chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Radiculitis brachial
Clinical narrative: JANSSEN SARS COVID19 VACCINE INDUCED BRACHIAL NEURITIS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. 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 lost 90 percent function of left arm in 10 days and dianosed with janssen SARS (Severe acute respiratory syndrome) covid19 vaccine induced brachial neuritis. His left thumb remained wet noodle. It was reported as "Lost 90 percent function of left arm in 10 days. Diagnosed with Janssen sarscovid19 vaccine induced brachial neuritis. Left thumb remains wet noodle. Their Team won't call back. Is their vaccine even legal to inject anymore" and "Changed my life for the worse in a week. Absolutely toxic." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from janssen sars covid19 vaccine induced brachial neuritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221229031- Janssen sars covid19 vaccine induced Brachial neuritis. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Headache, Hot flush
Clinical narrative: MENSTRUAL CYCLES STOPPED FOR MORE THAN A YEAR; HOT FLASHES; REPETITIVE HEADACHES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. 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 menstrual cycles stopped for more than a year, hot flashes, and repetitive headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstrual cycles stopped for more than a year, and the outcome of hot flashes and repetitive headaches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. 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 covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test Positive, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection. This report was non-serious. This report was associated with product quality complaint: 90000263135.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Off label use
Clinical narrative: SICK; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  The patient got sick following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  The patient got sick following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 3) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis which was associated with off label dosing frequency (Dose number in series 3). 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 sick (Dose number in series 3).  The reporter stated that " Johnson and Johnson I got the. Johnson one shot, then I got the booster, then I got a 2nd booster! Everyone made me sicker than a dog".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and sick was not reported. This report was non-serious. This case is linked with 20221232989 and 20221233290 as a same patient.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously 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, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. On an unspecified date, the patient experienced sick (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacture) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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 sick (dose number in series 2). It was reported that, "Johnson and Johnson I got the. Johnson one shot, then I got the booster, then I got a 2nd booster. Everyone made me sicker than a dog." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.  This case, involving the same patient is linked to 20221232897 and 20221233290.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient reports Adverse Reactions; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient reports Adverse Reactions) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient reports Adverse Reactions). At the time of the report, IMMUNISATION REACTION (Patient reports Adverse Reactions) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient received first dose of Moderna on 14-Jan-2021, Lot number 012L20A. Second dose of Moderna on 11-Feb-2022, Lot number 031L20A. Fourth dose (second booster) of Moderna on 02-Jun-2022, Lot number 054A22A.  After fifth dose of Moderna bivalent patient experienced adverse reaction. Treatment medication was not reported.   This case was linked to MOD-2022-685772 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt little tired) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic. Concomitant products included CORTISONE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt little tired). At the time of the report, FATIGUE (Felt little tired) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported.   This case was linked to MOD-2022-686103 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Friend who passed away after having the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Friend who passed away after having the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was performed, but no results were provided.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered DEATH (Friend who passed away after having the Moderna vaccine) to be related.    Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who died after receiving a dose of mRNA-1273.222 vaccine, latency is unknown. An autopsy was performed and it was reported that it may have been a result of the vaccine but no further information was provided. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who died after receiving a dose of mRNA-1273.222 vaccine, latency is unknown. An autopsy was performed and it was reported that it may have been a result of the vaccine but no further information was provided. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.; Reported Cause(s) of Death: may have been a result of the vaccine
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort
Clinical narrative: Patient had some issues with her heart after receiving her first booster dose one year ago; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (Patient had some issues with her heart after receiving her first booster dose one year ago) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 11-Feb-2021 and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISCOMFORT (Patient had some issues with her heart after receiving her first booster dose one year ago) (seriousness criterion hospitalization prolonged). At the time of the report, CARDIAC DISCOMFORT (Patient had some issues with her heart after receiving her first booster dose one year ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took 2nd dose of Moderna booster 1 month later of 1st dose. No concomitant medication information was provided. Patient went to ER and after 5 hours patient went home feeling better. No treatment medication was provided.  