chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Increased upper airway secretion, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: 11/14/22  I had phlegm in the back of my throat like a post nasal drip.  It did not get any better or worse. When I woke up the next day, I still had phlegm in my throat. On 11/16/22 I tested positive and negative with a home COVID test. The pharmacist gave me Paxlovid without a prescription. Since I had 1 negative and 1 positive test, I was a little nervous to take it. I did another rapid test, and it was negative. I took a PCR test. I started taking the Paxlovid on 11/16/22.  On 11/18/22, my PCR test came back positive.  I continued the Paxlovid for 5 days.  I was fine and thought I was finished. I was doing home testing and was negative for COVID.  On 11/26/22, I woke up with cold symptoms. I had a runny nose and sneezing. I did a home COVID test, and it was positive. I was not getting any better after 5 days. The cold was much worse than the time before. I called my doctor. She told me there was nothing more I could do. She told me to take Tylenol, Mucinex and nose spray. Eventually, I tested negative, it took a long time.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sneezing
Clinical narrative: 11/14/22  I had phlegm in the back of my throat like a post nasal drip.  It did not get any better or worse. When I woke up the next day, I still had phlegm in my throat. On 11/16/22 I tested positive and negative with a home COVID test. The pharmacist gave me Paxlovid without a prescription. Since I had 1 negative and 1 positive test, I was a little nervous to take it. I did another rapid test, and it was negative. I took a PCR test. I started taking the Paxlovid on 11/16/22.  On 11/18/22, my PCR test came back positive.  I continued the Paxlovid for 5 days.  I was fine and thought I was finished. I was doing home testing and was negative for COVID.  On 11/26/22, I woke up with cold symptoms. I had a runny nose and sneezing. I did a home COVID test, and it was positive. I was not getting any better after 5 days. The cold was much worse than the time before. I called my doctor. She told me there was nothing more I could do. She told me to take Tylenol, Mucinex and nose spray. Eventually, I tested negative, it took a long time.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; A patient received a PROQUAD on 15AUG2016 that their system is calling an "invalid dose". The HCP did not have an expiration date for the PROQUAD, and is not sure if the product was actually expired or not; This spontaneous report was received from a nurse referring to a 4-year-old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.   On 15-AUG-2016, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (human serum albumin) (PROQUAD) 0.5 cubic centimeters (cc) administered subcutaneously in his left thigh, as prophylaxis (lot number L004004 has been verified to be valid, expiration date was not reported but upon internal verification was established as 05-AUG-2016) (expired product administered).  Additionally, it was stated that the reporter was asked by the school nurse to investigate the dose given, however, in the facility the reporter was told that the patient was not theirs. They did not give the dose and did not have the paper record to check the appointment date (conflicting information). No adverse event was reported.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Product storage error
Clinical narrative: Customer called for a temperature excursion and reported VAQTA and MMR II that had undergone temperature excursion were administered to patients before calling Agency. No additional AE reported. No PQC reported. No further information was provided.; No additional AE reported. No PQC reported. No further information was provided.; This spontaneous report was received from a medical assistant concerning to an unspecified number of patients of unspecified ages and genders. They're, medical history, historical drugs, known allergies,, concurrent conditions and concomitant therapies were not reported.  On an unspecified dates, the were vaccinated with doses of hepatitis a vaccine, inactivated (VAQTA) lot #W017343 (expiration date: 13-DEC-2023); and measles, mumps, and rubella (Wistar ra 27-3) virus vaccine, live human recombinant albumin (rHA) (M-M-R II) lot##W012118 (expiration date: 24-DEC-2023) that upon internal review was confirmed to be a valid lot# for measles, mumps, and rubella (Wistar ra 27-3) virus vaccine, live human recombinant albumin (rHA) (M-M-R II) both administered for prophylaxis (strengths, doses, frequencies, and routes of administration were not provided) that had gone trough a temperature excursion at 24 degrees Fahrenheit [F]) during 14 hours (Improper storage of product in use), no previous temperature excursion had occurred and further information was not provided.  This case is non-valid due to the lack of patient identifiers.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: It definitely packed a punch for me. I'm over the side effect; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (It definitely packed a punch for me. I'm over the side effect) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 21-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (It definitely packed a punch for me. I'm over the side effect). At the time of the report, IMMUNISATION REACTION (It definitely packed a punch for me. I'm over the side effect) had resolved.            No concomitant medication details was reported.  No treatment medication details was reported.
