chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing). 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 "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
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 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 20Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 15Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 06May2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DICLOFENAC SODIUM; ATORVASTATIN; VITAMIN D 3. The following information was reported: VACCINATION FAILURE (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, notes: Indication: Covid-19 treatment.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: FN6194) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: She only takes the inhaler in the morning if she needs to.; "Insomnia" (unspecified if ongoing), notes: Insomnia; "Inflammatory Bowel" (unspecified if ongoing); "Supraventricular Tachycardia" (unspecified if ongoing); "allergic to Latex" (unspecified if ongoing); "Vitamin D deficient" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "GERD" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol increased; KLONOPIN taken for insomnia; PROTONIX [OMEPRAZOLE] taken for gastrooesophageal reflux disease; CARDIZEM [DILTIAZEM] taken for supraventricular tachycardia, start date: 2018; AIMOVIG taken for migraine; VITAMIN B [VITAMIN B NOS]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL] taken for vitamin d deficiency; ZINC. Past drug history included: Flu vaccine for Immunization, reaction(s): "allergic to the Flu Vaccine". Vaccination history included: Mmr, for Immunization, reaction(s): "had a reaction". The following information was reported: RASH (non-serious) with onset Mar2021, outcome "recovered". Therapeutic measures were taken as a result of rash.Patient did not received any prior Vaccinations (within 4 weeks). She hasn't gotten her shingles shot.
Age: 40.0
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) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 at 15:00 as dose 1, single (Lot number: EL0140), in right arm, on 24Jan2021 at 12:00 as dose 2, single (Lot number: EL3246), in left arm and on 26Sep2021 at 11:00 as dose 3 (booster), single (Lot number: 30130BA) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillins Allergy" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA, start date: 09Jun2022, stop date: 14Jun2022; MONTELUKAST, start date: 09Jun2022, stop date: 14Jun2022. Past drug history included: Cephalexin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022 at 09:00, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) Negative, notes: Rapid antigen test negative 3 days after completing paxlovid; (18Jun2022) Positive, notes: positive rapid antigen 4 days after completing course of paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid was taken as treatment drug for COVID-19 Treatment from 09Jun2022 to 14Jun2022. On 18Jun2022 at 09:00 AM Nasal congestion, sneezing and positive rapid antigen 4 days after completing course of paxlovid. Rapid antigen test negative 3 days after completing paxlovid. Patient is currently recovering and no treatment was received. Vaccine was received. Yes, other medication was taken in 2 weeks.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid on Friday, 03Jun; tested positive for covid on Friday, 03Jun; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 27Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disease" (unspecified if ongoing); "rheumatoid arthritis." (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. No other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 03Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 03Jun2022, outcome "recovering" and all described as "tested positive for covid on Friday, 03Jun". The patient tested positive for covid on Friday, 03Jun2022. Patient started Paxlovid that day. Patient took 5 days (30 pills) and took last dose on Tuesday, 07Jun2022. On Wednesday, 08Jun2022, patient home tested negative. Patient was fine for a week, then started having cold symptoms again on Thursday, 16Jun2022. Patient home tested positive again on Friday, 17Jun2022. Treatment start date was reported as 02Jun2022 and stop date was reported as 07Jun2022 for Covid-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (03Jun2022) Positive; (08Jun2022) Negative; (17Jun2022) 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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Rash
Clinical narrative: I have rash that keeps spreading on my face, it is limited to my face only, it started 2 weeks after I got my Booster shot; 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 male patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose number unknown (booster), single (Lot number: FD0809, Expiration Date: 31Jan2022) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization completed; Manufacturer unknown), for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset Dec2021, outcome "not recovered", described as "I have rash that keeps spreading on my face, it is limited to my face only, it started 2 weeks after I got my Booster shot". The event "i have rash that keeps spreading on my face, it is limited to my face only, it started 2 weeks after i got my booster shot" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: The patient called and stated that he was trying to narrow down, he have gone to his family doctor, have gone to dermatologist, also have gone to an allergist and he have this rash that keeps spreading on his face, it was limited to his face only and they all told me to contact Pfizer, it has been ongoing since Dec, but it started 2 weeks after he got Booster shot (Pfizer COVID-19 Vaccine) and nothing else that he tried it was helping and they recommended to contact Pfizer to see if there was anything in there that he might be allergic to or it was because of his immune system to act funky and cause the outbreak or they could tell him what was it. When asked for any treatment for the event occurred the patient stated, "Yes, he was doing the treatment, but it was not working, so the treatment medicine was Itraconazole". When asked for any other medication conditions or taking any concomitant medications, the patient stated, "At this time no". When asked for any laboratory test, the patient stated, "Yes, he did have blood work done on 02Jun2022 in the beginning of Jun this month, so about 3 weeks ago".
