chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in right arm, on 22Sep2021 as dose 3 (booster), single (Lot number: FE3592), in right arm and on 28Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: awaiting bilateral mastectomi which, was postponed due to getting Covid; "positive for CHEK2 variant." (unspecified if ongoing), notes: positive for CHEK2 variant; "Known allergies: dairy products" (unspecified if ongoing); "Known allergies: yellow dye, blue dye, red dye" (unspecified if ongoing); "Known allergies: Tegaderm" (unspecified if ongoing). The patient took concomitant medications. 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.Clinical Information:adverse event: I was feeling well again after finishing Paxlovid the morning of 22Jun. On 26Jun I woke up with cough and runny nose and it has only gotten worse. As of 29Jun coughing a lot, but no high temp. report about covid treatment: Yes.If vaccine received: Yes.Other medication in 2weeks: Yes.Anti viral details: Product-COVID 19 Treatment, Brand-Paxlovid Treatment start date- 16Jun2022, Treatment stop date- 21Jun2022, Indication: Treatment of COVID-19.Adverse event start date: 25Jun2022.Ae resulted in: [None of the above].If patient recovered: Not recovered.If treatment ae: No.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech 20Sep2021/ Treatment of COVID-19 6Jun2022; Pfizer / BioNTech 20Sep2021/ Treatment of COVID-19 6Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Sep2021 as dose 3 (booster), single (Lot number: 301358a) at the age of 73 years 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: "Allergic Asthma" (unspecified if ongoing); "bandages adhesive" (unspecified if ongoing), notes: known allergies bandages adhesive; "Acid reflux" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: Apr2003; SYMBICORT, start date: Apr2010; ALBUTEROL [SALBUTAMOL], start date: Apr2003; NEXIUM [ESOMEPRAZOLE MAGNESIUM], start date: Dec1999; ALLEGRA, start date: Mar2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech 20Sep2021/ Treatment of COVID-19 6Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies: bandage as adhesive. Other medical history: Allergic Asthma, Acid reflux, Arthritis, Obesity.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a literature report.  A 32-year-old female patient received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 15Dec2020, outcome "unknown", described as "anaphylaxis".  Clinical information: The Regulatory Agency (RA) was the first to authorize emergency use of the PfizerBioNTech mRNA vaccine. On December 8, 2020, within 24 hours after the start of the mass vaccination program for health care workers and elderly adults, the program reported probable cases of anaphylaxis in two women, 40 and 49 years of age, who had known food and drug allergies and were carrying auto-injectable epinephrine. On December 11, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the PfizerBioNTech mRNA vaccine, and general vaccination of health care workers was started on Monday, December 14. On December 15, a 32-year-old female health care worker who had no known allergies presented with an anaphylactic reaction within 10 minutes after receiving the first dose of the vaccine. The participants who had these initial three reported cases of anaphylaxis would not have been excluded on the basis of their histories from the mRNA vaccine clinical trials. Since the index case, several more cases of anaphylaxis associated with the Pfizer mRNA vaccine have been reported after vaccination of almost 2 million health care workers, and the incidence of anaphylaxis associated with the Pfizer SARS-CoV-2 mRNA vaccine appears to be approximately 10 times as high as the incidence reported with all previous vaccines, at approximately 1 in 100,000, as compared 1 in 1,000,000, the known and stable incidence of anaphylaxis associated with other vaccines. The EUA for the Moderna mRNA vaccine was issued on December 18, and it is currently too soon to know whether a similar signal for anaphylaxis will be associated with that vaccine.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event anaphylaxis and the use of suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202200902646 same aticle/drug/event and different patient;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 08Jan2021 as dose 2, single (Lot number: EJ1686), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12Apr2022 as dose 4 (booster), single (Lot number: O84S21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no 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: (unspecified date) Positive, notes: Strongly positive by antigen test; (24Jun2022) Negative, notes: Tested negative on 24Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech / Paxlovid Date of start of drug 11Jun2022; Pfizer / BioNTech / Paxlovid Date of start of drug 11Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "not recovered" and all described as "Pfizer / BioNTech / Paxlovid Date of start of drug 11Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) Negative; (19Jun2022) Positive; (29Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, 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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies- penicillan" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN. Past drug history included: Dilaudid, reaction(s): "Known allergies- dilaudid". 