chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Benign familial pemphigus, COVID-19
Clinical narrative: diagnosis (04May2022) of Hailey- Hailey disease/ Symptoms manifested (and persisted) starting a few weeks after initial two dose; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Lot number: EL9264) and on 26Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "some adhesives" (unspecified if ongoing), notes: known allergies: some adhesives; "Fungal disease" (unspecified if ongoing), notes: Antifungal cream'. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Manufacturer: Pfizer, Lot number: EL3247), administration date: 26Jan2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: BENIGN FAMILIAL PEMPHIGUS (non-serious) with onset 31May2021, outcome "not recovered", described as "diagnosis (04May2022) of Hailey- Hailey disease/ Symptoms manifested (and persisted) starting a few weeks after initial two dose". The event "diagnosis (04may2022) of hailey- hailey disease/ symptoms manifested (and persisted) starting a few weeks after initial two dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of benign familial pemphigus. Additional information: If other vaccine in four weeks: No. Other medications in two weeks: anti-fungal cream. Adverse event: New diagnosis (04May2022) of Hailey- Hailey disease. Symptoms manifested (and persisted) starting a few weeks after initial two dose covid vaccination. Multiple failed diagnoses prior to biopsy and today's diagnosis. Previous example of exacerbation noted in [site name]. AE treatment: medications. If covid prior vaccination: No. If covid tested post vaccination: Yes. known allergies: some adhesives.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Bone swelling, Vaccination site swelling, X-ray
Clinical narrative: That same night, she woke up and noticed that her left clavicle was swollen; That same night, she woke up and noticed that her left clavicle was swollen (the same side that she took the vaccine); 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 72-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 72 years, in left arm for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Lot Number: EM9809), administration date: 11Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, Lot Number: EN6207), administration date: 18Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 3, Lot Number: FC3183), administration date: 20Sep2021, when the patient was 71-year-old, for Covid-19 immunization. The following information was reported: BONE SWELLING (non-serious) with onset 26Apr2022 at 02:00, outcome "not recovered", described as "That same night, she woke up and noticed that her left clavicle was swollen"; VACCINATION SITE SWELLING (non-serious) with onset 26Apr2022 at 02:00, outcome "not recovered", described as "That same night, she woke up and noticed that her left clavicle was swollen (the same side that she took the vaccine)". The events "that same night, she woke up and noticed that her left clavicle was swollen" and "that same night, she woke up and noticed that her left clavicle was swollen (the same side that she took the vaccine)" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: She went to bed that night and woke up at 2 am and her left clavicle was swollen. She had received the shot in the same arm as the swelling. She explained that she has consulted doctors and made x-rays. Her case has not improved since that date. Caller wanted to know if there was some compensation program that could help her to cover the large medical bills that she has. It was reported that the doctor was scratching his head. They have done x rays which did not show anything wrong. They could not find anything wrong except that her clavicle was swollen. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient did not have any prior vaccinations (within 4 weeks). It was reported that there were no diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient did not go to emergency room as a result of the event.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Condition aggravated, Investigation, Polypectomy, Postmenopausal haemorrhage
Clinical narrative: 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 62-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "hysterectomy" (unspecified if ongoing), "menopause" (unspecified if ongoing), notes: Caller states she is 62 yrs old, 15 years into menopause, and all of a sudden, I am having constant bleeding. The patient's concomitant medications were not reported. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "15 years into menopause, and all of a sudden I am having constant bleeding"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "the bleeding is worse than ever"; POLYPECTOMY (medically significant), outcome "unknown", described as "I had one polyp removed". The patient underwent the following laboratory tests and procedures: Biopsy: Unknown results; invasive procedures: Unknown results. Therapeutic measures were taken as a result of postmenopausal haemorrhage, condition aggravated, polypectomy. Clinical course: It was regarding the PBCV and booster dose. Received her 1st vaccine dose Feb2021, her 2nd dose Mar2021 and her booster dose Nov2021. she will not be having anymore". Patient stated she was 62 yrs old, 15 years into menopause, and all of a sudden, she was having constant bleeding. She stated she had already had a D and C and 3 invasive procedures to make sure patient did not have cancer or something else and had nothing else. She had a Hysteroscopy and a biopsy because menopausal women shouldn't be bleeding. She did not have cancer. she had one polyp removed and the bleeding was worse than ever. Constant bleeding like a constant period. This was not normal, she knew the Covid Vaccine has caused some reactions with women's cycles and post-menopausal bleeding. She had done research on her own, but she wanted to have access to the studies that Pfizer has done. She had hysterectomy and she really did not want to have her uterus removed. The case was reported as non-serious. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
