chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient had COVID-19, treatment of Covid-19; Patient had COVID-19, treatment of Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Jun2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) and other medications in two weeks included: ZOLOFT; SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Patient had COVID-19, treatment of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive; (18Aug2022) Positive, notes: Tested positive for COVID again with at home test (Rapid). Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated for events from 05Aug2022 to 09Aug2022 with anti-viral product Paxlovid. The patient tested positive for COVID again with at home test (Rapid) on 18Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: died two weeks later from ITP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (death, medically significant), outcome "fatal", described as "died two weeks later from ITP". The patient date of death was unknown. Reported cause of death: "Immune thrombocytopenia". It was not reported if an autopsy was performed. Clinical Course:Female Reporter stated that she would like to be vaccinated with Pfizers Covid 19 vaccines but she was concerned because she has ITP Idiopathic thrombocytopenic purpura that she developed during her third pregnancy in 2002 and continued on until 2015 She states she has been in remission and her platelet counts have been within normal range for the last 5 years. She stated that she had Covid last year in Aug and did well . She stated that she was nervous because a Doctor in withheld took the vaccine and died two weeks later from ITP and he was healthy prior. She stated that she has been staying home and wearing a mask and waiting for more research but she has not seen any new information yet. Her hematologist relayed that getting any vaccine would be a risk for worsening ITP They suggested that she get the first shot and see how it goes and then wait 3 months to get the second shot Also relays that she has autoimmune disorder Hashimotos. She would like to know if there is any information or new data that would help her to know what her risks are when getting the Pfizer Covid 19 vaccine with ITP.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Immune thrombocytopenia
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Osteitis, Tinnitus
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 female patient received BNT162b2 (BNT162B2), in 2021 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: TINNITUS (non-serious), outcome "unknown", described as "developed ringing in my left ear"; OSTEITIS (non-serious), outcome "unknown", described as "I developed inflammation in my jaw"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "jaws stiff". Additional information: The caller stated that the patient had the vaccine, a year before that was the Pfizer BioNTech COVID19 Vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 08Aug2022 at 11:00 as dose 3 (booster), single (Lot number: FP7139) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Tetracyclines, reaction(s): "Dermographism", notes: known allergies: tetracyclines. Vaccination history included: BNT162b2 (prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot number=ER8733, Prev dose lot unknown=False,, Prev dose administration date=27Mar2021,, Prev dose dose number=1), administration date: 27Mar2021, when the patient was 59-year-old, for COVID-19 Immunization; BNT162b2 (prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot number=FF2593,, Prev dose lot unknown=False,, Prev dose administration date=21Oct2021,, Prev dose dose number=2, Prev dose vaccine location=Left arm), administration date: 21Oct2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 10Aug2022, outcome "not recovered", described as "rash on the injection arm (right arm) on my upper inner arm". Therapeutic measures were taken as a result of vaccination site rash. Additional information: Patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. He developed a 5 cm x 10 cm rash on the injection arm (right arm) on his upper inner arm below his arm pit and treated with OTC Topical cortisone ointment.
Sex: M
Vaccine: COVID19
Symptoms: Lyme disease
Clinical narrative: Lyme disease; 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-163-4501159-00. A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYME DISEASE (medically significant) with onset Aug2022, outcome "unknown". The action taken for adalimumab was unknown. Solicited report from the USA by a consumer of a 59-year-old male with events of non-serious Lyme disease and diagnosed with COVID again with Humira (Adalimumab). In Jul2022, the patient experienced diagnosed with COVID again. In Aug2022, the patient experienced Lyme disease. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Lyme disease and diagnosed with COVID again was not provided. Suspect drug: Humira (Solution for injection in pre-filled pen) (Adalimumab), Unknown. Causality: Lyme disease (Lyme disease). Causality as per reporter (drug/vaccine) was not reported. Dechallenge: N/A. Suspect drug: Pfizer BioNTech COVID-19 vaccine (Tozinameran) (Tozinameran). Causality: Lyme disease (Lyme disease), Causality as per reporter (drug/vaccine): Possible, Dechallenge: N/A. Did event abate after stopping drug: NA.  The reporter considered "lyme disease" related to BNT162b2.  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 provide and plausible temporal association, the causality between BNT162B2 and event LYME DISEASE cannot be completely 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Physician).  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Aug2022, outcome "unknown" and all described as "COVID".  Clinical information: Description of Potential AE: I'm a physician. Have 10 year old twin boys who are ex-31 week preemies. My husband and I have vaccinated our family as soon as this was available. We developed COVID for first time 15Aug2022 and now twins tested positive 17Aug2022. Is there any trial to allow them to as me antiviral. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200046249 same reporter/vaccine/AE, different patient;
