chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient received expired Moderna Covid-19 vaccine for her second primary series dose; More than 35 days between the first and second doses of the primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna Covid-19 vaccine for her second primary series dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the first and second doses of the primary series) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 042C22A and 074B22A) for COVID-19 prophylaxis.     It was reported that patient had no relevant medical history, allergy, concomitant diseases and risk factor or medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 Vaccine.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna Covid-19 vaccine for her second primary series dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the first and second doses of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna Covid-19 vaccine for her second primary series dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the first and second doses of the primary series) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna Covid-19 vaccine for her second primary series dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the first and second doses of the primary series).    No concomitant information was reported. It was reported that patient had no other adverse reactions from both doses. No treatment information was provided.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 16-Mar-2023.; No adverse event; expired dose was given to an 8 years old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given to an 8 years old patient), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023.) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019C22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 06-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given to an 8 years old patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose was given to an 8 years old patient), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired dose was given to an 8 years old patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023.).    No concomitant medications were reported.  It was reported that an expired dose of Monovalent vaccine was given to an 8 year old patient in a mobile clinic. Vial size was reported as 2.5 ml.  The vial was initially stored in the refrigerator on 16-Mar-2023. The vial did not undergo any temperature excursions. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: She took moderna primary series back in 2021 only the first dose; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (She took moderna primary series back in 2021 only the first dose) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (She took moderna primary series back in 2021 only the first dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (She took moderna primary series back in 2021 only the first 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 PRODUCT ADMINISTRATION INTERRUPTED (She took moderna primary series back in 2021 only the first dose).    No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 06DEC2022 and vaccine administered on 07APR2023; No adverse event; a Pediatric patient received expired 2nd primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a Pediatric patient received expired 2nd primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06DEC2022 and vaccine administered on 07APR2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (a Pediatric patient received expired 2nd primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06DEC2022 and vaccine administered on 07APR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a Pediatric patient received expired 2nd primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06DEC2022 and vaccine administered on 07APR2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (a Pediatric patient received expired 2nd primary dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06DEC2022 and vaccine administered on 07APR2023).    No concomitant medications was reported.  Reporter does not have patient's demographics handy, she was sure that the patient was pediatric. Vial size was 2.5 ml. The vial was initially stored in the refrigerator on 06DEC2022. The vial did not undergone any temperature excursions.  No treatment medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: long haul covid for 2 years; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (long haul covid for 2 years) 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 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 COVID-19 (long haul covid for 2 years). At the time of the report, COVID-19 (long haul covid for 2 years) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Reporter stated that one lady got covid after vaccine and had long haul COVID for 2 years. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: little arm soreness from the vaccine; accidentally administered an expired vaccine today 7Apr2023; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (little arm soreness from the vaccine) and EXPIRED PRODUCT ADMINISTERED (accidentally administered an expired vaccine today 7Apr2023) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2023, the patient experienced PAIN IN EXTREMITY (little arm soreness from the vaccine) and EXPIRED PRODUCT ADMINISTERED (accidentally administered an expired vaccine today 7Apr2023). At the time of the report, PAIN IN EXTREMITY (little arm soreness from the vaccine) had resolved and EXPIRED PRODUCT ADMINISTERED (accidentally administered an expired vaccine today 7Apr2023) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PAIN IN EXTREMITY (little arm soreness from the vaccine) to be related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered an expired vaccine today 7Apr2023).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.    The patient said she was fine. All she had was a little arm soreness from the vaccine. The expiration date was reported as 02-FEB-2023. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Type A flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Type A flu) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) 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 INFLUENZA (Type A flu). At the time of the report, INFLUENZA (Type A flu) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that vaccine was On Feb 14th, patient took the vaccine shot After 2 weeks patient had a type A flu, last about 4 days. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product availability issue