Age: 64.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: en6200), in left arm, on 11Mar2021 as dose 2, single (Lot number: 6206), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: fc3180), in left arm and on 15Mar2022 as dose 4 (booster), single (Lot number: fk9895) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Probably Cutaneous Lupis that has been in remission for 20 years" (unspecified if ongoing), notes: Probably Cutaneous Lupis that has been in remission for 20 years; "known allergies;Sulfa" (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 18Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Negative; (18Jun2022) Positive; (20Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient was Tested negative on Monday 13Jun after 5 days of Paxlovid treatment. The patient still had very mild congestion. On 17Jun the congestion and coughing was increasing and tested again in the morning of 18Jun and tested positive. The patient experienced fever in the evenings and continued coughing, sneezing and fatigue. The patient still testing positive today 20Jun. The patient daughter and her boyfriend stayed with patient and came down with Covid the day they left. The patient got it two days later. The patient daughter and her boyfriend also took Paxlovid. The patient daughter did not get a rebound, by her boyfriend did. His experience has been identical to patient. Treatment start date was 07Jun2022 and stop date was 12Jun2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Return of Covid symptoms and positive rapid test four or five days after completion of Paxlovid; Return of Covid symptoms and positive rapid test four or five days after completion of Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 01Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "G6PD deficiency" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: 31Dec2009, stop date: 19Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Return of Covid symptoms and positive rapid test four or five days after completion of Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown result; (unspecified date) Negative, notes: positive rapid test four or five days after completion of Paxlovid and negative test; (Jun2022) positive, notes: positive rapid test four or five days after completion of Paxlovid and negative test. Therapeutic measures were taken as a result of covid-19. Clinical Course: Anti-viral details was reported as Paxlovid with start date 9Jun2022,and stop date 14 Jun 2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My husband and I both tested positive and we were both boosted (Unspecified vaccine), 2 boosters. My husband is 84. He tested, since he is 84 his doctor recommended that he take Paxlovid; My husband and I both tested positive and we were both boosted (Unspecified vaccine), 2 boosters. My husband is 84. He tested, since he is 84 his doctor recommended that he take Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 84-year-old male 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), outcome "not recovered" and all described as "My husband and I both tested positive and we were both boosted (Unspecified vaccine), 2 boosters. My husband is 84. He tested, since he is 84 his doctor recommended that he take Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: we both tested positive after eight days; Positive, notes: he tested positive on 15; Positive, notes: he is still positive on 19 days. 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive six days after completing the treatment; I tested positive six days after completing the treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "I tested positive six days after completing the treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive six days after completing the treatment; Negative, notes: I had tested negative the day completed treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received other medication in 2 weeks was amlodipine and losartan. Paxlovid rebound-patient tested positive six days after completing the treatment. Patient had started feeling sick within 4 days, and tested positive on day 6 after treatment. Patient had tested negative the day completed treatment. Patient received Paxlovid (anti-viral) treatment from 13May2022 to 17May2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Autism spectrum disorder
Clinical narrative: Caller stated her great grandson got autism from a vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from medical information team.  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: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "Caller stated her great grandson got autism from a vaccine".  Clinical information: Caller stated she is a doctor. Caller wanted to know why Pfizer is insisting and pushing that children 6 months to 5 years get the Pfizer covid vaccine. Caller stated that doctors said the children did not need it. Caller stated babies have their natural immunity especially if they are breastfed.   Caller asked if Pfizer is that greedy. Caller stated her great grandson got autism from a vaccine. Caller stated Pfizer is the one that makes the vaccine and should stop making it. Caller stated Pfizer should stop pushing this. Caller stated she is trying to help babies that do not need it. Caller said this is getting out of hand. Caller stated Pfizer will be sued.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6-year-old female patient received BNT162b2 (BNT162B2), on 18Jun2022 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: PYREXIA (non-serious) with onset 18Jun2022, outcome "unknown", described as "fever".  