chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 056M21A and 047B21A) for COVID-19 prophylaxis.     Previously administered products included for an unreported indication: Moderna COVID-19 Vaccine on 23-Jun-2021.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-708314 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708314:Bivalent dose case
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19
Clinical narrative: He also mentioned that he had Covid Sep2022. He had very mild symptoms and they resolved within a week after testing positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He also mentioned that he had Covid Sep2022. He had very mild symptoms and they resolved within a week after testing positive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 032M20A and 024M20A) for COVID-19 prophylaxis.     The patient's past medical history included Partial hearing loss and Hay fever. Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine on 10-Feb-2021 and Moderna COVID-19 Vaccine on 11-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concomitant products included DIMENHYDRINATE (DRAMAMINE) for Vertigo and Nausea, FLUTICASONE PROPIONATE (FLONAZE) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (He also mentioned that he had Covid Sep2022. He had very mild symptoms and they resolved within a week after testing positive). At the time of the report, COVID-19 (He also mentioned that he had Covid Sep2022. He had very mild symptoms and they resolved within a week after testing positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, COVID-19: Positive. On 02-Feb-2023, Blood pressure measurement: 119/80.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   He also mentioned that he had Covid in Sep 2022. He had very mild symptoms and they resolved within a week after testing positive. He took Paxlovid for 5 days. On 28-Jan-2023, while he was playing golf, late in the round, he felt a little dizzy which lasted for about 15 minutes only. He did not had nausea and headache but his head was swimming. When he was lying down, it did not bother him. On 02-Feb-2023, it was still the same. He was prescribed with some exercise, Flonase inhaler Dramamine and Zyrtec. On 04-Feb-2023, he felt 50% better. On 05-Feb-2023, he felt 75% better.   This case was linked to MOD-2023-707791 (Patient Link).
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) 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 WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose).    Concomitant medication not reported. Treatment medication not reported.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Adult patient received a primary series vaccine ( Lot 055A22A) that had an expiration date of 02/02/2023. Question: Does the patient need to be revaccinated?; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Adult patient received a primary series vaccine ( Lot 055A22A) that had an expiration date of 02/02/2023. Question: Does the patient need to be revaccinated?) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Adult patient received a primary series vaccine ( Lot 055A22A) that had an expiration date of 02/02/2023. Question: Does the patient need to be revaccinated?) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Adult patient received a primary series vaccine ( Lot 055A22A) that had an expiration date of 02/02/2023. Question: Does the patient need to be revaccinated?) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Adult patient received a primary series vaccine ( Lot 055A22A) that had an expiration date of 02/02/2023. Question: Does the patient need to be revaccinated?).    No concomitant medications were provided. No treatment information provided.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) 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 WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) 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 WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose).    No concomitant medication were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Licensed Practical Nurse reported that 4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose.  No treatment medication were reported.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A pediatric patient received 3 doses of the monovalent vaccine instead of the intended bivalent booster after a primary series; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A pediatric patient received 3 doses of the monovalent vaccine instead of the intended bivalent booster after a primary series) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) 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 WRONG PRODUCT ADMINISTERED (A pediatric patient received 3 doses of the monovalent vaccine instead of the intended bivalent booster after a primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A pediatric patient received 3 doses of the monovalent vaccine instead of the intended bivalent booster after a primary series) 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 WRONG PRODUCT ADMINISTERED (A pediatric patient received 3 doses of the monovalent vaccine instead of the intended bivalent booster after a primary series).    No concomitant medication information provided. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No side effects were reported. No treatment information provided.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Poor quality product administered
