chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle pain; Joint pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Shingrix. On 19th May 2022, less than a day after receiving Shingrix, the patient experienced muscle pain and joint pain. On an unknown date, the outcome of the muscle pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and joint pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's Comment: The patient's wife reported this case. The patient received dose of Shingrix vaccine yesterday (day before reporting) and experienced joint and muscle pain which had not resolved.  The reporter did not consent to follow-up. Additional supportive information: This case has been linked with case US2022081903, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081903:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hemiplegia
Clinical narrative: Paralysis on one half of her whole body; Dizzy; This case was reported by a consumer via call center representative and described the occurrence of paralysis one side of body in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included narcolepsy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced paralysis one side of body (serious criteria GSK medically significant) and dizziness. On an unknown date, the outcome of the paralysis one side of body and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the paralysis one side of body and dizziness to be related to Shingrix.     Additional Information: GSK receipt date: 20-May-2022 Reporter's comment: The patient self reported this case. She received a dose of Shingrix about 18 months ago (exact date not provided). She noted that after receiving the vaccination, she became dizzy and experienced paralysis on one half of her whole body.  Her health care professional referred her to the emergency room which she did visit and they did not come to any conclusion and the symptoms did resolve. She also stated she never received the second dose due to the issue experienced and was not sure if she would. Referred to health care professional and provided medical advise disclaimer. The reporter consented to follow up. Note: There is discrepancy regarding the event outcome query was raised for the same.
Age: 0.5
Sex: F
Vaccine: JEV1
Symptoms: Fatigue
Clinical narrative: Tired looking; Mistakenly given 2 pediatric Ixiaro doses within 3 days; The following information was received from healtcare professional on 02 June 2021.  A vaccinee (no identifiers provided) received two pediatric doses of IXIARO (Japanese encephalitis vaccine, batch number not provided) within three days [instead of 28 days apart, which constitutes an accidential overdose].   ---  Follow up information 1 was received from healtcare professional on 10 June 2021.  Relevant vaccinee information included age and gender.  Relevant current medical history included atopic dermatitis rash.  The 6 month old girl also experienced tired looking one day after vaccination of the second dose (batch number JEV19H22E). Outcome of the event was not provided.; Sender's Comments: Assessment of 22 June 2021:  Causality assessment not applicable, as no adverse event occurred.  ---  Assessment of 20 July 2021:  Causality assessed as possibly related for the newly reported event tired looking, as this event is well known for IXIARO, indicative of a systemic vaccination reaction and the time to onset is plausible.
Sex: M
Vaccine: COVID19
Symptoms: Eye discharge, Hypersensitivity
Clinical narrative: GREEN OUT OF MY EYES; ALLERGY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: blurry eyes, and pollen allergy. The patient previously received with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 04A21A, expiry: UNKNOWN) dose was not reported, 1 in total, administered on 02-APR-2021 for prophylactic vaccination. 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 1). The patient received additional dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, 1 in total, administered on 02-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAY-2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced allergy (dose number in series 2) which lasted for one day but would still follow up with his doctor to make sure it was an actual allergy. On an unspecified date, the patient experienced green out of his eyes (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergy on 10-MAY-2022, and the outcome of green out of my eyes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dysgeusia, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; METALLIC TASTE IN THE MOUTH; DIARRHEA; This spontaneous report received from a patient via other company (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: anemia, anxiety disorder, and penicillin allergy. On 16-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered to right arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 29-OCT-2021, the patient received non-company suspect vaccine tozinameran (Pfizer BioNTech vaccine) (dose number in series: 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered to right arm for prophylactic vaccination. Concomitant medications included lorazepam. On an unspecified date, the patient experienced covid-19 (coded as suspected covid-19) (dose number in series: 2) which indicated suspected clinical vaccination failure (dose number in series: 1). On 12-MAY-2022, the patient was prescribed with non-company suspect drug Paxlovid (batch number: Fy7031) dose and frequency were not reported for covid-19. On 13-MAY-2022, the patient experienced metallic taste in the mouth, and diarrhea (dose number in series: 2). On an unspecified date in MAY-2022, the patient took the last dose of Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient was recovering from metallic taste in the mouth, and diarrhea, and the outcome of suspected covid-19 and suspected 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 was requested.; Sender's Comments: V0- 20220541580 -COVID-19 VACCINE Ad26.COV2.S- Suspected Clinical Vaccination failure- The event(s) has a unknown/unclear 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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Fatigue, Inappropriate schedule of product administration, Muscle spasms, Off label use
Clinical narrative: COULD NOT HOLD IN POOP; CRAMPS IN BUTT MUSCLE; TIRED; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Crohn's disease, and other pre-existing medical conditions included: No reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, and dose was not reported, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. No concomitant medications were reported.  On 03-MAY-2021, the patient had off label use, and inappropriate schedule of vaccine administered. On an unspecified date, the patient experienced could not hold in poop, cramps in butt muscle, and tired. 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 tired, and could not hold in poop, and the outcome of cramps in butt muscle, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Weight, Weight increased
