chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: mild pain at injection site; fever; mild shivering; lethargy; nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date the patient received 1st dose of Shingrix. Refer case US2022AMR156166).   On 25th October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, shivering, lethargy and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, shivering, lethargy and nausea were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, shivering, lethargy and nausea to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR156166   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter was the patient, who received her second dose of SHINGRIX 2 days ago.  The reporter stated that she states that since her 2nd dose, she has experienced a fever, shivering, lethargy, pain at the injection site and nausea.  The reporter also stated that states that these symptoms are worse than her first dose.  The symptoms after her second dose have not yet resolved. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR156166:Same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Nasopharyngitis, Rash papular, Sinusitis
Clinical narrative: non-itchy, bumpy rash on right forearm; cold progressed; sinus infection; cough; This case was reported by a consumer via call center representative and described the occurrence of cold in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included sinus infection, shingles and bronchitis. Concurrent medical conditions included runny nose and common cold.   On 24th October 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 24th October 2022, less than a day after receiving Shingrix, the patient experienced cold, sinus infection and cough. On 27th October 2022, the patient experienced papular rash. The patient was treated with antibiotics nos (Antibiotic (Active Ingredient Unknown)). On an unknown date, the outcome of the cold, sinus infection, cough and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the cold, sinus infection, cough and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The patient was the reporter.  The patient received her second Shingrix dose in her right deltoid on 24-OCT-2022.  The reporter mentioned prior to the vaccination she had a runny nose and a cold.  After the vaccination, on 24-OCT-2022, the cold progressed and she developed a sinus infection and cough. The patient's physician was prescribed an unknown antibiotic to treat the sinus infection.  On 27-OCT-2022, she developed a non-itchy, bumpy rash on her right forearm. The reporter give consent to follow up.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Boostrix administered  IV; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 63-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 23rd October 2022, the patient received Boostrix (intravenous). On 23rd October 2022, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The adverse event contains all reported information. The reporter unable to provide any additional information at this time. The reporter gave consented for safety team follow-up. Additional supportive information: The patient received Bostrix via intravenous route, which led to Intramuscular formulation administered by other route.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose administered to an adult patient; Pediatric dose administered to an adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 29-year-old female patient who received HBV (Engerix B pediatric) (batch number D294, expiry date 19th April 2024) for prophylaxis.   On 27th October 2022, the patient received Engerix B pediatric. On 27th October 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer 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, expiry: UNKNOWN) 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 experienced blood clots and had surgery to remove blood clots. It was reported as "Horrible company! My family member just got its COVID vaccine and just had surgery to remove blood clots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221059477-Blood clots. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (6) of an unspecified age, sex, race and ethnicity.  . The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) 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 6 patients died after getting the vaccine. It was reported as "The only people that my husband and I know that died during this pandemic time were 6 people that died after getting the jab". On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221100410.; Sender's Comments: V0:20221101100-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NEGATIVE SIDE EFFECTS; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnic origin. 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 not reported, batch number: unknown, expiry: UNKNOWN) 1 in total, 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 negative side effects, and was hospitalized (date unspecified). The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. It was reported that, "Hey my wife got the vaccine and immediately had negative side effects, which required hospitalization and thousands of dollars in medical bills. Can you help us out". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221101633- negative side effects. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID- 19 INFECTION; This spontaneous report received from a health care professional concerned a 24 year old female of an unspecified race. Initial information was processed along with the additional information received on 03-NOV-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, history of svt (Supraventricular tachycardia) penicillin allergy, and drug allergy (Amoxicillin, Augmentin, Tramadol, Hydrocodone, Codeine,). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 22 years old. No concomitant medications were reported. On 09-OCT-2021, the patient experienced covid-19 symptoms. On 11-OCT-2021 tested positive for covid-19 (Confirmed clinical vaccination failure) (Dose number in series 1). On 17-OCT-2021 tested negative for covid-19. On 19-OCT-2021, Covid symptoms rebound, Sore throat, headache, Congestion (Confirmed covid-19 infection) (Dose number in series 1). On 20-OCT-2021 and 21-OCT-2021 test was positive. The patient received Non-company suspect vaccine Tozinameran (Pfizer Biontech covid-19 vaccine) (Dose number in series 2) ( form of admin, route of admin, dose were not reported, batch number: EW0196 expiry: UNKNOWN, administered to left arm on 29-NOV-2021 for covid-19 prophylaxis and had Revaccination with different covid-19 vaccine (Dose number in series 2) It was unknown whether patient had any adverse events following covid-19 vaccine tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 2). The patient was treated with Paxlovid (form of admin, route of admin were not reported, batch number: GE8833 and expiry: UNKNOWN) dose was not reported administered from 12-OCT-2022 to 15-OCT-2022 for treatment of covid-19. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and treatment with Paxlovid was discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000257779; Sender's Comments: V0: 20221104276- Confirmed clinical vaccination failure- The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Myocarditis
Clinical narrative: chronic heart condition; Benign Myocarditis reaction from Moderna C19 vaccine is now chronic heart condition; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (chronic heart condition) and MYOCARDITIS (Benign Myocarditis reaction from Moderna C19 vaccine is now chronic heart condition) in a 38-year-old male 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 CARDIAC DISORDER (chronic heart condition) (seriousness criterion medically significant) and MYOCARDITIS (Benign Myocarditis reaction from Moderna C19 vaccine is now chronic heart condition) (seriousness criterion medically significant). The patient was treated with COLCHICINE ongoing since an unknown date at a dose of UNK, Doubled. At the time of the report, CARDIAC DISORDER (chronic heart condition) had not resolved and MYOCARDITIS (Benign Myocarditis reaction from Moderna C19 vaccine is now chronic heart condition) outcome was unknown.            Concomitant medication was not provided. It was explained by cardiologist as patient had  20% chance of living the next 9years.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 38-year-old male patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, and the unexpected and serious (due to medically significant) event of Cardiac disorder, which occurred on an unknown date after an unspecified dose of mRNA-1273.222 vaccine. Patient was told by his cardiologist that his benign myocarditis reaction from Moderna vaccine was now a chronic heart condition, and that he has 20% chance of living the next 9 years. He also doubled his colchicine. No information disclosed about diagnostic tests performed. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 38-year-old male patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, and the unexpected and serious (due to medically significant) event of Cardiac disorder, which occurred on an unknown date after an unspecified dose of mRNA-1273.222 vaccine. Patient was told by his cardiologist that his benign myocarditis reaction from Moderna vaccine was now a chronic heart condition, and that he has 20% chance of living the next 9 years. He also doubled his colchicine. No information disclosed about diagnostic tests performed. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/Headache/ Fever; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19/Headache/ Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 012M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (2 weeks ago (from 01Nov2022)). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Hypertension, Diabetes, Asthma and Drug allergy (Levaquin).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced COVID-19 (COVID-19/Headache/ Fever). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of took Paxlovid 4 days. At the time of the report, COVID-19 (COVID-19/Headache/ Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: Positive.         No concomitant medication information was provided.  Patient did not experience a similar event in the past.  Patient took Paxlovid 4 days and not feel so good after taking it so she did not complete the 5 days.   This case was linked to MOD-2022-667343 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Pyrexia, Thrombosis
Clinical narrative: heavy blood clots; really heavy bleeding during their period; everything else was as expected like fever; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (heavy blood clots), HEAVY MENSTRUAL BLEEDING (really heavy bleeding during their period) and PYREXIA (everything else was as expected like fever) 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.     Previously administered products included for Product used for unknown indication: Moderna (Dose 1), Moderna (Dose 3) and Moderna (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna, Moderna and Moderna. Concurrent medical conditions included Epilepsy, Fever and Immunocompromised (immunocompromised with neutropenia low white blood cell count). Concomitant products included LEVETIRACETAM and ZONISAMIDE for Epilepsy, PARACETAMOL (TYLENOL) for Fever.    In October 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 October 2022, the patient experienced THROMBOSIS (heavy blood clots), HEAVY MENSTRUAL BLEEDING (really heavy bleeding during their period) and PYREXIA (everything else was as expected like fever). At the time of the report, THROMBOSIS (heavy blood clots), HEAVY MENSTRUAL BLEEDING (really heavy bleeding during their period) and PYREXIA (everything else was as expected like fever) outcome was unknown.            