chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Inflammation
Clinical narrative: Inflammation increase; Immunization reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Immunization reaction) and INFLAMMATION (Inflammation increase) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Inflammation.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) pre-filled pen. In 2021, the patient experienced IMMUNISATION REACTION (Immunization reaction). On an unknown date, the patient experienced INFLAMMATION (Inflammation increase). At the time of the report, IMMUNISATION REACTION (Immunization reaction) had resolved and INFLAMMATION (Inflammation increase) had not resolved.            It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Concomitant medications details were not reported by the reporter.  The reporters causality for the event Immunization reaction and inflammation increase was not provided for HUMIRA (Adalimumab).  Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Dysgeusia
Clinical narrative: Bad / metallic taste for a few hours after taking a dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Bad / metallic taste for a few hours after taking a dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EW0153 Location of injection: Arm Left) on 07-Apr-2021 and Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EP7534 Location of injection: Arm Left) on 17-Mar-2022. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Allergy (No product reported).   On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 25-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Bad / metallic taste for a few hours after taking a dose). At the time of the report, DYSGEUSIA (Bad / metallic taste for a few hours after taking a dose) outcome was unknown.            No concomitant medications were reported.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 27-May-2022  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain, Vaccination site reaction
Clinical narrative: Stiffness; Vaccination site reaction; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), VACCINATION SITE REACTION (Vaccination site reaction) and VACCINATION SITE PAIN (Vaccination site pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    There was no reported medical history.    On 12-Apr-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), VACCINATION SITE REACTION (Vaccination site reaction) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) was resolving and VACCINATION SITE REACTION (Vaccination site reaction) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No Concomitant product use was reported.  The patient reported that they felt stiffness was coming back when over did yard work, with each Covid 19 vaccine site reaction was larger and lasted longer and soreness at Covid 19 vaccine site resolved. The patient reported that, if the patient over did yard work could feel stiffness was coming back. The patient had covid-19 vaccine site reaction with each covid-19 vaccine, it was larger and lasted longer. The patient had soreness at vaccination site except for the second booster and no reaction at all. It was unknown if the patient was enrolled in a COVID-19 Vaccine.  No treatment information was provided.   This case was linked to MOD-2022-580273 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: He is seeing bald patches all over his head; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALOPECIA (He is seeing bald patches all over his head) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (He is seeing bald patches all over his head). At the time of the report, ALOPECIA (He is seeing bald patches all over his head) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter It was reported that so ever since reporter  dad got Moderna vaccinated he was seeing bald patches all over His head that he has never had before . He  always had thick hair and now his hair has bald patches all over and this was caused from this shot and the reporter  googled and majority people experienced hair loss due to  vaccination and that was uncalled for. No treatment medications were provided by the reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Illness, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sick with symptoms; sinus infection; bad cold; sinus congestion; mild cough; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ILLNESS (sick with symptoms), SINUSITIS (sinus infection), NASOPHARYNGITIS (bad cold) and SINUS CONGESTION (sinus congestion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergy NOS.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-May-2022 at 7:00 PM, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 26-May-2022, the patient experienced ILLNESS (sick with symptoms), SINUSITIS (sinus infection), NASOPHARYNGITIS (bad cold), SINUS CONGESTION (sinus congestion) and COUGH (mild cough). At the time of the report, OROPHARYNGEAL PAIN (sore throat), ILLNESS (sick with symptoms), SINUSITIS (sinus infection), NASOPHARYNGITIS (bad cold), SINUS CONGESTION (sinus congestion) and COUGH (mild cough) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: neagtive (Negative) Tested negative for Covid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Reportedly, Patient Last course of treatment completed on May 18, 2022. He Developed minor sore throat on May 24, 2022. By May 26, 2022, he was definitely sick with symptoms mimicking a bad cold or sinus infection. Sore throat, sinus congestion, and mild cough and reports No fever.  Treatment details was not reported by the reporter.  Pfizer have permission to contact them and also have permission to contact the patient's healthcare provider about this report .  The device date was reported as 28-May-2022