Clinical narrative: seeking 2nd dose of primary series which is no longer available; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (seeking 2nd dose of primary series which is no longer available) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) 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 PRODUCT AVAILABILITY ISSUE (seeking 2nd dose of primary series which is no longer available) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT AVAILABILITY ISSUE (seeking 2nd dose of primary series which is no longer available) 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 PRODUCT AVAILABILITY ISSUE (seeking 2nd dose of primary series which is no longer available).    No concomitant medications were reported. Patient was seeking 2nd dose of Primary series which was no longer available. Patient received 1st dose of vaccine within this past 30 days and about to go over 30 days. No treatment details were reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administration of an expired Moderna Monovalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired Moderna Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     The medical conditions and allergy information was not known.     On 05-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 05-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired Moderna Monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired Moderna Monovalent vaccine) 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 (administration of an expired Moderna Monovalent vaccine).    No concomitant medications were reported.    It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 5.5 mL vial was initially stored in the refrigerator on 03-Apr-2023. The vial did no underwent any temperature excursions.  No treatment medications were reported.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine that was in the fridge for 35 days; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine that was in the fridge for 35 days) and NO ADVERSE EVENT (No adverse event) in a 13-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 05-Apr-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 (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine that was in the fridge for 35 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine that was in the fridge for 35 days) 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 (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vaccine that was in the fridge for 35 days).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.  The patient's previous COVID19 history was unknown. No adverse reaction reported.  The vial was initially stored in the refrigerator on 27-Feb-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023; No adverse event; Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023) 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-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 07-Apr-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 (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023) 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 received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023).    No concomitant medications was reported.  The dose of suspect Spikevax Bivalent was reported as additional booster. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 26-FEB-2023. The vial did not undergo any temperature excursions.    No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719045 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719045: Patient 2
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I've known at least 3 people who had stroke; The initial case was missing the following minimum criteria: [Identifiable reporter]. Upon receipt of the follow-up information on (05Apr2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I've known at least 3 people who had stroke".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (05Apr2023) : This is a spontaneous follow up report received from same non-contactable Consumer.  Updated information included: Case upgraded to valid. Patient gender removed as per query response received.  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-PV202300062721 Same reporter, same product, same event, different patient;US-PFIZER INC-202300145036 Same reporter, same product, same event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little bit achy/maybe a little bit achy; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "didn't feel a thing". The following information was reported: PAIN (non-serious), outcome "unknown", described as "a little bit achy/maybe a little bit achy".  Additional information: Second shot, didn't feel a thing and third shot, maybe a little bit achy nothing more so.  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-PV202300063739 Same patient, same vaccine but different doses with different events;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose 1,2,4,5: Pfizer and Dose 3: Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 12:00 as dose 5 (booster), single (Lot number: Gjg49693) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Mar2021 at 11:00 as dose 1, single (Lot number: ER8732) at the age of 60 years, in left arm, on 19Apr2021 as dose 2, single (Lot number: EW0162) at the age of 60 years, in left arm and on 04May2022 at 12:15 as dose 4 (booster), single (Lot number: Fm9992) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Dec2021 at 14:00 as dose 3 (booster), single (Lot number: 030H21B) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MELOXICAM, start date: 14Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Dec2021 at 14:00, outcome "recovered", described as "Dose 1,2,4,5: Pfizer and Dose 3: Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid from 25Mar2023 to 29Mar2023. Patient had no known allergy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146983 Same reporter, same patient, different product, different event;
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 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: "CHF (Congestive heart failure)" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had not taken any other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient had taken Paxlovid as COVID-19 treatment from 27Mar2023 to 31Mar2023. Paxlovid immediately lessened symptoms of sore throat, aches, sneezing. Cough  had also decreased to some extent till last Paxlovid date. Symptoms of sneezing, runny nose, congested nasal passage and some chills began on day 9 (05Apr2023 at 04:00 PM) of treatment start.  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-202300147047 same reporter/patient, different product/AE;
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Her cousin had taken a shot and got the virus/does not know what product; Her cousin had taken a shot and got the virus/does not know what product; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her cousin had taken a shot and got the virus/does not know what product".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pollakiuria
Clinical narrative: I've been trotting back and forth to the bathroom since 6 am this morning. I'm not sure where this liquid is coming from.; Stated that it is like she is drinking beer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Apr2023 as dose 5 (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 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: POLLAKIURIA (non-serious), outcome "unknown", described as "I've been trotting back and forth to the bathroom since 6 am this morning. I'm not sure where this liquid is coming from."; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Stated that it is like she is drinking beer".  Additional information: Patient had been trotting back and forth to the bathroom since 6 am this morning. she was not sure where this liquid was coming from. The only thing that changed was that she had shot. This was her fifth one. she reported yesterday's was slightly different.   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.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy"; Ibuprofen, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not taking any other medications within 2 weeks of starting COVID-19 treatment. She took Paxlovid treatment from 23Mar2023 to 27Mar2023.  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.
