chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pemphigoid, Pruritus
Clinical narrative: bullous pemphigoid; itchy blisters on my skin; itchy blisters on my skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 at 09:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, single, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: PEMPHIGOID (medically significant), outcome "not recovered", described as "bullous pemphigoid"; PRURITUS (non-serious), BLISTER (non-serious), outcome "not recovered" and all described as "itchy blisters on my skin". The events "bullous pemphigoid" and "itchy blisters on my skin" required physician office visit. Therapeutic measures were taken as a result of pemphigoid, pruritus, blister.  Additional information: the patient received the 4th dose of Pfizer Covid-19 vaccine on 11Nov2022 at 11:00 AM in the left arm. Within a week or two of the bivalent booster she developed itchy blisters on her skin similar to what happened after her last booster dose (Dose 3). It was reported that after the first incident, it was diagnosed by a dermatologist as bullous pemphigoid, patient was given oral and topical steroid and it improved. The blisters begin as itchy and if she scratched them they would pop and turn into a scab to heal. Patient have never had any of these symptoms before receiving the covid vaccine. The patient has no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300119722 same patient/events different vaccine doses;US-PFIZER INC-202300120267 same patient, different vaccine doses/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Headaches" (unspecified if ongoing); "Seronegative rheumatoid arthritis" (unspecified if ongoing); "Sjogren's Syndrome" (unspecified if ongoing); "Sweet's Syndrome" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Chronic Fatigue Syndrome" (unspecified if ongoing); "Fatty Liver Disease" (unspecified if ongoing); "Degenerative Disk Disease" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Carpal Tunnel" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Fentanyl, reaction(s): "Known allergies: fentanyl"; Imitrex, reaction(s): "Known allergies: Imitrex"; Cytomel, reaction(s): "Known allergies: Cytomel"; Abilify, reaction(s): "Known allergies: Abilify"; Buspar, reaction(s): "Known allergies: Buspar"; Reglan, reaction(s): "Known allergies: Reglan"; Haldol, reaction(s): "Known allergies: Haldol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccines cannot be excluded for suspected LOE. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Ear pain, Injection site erythema, Injection site warmth, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: large red hot spot at injection site; large red hot spot at injection site; severe sinus congestion; severe sinus congestion achy, sore throat and ache around ears; sore throat; ache around ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Feb2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for immunisation. The patient's relevant medical history included: "cancer", start date: 2011 (unspecified if ongoing), notes: X cancer patient diagnosed and treated 2011.; "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Oct2016. The following information was reported: EAR PAIN (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "ache around ears"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 01Mar2023 at 13:00, outcome "recovering" and all described as "large red hot spot at injection site"; SINUS CONGESTION (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "severe sinus congestion"; PAIN (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "severe sinus congestion achy, sore throat and ache around ears"; OROPHARYNGEAL PAIN (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth, sinus congestion, pain, oropharyngeal pain, ear pain. Additional information: Initially large red hot spot at injection site, severe sinus congestion achy, sore throat and ache around ears. No fever tested 2 times for Covid, both negative.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Sinus congestion, Sinus pain, Vaccination site erythema, Vaccination site warmth
Clinical narrative: large red hot spot at injection site; large red hot spot at injection site; severe sinus congestion; severe sinus congestion achy, sore throat and ache around ears; sore throat; ache around ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Feb2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for immunisation. The patient's relevant medical history included: "cancer", start date: 2011 (unspecified if ongoing), notes: X cancer patient diagnosed and treated 2011.; "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Oct2016. The following information was reported: EAR PAIN (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "ache around ears"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 01Mar2023 at 13:00, outcome "recovering" and all described as "large red hot spot at injection site"; SINUS CONGESTION (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "severe sinus congestion"; PAIN (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "severe sinus congestion achy, sore throat and ache around ears"; OROPHARYNGEAL PAIN (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth, sinus congestion, pain, oropharyngeal pain, ear pain. Additional information: Initially large red hot spot at injection site, severe sinus congestion achy, sore throat and ache around ears. No fever tested 2 times for Covid, both negative.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 22 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2022 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included: SYNTHROID; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Negative; (18Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient was treated for COVID-19 with Paxlovid from 08Mar2023 to 13Mar2023. Then, the patient was well and tested negative for COVID. 5 days after finishing Paxlovid and 3 days after testing negative, she became sick again and tested positive for COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Sep2022 as dose 1, single (Lot number: W5342) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: codeine, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: she was not feeling good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA).  A female patient received BNT162b2 (BNT162B2), as dose 2, 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), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "she was not feeling good".  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: Hypoaesthesia
