chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable consumer. The reporter is the patient. A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8727), in left arm, on 26Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 10Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Patient had not received other medication in 2 weeks. Past drug history included: Morphine, reaction(s): "allergies"; Fentanyl, reaction(s): "allergies"; Tramedol, reaction(s): "allergies". Patient received Paxlovid (Lot number: Gc2897) from 06Jul2022 to 11Jul2022 for Covid-19 treatment. Outcome of the events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear infection, Tinnitus
Clinical narrative: hearing loss in her left ear; ear infection; tinnitus; 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 75-year-old female patient received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Lot Number/Expiry Date: EW0173, Anatomical Location: unknown), administration date: 14May2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot Number/Expiry Date: EW0167/unknown, Anatomical Location: unknown), administration date: 05Jun2021, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Jan2022, outcome "not recovered"; DEAFNESS UNILATERAL (medically significant), outcome "not recovered", described as "hearing loss in her left ear"; EAR INFECTION (non-serious), outcome "not recovered". The events "hearing loss in her left ear", "ear infection" and "tinnitus" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of ear infection.  Additional Information: Caller reported that she had received her first two doses and booster dose of the Pfizer Covid-19 vaccine. Caller reports that she was having a lot of problems after booster dose of the Pfizer Covid-19 vaccine. She was having complaints of an ear infection after the booster dose of the Pfizer Covid-19 vaccine, took a dose of antibiotics, the ear infection did not clear up, took another dose antibiotics, and was then having complaints of tinnitus and hearing loss in her left ear. Caller stated that she did not know what to do about these complaints. After the booster dose, she was diagnosed with an ear infection. She was given an antibiotic, but the infection did not clear up, and was given a second dose of antibiotic. Stated she was given two doses of an antibiotic, and the medication did not help with the infection. Medication: Amoxicillin 500 mg. Vaccination Facility Type was at a pharmacy. Vaccine was not Administered at Facility. Adverse events required a visit to the Emergency Room. Discharged and referred to Ear, Nose, Throat specialist. Physician Office was also required. No prior vaccinations (within 4 weeks). Stated that Doctor looked in her ears and said nothing was wrong with her ears. Because of her hearing loss, she made another appointment for 25Jul2022. Stated she was given two doses of an antibiotic, and the medication did not help with the infection. Product strength and count size dispensed: 500mg/20 pills for 10 days.  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: COVID-19, Drug ineffective
Clinical narrative: Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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 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 "Paxlovid indication=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 the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 66.0
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 a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25May2022 at 17:30 as dose 4 (booster), single (Lot number: FM7553) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 27Jan2021 as dose 1, single (Lot number: 043L20A), in left arm, on 24Feb2021 as dose 2, single (Lot number: 001A21A), in left arm and on 29Dec2021 at 19:00 as dose 3 (booster), single (Lot number: 065F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE; BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Negative, notes: tested antigen negative on 07Jul; (unspecified date) Unknown results, notes: Treatment of COVID-19; (09Jul2022) Positive, notes: recurrent symptoms and positive test on 09Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 30Jun2022 to 04Jul2022.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6201) at the age of 65 years, in left arm, on 04Mar2021 at 12:00 as dose 2, single (Lot number: EN6205) at the age of 65 years, in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 66 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Gluten/celiac disease" (unspecified if ongoing); "Gluten/celiac disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (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: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Patient antiviral details included product -COVID 19 Treatment, treatment stop date=04Jul2022.