Age: 54.0
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 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 and concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "known allergies:doxycycline", notes: known allergies:doxycycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Recurrence of COVID symptoms & positive rapid test result starting 3 days after last dose of Paxlovid; (2023) Negative, notes: First had a negative Rapid test result on Day 8 and COVID symptoms mostly abated; (2023) Positive, notes: Symptoms resurged and tested positive again on Day 12. Continued having symptoms & testing positive thru Day 20; (2023) Negative, notes: Tested negative again on Days 21 & 22, but still had some lingering symptoms; (2023) Positive, notes: Continued to have symptoms & test positive for COVID for 8 more days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks. Covid-19 treatment was Paxlovid from Mar2023 to Mar2023. Other medication in 2 weeks product was escitalopram, bupropion, ibuprofen, Vit D, fish oil, magnesium. Other medication in 2 weeks brand was generic, start date Jan2023 and stop date was Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He had COVID 2 weeks ago; He had COVID 2 weeks ago; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 53-year-old male patient 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "He had COVID 2 weeks ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: He tested negative twice before no longer wearing a mask around other people; (Mar2023) Negative, notes: He tested negative twice before no longer wearing a mask around other people; (05Apr2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter reported that last dose was several months ago (I do not have access to his vaccination card to provide the exact date). Patient had COVID 2 weeks ago and took 5 days of paxlovid which patient finished on 30Mar2023. After 6 days of infection, patient tested negative twice before no longer wearing a mask around other people per CDC guidelines. On 03Apr2023 patient started sneezing. On 05Apr2023, patient developed a runny nose and increased sneezing and tested positive again that evening (appropriately 11pm).  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.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: F
Vaccine: COVID19, 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) (Nurse). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Iodine allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for COVID 19 Treatment from 21Mar2023 to 26Mar2023. Patient reported that after finishing Paxlovid 5 days treatment, 5 days later she had Covid-19 rebound symptoms include running nose, fatigue and dry cough.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID-19, which is considered as ineffectiveness of the vaccine, and the administration of BNT162B2, BNT162B2 OMI BA.4-5, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.,Linked Report(s) : US-PFIZER INC-202300147508 same patient, different drug/event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old patient 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; 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: "Asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "intracranial hypertension" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient received no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid, from 27Mar2023 to 01Apr2023.   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-202300147677 same patient, different drug/event;
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Expired product administered, Wheezing
Clinical narrative: Given expired vaccine; Patient was seen in the office that day for cough; Patient was seen in the office that day for wheezing; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2023 as dose 1 (orange cap), 0.2 ml single (Lot number: FL2757, Expiration Date: 31Mar2023) at the age of 8 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 04Apr2023, outcome "unknown", described as "Given expired vaccine"; COUGH (non-serious) with onset 2023, outcome "unknown", described as "Patient was seen in the office that day for cough"; WHEEZING (non-serious) with onset 2023, outcome "unknown", described as "Patient was seen in the office that day for wheezing". The events "patient was seen in the office that day for cough" and "patient was seen in the office that day for wheezing" required physician office visit.  Additional information: Caller Confirmed date of manufacturing as Oct2021 for Lot # FL2757. 18 month manufacturer expiration date was 31Mar2023 on this particular lot. Clarified that 2 patients received these vaccines; 1 patient received their vaccine 05Apr2023 and the other received theirs on 04Apr2023. Vaccination Facility Type was Doctor's Office. No prior vaccinations were given within 4 weeks. There was no family medical history relevant to adverse events. There was no investigation. Upon follow-up on 06Apr2023, it was stated that physician was out today, will contact parent tomorrow. Patient was seen in the office that day for cough and wheezing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300147411 same drug, different patient/ event;
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder, Interchange of vaccine products, Skin laceration
Clinical narrative: Interchange of Vaccine products; It trashed the patient's organs, emphasizing that it "completely" trashed her organs, it is bad, she had lacerations; It trashed the patient's organs, emphasizing that it "completely" trashed her organs, it is bad, she had lacerations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (ongoing), notes: she was on medications for blood sugar and the cholesterol; "high cholesterol" (ongoing), notes: she was on medications for blood sugar and the cholesterol. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown"; ILL-DEFINED DISORDER (non-serious), SKIN LACERATION (non-serious), outcome "unknown" and all described as "It trashed the patient's organs, emphasizing that it "completely" trashed her organs, it is bad, she had lacerations". The event "it trashed the patient's organs, emphasizing that it "completely" trashed her organs, it is bad, she had lacerations" required emergency room visit.  Additional information: Patient also received Moderna as booster dose. Both of those Pfizer inoculations occurred at (facility withheld) in the (withheld) and then she went to a pharmacy to get a Moderna booster. Caller also said that it trashed the patient's organs, emphasizing that it "completely" trashed her organs, it was bad, she had lacerations. Caller says the covid test came back negative twice in the ER when she was admitted on Monday night, she wondered why did her doctor kept telling her not to get tested. The question was why this happened and why even though the doctor knew she had these comorbidities he gave her this drug anyway. Why did the doctor prescribed the drug that was in conflict with her healthcare.  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-202300147060 same reporter, different drug and event;US-PFIZER INC-202300147151 Same patient, same product, different event (LOE).
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Pneumonia, Suspected COVID-19
Clinical narrative: Hospitalized with COVID; Hospitalized with COVID; Hospitalized with pneumonia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4715018, US-ABBVIE-4714204.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (prolonged hospitalization, medically significant), SUSPECTED COVID-19 (prolonged hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "Hospitalized with COVID"; PNEUMONIA (prolonged hospitalization, medically significant) with onset 2022, outcome "unknown", described as "Hospitalized with pneumonia".  Clinical course: In 2022, patient was hospitalized with Covid and hospitalized with pneumonia a second time. He stated that he took the Pfizer Covid vaccine and had been sick ever since getting the covid vaccines.  The reporter's causality for the event(s) of COVID and pneumonia with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Agency's opinion was that the causality for the event(s) of COVID and pneumonia with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  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-PV202300064269 Same patient, different drug and event;US-PFIZER INC-PV202300064749 Same patient, different drug and event;
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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: "Hypothyroidism" (unspecified if ongoing); "known allergies: Dust Mites" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Paxlovid for treatment of event from Mar2023 to Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; 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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 09Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive test 3 days after negative test; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148050 same patient/product, different dose/event;