chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Unevaluable event
Clinical narrative: No adverse event; Vaccine administered after beyond use date; Patient administered 0.2 ml of moderna booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date), UNDERDOSE (Patient administered 0.2 ml of moderna booster dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     Patient had no known allergies.     On 14-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and UNDERDOSE (Patient administered 0.2 ml of moderna booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date), UNDERDOSE (Patient administered 0.2 ml of moderna booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.0.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient administered 0.2 ml of moderna booster dose).    Concomitant Medication use information was not provided by reporter.  The patient was not ever been diagnosed with/ tested positive for COVID-19.  Patient had no acute illnesses at the time of vaccination and up to one month before.  Patient had no chronic or long-standing health conditions.  Prescriptions, over the counter medications, dietary supplements or herbal remedies was not being taken by the patient at the time of vaccination and/or at the time of adverse event.  Treatment Medication use information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2023: Updated report type, added reporter information, patient demographics, suspect product dose details, new events (Expired vaccine used and vaccine underdose) and updated narrative.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 4 patients received expired Moderna Bivalent Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Bivalent Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2023, 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 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Bivalent Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Bivalent Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Bivalent Covid-19 vaccine).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732790, US-MODERNATX, INC.-MOD-2023-732792, US-MODERNATX, INC.-MOD-2023-733320, US-MODERNATX, INC.-MOD-2023-733325, US-MODERNATX, INC.-MOD-2023-733328 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732790:Monovalent dose patient 5 US-MODERNATX, INC.-MOD-2023-732792:Bivalent dose patient 5 US-MODERNATX, INC.-MOD-2023-733328:Patient 2 US-MODERNATX, INC.-MOD-2023-733325:Patient 3 US-MODERNATX, INC.-MOD-2023-733320:Patient 4
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine).    Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 07-JUL-2023. Vial size was reported as 2.5 ml. Dosage text was reported as unknown. Vial did not undergo any temperature excursion. Treatment details was not reported by the reporter. This case contains information about patient 1 out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-732779, US-MODERNATX, INC.-MOD-2023-732776, US-MODERNATX, INC.-MOD-2023-732777, US-MODERNATX, INC.-MOD-2023-732778 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732779:case for Patient 5 US-MODERNATX, INC.-MOD-2023-732776:case for Patient 2 US-MODERNATX, INC.-MOD-2023-732777:case for Patient 3 US-MODERNATX, INC.-MOD-2023-732778:case for Patient 4
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, No adverse event
Clinical narrative: Circumstance or information capable of leading to medication error; no adverse event; another patient who had been administered but HCP is still verifying; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (another patient who had been administered but HCP is still verifying), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (no adverse event) 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)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (another patient who had been administered but HCP is still verifying). On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (another patient who had been administered but HCP is still verifying), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (another patient who had been administered but HCP is still verifying) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant medication was reported.  The date vial was first puncture on 10-JUL-2023. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-733054 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733054:Same reporter, Same product, Same Batch lot/number
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Depression, Lymphadenopathy, Mental disorder
Clinical narrative: chest pain; arm pain; sinus infection; anxiety; depression; panic attacks; severe mental illness; enlarged lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), PAIN IN EXTREMITY (arm pain), SINUSITIS (sinus infection), ANXIETY (anxiety) and DEPRESSION (depression) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ear infection, Throat infection and Hives.   On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced CHEST PAIN (chest pain), PAIN IN EXTREMITY (arm pain), SINUSITIS (sinus infection), ANXIETY (anxiety), DEPRESSION (depression), PANIC ATTACK (panic attacks), MENTAL DISORDER (severe mental illness) and LYMPHADENOPATHY (enlarged lymph nodes). At the time of the report, CHEST PAIN (chest pain), PAIN IN EXTREMITY (arm pain), SINUSITIS (sinus infection), ANXIETY (anxiety), DEPRESSION (depression), PANIC ATTACK (panic attacks), MENTAL DISORDER (severe mental illness) and LYMPHADENOPATHY (enlarged lymph nodes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Chest pain arm pain and sinus infection for 1 year straight with 2 sinus surgeries enlarged lymph nodes increased anxiety and depression panic attacks severe mental illness It was unknown if the patient experienced any additional symptoms/events. Patient was on antibiotics and steroids. Lab data was not reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Panic attack, Sinusitis