Age: 59.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 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 included: "bronchial pneumonia in past" (unspecified if ongoing), notes: other medical history: bronchial pneumonia in past. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: First round of Paxlovid was great. symptoms diminished by day 2, felt good for several days. But symptoms returned by @ day 9 or 10, positive test returned by day 12, symptoms continued and evolved (throat, nose, head, chest); (11Jul2022) Positive, notes: First round of Paxlovid was great. symptoms diminished by day 2, felt good for several days. But symptoms returned by @ day 9 or 10, positive test returned by day 12, symptoms continued and evolved (throat, nose, head, chest). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Patient received Anti-viral treatment for COVID 19 and product brand was Paxlovid. The treatment start date was 25Jun2022 and stop date was 30Jun2022. Treatment given for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Left deltoid has been aching for 6 weeks since injection; some sharp pain during movement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50-year-old male patient received BNT162b2 (BNT162B2), on 28May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient took concomitant medications. Vaccination history included: Comirnaty (Primary immunization complete, DOSE 1,2 and 3), for COVID-19 IMMUNISATION. The following information was reported: MYALGIA (non-serious) with onset 29May2022, outcome "not recovered", described as "Left deltoid has been aching for 6 weeks since injection"; PAIN (non-serious) with onset 29May2022, outcome "not recovered", described as "some sharp pain during movement". Therapeutic measures were not taken as a result of myalgia, pain.  Additional information: The patient was not given other vaccine in fourweeks. Other medications were given in two weeks but do not know details. The reporter stated that the patient experienced Left deltoid ache for 6 weeks since injection and some sharp pain during movement. All prior Comirnaty doses (N=3) have been in the left deltoid.The patient had other medical history but do not have details.  No statement required. FU will be conducted.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Type 1 Diabetes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 2, 0.2 ml single (Lot number: FL0007) at the age of 7 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, lot FL0007), administration date: 27Dec2021, when the patient was 7-year-old, for Covid-19 immunization. The following information was reported: TYPE 1 DIABETES MELLITUS (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "Type 1 Diabetes". The event "type 1 diabetes" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: more tests: (2022) diagnosed with type 1 diabetes; other tests: (2022) Negative; SARS-CoV-2 test: (2022) Negative; (2022) Negative; Viral test: (2022) Negative; Weight: (2022) losing, notes: but not rapidly. Therapeutic measures were taken as a result of type 1 diabetes mellitus.   Clinical Course-Caller was asking about the vaccine if it can be a cause of Type 1 Diabetes. Caller mentioned that right after his sons second vaccination, they were slowly noticing symptoms. They went to the doctor every now and then and even had his son for viral testing but he tested negative. Now, the doctor recommended his son for glucose, more energy, and exercise. However, after 6 months, the symptoms have been increasing more and more. His son became weak with type 1 diabetes. Caller was looking for additional resources about the vaccine and type 1 diabetes for his son. Caller stated the strange thing genetically it has to do with genes and viruses and it was not until after the 2nd dose. Caller stated that after the diagnoses they learned more about its symptoms and how it develops. Caller stated it continued and they started seeing more and more symptoms a month ago and they took him to the ER and learned he is Type 1 diabetic. Caller relays he was having more urination than normal, his body, they were especially able to notice his symptoms but not highly. Stated he was getting little breathing issues and more pee than usual and was losing weight but not rapidly. Stated over 2-3 months as time was going on they saw more and more impact and based on what the doctor said he was negative for COVID and fever and other things and they could not figure out what was taking place. Stated a week ago he was diagnosed, and they did not had family history of Type 1 diabetes and he does not see anything else to be considered there. States he was in the hospital around 19Jun2022 and was discharged home in 3 days and was doing well. Caller also wanted to learn as he has one more kid and does not want him vaccinated, he wanted to learn was there any other instances reported or anything like that. Stated to benefit or support him. Asking if there was a helpline to report adverse events.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Headache
Clinical narrative: legs are hurting and is having body pain; muscle pain; joint pain; nauseous; legs are hurting and is having body pain; vomiting; diarrhea; lost his appetite; headaches; chill; 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 35-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2022 as dose 1, single (Lot number: FN2908) at the age of 35 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: CHILLS (non-serious) with onset 09Jul2022, outcome "not recovered", described as "chill"; DIARRHOEA (non-serious) with onset 09Jul2022, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 09Jul2022, outcome "not recovered", described as "headaches"; PAIN IN EXTREMITY (non-serious) with onset 09Jul2022, outcome "not recovered", PAIN (non-serious), outcome "unknown" and all described as "legs are hurting and is having body pain"; DECREASED APPETITE (non-serious) with onset 09Jul2022, outcome "recovered", described as "lost his appetite"; VOMITING (non-serious) with onset 09Jul2022, outcome "not recovered"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; NAUSEA (non-serious), outcome "unknown", described as "nauseous". Therapeutic measures were taken as a result of pain in extremity, pain, vomiting, diarrhoea, decreased appetite, headache, chills, myalgia, arthralgia, nausea.  