Company comment: This is a spontaneous case 73 years old female patient, with no relevant medical history, who experienced unexpected serious (Hospitalization) event of cardiac discomfort (reported as Patient had some issues with her heart after receiving her first booster dose one year ago), which occurred unspecified days after first booster dose of mRNA-1273 vaccine. It is reported that patient went to Emergency and after 5 hours patient went to home and feeling better. At time of reporting outcome of the event is unknown. No further information on risk factors, concurrent illness, clinical course, treatment given was available in the report. Elderly age could be confounding for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case 73 years old female patient, with no relevant medical history, who experienced unexpected serious (Hospitalization) event of cardiac discomfort (reported as Patient had some issues with her heart after receiving her first booster dose one year ago), which occurred unspecified days after first booster dose of mRNA-1273 vaccine. It is reported that patient went to Emergency and after 5 hours patient went to home and feeling better. At time of reporting outcome of the event is unknown. No further information on risk factors, concurrent illness, clinical course, treatment given was available in the report. Elderly age could be confounding for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: bleeding; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (bleeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had bleeding and the patient had to go to the hospital. It happened over a year ago.  Treatment information was not provided.  Company comment: This is a spontaneous case regarding a patient of an unknown age and gender, with no reported medical history, who received a dose of mRNA-1273 vaccine and experienced unexpected, medically significant event of Haemorrhage. Vaccination date and onset date of the event were not provided, latency cannot be assessed. According to the report, approximately a year ago, patient experienced bleeding and had to go to the hospital. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case regarding a patient of an unknown age and gender, with no reported medical history, who received a dose of mRNA-1273 vaccine and experienced unexpected, medically significant event of Haemorrhage. Vaccination date and onset date of the event were not provided, latency cannot be assessed. According to the report, approximately a year ago, patient experienced bleeding and had to go to the hospital. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Fatigue, Feeling abnormal
Clinical narrative: felt really bad; not myself, no energy; bedridden; I'm worn out doing laundry; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really bad), ASTHENIA (not myself, no energy), BEDRIDDEN (bedridden) and FATIGUE (I'm worn out doing laundry) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose: 1, Lot number: 035C21A) on 15-May-2021, Moderna COVID-19 Vaccine (Dose: 2, Lot number: 0090214) on 15-Jun-2021, Moderna COVID-19 Vaccine (Dose: 3 and Lot number: 022521A) on 13-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Asthma, Allergy to antibiotic (Allergic to Bactrim) and Sulfonamide allergy (Allergic to sulfa). Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.    On 10-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Dec-2022, the patient experienced FEELING ABNORMAL (felt really bad), ASTHENIA (not myself, no energy), BEDRIDDEN (bedridden) and FATIGUE (I'm worn out doing laundry). At the time of the report, FEELING ABNORMAL (felt really bad) and ASTHENIA (not myself, no energy) outcome was unknown and BEDRIDDEN (bedridden) and FATIGUE (I'm worn out doing laundry) was resolving.            Patient stated that, on Sunday he felt really bad, the previous vaccine doses boosted his immune system, after next vaccination he was bedridden, not himself, and had no energy. Today, he was doing work around the house, and he was worn out doing laundry. He further stated, this dose was wow, holly moly. He was 75 percent better but not his normal self. He was hoping he would be protected.  No treatment medications were reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Caller states that her son had a fever for one or two days after receiving his primary series of the Moderna COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Caller states that her son had a fever for one or two days after receiving his primary series of the Moderna COVID-19 vaccine) in a 29-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy to nuts and Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Caller states that her son had a fever for one or two days after receiving his primary series of the Moderna COVID-19 vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Caller states that her son had a fever for one or two days after receiving his primary series of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.   The reporter did not remember fully, but might have given Tylenol to her son for the fever.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Skin exfoliation, Swelling face
Clinical narrative: swelling of face; 6 hrs later, patient experienced swelling of face, & her eyes; face pealed; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING FACE (swelling of face), EYE SWELLING (6 hrs later, patient experienced swelling of face, & her eyes) and SKIN EXFOLIATION (face pealed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052B22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Lung disease. Concomitant products included PREDNISONE for an unknown indication.    On 18-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced SWELLING FACE (swelling of face), EYE SWELLING (6 hrs later, patient experienced swelling of face, & her eyes) and SKIN EXFOLIATION (face pealed). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (swelling of face), EYE SWELLING (6 hrs later, patient experienced swelling of face, & her eyes) and SKIN EXFOLIATION (face pealed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported patient received 1st dose of primary series. 6hours later patient experienced swelling of face and her eyes and face pealed. Patient had prednisone at home.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Bivalent dose was administered as the 1st dose in primary series; No Adverse Reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Bivalent dose was administered as the 1st dose in primary series) and NO ADVERSE EVENT (No Adverse Reaction) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Bivalent dose was administered as the 1st dose in primary series) and NO ADVERSE EVENT (No Adverse Reaction). At the time of the report, WRONG PRODUCT ADMINISTERED (Bivalent dose was administered as the 1st dose in primary series) and NO ADVERSE EVENT (No Adverse Reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Reaction) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Bivalent dose was administered as the 1st dose in primary series).    Concomitant medications were not reported.  The Moderna Covid-19 Bivalent dose was administered as the 1st dose in the primary series. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got Covid after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid after being vaccinated) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got Covid after being vaccinated). At the time of the report, COVID-19 (got Covid after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The reporter stated that the niece of the reporter got Covid after being vaccinated. Both of them  got a very mild case. But the children of theirs who are 10 and 6 did not get the vaccine. No treatment medication was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Moderna primary series for ages 6 years through 11 years bivalent booster dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Moderna primary series for ages 6 years through 11 years bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Moderna primary series for ages 6 years through 11 years bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Moderna primary series for ages 6 years through 11 years bivalent booster dose) and NO ADVERSE EVENT (No adverse event) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Moderna primary series for ages 6 years through 11 years bivalent booster dose). Concomitant medications were not reported. 