Clinical narrative: chest pain; arm pain; sinus infection; anxiety; depression; panic attacks; severe mental illness; enlarged lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), PAIN IN EXTREMITY (arm pain), SINUSITIS (sinus infection), ANXIETY (anxiety) and DEPRESSION (depression) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ear infection, Throat infection and Hives.   On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced CHEST PAIN (chest pain), PAIN IN EXTREMITY (arm pain), SINUSITIS (sinus infection), ANXIETY (anxiety), DEPRESSION (depression), PANIC ATTACK (panic attacks), MENTAL DISORDER (severe mental illness) and LYMPHADENOPATHY (enlarged lymph nodes). At the time of the report, CHEST PAIN (chest pain), PAIN IN EXTREMITY (arm pain), SINUSITIS (sinus infection), ANXIETY (anxiety), DEPRESSION (depression), PANIC ATTACK (panic attacks), MENTAL DISORDER (severe mental illness) and LYMPHADENOPATHY (enlarged lymph nodes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Chest pain arm pain and sinus infection for 1 year straight with 2 sinus surgeries enlarged lymph nodes increased anxiety and depression panic attacks severe mental illness It was unknown if the patient experienced any additional symptoms/events. Patient was on antibiotics and steroids. Lab data was not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP advised that her office administered a vaccine that expired prior to vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine that expired prior to vaccination) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension.    On 29-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine that expired prior to vaccination). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine that expired prior to vaccination) and NO ADVERSE EVENT (No adverse event) outcome 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 EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine that expired prior to vaccination).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   Treatment medication not reported.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient has received an additional 5 shots of the Moderna COVID-19 vaccine, including a Moderna COVID-19 bivalent vaccine approximately 7.5 months ago; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient has received an additional 5 shots of the Moderna COVID-19 vaccine, including a Moderna COVID-19 bivalent vaccine approximately 7.5 months ago) and NO ADVERSE EVENT (No adverse event) in a 6-decade-old male patient 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 COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Additional 4 shots of the Moderna) and Moderna COVID-19 Vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    In January 2023, the patient received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced EXTRA DOSE ADMINISTERED (Patient has received an additional 5 shots of the Moderna COVID-19 vaccine, including a Moderna COVID-19 bivalent vaccine approximately 7.5 months ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient has received an additional 5 shots of the Moderna COVID-19 vaccine, including a Moderna COVID-19 bivalent vaccine approximately 7.5 months ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient has received an additional 5 shots of the Moderna COVID-19 vaccine, including a Moderna COVID-19 bivalent vaccine approximately 7.5 months ago).    No concomitant medication was reported.  Patient said that were getting all those shots like clockwork, every few months. He said that he was in his 50s and was a healthy individual. He wanted to know if having 7 shots so far was enough and did he need to get the next one that he has been asked to get. No treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Administered vaccine to a patient on 11JUN2023 after the published expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine to a patient on 11JUN2023 after the published expiration date) and NO ADVERSE EVENT (no adverse event) 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.     No Medical History information was reported.    On 11-Jun-2023, 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 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine to a patient on 11JUN2023 after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine to a patient on 11JUN2023 after the published expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered vaccine to a patient on 11JUN2023 after the published expiration date).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 0.75
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; child that received an incorrect dose/dark pink cap of 0.25 ml but instead received the dark pink cap 0.2 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (child that received an incorrect dose/dark pink cap of 0.25 ml but instead received the dark pink cap 0.2 ml) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Seizures and Stroke (neonatal strokes). Concurrent medical conditions included Developmental delay.    On 12-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 12-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (child that received an incorrect dose/dark pink cap of 0.25 ml but instead received the dark pink cap 0.2 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (child that received an incorrect dose/dark pink cap of 0.25 ml but instead received the dark pink cap 0.2 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (child that received an incorrect dose/dark pink cap of 0.25 ml but instead received the dark pink cap 0.2 ml).    No concomitant medication was reported.  No treatment information was reported.