Clinical narrative: my feet went numb/hands went numb; 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 male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "my feet went numb/hands went numb".  Additional information: After the patient's Pfizer Covid vaccination, his feet and hands went numb. After two more boosters, He can't walk without assistance.    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-202300122061 same patient different dose/drug/event;US-PFIZER INC-202300123168 Same reporter/patient, different dose/AE.;
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 15:30 as dose 4 (booster), single (Lot number: GH9693) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 09Mar2023 to 13Mar2023.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter (Pharmacist). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 63 years, in right arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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 included: "High blood pressure" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: ACE inhibitors" (unspecified if ongoing). Concomitant medications included: AMLODIPINE; FENOFIBRATE; LASIX [FUROSEMIDE]; OMEPRAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Mar2023, outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Mar2023) Positive; (13Mar2023) Negative; (20Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 06Mar2023 to 10Mar2023. Clinical course: Tested positive for COVID on 06Mar2023, tested negative for COVID on 13Mar2023, return of symptoms 11pm on 19Mar2023, tested positive for COVID on 20Mar2023.; Sender's Comments: Based on the available information, a possible contributory role of suspect drug BNT162B2 to the reported events COVID-19 (drug ineffective) cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Poor quality product administered, Product administration error
Clinical narrative: The COVID-19 vaccine gray cap bivalent was stored in the fridge 73 days instead of 70 and it was administered to a patient on the day 73; The COVID-19 vaccine gray cap bivalent was stored in the fridge 73 days instead of 70 and it was administered to a patient on the day 73; flu-like symptoms; headache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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, Primary immunization series completed), for COVID-19 Immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "The COVID-19 vaccine gray cap bivalent was stored in the fridge 73 days instead of 70 and it was administered to a patient on the day 73"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; HEADACHE (non-serious), outcome "unknown".  Additional information: Pharmacist was calling about the Pfizer COVID-19 vaccine bivalent that was left in the fridge and used beyond use date of 70 days. The vaccine was administered to a patient on 73 days so she wants to know if the patient should get vaccinated. The COVID-19 vaccine gray cap bivalent was stored in the fridge 73 days instead of 70 and it was administered to a patient on the day 73. The patient has had flu-like symptoms and headache, but no fever. Caller would like to know when the patient can be revaccinated, if at all.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chemical burn, Nail disorder, Pain, Rash macular, Skin discolouration
Clinical narrative: gained COVID back in the emergency; gained COVID back in the emergency; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 3 (booster), 0.3 ml single (Lot number: GJ6665, Expiration Date: 06Dec2022) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Lot number: EWO161, Expiration Date: 01Jul2021) and on 17May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Degenerative bone disease" (unspecified if ongoing), notes: Degenerative bone disease; "Insomnia" (unspecified if ongoing); "COPD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Emphysema" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "gained COVID back in the emergency". The patient was hospitalized for drug ineffective, covid-19 (start date: Nov2022, discharge date: Nov2022, hospitalization duration: 3 day(s)). The event "gained covid back in the emergency" required emergency room visit. Additional information: Consumer stated, "They tried a few things on me, but they could not figure out what  it was because, so they were treating me because they could, the CDC could not figured it out, the center could not figure out. Dermatologist could not figure out. I left home but with no answers and it is just recently I was reading some of the effects from COVID shots, side effects on people of my age and it was stating for some of them that they could become as long as 23 to 30 days after the injections. I asked about the time I was into the emergency the first time and then within a day and a half I gained COVID back in the emergency as being kept. So, when I spent 3 days in there, everybody came and checked on me. All I took was my regular med, basically in pain medication. So much pain. Name of the medication, consumer stated, "The pain medication they gave me? I honestly do not know."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation
Clinical narrative: gained COVID back in the emergency; gained COVID back in the emergency; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 3 (booster), 0.3 ml single (Lot number: GJ6665, Expiration Date: 06Dec2022) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Lot number: EWO161, Expiration Date: 01Jul2021) and on 17May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Degenerative bone disease" (unspecified if ongoing), notes: Degenerative bone disease; "Insomnia" (unspecified if ongoing); "COPD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Emphysema" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "gained COVID back in the emergency". The patient was hospitalized for drug ineffective, covid-19 (start date: Nov2022, discharge date: Nov2022, hospitalization duration: 3 day(s)). The event "gained covid back in the emergency" required emergency room visit. Additional information: Consumer stated, "They tried a few things on me, but they could not figure out what  it was because, so they were treating me because they could, the CDC could not figured it out, the center could not figure out. Dermatologist could not figure out. I left home but with no answers and it is just recently I was reading some of the effects from COVID shots, side effects on people of my age and it was stating for some of them that they could become as long as 23 to 30 days after the injections. I asked about the time I was into the emergency the first time and then within a day and a half I gained COVID back in the emergency as being kept. So, when I spent 3 days in there, everybody came and checked on me. All I took was my regular med, basically in pain medication. So much pain. Name of the medication, consumer stated, "The pain medication they gave me? I honestly do not know."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: gained COVID back in the emergency; gained COVID back in the emergency; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 3 (booster), 0.3 ml single (Lot number: GJ6665, Expiration Date: 06Dec2022) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Lot number: EWO161, Expiration Date: 01Jul2021) and on 17May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Degenerative bone disease" (unspecified if ongoing), notes: Degenerative bone disease; "Insomnia" (unspecified if ongoing); "COPD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Emphysema" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "gained COVID back in the emergency". The patient was hospitalized for drug ineffective, covid-19 (start date: Nov2022, discharge date: Nov2022, hospitalization duration: 3 day(s)). The event "gained covid back in the emergency" required emergency room visit. Additional information: Consumer stated, "They tried a few things on me, but they could not figure out what  it was because, so they were treating me because they could, the CDC could not figured it out, the center could not figure out. Dermatologist could not figure out. I left home but with no answers and it is just recently I was reading some of the effects from COVID shots, side effects on people of my age and it was stating for some of them that they could become as long as 23 to 30 days after the injections. I asked about the time I was into the emergency the first time and then within a day and a half I gained COVID back in the emergency as being kept. So, when I spent 3 days in there, everybody came and checked on me. All I took was my regular med, basically in pain medication. So much pain. Name of the medication, consumer stated, "The pain medication they gave me? I honestly do not know."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 19:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: tested negative for 2-3 days on antigen tests post paxlovid course; (Mar2023) Negative, notes: tested negative for 2-3 days on antigen tests post paxlovid course; (Mar2023) Negative, notes: tested negative for 2-3 days on antigen tests post paxlovid course; (17Mar2023) Positive; (20Mar2023) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Autoimmune thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 19Nov2008. The following information was reported: COVID-19 (medically significant) with onset Mar2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset Mar2023, outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment with Paxlovid from 05Mar2023 till 09Mar2023. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300122138 same patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccines cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, Glycosylated haemoglobin, SARS-CoV-2 test
Clinical narrative: took a test and it came back positive; took a test and it came back positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm and as dose number unknown (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), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (ongoing), notes: takes a medication for this but it is under control.; "Diabetes" (ongoing), notes: Borderline Type 2, A1C down below 5. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "recovered" (2021) and all described as "took a test and it came back positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; Glycosylated haemoglobin: (unspecified date) down below 5; SARS-CoV-2 test: (2021) Positive, notes: took a test and it came back positive.  Clinical course: Patient got Covid after 1 vaccine and 2 boosters (as reported) and didn't know he had it. States he went to his 55 year class reunion in 2021 that summer and 12 of them got Covid at the reunion. His buddy called him and said his wife and him both have Covid and he asked him if he had it. Patient said he had a runny nose and he didn't think so but he took a test and it came back positive. He had a runny nose for a day, that was all. Patient stated thank goodness for Pfizer, it was a non-event for him. States his friend's wife died 30 days after the reunion, but she was 78 and had underlying health issues.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Blood electrolytes, Blood pressure measurement, COVID-19, Drug ineffective, Glomerular filtration rate