Clinical narrative: No adverse event; Patient was administered Moderna Covid 19 Bivalent after 30 day use by date; Patient was administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient 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 06-Feb-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 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant medication was reported. No treatment medication was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient received only one dose of the Moderna COVID19 vaccine on Dec 07 2021/ did not receive the second dose because she missed the appointment; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received only one dose of the Moderna COVID19 vaccine on Dec 07 2021 / did not receive the second dose because she missed the appointment) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received only one dose of the Moderna COVID19 vaccine on Dec 07 2021 / did not receive the second dose because she missed the appointment) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received only one dose of the Moderna COVID19 vaccine on Dec 07 2021 / did not receive the second dose because she missed the appointment) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient received only one dose of the Moderna COVID19 vaccine on Dec 07 2021 / did not receive the second dose because she missed the appointment).    Concomitant product use was not provided by the reporter. It was unknown if the patient has received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 1 dose of Moderna Covid-19 vaccine (monovalent) was administered on 07Feb2023 BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (monovalent) was administered on 07Feb2023 BUD) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (monovalent) was administered on 07Feb2023 BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (monovalent) was administered on 07Feb2023 BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (monovalent) was administered on 07Feb2023 BUD).    Concomitant medication was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination complication
Clinical narrative: Last booster was on 23Nov2022. I'm having surgery on the 9th of this month; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Last booster was on 23Nov2022. I'm having surgery on the 9th of this month) 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. ) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-2022, 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 an unknown date, the patient experienced VACCINATION COMPLICATION (Last booster was on 23Nov2022. I'm having surgery on the 9th of this month). At the time of the report, VACCINATION COMPLICATION (Last booster was on 23Nov2022. I'm having surgery on the 9th of this month) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was reported that patient had a total of 4 injections. 2 shots and 2 boosters. Patient having surgery on the 9th of this month and they are saying patient was due for another booster.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) 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 WRONG PRODUCT ADMINISTERED (patient inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose).    Concomitant product use was not provided by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Four patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose and would like to know how to proceed. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-708305, US-MODERNATX, INC.-MOD-2023-708307, US-MODERNATX, INC.-MOD-2023-708309, US-MODERNATX, INC.-MOD-2023-708473, US-MODERNATX, INC.-MOD-2023-708473 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708305: US-MODERNATX, INC.-MOD-2023-708307: US-MODERNATX, INC.-MOD-2023-708309: US-MODERNATX, INC.-MOD-2023-708473: US-MODERNATX, INC.-MOD-2023-708473:
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) ongoing since an unknown date for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient previously received doses: 1st Dose administered on 21-JAN-2021 with Lot/batch no: 032L20A, 2nd Dose administered on 18-FEB-2021 with Lot/batch no: 024M20A, 3rd Dose administered on 21-NOV-2021 with Lot/batch no: 020F21A, 4th Dose administered on 19-APR-2022 with Lot/batch no: 056M21A. Patient states that patient received 5 doses of the Moderna COVID-19 vaccine so far and was just diagnosed with COVID yesterday and symptoms include runny nose, sore throat, headache, cough and aches. Patient was on Paxlovid for his symptoms. Patient was "on the mend" at that time.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccines given today from a vial that had been held past the published expiration date.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines given today from a vial that had been held past the published expiration date.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines given today from a vial that had been held past the published expiration date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines given today from a vial that had been held past the published expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines given today from a vial that had been held past the published expiration date.).    No concomitant medications were reported. No treatment medications were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day ; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day ) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day ).    No concomitant product was reported. It was confirmed by medical assistant that her office utilized a primary vaccine vial that expired 10 days ago wherein only 1 dose from 1 of the 10 vials of lot 015B22A was administered to the patient. HCP stated that they inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day use by date to a patient on 07-Feb-2023, at their facility. Lot number 015B22A, manufacturer expiration date 12-Feb-2023, date when the vaccine was initially stored in the refrigerator was 28-Dec-2022. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergic reaction".  Additional information: Caller mentioned she has a patient that was ordered to receive Darbepoetin (Aranesp is the brand name). This patient had an allergic reaction back in 2021 to a Pfizer BioNTech COVID 19 vaccine (for adults, no formulation was provided). The caller stated that the electronic medical record is flagging a contraindication to receive the Darbepoetin due to the history of allergic reaction to the Pfizer COVID 19 vaccine. Caller was advised to contact the Darbepoetin-Aranesp manufacturer for further information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Erythema, Joint stiffness, Joint swelling