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Infantile diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 20-month-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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFANTILE DIARRHOEA (medically significant), outcome "unknown", described as "Diarrhea". After getting pneumococcal 13-val conj vac (dipht CRM197 protein), the patient had been having diarrhea for 2 weeks. The reporter was requesting for reporting of diarrhea and further information on how long it typically lasted to provide reassurance to the mother if it was completely off or related to the vaccine.  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.; Sender's Comments: Based on the temporal relationship, the association between the event "diarrhea for 2 weeks" with PREVNAR 13 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick for a whole two years after the COVID shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male 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: Covid-19 vaccine (DOSE 1; MANUFCTURER UNKNOWN, Lot number and expiration date not provided.), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick for a whole two years after the COVID shot".  Additional Information: The reporter's son got his second COVID shot and got sick and had reported adverse side effects. Reporter had turned in all the paperwork, and needed to know what can be done for reimbursement to the son for being sick for a whole two years after the COVID shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sour Throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Covid-19 vaccine (Dose 1; manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2; manufacturer unknown), for Covid-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sour Throat". The event "sour throat" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain.  Additional information: It was reported that patient did not had covid prior vaccination. Patient tested for covid post vaccination. No Known allergies was reported. No other medical history.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness
Clinical narrative: had awful chills all night; flu like headache; flu like headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (COMIRNATY), on 09Jan2021 as dose 1, single (Lot number: EL3247) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "sensitive to drugs" (unspecified if ongoing), notes: She is sensitive to drugs; "cholesterol" (unspecified if ongoing), notes: her cholesterol medication they have her on. The patient took concomitant medications. Past drug history included: Benadryl, reaction(s): "allergic to Benadryl". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), HEADACHE (non-serious) all with onset 09Jan2021, outcome "recovered" (11Jan2021) and all described as "flu like headache"; CHILLS (non-serious) with onset 09Jan2021, outcome "recovered" (11Jan2021), described as "had awful chills all night". Additional information: Within 10 minutes, the patient had awful chills all night. She also had flu like headache and all that type for 3 days. Trying to contact primary doctor and didn't hear so scheduled 2nd one. She had the 2 main vaccines of Pfizer.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250669 Same patient/product; different dose/events;US-PFIZER INC-202300250670 Same patient/product; different dose/events;
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "Penicillin allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 07Jul2023 to 12Jul2023.  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: Linked Report(s) : US-PFIZER INC-202300250507 same patient/reporter, different drug/AE;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Blood pressure measurement, Blood pressure systolic increased, Chills, Face oedema
Clinical narrative: has covid; has covid; She had to switch to Moderna vaccines for the boosters; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EL3247), in right arm and on 09Feb2021 as dose 2, single (Lot number: EM9810) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 939903), in right arm, on 01Jun2022 as dose 4 (booster), single (Lot number: 054222A), in right arm and on 22Oct2022 as dose 5 (booster), single (Lot number: 0171422A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "sensitive to drugs" (unspecified if ongoing), notes: She is sensitive to drugs.; "cholesterol" (unspecified if ongoing), notes: her cholesterol medication they have her on. The patient took concomitant medications. Past drug history included: Benadryl, reaction(s): "allergic to Benadryl", notes: She is allergic to Benadryl.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "unknown", described as "She had to switch to Moderna vaccines for the boosters"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2023, outcome "not recovered" and all described as "has covid". The patient underwent the following laboratory tests and procedures: tested for flu: (unspecified date) Unknown results; (unspecified date) Unknown results; SARS-CoV-2 test: (02Jan2023) positive, notes: on 02Jan2023 a NP called and told her she was positive for Covid; (12Jul2023) positive, notes: 12Jul2023 tested positive for Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250650 same patient, different vaccine dose/AE;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Lip swelling, Neurological examination, Palpitations, Paraesthesia
Clinical narrative: has covid; has covid; She had to switch to Moderna vaccines for the boosters; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EL3247), in right arm and on 09Feb2021 as dose 2, single (Lot number: EM9810) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 939903), in right arm, on 01Jun2022 as dose 4 (booster), single (Lot number: 054222A), in right arm and on 22Oct2022 as dose 5 (booster), single (Lot number: 0171422A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "sensitive to drugs" (unspecified if ongoing), notes: She is sensitive to drugs.; "cholesterol" (unspecified if ongoing), notes: her cholesterol medication they have her on. The patient took concomitant medications. Past drug history included: Benadryl, reaction(s): "allergic to Benadryl", notes: She is allergic to Benadryl.