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Chills, Fatigue, Hyperkeratosis, Myalgia, Sciatica
Clinical narrative: UTI; Mortons calluses on her right foot; Sciatic issues; tiredness; she had a reaction to it with chills; everything hurt; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), HYPERKERATOSIS (Mortons calluses on her right foot), SCIATICA (Sciatic issues), MYALGIA (everything hurt) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    Concurrent medical conditions included Endometrial cancer.   On 19-May-2022, the patient LENVATINIB MESILATE (LENVIMA) (unknown route) dosage was changed to 14 milligram. On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 10 milligram. In October 2022, the patient experienced MYALGIA (everything hurt) and CHILLS (she had a reaction to it with chills). In November 2022, the patient experienced FATIGUE (tiredness). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI), HYPERKERATOSIS (Mortons calluses on her right foot) and SCIATICA (Sciatic issues). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for UTI, at an unspecified dose and frequency. In October 2022, MYALGIA (everything hurt) and CHILLS (she had a reaction to it with chills) had resolved. In December 2022, SCIATICA (Sciatic issues) had resolved. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown and HYPERKERATOSIS (Mortons calluses on her right foot) and FATIGUE (tiredness) had resolved.            The concomitant medication was not reported.  Patient stated she might be starting to have another episode of urinary track infection. The sciatic issue remained for 2.5 months and went away. The patient had three Mortons calluses on the right foot which a podiatrist carved. Applied urea cream which helped.
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Urinary tract infection
Clinical narrative: UTI; Mortons calluses on her right foot; Sciatic issues; tiredness; she had a reaction to it with chills; everything hurt; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), HYPERKERATOSIS (Mortons calluses on her right foot), SCIATICA (Sciatic issues), MYALGIA (everything hurt) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    Concurrent medical conditions included Endometrial cancer.   On 19-May-2022, the patient LENVATINIB MESILATE (LENVIMA) (unknown route) dosage was changed to 14 milligram. On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 10 milligram. In October 2022, the patient experienced MYALGIA (everything hurt) and CHILLS (she had a reaction to it with chills). In November 2022, the patient experienced FATIGUE (tiredness). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI), HYPERKERATOSIS (Mortons calluses on her right foot) and SCIATICA (Sciatic issues). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for UTI, at an unspecified dose and frequency. In October 2022, MYALGIA (everything hurt) and CHILLS (she had a reaction to it with chills) had resolved. In December 2022, SCIATICA (Sciatic issues) had resolved. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown and HYPERKERATOSIS (Mortons calluses on her right foot) and FATIGUE (tiredness) had resolved.            The concomitant medication was not reported.  Patient stated she might be starting to have another episode of urinary track infection. The sciatic issue remained for 2.5 months and went away. The patient had three Mortons calluses on the right foot which a podiatrist carved. Applied urea cream which helped.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: she had a reaction to all 4 Moderna COVID-19 vaccines that she received.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (she had a reaction to all 4 Moderna COVID-19 vaccines that she received.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had a reaction to all 4 Moderna COVID-19 vaccines that she received.). At the time of the report, IMMUNISATION REACTION (she had a reaction to all 4 Moderna COVID-19 vaccines that she received.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient had a reaction to all 4 Moderna COVID-19 vaccines.  It was reported that patient did not receive any other vaccine in the 4 weeks prior to COVID-19 vaccine. No treatment medication was provided.   This case was linked (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: mild tired feeling in the shoulder/some tiredness at night; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild tired feeling in the shoulder/some tiredness at night) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Prostate infection.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (mild tired feeling in the shoulder/some tiredness at night). At the time of the report, FATIGUE (mild tired feeling in the shoulder/some tiredness at night) outcome was unknown. Not Provided          No concomitant product reported by reporter. No treatment medication reported by reporter.    