Clinical narrative: WEIGHT GAINED BY 20 POUNDS; COVID-19 RECURRENT; This spontaneous report received from a patient concerned a 55 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on unspecified date for covid-19 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. The patient received Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. On an unspecified date, the patient experienced weight gained by 20 pounds, and got covid twice before and after getting vaccination (covid-19 recurrent) (Dose number in series 1). Laboratory data (dates unspecified) included: Weight (NR: not provided) Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the weight gained by 20 pounds and covid-19 recurrent was not reported. The patient received additional booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, and batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer, Inc.) concerned a 48 year old white female of an unspecified ethnicity.   The patient's height, and weight were not reported. The patient's past medical history included: cancer survivor, and concurrent conditions included: asthma, penicillin allergy, and sulfa drugs allergy. The patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination (dose number in series 1). The patient received second dose with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included estradiol.  On 2022, the patient experienced suspected covid-19 infection (dose number in series 2) and had suspected clinical vaccination failure (dose number in series 2). On 1-MAY-2022, patient was treated with Paxlovid for covid-19 and last administration was taken on 6-MAY-2022. On 15-MAY-2022, patient experienced resurgence of covid-19 after treating with Paxlovid within 1 week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not 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 and reference number requested.; Sender's Comments: V0: 20220542436-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear 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: Atrial fibrillation
Clinical narrative: A-FIB (ATRIAL FIBRILLATION); This spontaneous report received from a consumer via a company representative concerned a 58 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient never had problem before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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 following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced A-fib (atrial fibrillation), and was hospitalized (date unspecified) for two days (spent two nights in the hospital). It was reported that the patient heart was out of control. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a-fib (atrial fibrillation) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220542320-COVID-19 VACCINE AD26.COV2.S-A-FIB (ATRIAL FIBRILLATION). 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: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: DAMAGED FOR LIFE; This spontaneous report received from a consumer via social media via a company representative concerned a male of 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, and batch number were not reported, expiry date: 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 damaged for life. Reporter stated that "your covid vaccine nearly killed my brother who is now damaged for life. Anything with your name on it stays on the store shelf. Murders" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of damaged for life was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20220545174-covid-19 vaccine ad26.cov2.s -Damaged for life. 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: General physical health deterioration, Illness
Clinical narrative: HEALTH FAILING; GETTING SICKER BY THE DAY; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced health failing, and getting sicker by the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the health failing and getting sicker by the day was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: ARTHRALGIA AGGRAVATED/MORE SHOULDER PAIN; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Age at time of vaccination 49 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced arthralgia aggravated/more shoulder pain. Treatment medications (dates unspecified) included: methotrexate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from arthralgia aggravated/more shoulder pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Depression, Diarrhoea, Laboratory test, Social problem, Weight
Clinical narrative: EPISODES OF WATERY DIARRHEA/CHRONICITY PROMPTING HIM TO GO TO THE TOILET AROUND 10 TIMES A DAY; DEPRESSION; LOST AROUND 20 POUNDS OF WEIGHT; SOCIAL ISSUES; This spontaneous report received from a parent concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy man. 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 01-JUL-2021, Laboratory data included: Laboratory test (NR: not provided) Unknown. On an unspecified date, the patient experienced lost around 20 pounds of weight, depression, social issues, and episodes of watery diarrhea/chronicity prompting him to go to the toilet around 10 times a day. Laboratory data (dates unspecified) included: Weight (NR: not provided) lost 20 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from episodes of watery diarrhea/chronicity prompting him to go to the toilet around 10 times a day, and lost around 20 pounds of weight, and the outcome of depression and social issues was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: EPISODES OF WATERY DIARRHEA/CHRONICITY PROMPTING HIM TO GO TO THE TOILET AROUND 10 TIMES A DAY; DEPRESSION; LOST AROUND 20 POUNDS OF WEIGHT; SOCIAL ISSUES; This spontaneous report received from a parent concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy man. 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 01-JUL-2021, Laboratory data included: Laboratory test (NR: not provided) Unknown. On an unspecified date, the patient experienced lost around 20 pounds of weight, depression, social issues, and episodes of watery diarrhea/chronicity prompting him to go to the toilet around 10 times a day. Laboratory data (dates unspecified) included: Weight (NR: not provided) lost 20 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from episodes of watery diarrhea/chronicity prompting him to go to the toilet around 10 times a day, and lost around 20 pounds of weight, and the outcome of depression and social issues was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: EIGHT BLOOD CLOTS; This spontaneous report received from a patient via a company representative through social media concerned a patient of an 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, batch number: unknown, and expiry: UNKNOWN) dose, 1 total, 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 got eight blood clots. Reported stated that ''I am vaccinated and that's how got 8 blood clots, thank you very much for being a genius". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eight blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220547431-COVID-19 VACCINE AD26.COV2.S-Eight blood clots. 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: Pain