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 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: Now on Day 9, the patient was having symptoms again and tested positive; (May2022) Negative, notes: On day 8 of having COVID, the patient tested negative on a rapid antigen test. Therapeutic measures were taken as a result of covid-19.  Clinical information: Patient received other medication in 2 weeks. COVID 19 treatment with Pfizer product start date reported as 26Apr2022 and stop date was reported as 30Apr2022. The clinical course was reported as: on day 8 of having COVID and after complexing paxlovid, the patient tested negative on a rapid antigen test. Now on Day 9, the patient was having symptoms again and tested positive and reported viral rebound.  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: Menstrual disorder, Postmenopausal haemorrhage
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: POSTMENOPAUSAL HAEMORRHAGE (medically significant), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "Covid Vaccine has caused some reactions with women's cycles and post menopausal bleeding". The reported seriousness of the events was non-serious (as reported). This was not normal, she knew the Covid Vaccine has caused some reactions with women's cycles and post-menopausal bleeding. She has done research on my own, but reporter wanted to have access to the studies that Pfizer has done. She asked how can she get access to the studies and what Pfizer knows about this now. Because what was being discussed is a hysterectomy and she really did not want to have her uterus removed if she was needed to. She asked were there any studies that Pfizer has done on this, she understood she was not the only person this has happened to. She would like access to all the studies that Pfizer has done on this topic. Any research, any information about this that Pfizer knew so far, so she could make an informed decision about what to do. She had already called the CDC and already filed a report with the CDC. If she did not start to get somewhere with somebody, one company that was involved in this or somebody, she would just call the media. She did not believe that citizens should be, she thought that was needed to be transparent. We all took these shots, we trusted and it was important we all understand what it did to our bodies. What does she do about this, she should not be bleeding. The reporter was not saying it was the Covid vaccine, but we have ruled out everything else. She though it was funny when it was referred to as an emotional thing for women, when talking about women's health, it really bothered her. She was curious because she put this in her body. The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 36.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: PAA165969) at the age of 36 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: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Known allergies: Monocryl stitches" (unspecified if ongoing); "Known allergies: Dermabond glue" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE; ETHINYLESTRADIOL. Past drug history included: Zithromax, reaction(s): "Allergy".  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: Positive. Therapeutic measures were taken as a result of covid-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Condition aggravated
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4377338-00. A 34-year-old female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years and on 03Dec2021 as dose 2 , single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "pain as well as swollen knees associated with ankylosing spondylitis"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "flare up". The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of "pain as well as swollen knees associated with ankylosing spondylitis" and "flare up" with the suspect product(s) BNT162b2 was provided possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporters causality for the event(s) of Flare up with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporters causality for the events(s) of pain as well as swollen knees associated with ankylosing spondylitis was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information provided in the narrative, a possible contributory role of the suspect vaccine to reported event of ankylosing spondylitis and condition aggravated cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4377125-00. A 24-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 24 years intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unknown (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "rheumatoid arthritis flare up". The action taken for adalimumab was unknown. Clinical Course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter considered "rheumatoid arthritis flare up" related to BNT162b2. The reporter's causality for the event of rheumatoid arthritis flare up with HUMIRA (ADALIMUMAB) was no reasonable possibility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug 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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My husband and I were both fully vaccinated (Pfizer) last April and boosted in December, yet we both contracted COVID-19; My husband and I were both fully vaccinated (Pfizer) last April and boosted in December, yet we both contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "unknown" and all described as "My husband and I were both fully vaccinated (Pfizer) last April and boosted in December, yet we both contracted COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Negative, notes: I was symptomatic 30Apr, yet tested negative; (01May2022) Negative; (02May2022) Positive.  Clinical course: Patient was fully vaccinated (Pfizer) last Apr and boosted in Dec, yet contracted COVID-19. She was symptomatic 30Apr, yet tested negative that day and 01May, but then positive 02May. Patient had been separated as best as possible from her (21-year-old) daughter, but was curious to know if she'd qualify to participate.