girlfriend's date of birth is (DOB withheld).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Symptoms started to reappear on 27Apr2022; Symptoms started to reappear on 27Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL HFA, start date: Jan2022, stop date: Apr2022; ADVAIR, start date: Jan2022, stop date: Apr2022; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE], start date: Apr2022, stop date: Apr2022; SINGULAIR, start date: Jan2022, stop date: Apr2022; BUPROPION, start date: Jan2022, stop date: Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Symptoms started to reappear on 27Apr2022". Therapeutic measures were taken as a result of suspected covid-19. Clinical course included  patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient received Paxlovid as a treatment start date was19Apr2022 Treatment stop date was 23Apr2022. Patient previously received a COVID-19 Vaccine. It was reported symptoms started to reappear on 27Apr2022- congestion, fatigue, cough.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Fever; chest pain; two weeks after she went for the second one; 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 59-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "had an adult covid shot it was so awful". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHEST PAIN (non-serious), outcome "recovered"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "two weeks after she went for the second one". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chest pain.  Clinical courses: The patient already had an adult covid shot it was so awful, and two weeks after she went for the second one. She thought it was the second one. Later she mentioned that the first dose was okay but the second one was "deadly" so then she never went to get the boosters. Caller mentioned she did not want to get the adult dose again because she already received an adult one and that "it almost killed her". She also stated that she had a fever of 102.5 degree F and chest pain. She instantly called 911 and was advised to take 2  pills which relieved her symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive; testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm 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). The patient's relevant medical history included: "Former diabetic" (unspecified if ongoing), notes: Known allergies: No; "smoker" (unspecified if ongoing); "obese" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) positive, notes: 4 days after completion of medication, I was symptomatic and testing positive. Was non symptomatic during medication course. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: Anti viral details product=COVID 19 Treatment, brand Paxlovid, treatment start date was on15Apr2022, and treatment stop date was on 20Apr2022. Adverse event: 4 days after completion of medication, he was symptomatic and testing positive. Was non symptomatic during medication course.  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: Malaise
Clinical narrative: really got lousy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "really got lousy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: Pain at injection site; muscle aches; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FL3197) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; LISINOPRIL. Vaccination history included: Covid-19 vaccine (Dose: 01, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Apr2022 at 22:00, outcome "recovering", described as "Pain at injection site"; HEADACHE (non-serious) with onset 27Apr2022 at 22:00, outcome "recovering"; MYALGIA (non-serious) with onset 27Apr2022 at 22:00, outcome "recovering", described as "muscle aches". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, headache.  Additional information: No other vaccine in four weeks. Other medications in two weeks: Atorvastatin and Lisinopril. No covid prior vaccination. No covid tested post vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive in the morning on a rapid test; tested positive in the morning on a rapid test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 24Feb2021 as dose 2, single (Lot number: EN6201) and on 18Apr2021 as dose 3 (booster), single at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "SVA tachycardia" (unspecified if ongoing), notes: other medical history: SVA tachycardia. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, 19 days after the suspect product(s) administration, outcome "unknown" and all described as "tested positive in the morning on a rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Negative; (27Apr2022) Positive; (27Apr2022) Negative; (27Apr2022) Positive.  clinical information: patient recieved anti viral COVID 19 Treatment. patient finished Paxlovid on 12Apr2022 and tested negative after having COVID on 14Apr2022 and 15Apr2022. patient felt mostly recovered, except for some headaches and a slight cough. patient happened to test on 27Apr2022 because I was going to be seeing a friend's newborn baby soon. patient tested positive in the morning on a rapid test. Patient took another rapid test immediately and it was negative. Both tests were from separate kits. then took another test in the late afternoon and was positive, on another kit/type of test. Patient started feeling a little chest congestion. On 28Apr2022 I woke up feeling a like I had a little head cold but very mild. Later in the day I felt a bit worse, a bad headache and some slight body aches. Patient now isolating and will continue testing.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nerve injury, Product administration error
Clinical narrative: improper injection regarding the nerve damage;  it's about injection procedure done at a drug store that I went to; improper injection regarding the nerve damage;  it's about injection procedure done at a drug store that I went to; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVE INJURY (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "improper injection regarding the nerve damage; it's about injection procedure done at a drug store that I went to".  Additional Information: It was reported that improper injection of Pfizer COVID 19 vaccine not mentioned what is the caller of the cap and the effects of the improper injection regarding the nerve damage. It was not really in reference to the actual vaccine substance itself, it had to do with the actual injection procedure and the patient was to visit doctor regarding the injection issue, so reported about any side effects or any other issue with the substance of the actual vaccine. The patient was not reporting any substance reaction to its recent vaccine. The injection procedure was done at the drug store patient went to.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955), on 10Apr2021 as dose 2, single (Lot number: EW0153) and on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 37 years for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "Tree nuts" (unspecified if ongoing), notes: Tree nuts. Concomitant medication(s) included: LISINOPRIL, start date: Jan2013; AMLODIPINE BESYLATE, start date: Jan2013; METFORMIN, start date: Jan2017; METOPROLOL, start date: Jan2019; CANNABIS, start date: Jan2018; DAYQUIL, start date: 19Apr2022, stop date: 22Apr2022; NYQUIL, start date: 19Apr2022, stop date: 22Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected Covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  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-202200641912 Different patients, Same reporter, drug, event.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation, Scan
Clinical narrative: emergency room scans showed inflammation in my lower abdomen; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (Pfizer-BioNTech COVID-19), on 02Feb2022 as dose number unknown, single (Lot number: fj6369) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (hospitalization) with onset 13Feb2022, outcome "unknown", described as "emergency room scans showed inflammation in my lower abdomen". The event "emergency room scans showed inflammation in my lower abdomen" required emergency room visit. The patient underwent the following laboratory tests and procedures: Scan: inflammation, notes: scans showed inflammation in my lower abdomen.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: mini stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 87 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Heart Condition" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Hives"; Septra, reaction(s): "Hives". Vaccination history included: BNT162b2 (Dose 1, Lot number CR8730 or ER8730), administration date: 26Mar2021, for COVID-19 immunization, reaction(s): "No adverse effect"; BNT162b2 (Dose 2, Lot number EW0161), administration date: 16Apr2021, for COVID-19 Immunization, reaction(s): "No adverse effect"; Flu vaccine, for Immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset Nov2021, outcome "unknown", described as "mini stroke". Therapeutic measures taken as a result of transient ischaemic attack included clopidogrel; the patient stated that "she started it, probably in Nov2021 at 75 mg once daily when she had the stroke but, may have been after that. Indication: they say it's a life saver when you have a stroke".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200604654 same patient, different events after different doses of the vaccine
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: had administered an expired MENACTRA with no reported adverse event; Initial information received on 22-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 11-year-old male patient who had administered an expired menactra with no reported adverse event while receiving vaccine meningococcal A-C-Y-W135 (D CONJ) [Menactra].  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 5-component, tetanus vaccine toxoid (Adacel) and HPV vaccine VLP RL1 9V (Yeast) (Gardasil 9) both for Prophylactic vaccination.  On 21-Apr-2022, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine lot U6921AA, expiry date: 17-Apr-2022 with unknown formulation, strength via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient developed non-serious had administered an expired menactra with no reported adverse event (expired product administered) (latency same day) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment.  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.