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion, Sinusitis
Clinical narrative: sick with symptoms; sinus infection; bad cold; sinus congestion; mild cough; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ILLNESS (sick with symptoms), SINUSITIS (sinus infection), NASOPHARYNGITIS (bad cold) and SINUS CONGESTION (sinus congestion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergy NOS.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-May-2022 at 7:00 PM, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 26-May-2022, the patient experienced ILLNESS (sick with symptoms), SINUSITIS (sinus infection), NASOPHARYNGITIS (bad cold), SINUS CONGESTION (sinus congestion) and COUGH (mild cough). At the time of the report, OROPHARYNGEAL PAIN (sore throat), ILLNESS (sick with symptoms), SINUSITIS (sinus infection), NASOPHARYNGITIS (bad cold), SINUS CONGESTION (sinus congestion) and COUGH (mild cough) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: neagtive (Negative) Tested negative for Covid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Reportedly, Patient Last course of treatment completed on May 18, 2022. He Developed minor sore throat on May 24, 2022. By May 26, 2022, he was definitely sick with symptoms mimicking a bad cold or sinus infection. Sore throat, sinus congestion, and mild cough and reports No fever.  Treatment details was not reported by the reporter.  Pfizer have permission to contact them and also have permission to contact the patient's healthcare provider about this report .  The device date was reported as 28-May-2022
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose one administered on 24-MAR-2021 and dose 2 administered on 17-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose one administered on 24-MAR-2021 and dose 2 administered on 17-Apr-2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Astrocytoma (Astrocytoma in brain,100 percent resection, no chemo  or radiation) in 2019 and Astrocytoma resection (Astrocytoma in brain, 100 percent resection, no chemo  or radiation). Concurrent medical conditions included Allergy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose one administered on 24-MAR-2021 and dose 2 administered on 17-Apr-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose one administered on 24-MAR-2021 and dose 2 administered on 17-Apr-2021) outcome was unknown.            Concomitant medications were not reported.  Patient had took third dose of Moderna vaccine on 02-Dec-2021 on right arm.  Treatment information was not reported.   This case was linked to MOD-2022-580358 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash pruritic
Clinical narrative: Developed a  few blisters on legs; developed an itchy rash on right side of back--from waist to shoulder blade running diagonally toward spine; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Developed a  few blisters on legs) and RASH PRURITIC (developed an itchy rash on right side of back--from waist to shoulder blade running diagonally toward spine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 003F21A, 010M20A and 038K20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient did not have any drug allergy.  Concomitant products included SIMVASTATIN from January 2019 to 19-May-2022 for an unknown indication.   On 05-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022 at 12:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 20-May-2022, the patient experienced BLISTER (Developed a  few blisters on legs) and RASH PRURITIC (developed an itchy rash on right side of back--from waist to shoulder blade running diagonally toward spine). At the time of the report, BLISTER (Developed a  few blisters on legs) and RASH PRURITIC (developed an itchy rash on right side of back--from waist to shoulder blade running diagonally toward spine) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was in generally good health.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Reportedly, Events appeared on the first or second day of taking Paxlovid. They remains, though is not itchy, 12 days after starting Paxlovid and seven days after finishing it.  Treatment details was not reported by the reporter.  Pfizer have permission to contact them and also  have permission to contact the patient's healthcare provider about this report .  The device date was reported as 30-May-2022.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Rash macular, Vertigo