Clinical narrative: DYING FROM THE SEVERITY OF THE PAIN; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced dying from the severity of the pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dying from the severity of the pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H218) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EN6205 Location of injection: Arm Right) on 02-Mar-2021 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: ED6955 Location of injection: Arm Right) on 23-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 10-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive home COVID test. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication of the patient was not reported. It was also reported that, the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  On 15-May-2022, on the 5th day after final dose of Paxlovid, the patient had rebound of symptoms.  Company Comment: This is a spontaneous case concerning  a  patient of unknown age and gender with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on an unknown day after the third dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test. Patient was treated with nirmatrelvir, ritonavir of unknown dose and frequency. The events was reported as resolving. It was noted that 5th day of the final dose of nirmatrelvir, ritonavir which was on May 15, 2022, patient had rebound of symptoms and tested positive for SARS COV -2 Test. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  patient of unknown age and gender with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on an unknown day after the third dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test. Patient was treated with nirmatrelvir, ritonavir of unknown dose and frequency. The events was reported as resolving. It was noted that 5th day of the final dose of nirmatrelvir, ritonavir which was on May 15, 2022, patient had rebound of symptoms and tested positive for SARS COV -2 Test. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: One week after completing the medication my Covid system symptoms returned and I tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (One week after completing the medication my Covid system symptoms returned and I tested positive for Covid) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Levaquin and Biaxin. Past adverse reactions to the above products included Allergy with Biaxin and Levaquin. Concurrent medical conditions included Hypertension.    On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced COVID-19 (One week after completing the medication my Covid system symptoms returned and I tested positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 07-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (One week after completing the medication my Covid system symptoms returned and I tested positive for Covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. Device Date was reported as 16-May-2022. Company comment-This spontaneous case concerns a female patient aged 65 years, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 approximately 8 months 13 days after third dose of mRNA-1273 vaccine. Patient was being treated with Paxlovid (NIRMATRELVIR, RITONAVIR) for Covid from 3rd to 7th May2022, one week after completing the medication covid symptoms recurred, Covid antigen test done (13th May 2022) was positive. Treated in walk in clinic with over the counter medication. Outcome of the event was not resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient aged 65 years, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 approximately 8 months 13 days after third dose of mRNA-1273 vaccine. Patient was being treated with Paxlovid (NIRMATRELVIR, RITONAVIR) for Covid from 3rd to 7th May2022, one week after completing the medication covid symptoms recurred, Covid antigen test done (13th May 2022) was positive. Treated in walk in clinic with over the counter medication. Outcome of the event was not resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date; Dose 1 taken on 28-Feb-2022 and Dose 2 Taken on 08-Apr-2022; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 28-Feb-2022 and Dose 2 Taken on 08-Apr-2022) in an 84-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 084J21A and 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date). 08-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 28-Feb-2022 and Dose 2 Taken on 08-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 28-Feb-2022 and Dose 2 Taken on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. The vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. The patient had not reported adverse reaction.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-569767 (Patient Link).
Sex: U
Vaccine: COVID19, UNK
Symptoms: Dysgeusia, Feeling abnormal, Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: Terrible throat pain; Taste is indescribable/mouth tasted like chemicals/ 6 month old rotten grapefruit; Something else that did not know how to put in words; Patient felt like a metal ball lodged in the bottom of throat and moved around every time swallowed or moved head; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Terrible throat pain), DYSGEUSIA (Taste is indescribable/mouth tasted like chemicals/ 6 month old rotten grapefruit), FEELING ABNORMAL (Something else that did not know how to put in words) and OROPHARYNGEAL DISCOMFORT (Patient felt like a metal ball lodged in the bottom of throat and moved around every time swallowed or moved head) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    No Medical History information was reported.   On 15-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Terrible throat pain), DYSGEUSIA (Taste is indescribable/mouth tasted like chemicals/ 6 month old rotten grapefruit), FEELING ABNORMAL (Something else that did not know how to put in words) and OROPHARYNGEAL DISCOMFORT (Patient felt like a metal ball lodged in the bottom of throat and moved around every time swallowed or moved head). At the time of the report, OROPHARYNGEAL PAIN (Terrible throat pain), DYSGEUSIA (Taste is indescribable/mouth tasted like chemicals/ 6 month old rotten grapefruit), FEELING ABNORMAL (Something else that did not know how to put in words) and OROPHARYNGEAL DISCOMFORT (Patient felt like a metal ball lodged in the bottom of throat and moved around every time swallowed or moved head) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information were provided.  Device Date was given as 16May2022.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, COVID-19