Additional information: Reporter said that his daughter received the Pfizer Biontech Covid 19 vaccine two days ago. She is 6 years old. She began having symptoms yesterday of a fever, etc. They did a rapid test today to see if she had Covid and it is positive and asked if this was side effects of the vaccine, causing someone to test positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0162), in right arm, on 07May2021 as dose 2, single (Lot number: EW017D), in right arm and on 22Dec2021 as dose 3 (booster), single (Lot number: FP080D) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "moderate-severe asthma" (unspecified if ongoing), notes: moderate-severe asthma; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Negative, notes: I tested negative for COVID on 12Jun; (Jun2022) Rebound COVID, notes: Rebound COVID symptoms. My COVID symptoms started 04Jun; (16Jun2022) rebound COVID, notes: On 16Jun, I began having rebound COVID symptoms; (17Jun2022) positive, notes: On 17Jun, I tested positive again for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.No Other medication in 2weeks. Rebound COVID symptoms. COVID symptoms started 04Jun. Symptoms consisted of upper respiratory congestion, cough, fever, sore throat, headache, fatigue. However did not test positive for COVID until 07Jun. Started Paxlovid on 07Jun My symptoms greatly improved by 09Jun. Last day of Paxlovid was 11Jun. The patient tested negative for COVID on 12Jun. On 16Jun, began having rebound COVID symptoms. On 17Jun, tested positive again for COVID. Rebound symptoms consist of sinus congestion, headache, sore throat.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EN9581), in left arm, on 16Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Breast cancer Survivor" (unspecified if ongoing), notes: Breast cancer Survivor; "Removal of Gall Bladder" (unspecified if ongoing), notes: Removal of Gall Bladder; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: SULFA. Concomitant medication(s) included: TAMOXIFEN, start date: Sep2015; HYDROXYCHLOROQUIN, start date: May2016; VITAMIN D3, start date: Mar2013; VITAMIN B12 [CYANOCOBALAMIN], start date: Mar2013; VITAMIN E [TOCOPHEROL], start date: May2016; COLACE, start date: Sep2015. Past drug history included: Codeine, reaction(s): "known allergies: codiene", notes: known allergies: codeine; Percocet, reaction(s): "known allergies: Percocet", notes: known allergies: Percocet; Evista, reaction(s): "known allergies: Evista", notes: known allergies: Evista; Aromasin, reaction(s): "known allergies: Aromasin", notes: known allergies: Aromasin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: home test yesterday was positive for Covid 19; home test yesterday was positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EN5318, Expiration Date: 31May2021), on 16Feb2021 as dose 2, single (Lot number: EN5318, Expiration Date: 31May2021) and on 08Oct2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "unknown" and all described as "home test yesterday was positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Positive, notes: Result: positive; Unit: Not Provided; (18Jun2022) unknown results, notes: Result: unknown; Unit: Not Provided.  Clinical course: AE(s) did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations within 4 weeks was reported as none. Patient's Medical History and Family Medical History Relevant to AE was none.
Age: 70.0
Sex: M
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 70-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 30Mar2022 at 18:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ATORVASTATIN, start date: Apr2015, stop date: 07Jun2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Positive COVID test for the week up to this point. Therapeutic measures were taken as a result of vaccination failure, covid-19.
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).  A female patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 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: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: positive COVID test for the week up to this point. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Four days after completing the course of Paxlovid, patient started sneezing and by the next day patient had bad head cold symptoms. Patient only prescription medication was atorvastatin which he stopped taking while on Paxlovid. Events were not getting much better since 17Jun2022 but it was not worse so the patient hopes it goes away in the next days. Patient found in the internet that it seems like this may be a symptom of rebound effect of Paxlovid since patient has been isolating due to the positive COVID test for the week up to this point. The patient had penicillin allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Guillain-Barre syndrome, Muscular weakness, Polymerase chain reaction, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 13:30 as dose 1, single (Lot number: EN5318) at the age of 60 years intramuscular, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Migraine headache" (unspecified if ongoing); "Hypertension intermittent" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 05Feb2021 at 09:00, outcome "recovered with sequelae", described as "Difficulties focusing"; GUILLAIN-BARRE SYNDROME (medically significant), PYREXIA (non-serious) all with onset 05Feb2021 at 09:00, outcome "recovered with sequelae" and all described as "Guillain-Barre syndrome with fever"; MUSCULAR WEAKNESS (non-serious) with onset 05Feb2021 at 09:00, outcome "recovered with sequelae", described as "Severe muscle weakness"; SOMNOLENCE (non-serious) with onset 05Feb2021 at 09:00, outcome "recovered with sequelae". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (13Dec2020) Negative, notes: Nasal Swab; (13Jan2022) Negative, notes: Nasal Swab; (07Mar2022) Negative, notes: Nasal Swab; (27Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of Guillain-Barre syndrome, pyrexia, muscular weakness, somnolence, disturbance in attention. Clinical course: Patient experienced Guillain-Barre syndrome with fever, severe muscle weakness, somnolence, difficulties focusing and completing tasks for 2 and 3 weeks after 1st and 2nd vaccination respectively. It was reported that adverse events were treated with valacyclovir 1000 mg orally four times a day, Ibuprofen 400 mg orally three times a day and was said bed rest. It was said that the patient was recovered with lasting effects. It was reported that the patient never had Covid prior vaccination and was tested for Covid after vaccination. The patient had not taken other vaccine in four weeks and even no other medications within two weeks and other vaccine date was 06Feb2022. The patient had no known allergies. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event GUILLAIN-BARRE SYNDROME and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 13:30 as dose 1, single (Lot number: EN5318) at the age of 60 years intramuscular, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Migraine headache" (unspecified if ongoing); "Hypertension intermittent" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 05Feb2021 at 09:00, outcome "recovered with sequelae", described as "Difficulties focusing"; GUILLAIN-BARRE SYNDROME (medically significant), PYREXIA (non-serious) all with onset 05Feb2021 at 09:00, outcome "recovered with sequelae" and all described as "Guillain-Barre syndrome with fever"; MUSCULAR WEAKNESS (non-serious) with onset 05Feb2021 at 09:00, outcome "recovered with sequelae", described as "Severe muscle weakness"; SOMNOLENCE (non-serious) with onset 05Feb2021 at 09:00, outcome "recovered with sequelae". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (13Dec2020) Negative, notes: Nasal Swab; (13Jan2022) Negative, notes: Nasal Swab; (07Mar2022) Negative, notes: Nasal Swab; (27Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of Guillain-Barre syndrome, pyrexia, muscular weakness, somnolence, disturbance in attention. Clinical course: Patient experienced Guillain-Barre syndrome with fever, severe muscle weakness, somnolence, difficulties focusing and completing tasks for 2 and 3 weeks after 1st and 2nd vaccination respectively. It was reported that adverse events were treated with valacyclovir 1000 mg orally four times a day, Ibuprofen 400 mg orally three times a day and was said bed rest. It was said that the patient was recovered with lasting effects. It was reported that the patient never had Covid prior vaccination and was tested for Covid after vaccination. The patient had not taken other vaccine in four weeks and even no other medications within two weeks and other vaccine date was 06Feb2022. The patient had no known allergies. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event GUILLAIN-BARRE SYNDROME and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab: Positive on 03Jan2022; Nasal Swab: Positive on 03Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2021 as dose 1, single (Lot number: FC3182), in right arm and on 28Sep2021 as dose 2, single (Lot number: FF2589) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Nasal Swab: Positive on 03Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2022) Positive, notes: Nasal Swab.
Age: 58.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Lot number: EW0176), in left arm and on 15May2021 as dose 2, single (Lot number: EW0183) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 02May2022 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing), notes: High bp; "high cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details product COVID 19 Treatment, brand Paxlovid, treatment start date 08Jun2022, treatment stop date 12Jun2022, indication Treatment of COVID-19. Was the patient taking any other medications, products within 2 weeks of starting COVID-19 treatment was reported as yes. the patient previously receive a COVID-19 Vaccine was reported as yes. Reported Event: Runny nose and sneezing. Antigen Rapid Test for COVID-19 that was positive. known allergies was reported as No.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 33-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL3247), on 23Feb2021 as dose 2, single (Lot number: EL3247) and on 18Nov2021 as dose 3 (booster), single (Lot number: FF2589) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "recovering" and all described as "Contracted Covid". The event "contracted covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: There was no other vaccine in four weeks. There was covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 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 was not reported. Concomitant medication(s) included: DAYQUIL, start date: 09Jun2022, stop date: 13Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) negative, notes: Turned negative on a rapid antigen test after 5 days of Paxlovid treatment at day 7. Asymptomatic at day 7. Developed symptoms again at day 10, turned positive on the rapid antigen test again on day 11; (Jun2022) positive, notes: Turned negative on a rapid antigen test after 5 days of Paxlovid treatment at day 7. Asymptomatic at day 7. Developed symptoms again at day 10, turned positive on the rapid antigen test again on day 11. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Other medication details: Other medication in 2 weeks product: Dayquil, Other medication in 2weeks start date: 09Jun2022, Other medication in 2 weeks stop date: 13Jun2022. Turned negative on a rapid antigen test after 5 days of Paxlovid treatment at day 7. Asymptomatic at day 7. Developed symptoms again at day 10, turned positive on the rapid antigen test again on day 11. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 25Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 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) with onset 18Jun2022, outcome "recovering", COVID-19 (medically significant) with onset 18Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Contracted Covid. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course:If other vaccine in four weeks: Unknown. If covid prior vaccination: Unknown. If covid tested post vaccination: Yes. Covid tested post vaccination: [{Covid test type post vaccination: Unknown, Covid test date: 18Jun2022}]  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247), on 30Sep2021 as dose 3 (booster), single (Lot number: FF2589) and on 04Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 58 years 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 16Jun2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 16Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Unknown results.  Clinical course: Unknown if covid prior vaccination. Covid tested post vaccination. Covid test type post vaccination was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for COVID; I tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EK4776), in left arm, on 27Jan2021 as dose 2, single (Lot number: EL9261), in left arm and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 03Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 03Jun2022, outcome "not recovered" and all described as "I tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive; (13Jun2022) Negative; (19Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid, indication for use in the case: treatment of COVID-19, date of start of drug: 04Jun2022, date of last administration: 09Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.