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200664323 same reporter, vaccine, event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: headache; malaise; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): (Janssen).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown". Additional information: The patient was previously treated with 2 doses of Pfizer Covid-19 vaccine (tozinameran) (Dose Number in series 1) (form of admin, route of administration, dose, and batch number not reported) for prophylactic vaccination. On an unspecified date, the patient experienced headache, malaise and nausea (Dose Number in series 1). The patient was previously treated with Moderna COVID-19 vaccine (elasomeran) (Dose Number in series 2) (form of admin, route of admin, and batch number: unknown and expiry: unknown) dose was not reported for prophylactic vaccination. On an unspecified date, the patient experienced headache, malaise and nausea (Dose Number in series 2). The patient received additional company suspect vaccine covid-19 vaccine ad26.cov2.s (Dose Number in series 3) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination which was off label use as inappropriate schedule of vaccine administration (Dose Number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced headache, malaise and nausea which was worsened (Dose Number in series 3). It was stated that, "Just had a JnJ as a 4th shot after Pfizer primary series and one Moderna third shot (full strength). Anecdotally, the side effects from the JnJ shot were worse than the first three. Headache, malaise and nausea as with the others, but far greater intensity. The outcome of the headache worsened, malaise worsened and nausea worsened, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.  Reporter Causality was provided as Possible. 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: suspected clinical vaccination failure; COVID-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220438211 (Janssen).  A 32-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 12Apr2021 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 19Apr2022, outcome "unknown", described as "COVID-19 infection"; DRUG INEFFECTIVE (medically significant) with onset 19Apr2022, outcome "unknown", described as "suspected clinical vaccination failure". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical course: Case level outcome was unknown. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number was requested. Company Remarks (Senter's comments) included VO: 20220438211-COVID-19 VACCINE AD26.COV2.s- suspected clinically vaccination failure. The event (s) has compatible/ suggestive temporal relationship is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with event (s) than the drug. Specifically special situation. Therefore this event (S) is considered not related. Suspected clinical vaccination failure (vaccination failure) causality as per reporter (drug/vaccine) was possibility. Causality as per Mfr (drug/vaccine) was possibility. Suspected Covid-19 infection (Suspected Covid-19 infection) causality as per reporter (drug/vaccine) was possibility. Causality as per Mfr (drug/vaccine) was possibility.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 10Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRALUENT; OMEPRAZOLE. Past drug history included: Statins, reaction(s): "Known allergies: Statins", notes: Known allergies: Statins. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03May2022, outcome "unknown", COVID-19 (medically significant) with onset 03May2022, outcome "not recovered" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (03May2022) Positive, notes: Tested positive and symptoms returned 8 days after last does. Therapeutic measures were not taken as a result of covid-19.  Clinical information: Other medication in 2 weeks product was Praluent and Omeprazole.  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: 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 09:00 as dose 1, single (Lot number: EN5318), in left arm and on 25Feb2021 at 08:00 as dose 2, single (Lot number: ENG200) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 at 17:00 as dose 3 (booster), single (Lot number: 012H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 27Apr2022, stop date: 03May2022; BENZONATATE, start date: 29Apr2022, stop date: 03May2022; ESTRADIOL vaginal, start date: May2021; ESTRADIOL, start date: Aug2013; SYNTHROID, start date: Jan2012. Past drug history included: Sulfamethoxazole, reaction(s): "known allergies"; Trimethoprim, reaction(s): "known allergies: Trimethoprim". 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: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19. Patient received other medication in 2weeks. Anti viral details: product: COVID 19 treatment, brand: Paxlovid, treatment start date: 29Apr2022, treatment stop date: 03May2022, lot number: FY5656, indication: Treatment of COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: First dose: 10Apr2021, second dose: 02May2021, had a positive Covid test yesterday, 03May2022; First dose: 10Apr2021, second dose: 02May2021, had a positive Covid test yesterday, 03May2022; 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 29-year-old female patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0158), in left arm and on 02May2021 as dose 2, single (Lot number: EW0173) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: 067F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "Smoker" (unspecified if ongoing), notes: caller use to be a smoker. Concomitant medication(s) included: WELLBUTRIN taken for major depression. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "unknown" and all described as "First dose: 10Apr2021, second dose: 02May2021, had a positive Covid test yesterday, 03May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive; (04May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Reaction/Event as reported by primary source: Pfizer Covid Vaccine/Moderna: This morning, 04May2022, had severe muscle weakness, For about four or five days had severe pain in that arm and was not able to move arm up or down. Outcome of reaction/event at the time of last observation: Unknown. The patient received three doses of Vaccine that were all Pfizer. Patient states everything taste metallic. The patient has only taken one dose of Paxlovid around noon on 04May2022. The patient won't take the night time dose until around 2000, at least 8 hours between doses. Covid symptoms got patient really, really bad, just started yesterday, 03May2022. This morning, 04May2022, the caller had severe muscle weakness. Everything taste metallic. The patient received the Flu vaccine at the same time the patient received Moderna dose on 17Nov2021. For about four or five days the patient had severe pain in that arm and was not able to move arm up or down. The lymph nodes in armpit were huge for day. Patient states it is not a good idea to get the Flu vaccine while getting booster dose Moderna Vaccine, was pretty bad. Flu Vaccine: NDC/lot/expiration: Unknown, patient does not have this information to provide because the information was not provided to the patient.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, 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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2021 at 09:00 as dose 1, single (Lot number: EW0175), in right arm, on 25May2021 at 14:15 as dose 2, single (Lot number: EW0168), in right arm and on 23Dec2021 at 15:30 as dose 3 (booster), single (Lot number: FL3197) at the age of 57 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "ocular hypertension" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "depression" (unspecified if ongoing); "constipation" (unspecified if ongoing); "vaginal dryness from menopause" (unspecified if ongoing); "Known allergies: Sulphate drugs" (unspecified if ongoing), notes: Known allergies: Sulphate drugs. Concomitant medication(s) included: LEVOTHYROXINE (Brand:), start date: 01Oct2007; BUPROPION HCL  (Brand:), start date: 25Dec2021; BIMATOPROST ( (Brand: Somerset Therapeutics LLC), start date: 01Jan2021; METHYLPHENIDATE ( (Brand:), start date: 27Sep2021; MIRALAX (Brand:), start date: 30Sep2016, also reported as other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid (Anti-viral) started on 20Apr2022 and stopped on 24Apr2022. Clinical course was reported as, Covid symptoms returned on 29Apr2022, 5 days after finished patient last dose of Paxlovid. Runny and plugged nose, coughing, sore throat, heavy/tight chest. Patient never had the cough and sore throat when patient symptoms started before the Paxlovid, only the extremely runny nose, headache, chills, fatigue and tight chest. Patient was not recovered from symptoms and no treatment received for symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: verbatim: Known allergies: Sulfa. 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: After testing positive for Covid-19 on Day 1; Negative, notes: Negative antigen test on Day 11; Negative, notes: Negative antigen test Day 13; Positive, notes: Positive antigen test Day 14 - Covid-19 relapse on Day 14 post-Paxlovid treatment. Therapeutic measures were taken as a result of covid-19.  Clinical course: After testing positive for Covid-19 on Day 1, took Paxlovid on Day 2 through Day 7. Symptoms abated except for fatigue. Negative antigen test on Day 11. Symptoms started to return Day 12. Negative antigen test Day 13. Symptoms continued to get worse. Positive antigen text Day 14 - Covid-19 relapse on Day 14 post-Paxlovid treatment.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Erythema, Pain, Pruritus
Clinical narrative: Have red, big acne in my face and in my back and in my head; Have red, big acne in my face and in my back and in my head; Itchy, when I touch it, I feel pain; Itchy, when I touch it, I feel pain; 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 24-year-old female patient received BNT162b2 (BNT162B2), on 03May2022 as dose 1 (bla tris), single (Lot number: FJ4989) at the age of 24 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ACNE (non-serious), ERYTHEMA (non-serious) all with onset 05May2022, outcome "unknown" and all described as "Have red, big acne in my face and in my back and in my head"; PRURITUS (non-serious), PAIN (non-serious) all with onset 05May2022, outcome "unknown" and all described as "Itchy, when I touch it, I feel pain". Sender's Comments: Linked Report(s) : US-PFIZER INC-202200673319 Same reporter/ drug, different patients (mom baby)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: fully vaccinated with Pfizer COVID vaccine recently tested positive for COVID.; fully vaccinated with Pfizer COVID vaccine recently tested positive for COVID.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) 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), outcome "recovering", COVID-19 (medically significant), outcome "recovering" and all described as "fully vaccinated with Pfizer COVID vaccine recently tested positive for COVID.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course : Was made aware that individual who was fully vaccinated with Pfizer COVID vaccine recently tested positive for COVID. As the reporter I am unsure of number of boosters or brands of possible boosters. Reporting as an Pfizer employee to meet reporting responsibility. No COVID prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: experienced an energy increase after his vaccine; 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 65-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: ENERGY INCREASED (non-serious), outcome "recovered", described as "experienced an energy increase after his vaccine".  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: Fatigue, Malaise, Pain in extremity