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 87-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 87 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Dec2020 at 11:30 as dose 1, single (Lot number: EL3246), in left arm, on 21Jan2021 at 09:00 as dose 2, single (Lot number: FL9261), in left arm, on 28Feb2022 at 13:30 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 09Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Episodic atrial fibrillation" (unspecified if ongoing), notes: other medical history: Episodic atrial fibrillation; "post TAVR aortic valve replacement", start date: Sep2021 (unspecified if ongoing), notes: other medical history: Status post TAVR aortic valve replacement, Sep2021. The patient has no known allergies. Concomitant medication(s) included: CRESTOR, start date: 08May2007; CITALOPRAM, start date: 09Jun1992; PROSCAR, start date: 18Aug1987. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood electrolytes: Normal; Blood pressure measurement: 89/42; Glomerular filtration rate: GFR was low ar 49.; Myocardial necrosis marker: Normal. Therapeutic measures were taken (PAXLOVID) as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported events Drug ineffective and COVID-19 cannot be ruled out, based on the limited information currently available.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 87-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 87 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Dec2020 at 11:30 as dose 1, single (Lot number: EL3246), in left arm, on 21Jan2021 at 09:00 as dose 2, single (Lot number: FL9261), in left arm, on 28Feb2022 at 13:30 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 09Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Episodic atrial fibrillation" (unspecified if ongoing), notes: other medical history: Episodic atrial fibrillation; "post TAVR aortic valve replacement", start date: Sep2021 (unspecified if ongoing), notes: other medical history: Status post TAVR aortic valve replacement, Sep2021. The patient has no known allergies. Concomitant medication(s) included: CRESTOR, start date: 08May2007; CITALOPRAM, start date: 09Jun1992; PROSCAR, start date: 18Aug1987. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood electrolytes: Normal; Blood pressure measurement: 89/42; Glomerular filtration rate: GFR was low ar 49.; Myocardial necrosis marker: Normal. Therapeutic measures were taken (PAXLOVID) as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported events Drug ineffective and COVID-19 cannot be ruled out, based on the limited information currently available.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Jan2013; PRAVASTATIN, start date: Jan2013. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as Covid-19 treatment. The patient has no known allergies.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported events Drug ineffective and COVID-19 cannot be ruled out, based on the limited information currently available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GH9694), in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 01Mar2023 to 06Mar2023.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received Paxlovid from 12Mar2023 to 17Mar2023 as treatment for the event.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 94-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 at 17:00 as dose 2, single (Batch/Lot number: unknown) at the age of 94 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension Cardiac" (unspecified if ongoing), notes: Hypertension Cardiac; "allergy" (unspecified if ongoing), notes: Known allergies:None. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization, reaction(s): "hives". The following information was reported: URTICARIA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "hives". The event "hives" required physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional Information:Reporting for my 94 year old mother. After first vaccine she started having hives. For 2 years she has dealt with this issue. Treated and seen by multiple doctors. Phototherapy was used as well as medications.No any other vaccine in four weeks.Patient received Other medications in two weeks.No any covid prior vaccination and No any covid tested post vaccination  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-202300124954 same patient/event and different drug dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: He got COVID a month after getting the shot; He got COVID a month after getting the shot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GJ3277) for COVID-19 immunisation; 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He got COVID a month after getting the shot". Clinical course: The patient reported that he had a total of 5 of the Pfizer vaccines. He would like to know if the shot that he had was the bivalent. He mentioned he got COVID a month after getting the shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer). The reporter is the patient. A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Feb2023 as dose 3 (booster), single (Lot number: 6J6796) at the age of 71 years, in right arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "known allergies: sulfa" (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 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective and COVID-19 with PAXLOVID from 08Mar2023 until 13Mar2023.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 1, single (Lot number: FC3184), in left arm and in Oct2021 as dose  2, single (Lot number: FF2589) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: eye drops" (unspecified if ongoing); "Known allergies: BP medication" (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 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which include Paxlovid from 16Mar2023 to 20Mar2023.