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face began to swell after 24 hours of receiving COVID booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10-year-old male patient received BNT162b2 (BNT162B2), on 16Aug2022 at 15:45 as dose 3 (booster), single (Lot number: FL2757) at the age of 10 years intramuscular, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FK5127), administration date: 06Dec2021, when the patient was 10-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127), administration date: 15Nov2021, when the patient was 10-year-old, for COVID-19 immunization. The following information was reported: SWELLING FACE (non-serious) with onset 17Aug2022, outcome "unknown", described as "Face began to swell after 24 hours of receiving COVID booster". Therapeutic measures were taken as a result of swelling face. The patient took 25 mg Benadryl to reduce swelling.  Follow-up (22Aug2022): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Feb2021 as dose 1, single (Lot number: 031L20A), in left arm, on 17Mar2021 as dose 2, single (Lot number: ? 010 A21A), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: 038C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic rhinitis" (unspecified if ongoing); "Seasonal" (unspecified if ongoing); "Intolerances" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive; (Aug2022) Negative, notes: previously negative; (18Aug2022) Positive, notes: again positive today; (08Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, Patient received Paxlovid for COVID-19 Treatment, start date 09Aug2022 and treatment stop date "06Aug2022".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and drug ineffective, Covid 19 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Anxiety
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ADVERSE EVENT (non-serious), outcome "unknown", described as "experiencing adverse health effects"; ANXIETY (non-serious), outcome "unknown", described as "since all are in the process of killing my sister". Additional information: Reporter was non-hcp/general public. It was reported the reporter sister was experiencing adverse health effects after having the COVID vaccine. Reporter is pleading with Pfizer to please quit producing Premarin manufactured from pregnant mares urine. Caller reports this practice is barbaric, the horses are chained 24Jul2022 and once their foals are birthed, they are not allowed to nurse them. The caller says she will reach out to withheld. Caller said a synthetic product should be used instead. Caller said the diphtheria vaccine was once made with horse serum and now uses a synthetic. Caller also said that Pfizer has made plenty of money off the COVID vaccine and does not need this product to make profit. Caller also said going to label a threat: her mother used Premarin and passed in 2007 from its use and since all are in the process of killing my sister. she believed all about the COVID vaccine and is experiencing adverse health effects. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Aug2021 as dose 3 (booster), single (Lot number: FC3181), in left arm, on 22Jan2022 as dose 4 (booster), single (Lot number: 33130BA), in left arm and on 22May2022 as dose 5 (booster), single (Lot number: FJ4989) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: other medical history: RA. Concomitant medication(s) included: TYLENOL, start date: 07Aug2022, stop date: 11Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Covid-19"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Covid treatment from 08Aug2022 to 12Aug2022. No known allergies. The patient received vaccine and other medication in two weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Glomerulonephritis, Nephropathy, Vasculitis
Clinical narrative: flare up of his glomerulonephritis kidney disease stage 4 and it had previously been diagnosed in 2013, then went into remission; The patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021; The patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021; The patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022CCX00281.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vasculitis glomerulonephritis kidney disease stage 4", start date: 2013 (unspecified if ongoing), notes: it had previously been diagnosed in 2013 then went into remission; "Vasculitis glomerulonephritis kidney disease stage 4", start date: 2013 (unspecified if ongoing), notes: it had previously been diagnosed in 2013 then went into remission; "Vasculitis glomerulonephritis kidney disease stage 4", start date: 2013 (unspecified if ongoing), notes: it had previously been diagnosed in 2013 then went into remission. The patient's concomitant medications were not reported. The following information was reported: GLOMERULONEPHRITIS (medically significant), NEPHROPATHY (non-serious), VASCULITIS (non-serious) all with onset 2021, outcome "unknown" and all described as "The patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "flare up of his glomerulonephritis kidney disease stage 4 and it had previously been diagnosed in 2013, then went into remission".  Clinical course: On 08Aug2022, it was reported that a patient started treatment on an unspecified date with the Covid vaccine and boosters (Mfr. Pfizer) at unreported doses and frequencies of administration for vaccination. It was reported the patient experienced a flare up of his vasculitis glomerulonephritis kidney disease stage 4 in the spring of 2021 (it had previously been diagnosed in 2013, then went into remission). They (not further clarified) thought the Covid vaccine and boosters caused the flare up and that it really messed with his immune system. No further follow-up is anticipated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as DOSE 1, SINGLE (lot number: EN6208); on 14Apr2021 as DOSE 2, SINGLE (lot number: ER8729); on 17Aug2021 as DOSE 3 (BOOSTER), SINGLE (lot number: FD8448); on 14Jan2022 as DOSE 4 (BOOSTER), SINGLE (lot number: FJ1614); and on 20May2022 as DOSE 5 (BOOSTER), SINGLE (lot number: FM9992) at the age of 35 years for COVID-19 immunization. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medications included: ADDERALL and TYLENOL. Past drug history included: Amoxicillin, reaction: "Allergy"; Ceclor, reaction: "Allergy." The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): result not reported, notes: "Treatment of COVID-19." Therapeutic measures were taken as a result of Vaccination failure, Covid-19 which included Paxlovid taken from 06Aug2022 to 11Aug2022.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 at 15:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: Unknown, Anatomical location: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 26Oct2021, when the patient was 68-year-old, for Covid-19 Immunization, reaction(s): "Covid-19"; BNT162b2 (DOSE 2, SINGLE, Lot Number: Unknown. Anatomical Location: Arm Left, Vaccine administration time: 07:30 AM), administration date: 05Apr2021, when the patient was 68-year-old, for Covid-19 Immunization, reaction(s): "Covid-19"; BNT162b2 (DOSE 1, SINGLE, Lot Number: Unknown. Anatomical Location: Arm Left, Vaccine administration time: 07:30 AM), administration date: 15Mar2021, when the patient was 68-year-old, for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: COUGH (non-serious) with onset 2022, outcome "unknown", described as "bronchitis-like cough"; HEADACHE (non-serious) with onset 2022, outcome "unknown"; NAUSEA (non-serious) with onset 2022, outcome "unknown", described as "nauseous". Additional Information: The patient had no known allergies or other medical history. The patient did not receive any other medication in 2 weeks. The patient was nauseous and had headache. When she first started feeling sick, she was experiencing only a bronchitis-like cough. In fact, that was what she thought she had.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the parent. A 6-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2022 as dose number unknown (orange cap), single (Lot number: FL2757) at the age of 6 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Aug2022, outcome "unknown", described as "excruciating pain in her right leg, it was administered in her left arm/ extreme pain in her right leg/ it was the worst pain"; CRYING (non-serious) with onset 18Aug2022, outcome "unknown", described as "she was just crying really bad". Therapeutic measures were taken as a result of pain in extremity, crying. Additional information: It was reported that, it had been like 4 hours ago (as reported). It was 7 or the reporter thought it was administered somewhere around 7 in the morning and everything was fine. She had put her in the bed, she was about little bit late and she just came downstairs about 10 minutes ago and all of sudden have excruciating pain in her right leg, it was administered in her left arm. She was complaining about extreme pain in her right leg and like she even stopped at a point and said she could not take it anymore, she had rather died, she cannot feel this, it was the worst pain she ever had in her life and she was just crying really bad. It was eased up a little bit, the nurse gave her some Ibuprofen. The patient concomitantly received vitamins probiotics. The patient did not had any prior vaccinations.
Age: 78.0
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) from product quality group. The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 24Jan2021 at 14:00 as dose 1, single (Lot number: EN5318), in left arm, on 13Feb2021 at 14:00 as dose 2, single (Lot number: EN6201), in left arm and on 16Sep2021 at 16:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiac issues" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2weeks. The patient Paxlovid from 07Aug2022 to 11Aug2022 for the treatment of COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment - Paxlovid; COVID-19 Treatment - Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6204), in left arm and on 05Apr2021 as dose 2, single (Lot number: EN8732) at the age of 27 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 072H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetic" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; ALLEGRA D, start date: 08Aug2022; Z-PAK, start date: 09Aug2022, stop date: 12Aug2022. Past drug history included: Cefzil, reaction(s): "Known allergies: Cefzil". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment - Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks was Yes. Anti-viral details: Product was COVID 19 Treatment, Brand was Paxlovid, Treatment start date was 10Aug2022, Treatment stop date was 14Aug2022, Indication was Treatment of COVID-19. Adverse event for paxlovid were Congestion in nose, cough, headache, Adverse event start date was 18Aug2022, adverse events were not recovered and patient was not received any treatment for the adverse events.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Dysstasia, Hunger, Hypoaesthesia
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 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown" and all described as "legs and knees are feeling funny, heavy"; HYPOAESTHESIA (non-serious), MUSCLE TIGHTNESS (non-serious), outcome "unknown" and all described as "numb and tightness"; HUNGER (non-serious), outcome "unknown", described as "hungry all the time"; DYSPNOEA (non-serious), DYSSTASIA (non-serious), outcome "unknown" and all described as "She states she also sometimes has SOB, cannot stand for long"; PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "her legs and back are achy". Additional information: It was reported that patient received the Pfizer COVID 19 vaccine a year ago. She states now her legs and knees are feeling funny, heavy, numb and tightness. She states she also sometimes has SOB, cannot stand for long.  When she goes to the grocery store, she has to lean on the cart because her legs and back are achy. She states she is hungry all the time. Patient wants to know could be a side effect from the 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: Limb discomfort, Muscle tightness, Musculoskeletal discomfort, Pain in extremity