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: SARS-CoV-2 test: Unknown Results. 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive; I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EN5318), on 15Feb2021 as dose 2, single (Lot number: EN5318) and on 09Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "various antibiotic sensitivities" (unspecified if ongoing); "latex contact" (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 27Jun2022, outcome "recovered" and all described as "I tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive, notes: covid test type post vaccination=Nasal Swab, covid test name post vaccination=BinaxNow. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Course: According to Pfizer employee training having covid 19 symptoms after vaccination counts as adverse event. I tested positive and symptoms were body aches, chills but not fever on my thermometer, tired, turned into head cold with snot and cough, sinus headache. Patient had not received any other vaccines within 4 weeks before COVID vaccine. Patient had not diagnosed with COVID-19 before vaccination and diagnosed with COVID-19 after vaccination. Facility type vaccine: Workplace clinic. Known allergies: various antibiotic sensitivities and latex contact. Other medical history: No.  No follow-up attempts are possible. No further information is expected.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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), 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: "HCM" (unspecified if ongoing). 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Positive; (unspecified date) Unknown result; (unspecified date) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received any other medication within 2 weeks. Paxlovid was given for Covid-19 treatment from 14Jun2022 to 18Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The caller stated that they have already had the primary series and the first booster of the Pfizer Biontech COVID.19 vaccine before getting infected with COVID-19; The caller stated that they have already had the primary series and the first booster of the Pfizer Biontech COVID.19 vaccine before getting infected with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The caller stated that they have already had the primary series and the first booster of the Pfizer Biontech COVID.19 vaccine before getting infected with COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: infected with COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The caller states that she and her husband had COVID and took a whole treatment of Paxlovid. She asks when can she have their second booster dose after finishing the Paxlovid treatment. The caller stated that they have already had the primary series and the first booster of the Pfizer Biontech COVID.19 vaccine before getting infected with COVID-19. Failed to probe for age. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: confirmed positive test; confirmed positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 06Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hodgkins disease" (unspecified if ongoing); "two stem cell transplants" (unspecified if ongoing), notes: two stem cell transplants; "Post Transplant Lymphoperphial Disease" (unspecified if ongoing), notes: Post Transplant Lymphoperphial Disease. Concomitant medication(s) included: LEVOTHYROXINE; METOPROLOL; PRAVASTATIN; NITROFURANTOIN. Past drug history included: Erythromycin, reaction(s): "allergy: erythromycin", notes: known allergies erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "confirmed positive test". Clinical course: On day 12 after testing negative on day 11, her nose was itchy and runny. Day 13 patient took another home covid test and was positive. Patient took an additional covid test (different brand) and confirmed positive test. Began isolating again. Patient received Paxlovid from 14Jun2022 to  19Jun2022 for COVID-19 treatment. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: I took an additional covid test (different brand); (Jun2022) Negative, notes: testing negative on day 11; (Jun2022) Positive, notes: home covid test and was positive- Day 13. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. 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: COVID-19: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 27Jun2022(no stop date provided). Clinical course: Patient did not receive any other medication in 2weeks.  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, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "HTN" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Chronic back pain" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Rebound Rapid covid test after negative test after treatment with paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound Rapid covid test after negative test after treatment with paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6201), on 18Mar2021 as dose 2, single (Lot number: EN6204) and on 30Sep2021 as dose 3 (booster), single (Lot number: 30135BA) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOESTRIN 24 FE; FLONASE [FLUTICASONE PROPIONATE]; SINGULAIR; HYDROXYZINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: For COVID 19 Treatment patient took Paxlovid on 16jun2022 and stopped on 21Jun2022. Rebound case sinus headache, sneezing, drainage, runny nose, stomach ache, positive at-home test.  