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "unknown", described as "She had to switch to Moderna vaccines for the boosters"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2023, outcome "not recovered" and all described as "has covid". The patient underwent the following laboratory tests and procedures: tested for flu: (unspecified date) Unknown results; (unspecified date) Unknown results; SARS-CoV-2 test: (02Jan2023) positive, notes: on 02Jan2023 a NP called and told her she was positive for Covid; (12Jul2023) positive, notes: 12Jul2023 tested positive for Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250650 same patient, different vaccine dose/AE;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, Investigation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: has covid; has covid; She had to switch to Moderna vaccines for the boosters; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EL3247), in right arm and on 09Feb2021 as dose 2, single (Lot number: EM9810) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 939903), in right arm, on 01Jun2022 as dose 4 (booster), single (Lot number: 054222A), in right arm and on 22Oct2022 as dose 5 (booster), single (Lot number: 0171422A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "sensitive to drugs" (unspecified if ongoing), notes: She is sensitive to drugs.; "cholesterol" (unspecified if ongoing), notes: her cholesterol medication they have her on. The patient took concomitant medications. Past drug history included: Benadryl, reaction(s): "allergic to Benadryl", notes: She is allergic to Benadryl.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "unknown", described as "She had to switch to Moderna vaccines for the boosters"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2023, outcome "not recovered" and all described as "has covid". The patient underwent the following laboratory tests and procedures: tested for flu: (unspecified date) Unknown results; (unspecified date) Unknown results; SARS-CoV-2 test: (02Jan2023) positive, notes: on 02Jan2023 a NP called and told her she was positive for Covid; (12Jul2023) positive, notes: 12Jul2023 tested positive for Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250650 same patient, different vaccine dose/AE;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Investigation, SARS-CoV-2 test
Clinical narrative: has covid; has covid; She had to switch to Moderna vaccines for the boosters; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EL3247), in right arm and on 09Feb2021 as dose 2, single (Lot number: EM9810) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 939903), in right arm, on 01Jun2022 as dose 4 (booster), single (Lot number: 054222A), in right arm and on 22Oct2022 as dose 5 (booster), single (Lot number: 0171422A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "sensitive to drugs" (unspecified if ongoing), notes: She is sensitive to drugs.; "cholesterol" (unspecified if ongoing), notes: her cholesterol medication they have her on. The patient took concomitant medications. Past drug history included: Benadryl, reaction(s): "allergic to Benadryl", notes: She is allergic to Benadryl.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "unknown", described as "She had to switch to Moderna vaccines for the boosters"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2023, outcome "not recovered" and all described as "has covid". The patient underwent the following laboratory tests and procedures: tested for flu: (unspecified date) Unknown results; (unspecified date) Unknown results; SARS-CoV-2 test: (02Jan2023) positive, notes: on 02Jan2023 a NP called and told her she was positive for Covid; (12Jul2023) positive, notes: 12Jul2023 tested positive for Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250650 same patient, different vaccine dose/AE;
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: had COVID in Jul2022; had COVID in Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8733), on 19Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: Alcohol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "had COVID in Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (12Jun2023) Negative, notes: Blood test; (03Jul2023) Negative, notes: Blood test; (12Jun2023) Negative, notes: Blood test; (03Jul2023) Negative, notes: Blood test. Clinical course included that patient had also received BNT162b2 (BNT162B2), on 25Oct2022 as dose 4 (booster), single (Lot number: GH9703) in left arm, on 09May2023 as dose 5 (booster), single (Lot number: FJ4991), in left arm for COVID- 19 immunisation.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; 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 01Apr2021 as dose 1, single (Lot number: ER7832) and on 24Apr2021 as dose 2, single (Lot number: ER8735) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Lot number: 076C21A) for covid-19 immunisation. The patient's relevant medical history included: "iron deficiency anemia" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Dec2021, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, latency 15 days after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 29Jun2023 to 04Jul2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250763 same reporter/patient, different drug/event;
Age: 29.0
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) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 29 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), 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: "Pituitary surgeries" (not ongoing); "hypopituitarism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cefepime, reaction(s): "ALLERGY TO CEFEPIME". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2023) Negative, notes: Rebound / return of symptoms after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 05Jul2023 and stop date 10Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250720 same reporter/patient, different drug/event;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 63 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in right arm, on 15Apr2021 as dose 2, single (Lot number: EW0158), in right arm, on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa based antibiotics" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2013, stop date: Jul2023; LOVASTATIN, start date: Jan2013, stop date: Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 03Jul2023 to 06Jul2023.  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-202300250657 same reporter/patient, different drug/event;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 17Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Otherwise excellent health. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Jan2022, outcome "recovered"; COVID-19 (medically significant) with onset Jun2023, outcome "recovered"; DRUG INEFFECTIVE (medically significant) with onset Jun2023, outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Negative, notes: Tested negative 4 days upon completion of Paxlovid; (Jul2023) Positive, notes: positive again 2 days later; (Jul2023) Positive, notes: since testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 26Jun2023 and stop date 01Jul2023. Tested negative 4 days upon completion of Paxlovid. Then positive again 2 days later. Today is day 6 since testing positive and was feeling more sick each day. Mild symptoms, but going in the wrong direction. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250571 same reporter/patient, different drug/event;