Clinical narrative: feeling sick; tiredness; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FE3590) for COVID-19 immunization. The patient's relevant medical history included: "she has pollen/seasonal allergies" (unspecified if ongoing), notes: she has a seasonal allergy (allergic to pollen); "she has pollen/seasonal allergies" (unspecified if ongoing), notes: she has a seasonal allergy (allergic to pollen). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, LOT: EN6201), for Covid-19 Immunization; Bnt162b2 (Dose:2, LOT: EN6208), for Covid-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "feeling sick"; FATIGUE (non-serious), outcome "recovered", described as "tiredness"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional information: The patient stated that she already got two doses of the primary series and one dose of the booster shot of the Pfizer COVID-19 vaccine. patient also stated that she experienced feeling sick, tiredness, sore arm which only lasted a day and a half at maximum.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID virus; Tested positive for COVID virus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  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 immunization. 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 "Tested positive for COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 4-5 days after that she felt funny and went to the drug store and bought a home testing kit. Hers was positive; unknown; unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. Clinical course was reported as, Received call from reporter who bought product from Pfizer - Paxlovid for the COVID 19 virus. He got phone call from Pfizer and said Reference #. He took Paxlovid for 5 days. Somebody called him back. He clarified that he had just left a message for medical information and had not completed a safety report before. He did not wish to provide an address, phone, email or date of birth. He said he just wanted to speak to someone who could answer his question. Reporter asked about, After you take it for 5 days, what do you do. It is like a doctor should have the answer. They just tell you don't do anything and test negative. He then stated his wife (patient) tested positive and took the pills also. This report is to capture information for his wife. In Feb (year not provided), they got COVID 19 shots. They got Pfizer 2 shots and the booster and then everything was ok and then his wife went traveling and they were tested when they get out of the plane and ship. She came back and got tested in # and came back to #. 4-5 days after that she felt funny and went to the drug store and bought a home testing kit. Hers was positive and his was negative. They don't know how she got it. He was surprised because they got the 2 shots and the booster. She wore the mask. He then asked what is the use of taking the shots. Does it just not make it as bad. She took the 5 pills and wants to know what is the next step. He took them took because he did not want to take any chances and thought it will not hurt him to take the Paxlovid. On his, it tested negative and the next day positive and the next day negative. He did not know what to make of it.  He is an old man and doesn't have time to talk. He did not wish to complete report on himself or his wife and requested to be transferred to have his questions answered. No further details provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "leg inflammation" (unspecified if ongoing); "ACL surgery" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN; METFORMIN; LIPITOR; OZEMPIC; ALLOPURINOL; CELECOXIB taken for ligament operation, inflammation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller is asking if he can still receive his 2nd booster of Pfizer covid vaccine even after having a covid infection and finishing Paxlovid treatment. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue
Clinical narrative: Still got COVID; Still got COVID; Fatigue; 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 93-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 93 years for covid-19 immunisation. The patient's relevant medical history included: "Hard of hearing" (unspecified if ongoing), notes: Caller states she was hard of hearing before she took the vaccines. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Still got COVID".  Clinical Course: Reporter states that she was prescribed Paxlovid. She was told to take 2 tablets in the morning and 2 tablets in the evening. However, when she opened the box, it said she had to take three tablets. She was confused. Should she took two or three. She was in great condition. She don't had any kidney problem. She hard of hearing, though". She was fully vaccinated. She received two shots from Pfizer and then 2 boosters. And she got COVID this week". The fact sheet includes only one reason to reduce the dose, and that is kidney impairment. It would be advisable to consult this dosage reduction with your HCP. Reporter states she was calling about Paxlovid, 300-100, two tablets twice a day. Reporter states when she looks at her actual pharmacy prescription, the directions states to take two tablets twice a day, when she looks at the medication box, each card, in the package, the direction states to take three tablets twice a day, asks for clarification on the directions, Later in report, reporter clarifies that she has not started taking the medication yet, until she finds out more information. Reporter states before transfer, that she had two shots, and two boosters of the Pfizer COVID vaccine, and still got COVID. Reporter states that the vaccine, did not give her any trouble, except for fatigue, she was hard of hearing before she took the vaccines, and states it happened because she was a swimmer.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: MODERNA COVID-19 VACCINE taken for covid-19 immunisation, on 04Feb2021 as dose 1, single, on 04Mar2021 as dose 2, single, on 22Sep2021 as dose 3 (booster), single. Past drug history included: Methyl prednisone for Allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Information: It was reported that The patient was not taking any other medications products within 2 weeks of starting COVID-19 treatment and patient previously receive a COVID-19 Vaccine. Days 2-8 very mild symptoms and faint COVID line on rapid test. if patient recovered: Not recovered. No treatment ae reported. known allergies: Penicillin, methyl prednisone, sulfa drugs Device Date :02May2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.