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 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown" and all described as "legs and knees are feeling funny, heavy"; HYPOAESTHESIA (non-serious), MUSCLE TIGHTNESS (non-serious), outcome "unknown" and all described as "numb and tightness"; HUNGER (non-serious), outcome "unknown", described as "hungry all the time"; DYSPNOEA (non-serious), DYSSTASIA (non-serious), outcome "unknown" and all described as "She states she also sometimes has SOB, cannot stand for long"; PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "her legs and back are achy". Additional information: It was reported that patient received the Pfizer COVID 19 vaccine a year ago. She states now her legs and knees are feeling funny, heavy, numb and tightness. She states she also sometimes has SOB, cannot stand for long.  When she goes to the grocery store, she has to lean on the cart because her legs and back are achy. She states she is hungry all the time. Patient wants to know could be a side effect from the vaccine. 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: Insomnia, Pain assessment, Vaccination site pain
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 78-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left hand for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (FIRST BOOSTER, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "nagging pain at the injection site"; INSOMNIA (non-serious), outcome "unknown", described as "annoying to get to sleep". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that, the patient did feel right when he got the shot, after the shot, have slight pain but the last 3 weeks, the pain instead of being like a two would go up mostly when sleeping to 5 or 6, annoying to get to sleep. The patient couldn't sleep with the pain in the area of the injection. The patient was right-handed the site is on his left hand, he don't do any work as well. Caller also mentioned there's other people experiencing this. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
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) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6205), in left arm, on 20Mar2021 as dose 2, single (Lot number: EN6204), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 03Jul2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Heart disease (shone's complex), 2 mechanical valves" (unspecified if ongoing), notes: Congenital Heart disease (shone's complex), 2 mechanical valves. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Negative, notes: After two negative tests on 12Aug and 14Aug I tested positive again on 17Aug; (14Aug2022) Negative, notes: After two negative tests on 12Aug and 14Aug I tested positive again on 17Aug; (17Aug2022) Positive, notes: After two negative tests on 12Aug and 14Aug I tested positive again on 17Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: There were no other medication in 2 weeks. Patient took Antiviral Product Paxlovid as covid 19 treatment starting on date 25Jul2022 and stopped on 30Jul2022. Adverse Event reported as After two negative tests on 12Aug and 14Aug tested positive again on 17Aug. Patient tested three times to make sure there was no mistake. Positive all three times. Mild symptoms returned, including scratchy sore throat and some chest congestion. No other symptoms so far.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Disease recurrence, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis came back after the 3rd booster of COVID-19 Vaccine; rheumatoid arthritis came back after the 3rd booster of COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), for rheumatoid arthritis. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: in remission. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), DISEASE RECURRENCE (medically significant), outcome "not recovered" and all described as "rheumatoid arthritis came back after the 3rd booster of COVID-19 Vaccine". The action taken for tofacitinib citrate was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Infection, Insomnia, Laboratory test
Clinical narrative: I have looked it up I see what gland it is, it is my salivary gland, the saliva gland and it is the same one and it keeps popping up/its my salivary gland it swells up; it is painful; this things hurts/ taking pain killers like crazy; makes my face swells up on that side; kind of like an infection; makes my heart beats; it makes it very hard for me even sleep; 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 38-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EW0158), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic pain" (unspecified if ongoing); "Herniated disc" (unspecified if ongoing), notes: gets injections in the spine that deals with the pain. Concomitant medication(s) included: TRAMADOL; ADVIL [IBUPROFEN]; GABAPENTIN. Vaccination history included: Bnt162b2 (Dose 1, Lot Number: EW0151), for COVID-19 immunization, reaction(s): "it is painful; this things hurts", "swollen salivary gland; keeps coming back; already had this side effect pop up three more times after that"; Bnt162b2 (Dose 1, Lot Number: EW0151), for Covid-19 immunization, reaction(s): "makes my heart beats", "kind of like an infection", "makes my face swells up on that side". The following information was reported: SALIVARY GLAND ENLARGEMENT (non-serious), outcome "unknown", described as "I have looked it up I see what gland it is, it is my salivary gland, the saliva gland and it is the same one and it keeps popping up/its my salivary gland it swells up"; PAIN (non-serious), outcome "unknown", described as "it is painful; this things hurts/ taking pain killers like crazy"; SWELLING FACE (non-serious), outcome "unknown", described as "makes my face swells up on that side"; INFECTION (non-serious), outcome "unknown", described as "kind of like an infection"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "makes my heart beats"; INSOMNIA (non-serious), outcome "unknown", described as "it makes it very hard for me even sleep". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of salivary gland enlargement, pain, swelling face, infection, heart rate increased, insomnia. Additional information: Patient was also taking an unspecified penicillin. The patient reported side effects that keep coming after getting all shots. Patient thinks it was some kind of infection and took some antibiotics and some pain killers just to try to keep away the pain and swelling (facial and salivary glands).
