chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired vaccine applied; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HAB (Twinrix) (batch number 3Y7NL, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th May 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 25th May 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was recovered/resolved.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The health care professional stated they gave a patient an expired vaccine.  The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient received Twinrix which was already expired which led to expired vaccine used.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received only first dose in 2019; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose on 22nd May 2019, batch number: 9T25S).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The health care professional reported patient received only first dose of Engerix-B and never came for the rest. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Engerix-B which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: PARALYSIS; This spontaneous report received from a consumer via social media  through a company representative concerned a female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and and expiry were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced paralysis. Reporter stated that "I personally know of 7 cases of paralysis of which one is my neighbors daughter in law". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralysis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220548149, 20220548194 and 20220548524.; Sender's Comments: V0: 20220547591-covid-19 vaccine ad26.cov2.s- paralysis . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia
Clinical narrative: EXTREMELY BITTER TASTE IN THE BACK OF MOUTH ON TONGUE; This spontaneous report received from a patient via Pfizer concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression. The patient was previously received two doses of Moderna vaccine (Spikevax) (elasomeran) (Dose number in series 1) (form of admin, route of admin not reported, batch number: 038A21A for dose 1, batch number: 046821A for dose 2 and expiry: UNKNOWN) dose was not reported, administered on right arm on 11-MAR-2021 and second dose on 20-APR-2021 for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first two doses of Moderna (Spikevax) covid-19 vaccine (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 20J14-03, and expiry: UNKNOWN) dose was not reported, 1 total, administered on DEC-2021 for prophylactic vaccination. Age at time of vaccination 27 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 2)  The patient received non-company suspect Pfizer Biontech covid-19 vaccine (Tozinameran) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: GA1188 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2022 for prophylactic vaccination. Concomitant medications included amlodipine (from MAR-2022), dextromethorphan hydrobromide/paracetamol/pseudoephedrine hydrochloride (18-MAY-2022), and duloxetine (from JUL-2020) for unknown indication.  On 18-MAY-2022, the patient experienced extremely bitter taste in the back of mouth on tongue, similar to bitter grapefruit. It woke patient up several times throughout the night (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and Tozinameran was not applicable. The patient had not recovered from extremely bitter taste in the back of mouth on tongue, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Thrombotic stroke
Clinical narrative: BLOOD CLOT IN BRAIN LED TO A STROKE; This spontaneous potential legal case report received from a patient via social media through a company representative concerned a 38 year old patient of an unspecified sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. Age at time of vaccination 4 decade. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot in brain that led to a stroke. Reporter stated that "Looking for someone to help me with a case against, vaccine giving me a blood clot in my brain that led to a stroke at the age of 38". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in brain led to a stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220547672-covid-19 vaccine ad26.cov2.s-Blood clot in brain led to a stroke. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 21-JAN-2022) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient received additional two dose of non-company suspect vaccine included: Moderna covid-19 vaccine (Elasomeran) (dose number in series 2) first dose as (batch number: 076c21a, form of admin, route of admin, and were not reported) dose was not reported, administered on 24-OCT-2021 for prophylactic vaccination, and second dose (batch number: 033h21a, form of admin, route of admin, and were not reported) dose was not reported, administered on 22-JAN-2022 for prophylactic vaccination.  On 19-MAY-2022, the patient tested positive for Covid-19 with 2 rapid test and had runny nose at same time (suspected covid-19 infection) (dose number in series 2). This led to suspected clinical vaccination failure (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220548145-COVID-19 VACCINE Ad26.COV2.S-suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: PARALYSIS; This spontaneous report received from a consumer via social media via a company representative concerned 4 patients of unspecified age, sex, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced paralysis. The reporter stated that "I personally know of 7 cases of paralysis of which one is my neighbor's daughter in law and know of 2 kids paralyzed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralysis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220548194 and 20220547591.; Sender's Comments: V0-20220548149-covid-19 vaccine ad26.cov2.s-Paralysis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: PARALYZED; This spontaneous report received from a consumer via social media via a company representative concerned 2 patients of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced paralysis. Reporter stated that, "I personally know of 7 cases of paralysis of which one is my neighbors daughter in law and know of 2 kids paralyzed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralyzed was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220548149, 20220547591 and 20220548524.; Sender's Comments: V0: 20220548194-Covid-19 vaccine ad26.cov2.s- paralyzed. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 30.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Haemorrhage, Inflammation, Product temperature excursion issue
Clinical narrative: BLEEDING; CONDITION AGGRAVATED; INFLAMMATION; HUMIRA PRODUCT TEMPERATURE EXCURSION ISSUE; This spontaneous report received from a consumer via another pharmaceutical company concerned a 30 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 09-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 30 years old. Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported), citrate free, dose, frequency, and therapy dates were not reported was administered for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced bleeding, condition aggravated, inflammation, and humira product temperature excursion issue. The icepack was completely liquid but was cool to touch even though the little thermometer strip was in or on box received like that from pharmacy with Humira. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from condition aggravated, and inflammation, and the outcome of bleeding and humira product temperature excursion issue was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220548649-COVID-19 VACCINE AD26.COV2.S-Bleeding. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: VACCINE INJURY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injury was not reported. This report was non-serious