This case was linked (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; inadvertently administered with a dose of 0.5 mL of the primary series of Moderna COVID-19 Vaccine instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (inadvertently administered with a dose of 0.5 mL of the primary series of Moderna COVID-19 Vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No Adverse Event) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently administered with a dose of 0.5 mL of the primary series of Moderna COVID-19 Vaccine instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (inadvertently administered with a dose of 0.5 mL of the primary series of Moderna COVID-19 Vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (inadvertently administered with a dose of 0.5 mL of the primary series of Moderna COVID-19 Vaccine instead of the bivalent booster).    No concomitant medications were reported. Patient was not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The reporter does not have information on the previous doses given to this patient. No treatment medications were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: gastro problems; This spontaneous case was reported by a patient and describes the occurrence of GASTROINTESTINAL DISORDER (gastro problems) in a 74-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (gastro problems). At the time of the report, GASTROINTESTINAL DISORDER (gastro problems) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient explained that he was super fit and had done sports all his life. People won't believe him when he told them he was 74.  No treatment medications were reported.   This case was linked (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 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), 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: "Polycystic Ovarian Syndrome" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "History of stroke" (unspecified if ongoing); "Environmental allergies/asthma" (unspecified if ongoing); "Environmental allergies/asthma" (unspecified if ongoing); "Known allergies: Amoxicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METOPROLOL; ASPIRIN [ACETYLSALICYLIC ACID]; METFORMIN; ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]; LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Sex: F
Vaccine: PNC13
Symptoms: Asthma
Clinical narrative: has asthma (unclear of timeline); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine (PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE]), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumovax 23, administration date: 2012, for IMMUNIZATION. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "has asthma (unclear of timeline)".  Additional information: Patient recently had pneumovax 23 about 9 months ago which was she thinks the 3rd time she would have received it in her lifetime (2012 and 2022). States she had prevnar 13, 7 years. She was 76 yrs of age and has asthma (unclear of timeline). She discussed it with her hcp who thought maybe should have pcv 20.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 12.0
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 13-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 11Sep2021 as dose 2, single (Lot number: FD8448) at the age of 12 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. 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 "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (19Dec2022) positive, notes: tested positive on 19Dec after taking Paxlovid for a previous case on 30Nov. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She had COVID 19 symptoms again & tested positive on 19Dec after taking Paxlovid for a previous case on 30Nov.Known allergies: No, Other medical history: No, Other medication in 2weeks: No.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood albumin, COVID-19, Condition aggravated, Drug ineffective
Clinical narrative: mild COVID-19 infection; mild COVID-19 infection; asymptomatic GH (gross hematuria)/ sub-nephrotic range proteinuria (SNRP); IgA Nephropathy; This is a literature report for the following literature source(s): A 23-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization, reaction(s): "mild COVID-19 infection", "IgA Nephropathy Following mRNA COVID-19 Vaccine", "mild COVID-19 infection". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mild COVID-19 infection"; CONDITION AGGRAVATED (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "asymptomatic GH (gross hematuria)/ sub-nephrotic range proteinuria (SNRP)"; IGA NEPHROPATHY (medically significant), 2 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy kidney: showed IgAN; Blood albumin: normal; Oxford MEST-C score: M1E0S1T0C0; Microscopy: continued to have persistent, notes: microscopic hematuria; Protein urine: continued to have subnephrotic proteinuria; Red blood cells urine: dysmorphic; Renal function test: normal; Rheumatological examination: Negative; Urinary casts: rare; Urine analysis: revealed proteinuria, dysmorphic red blood cells,, notes: and rare granular casts; Urine protein/creatinine ratio: 14, notes: Unit: g/g; 976, notes: Unit: mg/24h; 2063, notes: Unit: mg/24h.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug 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.,Linked Report(s) : PFIZER INC-PV202200130613 Same article/event/drug/patient (Dose 1);
Sex: F
Vaccine: COVID19
Symptoms: IgA nephropathy, Investigation, Microscopy, Protein urine, Red blood cells urine