Clinical narrative: Both knees began to ache and turn stiff; Both knees began to ache and turn stiff; Can hardly stand up; His knees became puffy, pink, swollen, and warm; His knees became puffy, pink, swollen, and warm; His knees became puffy, pink, swollen, and warm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EN5318) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). Concomitant medication(s) included: TOPROL XL taken for blood pressure measurement (ongoing); LIPITOR (ongoing); HYDROCHLOROTHIAZIDE;SPIRONOLACTONE. Vaccination history included: Flu shot (He gets a Flu shot every year.), for Immunization.  The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Both knees began to ache and turn stiff"; DYSSTASIA (non-serious) with onset 2021, outcome "not recovered", described as "Can hardly stand up"; JOINT SWELLING (non-serious), JOINT WARMTH (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "not recovered" and all described as "His knees became puffy, pink, swollen, and warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint stiffness.  Additional information: The patient Prior Vaccinations (within 4 weeks): none. If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. Relevant Tests: None.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300053948 Same patient/vaccine/event, different dose;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Joint warmth, Rheumatoid factor, X-ray
Clinical narrative: Both knees began to ache and turn stiff; Both knees began to ache and turn stiff; Can hardly stand up; His knees became puffy, pink, swollen, and warm; His knees became puffy, pink, swollen, and warm; His knees became puffy, pink, swollen, and warm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EN5318) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). Concomitant medication(s) included: TOPROL XL taken for blood pressure measurement (ongoing); LIPITOR (ongoing); HYDROCHLOROTHIAZIDE;SPIRONOLACTONE. Vaccination history included: Flu shot (He gets a Flu shot every year.), for Immunization.  The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Both knees began to ache and turn stiff"; DYSSTASIA (non-serious) with onset 2021, outcome "not recovered", described as "Can hardly stand up"; JOINT SWELLING (non-serious), JOINT WARMTH (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "not recovered" and all described as "His knees became puffy, pink, swollen, and warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint stiffness.  Additional information: The patient Prior Vaccinations (within 4 weeks): none. If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. Relevant Tests: None.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300053948 Same patient/vaccine/event, different dose;
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: HCTZ, start date: 01Nov2022. Past drug history included: Epinephrine, reaction(s): "drug allergies: Epinephrine".The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" 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, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: full series of standard vaccine with Pfizer and Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Suspect possible psoriatic arthritis (mild)" (unspecified if ongoing), notes: not currently diagnosed or undergoing treatment.; "known allergies: certain metals and dyes" (unspecified if ongoing); "known allergies: certain metals and dyes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Rabies vaccine (known allergies: Rabies vaccine), for Immunization, reaction(s): "known allergies: Rabies vaccine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "full series of standard vaccine with Pfizer and Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Test was never negative, but had faded to faint positive; Positive, notes: now much darker than initial positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: This report was about covid treatment. Patient received covid vaccine Moderna Bivalent (rec'd full series of standard vaccine with Pfizer and Moderna). Vaccine lot unknown reason stated as not available/provided to reporter at the time of report completion. Patient received anti-viral product Paxlovid for COVID 19 Treatment from 25Jan2023 till 29Jan2023. Experienced rebound COVID symptoms approx. 4 days after finishing Paxlovid course.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective, COVID-19 and Interchange of vaccine products cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive with Covid again; Positive, notes: tested positive with Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Patient received Paxlovid treatment from 04Jan2023  to 09Jan2023 for 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: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in my arm rendering it almost useless since my second Covid shot on 07Mar2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:  The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 07Mar2022 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), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Mar2022, outcome "not recovered", described as "pain in my arm rendering it almost useless since my second Covid shot on 07Mar2022".  Additional information: It was reported that Customer don't know who else to contact about the pain in her arm rendering it almost useless since her second Covid shot on 07Mar2022. The nurse put the shot about 6 inches down & the pain has been unbearable ever since. She asked, have you any patience with similar problems or can you tell me what I can do? Even her Dr doesn't know. She asked for help.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal disorder, Pain in extremity, Wrong technique in product usage process