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 54 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included: The patient stated he was not taking any other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 in total was administered on 12-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. The patient age at time of vaccination was 53 years old. No concomitant medications were reported. The patient additionally received non-company suspect vaccine Moderna Covid-19 vaccine (elasomeran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, administered on 15-NOV-2021 to left arm for prophylactic vaccination. On 09-MAY-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 13-MAY-2022. On 15-MAY-2022, 2 days after non company suspect drug paxlovid treatment (for covid-19) laboratory data included: COVID-19 virus test (NR: not provided) Negative.  On 17-MAY-2022, three days after non company suspect drug paxlovid treatment symptoms returned the patient had confirmed covid-19 infection (dose number in series 2) and confirmed clinical vaccination failure (dose number in series 1). On same day laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with Paxlovid was drug discontinued on 13-MAY-2022. . The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number requested.; Sender's Comments: V0: 20220551187- COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE / VACCINE HAD BEEN LEFT OUT IN THE PHARMACY FOR GREATER THAN TWO HOURS PRIOR TO ADMINISTRATION; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced out of specification product use, and incorrect product storage / vaccine had been left out in the pharmacy for greater than two hours prior to administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage / vaccine had been left out in the pharmacy for greater than two hours prior to administration was not reported. This report was non-serious. This case, involving the same patient is linked to 20220548150.
Sex: U
Vaccine: COVID19
Symptoms: Coma, Seizure
Clinical narrative: This spontaneous report received from a patient via social media (J&J) via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced seizure disorder, and coma for two months. The reporter stated that, "PRIVATE" put me in a coma for 2 months and now I have a seizure disorder thanks to them". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coma for two months, and the outcome of seizure disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220552900 -COVID-19 VACCINE AD26.COV2.S- coma for two months, seizure disorder. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; FLU- LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 49 year old male. The patient's concurrent conditions included: migraine, irritable bowel syndrome (IBS) and latex allergy. The patient was a health care professional (registered nurse). On FEB-2021 or MAR-2021, patient had lost sense of taste and smell prior to vaccination, even though the patient was tested negative for covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered to the left arm on 12-APR-2021 for prophylactic vaccination. Age at time of vaccination was 49 years old. No concomitant medications were reported. On 13-APR-2021 (the day post vaccination), the patient had experienced flu-like symptoms. The patient also felt tired and achy (flu- like symptoms) for a few days which got resolved pretty quick. On 22-DEC-2021 or 23-DEC-2021 (before Christmas), the patient tested positive for covid-19 via swab test at the hospital he works (confirmed clinical vaccination failure, confirmed covid-19 infection). The lost sense of taste and smell (covid-19 infection) resolved after covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu- like symptoms and the outcome of confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000232849.; Sender's Comments: V0:20220552926-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Pneumonia, Thrombosis
Clinical narrative: BLOOD CLOTS; STROKES; BRAIN BLEED; SEVERE RESPIRATORY PNEUMONIA; This spontaneous report received from a consumer via a company representative through social media concerned a 53 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported, 1 total was administered for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots, strokes (transient ischemic attack) affecting her circulation to face and brain. Patient had lots of blood thinners and later she was able to work until she had brain bleed and severe respiratory pneumonia and she was hospitalized (date unspecified). Again she had more strokes and currently her memory and speech was affected and she has to go on disability.  It was reported that "Your Covid-19 shot disabled my sister permanently blood clots giving her TIA strokes affecting her circulation to her face and brain. Lots of blood thinners later she was able to work until a brain bleed and severe respiratory pneumonia forced her to be hospitalized again where she had more strokes. Now her memory and speech are affected she has to go on disability. She was a healthy 53 year old and j and j cannot be sued." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots, strokes, brain bleed and severe respiratory pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220554056-covid-19 vaccine ad26.cov2.s - blood clots, strokes, brain bleed and severe respiratory pneumonia. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: Unknown) dose was not reported, 1 total administered on 24-MAY-2021 to left arm for prophylactic vaccination. Age at time of vaccination 46 years old. No concomitant medications were reported.  On an unspecified date, patient experienced symptoms fever, chills and feeling really tired which led to suspected covid-19 infection. On 17-JAN-2022, patient did rapid antigen test, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive and that indicates suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000232955.; Sender's Comments: V0: 20220554257- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Laboratory test, Pyrexia, Tremor