Additional information: Reporter had the first dose this past Friday, has been experiencing vomiting, diarrhea, leg pain b/l and loss of appetitive, and headache that hasn't gone away. Some side effects that have been reported was headache, muscle pain, joint pain, diarrhea, vomiting, nauseous. Loss of appetite was not mentioned in the reported side effects. These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials; Persons 18 Years and Older: Systemic reactions usually lasted around 1 day. When clarifying that the reporter was calling regarding the Pfizer Covid-19 vaccine and not Paxlovid, transferring agent states that patient was actually calling from support line as previously stated. Reporter states patient was having diarrhea, headaches and chills, legs are hurting and is having body pain. Adverse Event: diarrhea, headaches and chills, pain in both legs, loss of appetite; Time of Onset: 9Jul2022.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Vomiting
Clinical narrative: legs are hurting and is having body pain; muscle pain; joint pain; nauseous; legs are hurting and is having body pain; vomiting; diarrhea; lost his appetite; headaches; chill; 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 35-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2022 as dose 1, single (Lot number: FN2908) at the age of 35 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: CHILLS (non-serious) with onset 09Jul2022, outcome "not recovered", described as "chill"; DIARRHOEA (non-serious) with onset 09Jul2022, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 09Jul2022, outcome "not recovered", described as "headaches"; PAIN IN EXTREMITY (non-serious) with onset 09Jul2022, outcome "not recovered", PAIN (non-serious), outcome "unknown" and all described as "legs are hurting and is having body pain"; DECREASED APPETITE (non-serious) with onset 09Jul2022, outcome "recovered", described as "lost his appetite"; VOMITING (non-serious) with onset 09Jul2022, outcome "not recovered"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; NAUSEA (non-serious), outcome "unknown", described as "nauseous". Therapeutic measures were taken as a result of pain in extremity, pain, vomiting, diarrhoea, decreased appetite, headache, chills, myalgia, arthralgia, nausea.  Additional information: Reporter had the first dose this past Friday, has been experiencing vomiting, diarrhea, leg pain b/l and loss of appetitive, and headache that hasn't gone away. Some side effects that have been reported was headache, muscle pain, joint pain, diarrhea, vomiting, nauseous. Loss of appetite was not mentioned in the reported side effects. These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials; Persons 18 Years and Older: Systemic reactions usually lasted around 1 day. When clarifying that the reporter was calling regarding the Pfizer Covid-19 vaccine and not Paxlovid, transferring agent states that patient was actually calling from support line as previously stated. Reporter states patient was having diarrhea, headaches and chills, legs are hurting and is having body pain. Adverse Event: diarrhea, headaches and chills, pain in both legs, loss of appetite; Time of Onset: 9Jul2022.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Breakthrough Infection; COVID-19 Breakthrough Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old male patient received BNT162b2 (BNT162B2), on 29May2021 as dose 1, single (Lot number: EW0179), on 21Jun2021 at 12:00 as dose 2, single (Lot number: EW0202) and on 24Mar2022 at 12:00 as dose 3 (booster), single (Lot number: FJ6369) at the age of 16 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Autism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022 at 15:00, outcome "recovering" and all described as "COVID-19 Breakthrough Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: covid test type post vaccination=Nasal  Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.   Clinical information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 42-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Lipids, SARS-CoV-2 test, Vaccination failure
Clinical narrative: They have both contracted COVID; They have both contracted COVID; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL0142), on 05Feb2021 as dose 2, single (Lot number: EN5318, Expiration Date: May2021) and on 22Sep2021 as dose 3 (booster), single (Lot number: 38315E1A) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Muscle cramps" (unspecified if ongoing), notes: taken Statins in the past and he had muscle cramps.; "Arthritic Changes secondary to being active several joints in his fingers and hands have no cartilage left" (ongoing), notes: Arthritic Changes to being active several joints.; "Elevated Lipids" (ongoing), notes: Elevated Lipids on hold while on Paxlovid; "Cardiovascular disease" (unspecified if ongoing). Concomitant medication(s) included: MAGNESIUM; COQ-10; PRILOSEC [OMEPRAZOLE]; CELEBREX; CRESTOR taken for lipids increased; ALLEGRA; CIALIS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "not recovered" and all described as "They have both contracted COVID". The patient underwent the following laboratory tests and procedures: Lipids: (unspecified date) Elevated, notes: Elevated Lipids Takes Crestor 5mg for it but it is on hold while on Paxlovid; SARS-CoV-2 test: (09Jul2022) Positive, notes: Tested positive for Covid 19 after receiving Pfizer Covid 19 Vaccines. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: fully vaccinated with the Pfizer COVID 19 vaccine and they have both contracted COVID; fully vaccinated with the Pfizer COVID 19 vaccine and they have both contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "A little bit of high Cholesterol" (ongoing). Concomitant medication(s) included: MAGNESIUM; SELENIUM; VITAMINS NOS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022, outcome "not recovered" and all described as "fully vaccinated with the Pfizer COVID 19 vaccine and they have both contracted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, 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 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.,Linked Report(s) : US-PFIZER INC-202200949948 same reporter/drug/AE, different patient.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She has had both doses of the covid 19 vaccine and two boosters, all were Pfizer covid 19 vaccines/first day of covid; She has had both doses of the covid 19 vaccine and two boosters, all were Pfizer covid 19 vaccines/first day of covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "She has had both doses of the covid 19 vaccine and two boosters, all were Pfizer covid 19 vaccines/first day of covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) positive, notes: I tested positive on the 6th of last week and my doctor started me on the Paxlovid,. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient tested positive on the 6th of last week and her doctor started her on the Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient. A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. Patient received Paxlovid for COVID-19 Treatment from 01Jul2022 to 05Jul2022 and COVID-19 was tested negative on an unspecified date. Outcome of the events was recovered in 2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea
Clinical narrative: felt like she was going to pass out; felt nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 2 (booster), single (Lot number: FG3527) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Primary aldosteronism" (unspecified if ongoing); "Bilateral adrenal hyperplasia" (unspecified if ongoing), notes: Bilateral adrenal hyperplasia. The patient's family history included: "Primary aldosteronism" (unspecified if ongoing), notes: Mother. There were no concomitant medications. Past drug history included: Eplerenone, reaction(s): "renal insufficiency", notes: About a year ago; Eplerenone, reaction(s): "was not able to urinate/ was not able to pee for like a month", notes: About a year ago; Eplerenone, reaction(s): "terrible back pain", notes: About a year ago; Eplerenone, reaction(s): "urine was extra dark", notes: About a year ago. Vaccination history included: janssen shot (First Dose:, Lot: 1805018, Route: Injection in the left arm), administration date: 24Mar2021, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "sick for 2 full weeks". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 03Nov2021, outcome "recovered" (03Nov2021), described as "felt like she was going to pass out"; NAUSEA (non-serious) with onset 03Nov2021, outcome "recovered" (03Nov2021), described as "felt nausea". Therapeutic measures were taken as a result of loss of consciousness, nausea. She was not safe to drive home. She said that she felt better after 15 minutes. She got coconut water and crackers and waited for close to a hour and then was fine after that.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: we already had the COVID; we already had the COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "we already had the COVID". 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 information available, there is causal association between the events drug ineffective, covid-19 and the suspect drug BNT162b2 cannot be excluded . The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200020676 same drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: we already had the COVID; we already had the COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we already had the COVID".  Clinical course: Reported inefficacy after COVID vaccine. Probably, because they already had the COVID in May.  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 information in the case, the causal association between the events Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200020676 same drug/event, different patient;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: she had another episode the other night that it woke her up/then it woke her up again a couple nights ago, out of her sleep; she experienced pins and needles and tingling in hands for about a day and night after the shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 20Jun2022 as dose 1, 0.3 ml single (Lot number: FM0173, Expiration Date: 12Aug2022) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine since she was a teenager" (ongoing). There were no concomitant medications. The following information was reported: PARAESTHESIA (medically significant) with onset 20Jun2022, outcome "unknown", described as "she experienced pins and needles and tingling in hands for about a day and night after the shot"; SLEEP DISORDER (non-serious), outcome "unknown", described as "she had another episode the other night that it woke her up/then it woke her up again a couple nights ago, out of her sleep". Clinical course: Caller stated she was calling about the gray cap Covid 19 vaccine, stated a patient had a reaction to first vaccine and was due for her second dose, explained she experienced pins and needles and tingling in hands for about a day and night after the shot. Clarifies she had another episode the other night that it woke her up. She had pins and needles and tingling that night; and then it woke her up again a couple nights ago, out of her sleep, with that. Caller wanted to know if it is safe for the patient to get her second dose.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events paraesthesia and sleep disorder and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 test positive; COVID-19 test positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An 85-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Feb2022 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) all with onset 10Jul2022, outcome "recovered" and all described as "COVID-19 test positive". The event "covid-19 test positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: COVID test type post vaccination=Unknown. 