Follow-Up (01Jul2022): Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 67-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 at 14:00 as dose 1, single (Lot number: EL9267), in left arm, on 02Mar2021 at 14:00 as dose 2, single (Lot number: EN6202), in left arm and on 07Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MGUS - lowest level of measurement" (unspecified if ongoing). Patient did not have any Known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Treatment included Paxlovid from 09Jun2022 to 14Jun2022. Reporter stated, felt like the sinus portion of my covid infection came back for about 3 to five days beginning 20Jun2021. My initial covid symptoms had resolved by 18Jun2021. Patient did not receive other medication in 2 weeks.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive pcr test; positive pcr test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL9264), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 78 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "peripheral neuropathy" (unspecified if ongoing); "insomnia" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 31Dec2004; AMITRIPTYLINE, start date: 31Dec2004; ALPRAZOLAM, start date: 31Dec2004; PRAVASTATIN, start date: 31Dec2004. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "not recovered" and all described as "positive pcr test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: positive pcr test on day 1; (15Jun2022) Positive, notes: rapid binax test has been positive from day 2 through day 14 (today); (27Jun2022) Positive, notes: rapid binax test has been positive from day 2 through day 14 (today). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course reported as follows: Patient had no known allergies. Patient received other medication in 2weeks. Patient received treatment anti viral details product: COVID 19 Treatment, brand: Paxlovid. Treatment start date: 15Jun2022 and Treatment stop date: 20Jun2022. Indication: Treatment of COVID-19. Adverse event: Mild cold symptoms (headache, temp, sore throat) on day 0; positive pcr test on day 1; I started 5-day paxlovid course on day 2; rapid binax test has been positive from day 2 through day 14 (today); test showed weak band on days 9 and 10 but on day 11 through today, binax test band is strong. Cold symptoms have persisted: hoarse throat, dry coughing, temp fluctuating above basal state. Oxygen has been at 98% throughout. Very concerned that test remains positive at 14 days and mild cold symptoms persist though less than onset symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound COVID; Rebound COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FP4554) at the age of 73 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 cholesterol" (unspecified if ongoing). Patient was not pregnant at the time of vaccination had no known allergies. Concomitant medication(s) included: CRESTOR, stop date: 15Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Jun2022 at 20:00, outcome "unknown", COVID-19 (medically significant) with onset 27Jun2022 at 20:00, outcome "recovering" and all described as "Rebound COVID". 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, covid-19. Patient received anti-viral for treatment of COVID-19 which included Paxlovid, from 15Jun2022 till 19Jun2022.
Age: 70.0
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 at 16:00 as dose 4 (booster), single (Lot number: FJ4987) at the age of 70 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 was not reported. There were no concomitant medications. 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: SARS-CoV-2 test: Unknown. Additional information: Other medication in 2weeks: No. Anti viral details: product: COVID 19 Treatment, brand: Pfizer Paxlovid, treatment start date: 16Jun2022, treatment stop date: 21Jun2022. Adverse event: None to vaccinations. covid rebound following Paxlovid treatment. Adverse event start date: 24Jun2022. The patient was recovering. AE treatment: Augmentin. known allergies: No. other medical history: healthy.  results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I took a PCR test on 27Jun2022. Today 29Jun2022 I received the results that i tested positive for COVID.; I took a PCR test on 27Jun2022. Today 29Jun2022 I received the results that i tested positive for COVID./sinus congestion/ cough/ cold/ low grade fever (99.5)/ felt tired/ sluggish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL3247) and on 17Mar2021 as dose 2, single (Lot number: EL3247) at the age of 41 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "recovering", described as "I took a PCR test on 27Jun2022. Today 29Jun2022 I received the results that i tested positive for COVID."; COVID-19 (medically significant) with onset Jun2022, outcome "recovering", described as "I took a PCR test on 27Jun2022. Today 29Jun2022 I received the results that i tested positive for COVID./sinus congestion/ cough/ cold/ low grade fever (99.5)/ felt tired/ sluggish". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.5, notes: low grade fever (99.5); SARS-CoV-2 test: (27Jun2022) Positive, notes: I took a PCR test on 27Jun2022 Today 29Jun2022 I received the results that i tested positive for COVID; (26Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: if other vaccine in four weeks: No. other medications in two weeks: Metoprolol 25mg bid (twice a day). Adverse event - On 22Jun2022 I started feeling symptoms of sinus congestion and cough that i thought were attributed to a cold. On 25Jun2022 I had a low grade fever (99.5) and felt tired and sluggish the entire weekend. I took a PCR test on 27Jun2022. Today 29Jun2022 I received the results that i tested positive for COVID. If covid prior vaccination: No. If covid tested post vaccination: Yes.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; 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 50-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613), on 10Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "COVID-19 Treatment"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Trichorrhexis