Clinical narrative: SHAKES; WICKED BAD FEVER; This spontaneous report received from a patient via a company representative concerned a 32 year old male. The patient's weight was 170 pounds, and height was 175.26 centimeters. The patient's past medical history included: covid (sick with COVID before the first vaccination), and concurrent conditions included: non alcohol user, and non smoker. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 180860P expiry: UNKNOWN) .5 ml, administered on 27-MAR-2021 for prophylactic vaccination. Age at time of vaccination 32 years old. Concomitant medications included ascorbic acid/betacarotene/biotin/boron/calcium/calcium pantothenate/chloride/chromium/colecalciferol/copper/cyanocobalamin/folic acid/iodine/iron/lycopene/magnesium/manganese/molybdenum/nickel/nicotinamide/phosphorus/potassium/pyridoxine hydrochloride/retinol/riboflavin/selenium/silicon dioxide/thiamine/tin/tocopheryl acetate/vanadium/vitamin k nos/zinc. On 2021, Laboratory data included: Laboratory test (NR: not provided) not reported. On 27-MAR-2021, the patient experienced wicked bad fever. Laboratory data included: Body temperature (NR: not provided) fever of 102. On an unspecified date, the patient experienced shakes. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wicked bad fever and shakes was not reported. This report was non-serious. This case, involving the same patient is linked to 20220526805.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: SLIGHT SWELLING ON FIRST DAY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slight swelling on first day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight swelling on first day was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the Vial was Stored in Refrigerator for 5 day post first punctured; Received expired 2nd Booster more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Booster more than 12 hours post puncture) and PRODUCT STORAGE ERROR (the Vial was Stored in Refrigerator for 5 day post first punctured) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022 at 12:10 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022 at 12:10 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Booster more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the Vial was Stored in Refrigerator for 5 day post first punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Booster more than 12 hours post puncture) and PRODUCT STORAGE ERROR (the Vial was Stored in Refrigerator for 5 day post first punctured) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was received from the department of health and the  Expiry Date written on the box was 09JUN2022  The Vial initially was stored in refrigerator on 12MAY2022, vial was first punctured on 19MAY2022 at 10:30AM. The vial was stored post puncture in refrigerator. The vial did not undergo any temperature excursions. the vial was exposed to refrigerated Temperature range for 5 days. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C; possible administration of invalid dose to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and PRODUCT TEMPERATURE EXCURSION ISSUE (possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and PRODUCT TEMPERATURE EXCURSION ISSUE (possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and PRODUCT TEMPERATURE EXCURSION ISSUE (possible administration of invalid dose to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data (between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Freezer temperature warm by atleast 2 degree C for 4 days; Never reached an acceptable range and was warm by at least 2 degree C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was warm by at least 2 degree C) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was warm by at least 2 degree C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was warm by at least 2 degree C) outcome was unknown.        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 there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Developed Covid after Moderna Dose 3; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed Covid after Moderna Dose 3) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Drug allergy.   On 14-Mar-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Developed Covid after Moderna Dose 3). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 08-May-2022 to 12-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Developed Covid after Moderna Dose 3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter. Patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 19-May2022.  Company Comment: This spontaneous case concerns a 41-year-old, male patient with past drug history of administration of the second dose of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 6 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed COVID-19, however, no symptoms were reported. He took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 08May2022 to 12May2022. It was reported that the patient developed COVID-19 rebound 7 days after treatment with Paxlovid. No additional details were provided at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old, male patient with past drug history of administration of the second dose of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 6 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed COVID-19, however, no symptoms were reported. He took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 08May2022 to 12May2022. It was reported that the patient developed COVID-19 rebound 7 days after treatment with Paxlovid. No additional details were provided at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The 4th day I tested positive again; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2022 and was forwarded to Moderna on 24-May-2022.    This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The 4th day I tested positive again) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Migraine and Drug allergy.   On 15-Apr-2022 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022, the patient experienced COVID-19 (The 4th day I tested positive again). At the time of the report, COVID-19 (The 4th day I tested positive again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. The patient took other medications/products within 2 weeks of starting COVID-19 treatment.  After completing the 5 day treatment the patient tested negative the following day. 3 days later the patient had a runny nose and sore throat again. The 4th day I tested positive again.  Device date: 22-MAY-2022 COMPANY COMMENT: This is an spontaneous case concerning a 63-years-old female patient with medical history of Co-suspect product PAXLOVID for COVID-19 treatment, concurrent medical conditions included Migraine and Drug allergy who experienced the unexpected  event of COVID-19 36 days after  receiving a  dose of  mRNA-1273 vaccine. On 17-May-2022, SARS-CoV-2 test: negative; On 21-May-2022, SARS-CoV-2 test: positive  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 63-years-old female patient with medical history of Co-suspect product PAXLOVID for COVID-19 treatment, concurrent medical conditions included Migraine and Drug allergy who experienced the unexpected  event of COVID-19 36 days after  receiving a  dose of  mRNA-1273 vaccine. On 17-May-2022, SARS-CoV-2 test: negative; On 21-May-2022, SARS-CoV-2 test: positive  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C; Possible administration of invalid dose to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data (between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided (057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A). Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) outcome was unknown.        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 there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There was no temperature data for that storage unit.  Treatment information was not reported.