7 adult patients received the vaccine primary series for ages 6 years through 11 years bivalent booster dose. No treatment information was provided by the reporter.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No Adverse Event; the dose came from a vial punctured 23 hours ago; the dose came from a vial punctured 23 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (the dose came from a vial punctured 23 hours ago), EXPIRED PRODUCT ADMINISTERED (the dose came from a vial punctured 23 hours ago) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (the dose came from a vial punctured 23 hours ago). In December 2022, the patient experienced PRODUCT STORAGE ERROR (the dose came from a vial punctured 23 hours ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (the dose came from a vial punctured 23 hours ago), EXPIRED PRODUCT ADMINISTERED (the dose came from a vial punctured 23 hours ago) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (the dose came from a vial punctured 23 hours ago) and EXPIRED PRODUCT ADMINISTERED (the dose came from a vial punctured 23 hours ago).    No relevant concomitant medications were reported. Patient received Moderna Covid-19 vaccine for her second Moderna Covid-19 vaccine series. No treatment medication reported.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nipple pain, Paraesthesia, Scratch
Clinical narrative: pain in the right nipple/ pain in the nipple feels like a first degree burn; he felt scratchy on knee caps; Tingly legs; swelling (Lymph node) to the right of the nipple; This spontaneous case was reported by a consumer and describes the occurrence of NIPPLE PAIN (pain in the right nipple/ pain in the nipple feels like a first degree burn), SCRATCH (he felt scratchy on knee caps), PARAESTHESIA (Tingly legs) and LYMPHADENOPATHY (swelling (Lymph node) to the right of the nipple) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.    On 14-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced NIPPLE PAIN (pain in the right nipple/ pain in the nipple feels like a first degree burn), SCRATCH (he felt scratchy on knee caps), PARAESTHESIA (Tingly legs) and LYMPHADENOPATHY (swelling (Lymph node) to the right of the nipple). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NIPPLE PAIN (pain in the right nipple/ pain in the nipple feels like a first degree burn) and LYMPHADENOPATHY (swelling (Lymph node) to the right of the nipple) had not resolved and SCRATCH (he felt scratchy on knee caps) and PARAESTHESIA (Tingly legs) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient stated that this was patient's 4th shot. Patient did not have his vaccination card handy. About a week after the bivalent booster, felt scratchy on knee caps and tingly legs. Patient used Topical Cortisone, and it went away in a couple of days. But what was still bothering him was pain in the right nipple and swelling (Lymph node) to the right of the nipple. The pain in the nipple feels like a first-degree burn. He had seen a doctor and he was going for a sonogram.   This case was linked to MOD-2022-686252 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Refractory immune thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Refractory immune thrombocytopenia) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Refractory immune thrombocytopenia) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Refractory immune thrombocytopenia) 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 medications were not reported.  Patient experienced epistaxis, extensive skin rash and refractory immune thrombocytopenia after the first dose of Moderna vaccine.  Company Comment: This is a literature non-study case concerning a 65 year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI of Immune thrombocytopenia, which occurred after the first dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Patient developed epistaxis, extensive skin rash and Refractory immune thrombocytopenia. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment: This is a literature non-study case concerning a 65 year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI of Immune thrombocytopenia, which occurred after the first dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Patient developed epistaxis, extensive skin rash and Refractory immune thrombocytopenia. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 27-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient developed myocarditis 3 days after 2nd dose of mRNA-1273 (Moderna) vaccine.  Company Comment: This literature non-study case concerns a 27-year-old female patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred 3 days after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.           This case was linked to US-MODERNATX, INC.- MOD-2022-686179 (Linked Report).; Sender's Comments: This literature non-study case concerns a 27-year-old female patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred 3 days after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.- MOD-2022-686179:(26 YO male)
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received these vaccines post excursion; No Adverse event; Patient received these vaccines post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received these vaccines post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received these vaccines post excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received these vaccines post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received these vaccines post excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion).    No concomitant medications were reported.  The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown. The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F  for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state. The patient received the vaccine post excursion and remaining vials were discarded.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion; No Adverse event; Patient received these vaccines post excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported. The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown. The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F  for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state. The patient received the vaccine post excursion and remaining vials were discarded.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion; No Adverse event; Patient received these vaccines post excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported. The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown. The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state. The patient received the vaccine post excursion and remaining vials were discarded.  The vial did not undergo any temperature excursions. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion; No Adverse event; Received these vaccines post excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion) had not resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported. The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown.The patient received the vaccine post excursion and remaining vials were discarded.  The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.