Clinical narrative: pain in my arm rendering it almost useless since my second Covid shot on 07Mar2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:  The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 07Mar2022 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), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Mar2022, outcome "not recovered", described as "pain in my arm rendering it almost useless since my second Covid shot on 07Mar2022".  Additional information: It was reported that Customer don't know who else to contact about the pain in her arm rendering it almost useless since her second Covid shot on 07Mar2022. The nurse put the shot about 6 inches down & the pain has been unbearable ever since. She asked, have you any patience with similar problems or can you tell me what I can do? Even her Dr doesn't know. She asked for help.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick after getting the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the parent.  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick after getting the Pfizer Covid 19 vaccine".  Additional information: The reporter was calling on behalf of her children who got sick after getting the Pfizer Covid 19 vaccine and also her uncle and her girlfriend that got sick after getting the vaccine. Asking if there are some vitamins or medications that can boost their immune systems. Caller also reported that she had 2 young adult children that got sick after getting the Pfizer Covid 19 Vaccine, and also her uncle and her brother. She was only looking to find a medication or product so they could get immediate relief, but she was not finding any products that can help them. Her friend (withheld) that she worked with, had diarrhea for almost a year and was told that she had long covid. Her other friend (withheld) that lives in (state name withheld) had a heart attack and appendicitis in the same day. Attempted to verify the caller's name and phone number that was provided by the transferring agent, but caller stated that she doesn't want to be on the radar. She just wanted to know if there is a product that can alleviate the symptoms, or is it just pushing the vaccine. Verified that all patients received the Pfizer Covid 19 Vaccine. This report was for the caller's 2 young adult children.  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) : PFIZER INC-202300056777 same reporter, product and event, different patient; PFIZER INC-202300056750 same reporter, product and event, different patient (report 3 of 5);PFIZER INC-202300056738 same reporter, product and event, different patient (report 2 of 5);
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: long covid; diarrhea for almost a year/long covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "long covid"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "diarrhea for almost a year/long covid".  Additional information: Her friend (Name withheld) that she works with, has had diarrhea for almost a year and was told that she has long covid.She just wants to know if there is a product that can alleviate the symptoms, or is it just pushing the vaccine. Verified that all patients received the Pfizer Covid 19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick after getting the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick after getting the Pfizer Covid 19 vaccine".  Additional Information: She was calling on behalf of her children who got sick after getting the Pfizer Covid 19 vaccine. And also her uncle and her girlfriend that got sick after getting the vaccine. Asking if there are some vitamins or medications that can boost their immune systems. Caller stated that she has 2 young adult children that got sick after getting the Pfizer Covid 19 Vaccine, and also her Uncle and her brother. She was only looking to find a medication or product so they can get immediate relief, but she was not finding any products that can help them. Her friend (Name withheld) that she works with, has had diarrhea for almost a year and was told that she has long covid. Her other friend (Name withheld) that lives in (state withheld) had a heart attack and appendicitis in the same day. Attempted to verify the caller's name and phone number that was provided by the transferring agent, but caller stated that she doesn't want to be on the radar. She just wants to know if there was a product that can alleviate the symptoms, or was it just pushing the vaccine. This report was for the caller's Uncle.   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) : PFIZER INC-202300056731 same reporter, product and event, different patient (report 2 of 5);
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick after getting the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got sick after getting the Pfizer Covid 19 vaccine".  Additional information: It was reported that " Caller states that she had 2 young adult children that got sick after getting the Pfizer Covid 19 Vaccine, and also her Uncle and her brother. She was only looking to find a medication or product so they can get immediate relief, but she was not finding any products that can help them. She just wants to know if there was a product that can alleviate the symptoms, or is it just pushing the vaccine. Verified that all patients received the Pfizer Covid 19 Vaccine. This report was for the caller's brother.   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-202300056731 same reporter, product and event, different patient (report 3 of 5);