Clinical narrative: my hair has broke off all the way up to my head; alopecia; 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 63-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: WA610390), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Deep depression" (ongoing), notes: Deep depression Said that she has had it for years and years; "Post-traumatic stress disorder" (ongoing), notes: Post-traumatic stress disorder Said that she has had it for years and years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: FA6780, Anatomical site:left arm), administration date: 28Jun2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: None". The following information was reported: ALOPECIA (non-serious) with onset Aug2021, outcome "not recovered"; TRICHORRHEXIS (non-serious) with onset Aug2021, outcome "not recovered", described as "my hair has broke off all the way up to my head". The events "my hair has broke off all the way up to my head" and "alopecia" required physician office visit. Therapeutic measures were taken as a result of trichorrhexis, alopecia.  Additional information: The reporter states she got the Pfizer COVID vaccine and that her hair has broken off all the way up to her head and the onset was reported as several weeks to a month after receiving the second injection. Exact time was not known. She also mentioned that she has never had COVID. Weight was reported as 159-164lbs. The physician was treating her for alopecia to try and get her hair to grow back. Her symptoms started like a month after she got the second injection and she started showing her symptoms. The caller said that she had long hair and now it was all the way up to her head. It was reported that no additional vaccines administered on same date of the Pfizer. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Family Medical History Relevant to AE(s) and relevant tests was reported as none. Treatment was reported as the physician gave her drops to put on her head and put down alopecia as the indication for the drops because he did not know what else to put down (as reported). The reporter said that they were drops you put on your scalp and massage in and clarified the name of the medication as Betamethasone Dipropionate USP Lotion 5%.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue
Clinical narrative: undiluted dose of the vaccine; undiluted dose of the vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  An 11-year-old female patient received BNT162b2 (BNT162B2), on 29Jun2022 as dose number unknown (booster), 0.2 ml single (Batch/Lot number: unknown, Expiration Date: 31Aug2022) at the age of 11 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (medically significant), PRODUCT PREPARATION ISSUE (medically significant) all with onset 29Jun2022 and all described as "undiluted dose of the vaccine".  Additional Context: Warm transfer from agent #withheld Medical Information has a LPN who reported that an 11 year old female patient received an undiluted Pfizer BioNTech Covid 19 (orange cap). Stated that she had called and wanted to know what to expect and what they needed to do. Information confirmed as provided. Patient details: Stated that she was 11 years, one week old. Reporter details: Email address captured as provided. Physician details: Does not provide an email address. Treatment: None. Product details: Stated that she needed a magnifying glass.  Description of Product Complaint: Description of complaint: Pfizer BioNTech Covid 19 (orange cap): Stated that she needed a magnifying glass. Product strength and count size dispensed: 10mcg/0.2ml when diluted; unknown count NDC number of Pfizer BioNTech Covid 19 (orange cap).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported events and the suspect drug cannot be excluded.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 38 years intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Feb2021 as dose 1, single (Lot number: 014M20A) and on 26Mar2021 as dose 2, single (Lot number: 038A121A), all intramuscular 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) with onset 28Jun2022 at 14:30, outcome "recovering", described as "Tested positive for COVID"; COVID-19 (medically significant) with onset 28Jun2022 at 14:30, outcome "recovering", described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Positive; (28Jun2022) Positive.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia, Tremor