Clinical narrative: Felt full effect of COVID, same as day 1; asthma seemed to be worse; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Felt full effect of COVID, same as day 1) and ASTHMA (asthma seemed to be worse) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy (Drug name was not reported(past drug history)). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 04-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2022, the patient experienced COVID-19 (Felt full effect of COVID, same as day 1) and ASTHMA (asthma seemed to be worse). At the time of the report, COVID-19 (Felt full effect of COVID, same as day 1) and ASTHMA (asthma seemed to be worse) had not resolved.            It was reported that patient previously received a COVID-19 vaccine. Patient was taking other medications or products within 2 weeks of starting COVID-19 treatment. Patient received covid-19 treatment from 05-May-2022 to 09-May-2022 with unknown Pfizer medication. Device date was reported as 17-May-2022.  Company Comment:  This spontaneous case concerns a 63-year-old female patient with concurrent Asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19 (Felt full effect of COVID, same as day 1), that occurred 2 months and 11 days after receiving mRNA-1273 Vaccine as fourth dose in the COVID-19 vaccination series.  Patient underwent COVID-19 treatment for 5 days with an unspecified Pfizer product 10 days prior to the onset of the event.  Six days after completion of COVID-19 treatment, patient reportedly experienced the full effect of COVID-19 as when she had it on day 1 along with worsened asthma. No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient. The concurrent asthma could be considered as a contributory factor to COVID-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with concurrent Asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19 (Felt full effect of COVID, same as day 1), that occurred 2 months and 11 days after receiving mRNA-1273 Vaccine as fourth dose in the COVID-19 vaccination series.  Patient underwent COVID-19 treatment for 5 days with an unspecified Pfizer product 10 days prior to the onset of the event.  Six days after completion of COVID-19 treatment, patient reportedly experienced the full effect of COVID-19 as when she had it on day 1 along with worsened asthma. No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient. The concurrent asthma could be considered as a contributory factor to COVID-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 76-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 75 years for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 08Feb2021 as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM2" (unspecified if ongoing); "Interchange of vaccine products", start date: 02Nov2021, stop date: 02Nov2021, notes: Dose 1 and Dose 2 Moderna vaccine. Dose 3 Pfizer vaccine. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Diagnosed with COVID 06May. Therapeutic measures were taken as a result of Covid-19. Clinical course included: No known allergies. Unknown whether patient took other medication in 2 weeks of vaccination. Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 76-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 75 years for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 08Feb2021 as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM2" (unspecified if ongoing); "Interchange of vaccine products", start date: 02Nov2021, stop date: 02Nov2021, notes: Dose 1 and Dose 2 Moderna vaccine. Dose 3 Pfizer vaccine. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Diagnosed with COVID 06May. Therapeutic measures were taken as a result of Covid-19. Clinical course included: No known allergies. Unknown whether patient took other medication in 2 weeks of vaccination. Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: Anal abscess, Influenza like illness, Sinus disorder, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: abscess on anal; sinus issues; flu like symptoms; trickle of blood at injection site; sometimes caused stinging; This spontaneous case was reported by a consumer and describes the occurrence of ANAL ABSCESS (abscess on anal) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ANAL ABSCESS (abscess on anal) (seriousness criterion medically significant), SINUS DISORDER (sinus issues), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE HAEMORRHAGE (trickle of blood at injection site) and VACCINATION SITE PAIN (sometimes caused stinging). At the time of the report, ANAL ABSCESS (abscess on anal), SINUS DISORDER (sinus issues), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE HAEMORRHAGE (trickle of blood at injection site) and VACCINATION SITE PAIN (sometimes caused stinging) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was provided.  Company comment: This spontaneous case concerns a 65-year-old male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Anal abscess unknown days after receiving an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Medical judgement.; Sender's Comments: This spontaneous case concerns a 65-year-old male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Anal abscess unknown days after receiving an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Medical judgement.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate irregular, Insomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (chest tightness), HEART RATE IRREGULAR (irregular heartbeat) and INSOMNIA (insomnia) in a 39-year-old female patient who received mRNA-1273 (Spikevax) 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 DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (chest tightness), HEART RATE IRREGULAR (irregular heartbeat) and INSOMNIA (insomnia). At the time of the report, DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (chest tightness), HEART RATE IRREGULAR (irregular heartbeat) and INSOMNIA (insomnia) 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 and treatment medication was not reported. COMPANY COMMENT: This is a spontaneous case concerning a 39-years-old female patient, with no medical history, who experienced unexpected non serious AESI event of hear rate irregular, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. Additionally non serious events dysponea, chest discomfort, and insomnia. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 39-years-old female patient, with no medical history, who experienced unexpected non serious AESI event of hear rate irregular, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. Additionally non serious events dysponea, chest discomfort, and insomnia. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.