Sex: M
Vaccine: COVID19
Symptoms: Pain, Salivary gland enlargement, Swelling face, Weight
Clinical narrative: I have looked it up I see what gland it is, it is my salivary gland, the saliva gland and it is the same one and it keeps popping up/its my salivary gland it swells up; it is painful; this things hurts/ taking pain killers like crazy; makes my face swells up on that side; kind of like an infection; makes my heart beats; it makes it very hard for me even sleep; 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 38-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EW0158), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic pain" (unspecified if ongoing); "Herniated disc" (unspecified if ongoing), notes: gets injections in the spine that deals with the pain. Concomitant medication(s) included: TRAMADOL; ADVIL [IBUPROFEN]; GABAPENTIN. Vaccination history included: Bnt162b2 (Dose 1, Lot Number: EW0151), for COVID-19 immunization, reaction(s): "it is painful; this things hurts", "swollen salivary gland; keeps coming back; already had this side effect pop up three more times after that"; Bnt162b2 (Dose 1, Lot Number: EW0151), for Covid-19 immunization, reaction(s): "makes my heart beats", "kind of like an infection", "makes my face swells up on that side". The following information was reported: SALIVARY GLAND ENLARGEMENT (non-serious), outcome "unknown", described as "I have looked it up I see what gland it is, it is my salivary gland, the saliva gland and it is the same one and it keeps popping up/its my salivary gland it swells up"; PAIN (non-serious), outcome "unknown", described as "it is painful; this things hurts/ taking pain killers like crazy"; SWELLING FACE (non-serious), outcome "unknown", described as "makes my face swells up on that side"; INFECTION (non-serious), outcome "unknown", described as "kind of like an infection"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "makes my heart beats"; INSOMNIA (non-serious), outcome "unknown", described as "it makes it very hard for me even sleep". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of salivary gland enlargement, pain, swelling face, infection, heart rate increased, insomnia. Additional information: Patient was also taking an unspecified penicillin. The patient reported side effects that keep coming after getting all shots. Patient thinks it was some kind of infection and took some antibiotics and some pain killers just to try to keep away the pain and swelling (facial and salivary glands).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 48-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in left arm 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 2022, outcome "unknown" and all described as "COVID 19 Treatment". 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.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for covid but has no symptoms; positive for covid but has no symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71-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 included: "COVID-19" (not ongoing), notes: He had covid in the past before getting the vaccine and had headache and diarrhea.; "headache" (not ongoing), notes: He had covid in the past before getting the vaccine and had headache and diarrhea.; "diarrhea" (not ongoing), notes: He had covid in the past before getting the vaccine and had headache and diarrhea. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant), outcome "unknown" and all described as "positive for covid but has no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: He has tested positive for covid but has no symptoms; Positive, notes: He stayed home for 7 days and is still testing positive. Clinical information: Caller states her 71 year old husband had 4 Pfizer covid vaccine doses(the 2 doses and 2 boosters) and had no reaction to the vaccine. He has tested positive for covid but has no symptoms. He stayed home for 7 days and is still testing positive. He doesn't want to infect anyone so is wondering how long does he have to quarantine and does he have to keep testing. He had covid in the past before getting the vaccine and had headache and diarrhea. A friend's daughter tested positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID: (159558). A 5-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (orange cap), single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "Pharmacist seeking guidance after administering undiluted orange-cap Covid vaccine to 5 year old patient."; RASH (non-serious), outcome "unknown", described as "caller reported a rash on patient's neck.". Additional information: It was reported that the patient was waiting for vaccination. They were accidently administered a COVID 19 vaccine to a patient without diluting. The patient's mom and dad are outside. The patient had a rash on his neck. She just wants to know what to do. She was filling in at this store today. Pharmacist was seeking guidance after administering undiluted orange-cap Covid vaccine to patient. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.