Clinical narrative: I woke up and could not stop shaking. My hand was shaking so bad (almost like a Parkinson's type shake) that I could not even put a thermometer in (my hands could not stop shaking); had a fever of about 101; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jun2022 at 09:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic daily Migraines" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; CYCLOBENZAPRINE; FROVATRIPTAN; NALTREX. Past drug history included: Levaquin, reaction(s): "Drug Allergy"; Topomax, reaction(s): "Drug Allergy". Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), Lot number: Fh8030, Vaccine Administration Date: 21Nov2021, Vaccine Administration Time: 09:00AM, Vaccine location: Arm Left), administration date: 21Nov2021, when the patient was 61-year-old, for COVID-19 immunization; Bnt162b2 (DOSE 2, Lot number: En6201,, Vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (DOSE 1, Lot number: El1284,, Vaccine location: Left arm), for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 20Jun2022 at 01:30, outcome "recovered", described as "I woke up and could not stop shaking. My hand was shaking so bad (almost like a Parkinson's type shake) that I could not even put a thermometer in (my hands could not stop shaking)"; PYREXIA (non-serious) with onset 20Jun2022 at 01:30, outcome "recovered", described as "had a fever of about 101". The events "i woke up and could not stop shaking. my hand was shaking so bad (almost like a parkinson's type shake) that i could not even put a thermometer in (my hands could not stop shaking)" and "had a fever of about 101" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tremor, pyrexia.  Additional information: She woke up and could not stop shaking. she hand was shaking so bad (almost like a Parkinson's type shake) that she could not even put a thermometer in (She hands could not stop shaking) she could barely keep the thermometer in She mouth because even She mouth was shaking. She had a fever of about 101 and once She took Tylenol the shaking subsided.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Tinnitus
Clinical narrative: chills; tinnitus; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A child patient received BNT162b2 (BNT162B2), as dose 1, 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: PYREXIA (non-serious), outcome "unknown", described as "fever". It was unknown if therapeutic measures were taken as a result of pyrexia.  Additional information: I was in a meeting with (Pfizer colleague) today and she said that her child had a fever a few days after receiving the childhood vaccine for under 5s (5 years).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: have not been having regular periods anymore; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6208) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "childhood asthma" (unspecified if ongoing); "epilepsy" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies. Concomitant medication(s) included: DEPAKOTE; FOLIC ACID; VITAMIN D [VITAMIN D NOS]. Past drug history included: Cephalexin, reaction(s): "known allergies: cephalexin"; Bactrim, reaction(s): "known allergies: bactrim". The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Mar2021, outcome "not recovered", described as "have not been having regular periods anymore". The event "have not been having regular periods anymore" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of menstruation irregular.  Additional information: Serious: No -Results in death: No Life threatening: No Caused/prolonged hospitalization: No Disabling/Incapacitating: No Congenital anomaly/birth defect: No. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Ever since receiving her Covid vaccines patient had not been having regular periods anymore. After her initial covid vaccine she thought it could just be a coincidence but after she received subsequent doses it was apparent that it was related. Patient still have not had a period after receiving last dose & her husband & she were hoping to have another child.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: just a small rash around the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 92-year-old female patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster) , single (Lot number: FC3189) at the age of 91 years for covid-19 immunisation. The patient's relevant medical history included: "Painful hip" (unspecified if ongoing), notes: she has any kind of shot was the last week in May2022. Had a Kenalog injection for a painful hip. Concomitant medication(s) included: ELIQUIS; KENALOG 40 taken for arthralgia, start date: May2022, stop date: May2022. Vaccination history included: BNT162b2 (Dose 1:, Date: 06Feb2021, LOT: EM9809), administration date: 06Feb2021, when the patient was 90-year-old, for Covid-19 immunization; BNT162b2 (Dose 2:, Date: 03Mar2021, LOT: EN6198), administration date: 03Mar2021, when the patient was 90-year-old, for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "just a small rash around the injection site". The event "just a small rash around the injection site" required physician office visit.  Additional information: There was no other conditions, no investigations. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Emergency Room visit. No Prior Vaccinations (within 4 weeks) and no list of any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No other reactions prior vaccinations. No Family Medical History Relevant to adverse event.
Age: 44.0
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, 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), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Additional information: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Reported Event: Stuffy nose, Sneezing, Headache, Fatigue, Fever.adverse event start date: 28Jun2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.