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID vaccine inefficacy; COVID vaccine inefficacy; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID vaccine inefficacy". 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 information available, there is causal association between the events drug ineffective, covid-19 and the suspect drug BNT162b2 cannot be excluded . The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, 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) (Pharmacist).  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 at 17:45 as dose 3 (booster), single (Lot number: EE2593) at the age of 59 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) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE oral, start date: Jan2022, stop date: 11Jul2022; TURMERIC [CURCUMA LONGA] oral, start date: Jan2022, stop date: 11Jul2022; DEXMETHYLPHENIDATE oral, start date: Jan2022, stop date: 11Jul2022; BUPROPION oral, start date: Jan2022, stop date: 11Jul2022; L-METHYLFOLATE CALCIUM [CALCIUM LEVOMEFOLATE] oral, start date: Jan2022, stop date: 11Jul2022; TRINTELLIX oral, start date: Jan2022, stop date: 11Jul2022; ATORVASTATIN oral, start date: Jan2022, stop date: 27Jun2022; FAMOTIDINE oral, start date: Jan2022, stop date: 11Jul2022; BACLOFEN oral, start date: Jan2022, stop date: 11Jul2022; METOPROLOL XL oral, start date: Jan2022, stop date: 11Jul2022. 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: Body temperature: 100.7; SARS-CoV-2 test: Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Anti-Viral Details ,Product: COVID 19 Treatment, Brand: Paxlovid, Treatment Start Date was 28Jun2022, Treatment Stop Date was 03Jul2022, Indication was Treatment of COVID-19, Administration route: oral. Adverse Event: Patient completed 5 days of Paxlovid and improved. Last dose 7/3 AM. On 7/6 PM patient started experiencing congestion, runny nose and sneezing. On 07Jul patient developed headache, body aches, and fever of 100.7 and tested positive for COVID. Adverse Event Start Date was 06Jul2022, Adverse Event Start time was 10:00 PM, Patient was Recovered: Recovering.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Heart rate, Oxygen saturation, 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 75-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EK4176), in left arm, on 06Feb2021 as dose 2, single (Lot number: EL9265), in left arm, on 13Sep2021 as dose 3 (booster), single (Lot number: FP2588), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bradycardia" (unspecified if ongoing), notes: other medical history: Bradycardia; "been on CPAP for 4 months" (unspecified if ongoing), notes: other medical history: Been on CPAP for 4, months; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: VERAPAMIL, start date: Sep2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 107/73 mmHg, notes: BP 107/73 with 70 pulse; Heart rate: (unspecified date) 70, notes: BP 107/73 with 70 pulse; (unspecified date) 68, notes: 68/97 pulse/ox; Oxygen saturation: (unspecified date) 97 %, notes: 68/97 pulse/ox; SARS-CoV-2 test: (27Jun2022) Positive; (03Jul2022) Negative; (04Jul2022) Negative; (05Jul2022) Negative; (07Jul2022) Negative; (09Jul2022) Negative; (10Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Tested positive for covid on 27Jun emergency room. Prescribed the Paxlovid/Ritonavir regimen which was started on 27Jun2022 and completed on Saturday morning of 02Jul. Tested negative on 03Jul, 04Jul, 05Jul, 07Jul. On 09Jul awoke congested, puffy eyes, cough but again tested negative. 10Jul awoke with 99.9 temp and tested positive. 68/97 pulse/ox. BP 107/73 with 70 pulse. Adverse event start date 09Jul2022, 06:15 AM. Another course of Paxlovid starting on 10Jul.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
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 75-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EK4176), in left arm, on 06Feb2021 as dose 2, single (Lot number: EL9265), in left arm, on 13Sep2021 as dose 3 (booster), single (Lot number: FP2588), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bradycardia" (unspecified if ongoing), notes: other medical history: Bradycardia; "been on CPAP for 4 months" (unspecified if ongoing), notes: other medical history: Been on CPAP for 4, months; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: VERAPAMIL, start date: Sep2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 107/73 mmHg, notes: BP 107/73 with 70 pulse; Heart rate: (unspecified date) 70, notes: BP 107/73 with 70 pulse; (unspecified date) 68, notes: 68/97 pulse/ox; Oxygen saturation: (unspecified date) 97 %, notes: 68/97 pulse/ox; SARS-CoV-2 test: (27Jun2022) Positive; (03Jul2022) Negative; (04Jul2022) Negative; (05Jul2022) Negative; (07Jul2022) Negative; (09Jul2022) Negative; (10Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Tested positive for covid on 27Jun emergency room. Prescribed the Paxlovid/Ritonavir regimen which was started on 27Jun2022 and completed on Saturday morning of 02Jul. Tested negative on 03Jul, 04Jul, 05Jul, 07Jul. On 09Jul awoke congested, puffy eyes, cough but again tested negative. 10Jul awoke with 99.9 temp and tested positive. 68/97 pulse/ox. BP 107/73 with 70 pulse. Adverse event start date 09Jul2022, 06:15 AM. Another course of Paxlovid starting on 10Jul.
Sex: F
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(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result; Negative, notes: 3 days after I tested negative; Positive, notes: I started to fill ill again and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient had other unspecified medical history. Concomitant medications information: pantoprazole, hydrochlothiazide. 3 days after, patient tested negative, patient started to feel ill again and tested positive. Patient had Paxlovid for COVID 19 Treatment from 30Jun2022 to 05Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.