Clinical narrative: mild COVID-19 infection; mild COVID-19 infection; asymptomatic GH (gross hematuria)/ sub-nephrotic range proteinuria (SNRP); IgA Nephropathy; This is a literature report for the following literature source(s): A 23-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization, reaction(s): "mild COVID-19 infection", "IgA Nephropathy Following mRNA COVID-19 Vaccine", "mild COVID-19 infection". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mild COVID-19 infection"; CONDITION AGGRAVATED (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "asymptomatic GH (gross hematuria)/ sub-nephrotic range proteinuria (SNRP)"; IGA NEPHROPATHY (medically significant), 2 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy kidney: showed IgAN; Blood albumin: normal; Oxford MEST-C score: M1E0S1T0C0; Microscopy: continued to have persistent, notes: microscopic hematuria; Protein urine: continued to have subnephrotic proteinuria; Red blood cells urine: dysmorphic; Renal function test: normal; Rheumatological examination: Negative; Urinary casts: rare; Urine analysis: revealed proteinuria, dysmorphic red blood cells,, notes: and rare granular casts; Urine protein/creatinine ratio: 14, notes: Unit: g/g; 976, notes: Unit: mg/24h; 2063, notes: Unit: mg/24h.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug 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.,Linked Report(s) : PFIZER INC-PV202200130613 Same article/event/drug/patient (Dose 1);
Sex: F
Vaccine: COVID19
Symptoms: Renal function test, Rheumatological examination, Urinary casts, Urine analysis, Urine protein/creatinine ratio
Clinical narrative: mild COVID-19 infection; mild COVID-19 infection; asymptomatic GH (gross hematuria)/ sub-nephrotic range proteinuria (SNRP); IgA Nephropathy; This is a literature report for the following literature source(s): A 23-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization, reaction(s): "mild COVID-19 infection", "IgA Nephropathy Following mRNA COVID-19 Vaccine", "mild COVID-19 infection". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mild COVID-19 infection"; CONDITION AGGRAVATED (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "asymptomatic GH (gross hematuria)/ sub-nephrotic range proteinuria (SNRP)"; IGA NEPHROPATHY (medically significant), 2 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy kidney: showed IgAN; Blood albumin: normal; Oxford MEST-C score: M1E0S1T0C0; Microscopy: continued to have persistent, notes: microscopic hematuria; Protein urine: continued to have subnephrotic proteinuria; Red blood cells urine: dysmorphic; Renal function test: normal; Rheumatological examination: Negative; Urinary casts: rare; Urine analysis: revealed proteinuria, dysmorphic red blood cells,, notes: and rare granular casts; Urine protein/creatinine ratio: 14, notes: Unit: g/g; 976, notes: Unit: mg/24h; 2063, notes: Unit: mg/24h.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug 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.,Linked Report(s) : PFIZER INC-PV202200130613 Same article/event/drug/patient (Dose 1);
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm was moderately sore throughout the day yesterday; This is a spontaneous report received from non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing). Concomitant medication(s) included: SYNTHROID; OMEPRAZOLE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Dec2022, outcome "recovering", described as "left arm was moderately sore throughout the day yesterday". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  Additional information: The patient has no reported allergies. The patient did not receive any other vaccines within 4 weeks prior vaccination. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain
Clinical narrative: Soreness on right side of throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Dec2022 at 12:00 as dose 5 (booster), single (Lot number: GJ6743, Expiration Date: 31Jan2024) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). Concomitant medication(s) included: MAXZIDE taken for hypertension. Vaccination history included: BNT162b2 (Lot number: EW0156 as dose 1, single), administration date: 09Mar2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Lot number: EW6207 as dose 2, single), administration date: 30Mar2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Lot number: EW0217, Exp Date: 21Dec2021 as dose 3 (booster), single), administration date: 26Oct2021, when the patient was 62-year-old, for COVID-19 Immunization; Bnt162b2 (Lot number: FN2908, Exp Date: 21Jun2022 as dose 4 (booster), single, ), for COVID-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 22Dec2022, outcome "recovered" (Dec2022), described as "Soreness on right side of throat". Therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: Patient was calling to report side effects she had from Pfizer booster which was sore throat, it was only on one side of her throat. It is not with her first shot, the third one (booster), she mentioned she have gotten every shots (unspecified Booster). It was soreness on right side of her throat, the day after she got her shot (yesterday's evening, 22Dec2022) and she got her shot on Wednesday afternoon (21Dec2022). It was reported that she took some paracetamol (TYLENOL) the day before.