Clinical narrative: severe vertigo; constant dizziness; i trip down steps; severe skin blotches; The initial case was missing the following minimum criteria: ICH-Unspecified product. Upon receipt of follow-up information on (23May2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 20Nov2021 at 13:30 as dose 2, single (Lot number: FH8030) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Lot number/Expiry date: FF8891, Anatomical location: Left arm, Time the vaccination was given: 11: 00), administration date: 30Oct2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: FALL (non-serious) with onset 10Dec2021, outcome "not recovered", described as "i trip down steps"; RASH MACULAR (non-serious) with onset 10Dec2021, outcome "not recovered", described as "severe skin blotches"; DIZZINESS (non-serious) with onset 14Feb2022, outcome "not recovered", described as "constant dizziness"; VERTIGO (non-serious) with onset 14Feb2022, outcome "not recovered", described as "severe vertigo". Therapeutic measures were not taken as a result of vertigo, dizziness, fall, rash macular.  Additional Information: Did the reported issue occur after use of a Pfizer product: Yes. If surgical treatment needed for the event: Was the surgery planned prior to taking the product: No, No. It was reported that, patient never got covid. Wish I never got vaccine, I suffer constant dizziness, even in bed. I am afraid I will have an accident falling. I avoid all activity. I was a very active person, not now. Government told me it was tested, that was a lie.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Rebound of Covid after testing negative for 3 days after last dose of Paxlovid, tested positive again 21Apr; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: other medical istory Allergies; "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: 01Mar2022; CLARITIN ALLERGIC, start date: 01Mar2022. The following information was reported: COVID-19 (non-serious) with onset 21Apr2022, outcome "not recovered", described as "Rebound of Covid after testing negative for 3 days after last dose of Paxlovid, tested positive again 21Apr". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: My skin has hives; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Left arm, Manufacturer unknown), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 26Apr2022, outcome "unknown", described as "My skin has hives"; PRURITUS (non-serious) with onset 26Apr2022, outcome "unknown", described as "itching".  Additional information: No covid prior vaccination. No covid tested post vaccination.  The lot number for the vaccine BNT162b2 (COMIRNATY), was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Asthma" (unspecified if ongoing); "Known allergies: Drupes" (unspecified if ongoing), notes: drupes; "Known allergies: Pollen" (unspecified if ongoing), notes: pollen; "Known allergies: cat/dog dander" (unspecified if ongoing), notes: cat/dog dander. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical course: Rebound of Covid symptoms day 12 after taking Paxlovid. 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: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Aug2021 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information:The patient had no known allergies and other medical history.The patient did not receive other medications in two weeks. The patient was administered with Paxlovid for treatment of covid-19   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster) single (Lot number: FD0809) at the age of 37 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) positive, notes: home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received any Other medication in 2weeks, had no known allergies and no other medical history. Patient took Paxlovid for treatment of COVID-19 from 14May2022 to 19May2022. Took Paxlovid for 5 days and Covid symptoms resolved for three days and tested negative on day 5. Symptoms returned on day 9 with dark and fast line on at home test and positive on rapid test st doctor.
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 contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 81-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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient had Covid, but did not take Paxlovid.  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-202200749765 similar report from same reporter
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Started having cough and nasal congestion / runny nose approximately 6 days after my last day of the 5 day treatment course of paxlovid. Coughing a fair bit, every few minutes or so, and rhinorrhea.; Started having cough and nasal congestion / runny nose approximately 6 days after my last day of the 5 day treatment course of paxlovid. Coughing a fair bit, every few minutes or so, and rhinorrhea.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 19:00 as dose 1, single (Batch/Lot number: unknown), on 21Feb2021 at 16:00 as dose 2, single (Batch/Lot number: unknown) and on 26Sep2021 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 06Jun2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Kidney Disease" (unspecified if ongoing); "ESRD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE MOFETIL, start date: 08Nov2019; NULOJIX, start date: 08Nov2019; PREDNISONE, start date: 08Nov2019; NATURE'S BOUNTY IRON; WELLBUTRIN, start date: 12May2021. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Started having cough and nasal congestion / runny nose approximately 6 days after my last day of the 5 day treatment course of paxlovid. Coughing a fair bit, every few minutes or so, and rhinorrhea.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19.  Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand- Paxlovid by Pfizer, Treatment start date: 10May2022,Treatment stop date: 15May2022, Treatment Indication: Treatment of COVID-19. Adverse event: Started having cough and nasal congestion / runny nose approximately 6 days after my last day of the 5 day treatment course of paxlovid. Coughing a fair bit, every few minutes or so, and rhinorrhea.  The information on the batch/lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: I woke up with leg pain and very tired / Same reaction with 2nd vaccine; I woke up with leg pain and very tired / Same reaction with 2nd vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 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 Number: 1, Batch/Lot No: Unknown. don't have card on me at this time, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09Mar2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "I woke up with leg pain and very tired / Same reaction with 2nd vaccine".  Additional information: Patient Age group: Adult (18-64 Years). There were no other vaccine in four weeks and no Other medications in two weeks. The patient received the 1st booster on 20May at 4pm at her local drug store she was fine until 3am she woke up with leg pain and very tired. Went back to sleep throughout saturday she slept most of the day. Same reaction with 2nd vaccine. Late saturday after noon the back of her head became itchy and then itchy behind her ears. She took a antihistamine n put cream on. Sunday same thing happened. Monday at 4 am work up to a rash and itchy areas to her neck n chest. It was driving me crazy. She took another antihistamine and added more cream like she did on Saturday and Sunday. Monday called Dr. was seen at 330 pm yes allergic reaction. Never in her life have she had an allergic reaction and or rash. Dr. put her on steriod, Pepcid for her stomach because of steriods, Benedryl and cream. Have to see an allergist earliest appointment is Jul12. Again never a reaction to anything in her life. She have pictures from Monday morning.  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-202200751697 similar report from same reporter
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 18Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 22Oct2021 at 20:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes T1" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Heart" (unspecified if ongoing); "Back" (unspecified if ongoing). Concomitant medication(s) included: INSULIN. 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. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: No known allergies. The patient received other medications in 2 weeks are Insulin, many, medications for chronic illness. The patient was treated for COVID 19 with Paxlovid from 16May2022 to 22May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 65 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) and other medication in 2 weeks included: LOSARTAN; AMLODIPINE; OMEPRAZOLE; SUCRAFATE; GEMTESA; FINASTERIDE; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; B12 [CYANOCOBALAMIN]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (14May2022) Unknown results, notes: symptoms reoccurred. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 07May2022 to 11May2022. Four days after completing therapy, symptoms reoccurred on 14May2022.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 41.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9261), on 05Mar2021 as dose 2, single (Lot number: EL6199) and on 09Oct2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 41 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results; (10May2022) Negative, notes: I tested negative by the 4th day of taking it; (21May2022) Positive, notes: Had a rebound infection on 21May2022; (23May2022) Positive, notes: Still positive and symptomatic today on 23May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 07May2022 to 11May2022. Clinical course: The paxlovid seemed to work and patient tested negative by the 4th day (10May2022) of taking it. Had a rebound infection on 21May2022. Still positive and symptomatic today on 23May2022. No other medication were received in 2weeks. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I do have; the vaccine (Unspecified Vaccine) information and the adverse effect information (Unknown if consumer experienced any adverse effect after administration of vaccine); I do have; the vaccine (Unspecified Vaccine) information and the adverse effect information (Unknown if consumer experienced any adverse effect after administration of vaccine); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Intermittent Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I do have; the vaccine (Unspecified Vaccine) information and the adverse effect information (Unknown if consumer experienced any adverse effect after administration of vaccine)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Home quick view COVID-19 antigen test; Positive, notes: I started testing positive about day may be 9. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: I had a re-bound effect starting the Paxlovid, 10 days after taking the Paxlovid. I am very frustrated because over the weekend I filled out your form on your adverse event reporting on website and after filling out all the detail information you ask for which waste my 45 minutes, your website is crashed would not accept the submission. So, I captured a PDF of the filled out form so I would like to know where I can email it and get it in your system. When probed to spell first name, Consumer stated, "(withheld) (First name not appropriately clarified hence not captured in tab, initials clarified and captured as (withheld)). Reporter stated, "Whatever is in your packaging. Five days, twice a day and you take one pill and one there is two drugs, so each drug is one pill of single drug and all these two pills for the other drugs. Right. Consumer stated, So, the stop date was 09May. Actually, no its the 8, so that will be five days, 08May2022.  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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of covid-19; Treatment of covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 at 14:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing), notes: Note: Diabetes Type 2. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (14May2022) Positive; (18May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical significance : Reporter reported about covid vaccine received. No other medication taken in 2 weeks. Received paxlovid for covid 19 treatment as start date=14May2022, stop date=19May2022. Adverse event: Tested positive on Sat 14May, started Paxlovid that evening, symptoms were bad on Sat but cleared up Sunday. By Tuesday I felt pretty back to normal, just an occasional cough. Tested negative on Wednesday the 18th. Today Monday the 23rd I noticed a minor headache that would not go away and also felt some facial numbness. I took another test just in case and it came back positive. Patient had no known allergies.  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: Cardiac function test, Chest discomfort, Chest pain, Mitral valve incompetence, SARS-CoV-2 test
Clinical narrative: diagnosed with degenerative mitral regurgitation; I have had a tightness and pain in my chest since a week after my first dose; I have had a tightness and pain in my chest since a week after my first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEST DISCOMFORT (disability), CHEST PAIN (disability) all with onset 2021, outcome "not recovered" and all described as "I have had a tightness and pain in my chest since a week after my first dose"; MITRAL VALVE INCOMPETENCE (disability, medically significant) with onset 2021, outcome "not recovered", described as "diagnosed with degenerative mitral regurgitation". The events "diagnosed with degenerative mitral regurgitation" and "i have had a tightness and pain in my chest since a week after my first dose" required physician office visit. The patient underwent the following laboratory tests and procedures: Cardiac function test: (unspecified date) generative mitral regurgitation; SARS-CoV-2 test: (May2022) Negative. It was unknown if therapeutic measures were taken as a result of mitral valve incompetence, chest discomfort, chest pain.  Adverse event: Consumer have had a tightness and pain in his chest since a week after his first dose of the Pfizer covid vaccine. He finally got into a cardiologist where they ran tests and he was diagnosed with degenerative mitral regurgitation. The doctor confirmed he did not have it prior to getting the vaccine as he had many tests done on his heart in years prior due to service and it has always came back normal until this. AE resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
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 non-contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 05Jan2021 as dose 2, single (Lot number: EL3246), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: EW0185), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 11 days after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies. Patient received other medication in 2 weeks was Atorvastatin. Coivd-19 treatment with Paxlovid day 1-5 completed from 12May2022 to 15May2022. Rebound Covid-19 symptoms at day 12 on 23May2022 and was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Loss of personal independence in daily activities, Mental impairment
Clinical narrative: felt mentally "foggy"; very dizzy/light headed; disoriented; unable to operate his car; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 2; Moderna,), for Covid-19 immunization; Jnj covid vaccine (dose 1;JnJ,), for Covid-19 immunization. The following information was reported: MENTAL IMPAIRMENT (medically significant) with onset May2022, outcome "recovered" (May2022), described as "felt mentally "foggy""; DISORIENTATION (non-serious) with onset May2022, outcome "recovered" (May2022), described as "disoriented"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset May2022, outcome "unknown", described as "unable to operate his car"; DIZZINESS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "very dizzy/light headed". Therapeutic measures were not taken as a result of mental impairment, dizziness, disorientation.  Clinical course: Reporter stated that patient had second COVID booster (this one from Pfizer) last week. He recounted that, shortly after receiving the vaccine he very dizzy and light headed and was unable to operate his car. He recalled that he continued to feel this way for the rest of the day and that he felt mentally "foggy". In the next day he felt normal.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.