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Nov2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Morbid Obesity" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient reported positive COVID antigen test seven days after completing five day Paxlovid regimen. He was currently experiencing mild COVID symptoms, no other medical attention / treatment sought at this time. Plan was to use OTC medication to treat symptoms and isolate 5 days at this time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
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) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "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, notes: Treatment of COVID-19; (Dec2022) Positive, notes: positive test day 10; (Dec2022) Negative, notes: tested negative/ resolved symptoms starting at day 7. 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. Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pcos" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Dec2022 to 18Dec2022.  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: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Second dose, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Third dose, unknown manufacturer), for COVID-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 25Dec2022, outcome "recovering", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Post the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: I have lost 50 pounds or something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 14May2021 as dose 1, single (Lot number: ER8736) at the age of 46 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "mental health reasons" (unspecified if ongoing), notes: I take medications for mental health reasons. The patient took concomitant medications. The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "I have lost 50 pounds or something". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of weight decreased.  Additional information:It was reported that patient had an adverse reaction to the first vaccine. Patinet just wanted to make sure, patient was just wondering patient could have the list of ingredients just to make sure if she can go for my medical person. patient  would just like to know about the ingredients because patient might be having an adverse reaction.Consumer was informed the role of Pfizer Drug Safety and when probed to proceed with question .consumer stated, "Of course, was there any way you might be able to help patient with the ingredient patient would like to know tonight because patient going. patient just want to make sure patient not allergic to anything that is all". Consumer stated, "195, patient  have lost 50 pounds or something." Concomitant Products Consumer stated, " patient take medications for mental health reasons, mental health medications"(Further not clarified). Consumer stated, no treatment received. NDC and UPC number of COVID -19 vaccine was Unknown
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash
Clinical narrative: rash in her biceps; some allergic reactions to the vaccine to her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (ongoing); "lymphoma" (ongoing); "leukemia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "allergic reactions to the vaccine", "rash". The following information was reported: RASH (non-serious), outcome "unknown", described as "rash in her biceps"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "some allergic reactions to the vaccine to her arm".  Clinical information: Caller is a cancer patient with lymphoma and leukemia. Her oncologist is recommending cancer patients to get the Pfizer Bivalent Vaccine. Caller wants to know if it's okay for her to take it. She wants to know more medical information about the vaccine. She had her 2 shots vaccine from Pfizer and she had some allergic reactions to the vaccine to her arm. Resolution -1st and Last name phone number Gathered -Read ISI -Provided PMI Phone Number and HOO -Created. Manual AE Form since the caller mentioned that she had a rash in her biceps.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oral herpes, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: low grade fever; sore throat; Rash; headache; cold sore outbreak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: 7J8762) at the age of 29 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hodgkin's Lymphoma", start date: 01Oct2013, stop date: 01May2014; "ABVD treatment" (unspecified if ongoing), notes: ABVD treatment, 6 cycles; "Biopsy surgery", start date: Oct2013 (unspecified if ongoing); "port-a-cath surgery", start date: Oct2013 (unspecified if ongoing); "port-a-cath surgery", start date: May2014 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 2nd, Anatomical Site of injection: Left arm, Route of administration: Intramuscular (checked), Batch/Lot number: Pfizer ER8734), administration date: 07Apr2021, when the patient was 29-year-old, for COVID-19 immunization; BNT162b2 (Dose: 1st, Anatomical Site of injection: Left arm, Route of administration: Intramuscular (checked), Batch/Lot number: Pfizer EN6207), administration date: 11Mar2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 11May2022, outcome "recovering"; ORAL HERPES (non-serious) with onset 11May2022, outcome "recovering", described as "cold sore outbreak"; HEADACHE (non-serious) with onset 11May2022, outcome "recovering"; OROPHARYNGEAL PAIN (non-serious) with onset 12May2022, outcome "recovering", described as "sore throat"; PYREXIA (non-serious) with onset 13May2022, outcome "recovering", described as "low grade fever". Therapeutic measures were taken as a result of rash, headache, oral herpes, oropharyngeal pain, pyrexia.; Sender's Comments: Linked Report(s) :PFIZER INC-202200715001 same reporter, patient and suspect drug/different dose (3rd dose) and AE;
Sex: F
Vaccine: FLUX
Symptoms: Dehydration, Gait inability, Illness, Influenza
Clinical narrative: had the flu shot and then got the flu; severe dehydration; Could not walk; been sick for 4 weeks; Initial information received  on 25-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case is linked to case 2022SA521395.  This case involves an unknown age Female patient who had the flu shot and then got the flu, severe dehydration, could not walk and been sick for 4 weeks while receiving vaccine Influenza Vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, dose, strength, form was not reported) not reported via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a serious had the flu shot and then got the flu (influenza) (unknown latency) following the administration of Influenza Vaccine. The patient was hospitalized for this event. On an unknown date the patient developed a non-serious severe dehydration (dehydration), could not walk (gait inability) and been sick for 4 weeks (illness) (unknown latency) following the administration of Influenza Vaccine.  The lab data was not reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.   At time of reporting, the outcome was Recovered / Resolved on an unknown date for the events.; Sender's Comments: Sanofi company comment for information received on 27-Dec-2022: This case involves an unknown age Female patient who had the flu shot and then got the flu, severe dehydration, could not walk and been sick for 4 weeks while receiving vaccine Influenza Vaccine. Further information regarding medical history, concurrent condition during vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: have the flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who had the flu after receiving vaccine Influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 05-Oct-2022, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, expiry date, strength, form and dose not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient have the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 23-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer.  This case involves an unknown age and unknown gender patient who got the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, route, administration site, strength, lot number, expiry date: not reported) for prophylactic vaccination.  On an unknown date the patient had a non-serious event of got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported: Got my flu shot. Also got the flu  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event got the flu.