Patient got the new Bivalent booster shot last Tuesday and experienced really heavy bleeding during her period, heavy blood clots, everything else was as expected like fever. No treatment information was provided by the reporter.   This case was linked to MOD-2022-667341 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: problems with inflammation in the joints/ pain/ achy joints; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRITIS (problems with inflammation in the joints/ pain/ achy joints) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005m214, 0760217, 024m20a and 041l20a) for COVID-19 vaccination.     Patient had Allergies to some medications but not true allergies and had side effects, TIA with hormonal replacement therapy- Fem hrt. Patient never had COVID positive test or diagnosis in the past before.  The patient's past medical history included Aching joints and Transient ischemic attack. Previously administered products included for Drug use for unknown indication: flu vaccine (received the flu vaccine on Aug 24). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Arthritis and Spinal cord disorder.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient height was Height 5'1''. No concomitant medications were provided. Patient had problems with inflammation in the joints and pain Treatment medication also included Sudafed.   Sender's Comments: This spontaneous case concerns a 78-year-old female patient with medical history of arthritis and spine issues, who experienced the unexpected non-serious arthritis, A second booster dose of mRNA-1273 vaccine was administered, onset date of the event was not provided hence latency cannot be assessed.  It was reported patient had after vaccination problems with inflammation in the joints and pain. Medical history of arthritis remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Feeling abnormal, Hypothyroidism
Clinical narrative: low thyroid numbers; balance/equilibrium problem; felt like falling over; This spontaneous case was reported by a patient and describes the occurrence of HYPOTHYROIDISM (low thyroid numbers) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Type 2 diabetes mellitus, Blood pressure high and Thyroid disorder. Concomitant products included METFORMIN and BISOPROLOL FUMARATE for an unknown indication.   On 30-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOTHYROIDISM (low thyroid numbers) (seriousness criterion medically significant), BALANCE DISORDER (balance/equilibrium problem) and FEELING ABNORMAL (felt like falling over). The patient was treated with LEVOTHYROXINE ongoing since an unknown date for Thyroid disorder, at a dose of 25 milligram(once). At the time of the report, HYPOTHYROIDISM (low thyroid numbers), BALANCE DISORDER (balance/equilibrium problem) and FEELING ABNORMAL (felt like falling over) was resolving.            Patient had no allergies. Patient did not had COVID positive test or diagnosis. No treatment information was provided. Patient took the Pfizer for the bivalent booster as 3rd booster dose on 19Sep2022, lot number W25J2524 and did not have any problems, also had flu vaccine in Sep2022 but not the same day as the Covid-19 vaccine.  Company comment:  This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the serious (medically significant) unexpected event of hypothyroidism on an unknown date after receiving a fourth dose of mRNA-1273. Patient states that on the last medical checkup, thyroid numbers were low, and levothyroxine was prescribed. No further information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-667381 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the serious (medically significant) unexpected event of hypothyroidism on an unknown date after receiving a fourth dose of mRNA-1273. Patient states that on the last medical checkup, thyroid numbers were low, and levothyroxine was prescribed. No further information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 79.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Headache, Illness, Influenza, Malaise
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling lousy), ILLNESS (been in bed for 5 weeks since received flu shot and Moderna Covid-19 vaccine on the same day), INFLUENZA (flu immediately after the Moderna Covid-19 vaccine and the flu shot) and HEADACHE (Immediately after received the vaccine had a headache) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 28-Sep-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. On an unknown date, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced MALAISE (feeling lousy), ILLNESS (been in bed for 5 weeks since received flu shot and Moderna Covid-19 vaccine on the same day), INFLUENZA (flu immediately after the Moderna Covid-19 vaccine and the flu shot) and HEADACHE (Immediately after received the vaccine had a headache). At the time of the report, MALAISE (feeling lousy), ILLNESS (been in bed for 5 weeks since received flu shot and Moderna Covid-19 vaccine on the same day) and HEADACHE (Immediately after received the vaccine had a headache) outcome was unknown and INFLUENZA (flu immediately after the Moderna Covid-19 vaccine and the flu shot) had not resolved.            No concomitant medications were reported. First dose on 16-Feb-2021 lot number 007M20A, second dose 6-Mar-2021 Lot No. 032M20A left Arm and first booster dose on 20-Nov-2021 Lot number 018F21A left arm. Patient did not know which arm he received the vaccine in. The patient went to see his physician and the physician sent him to the emergency room. Several tests were run on the patient and they all returned normal.     The patient reported that because he had been in bed for 5 weeks that must have received a bad batch of the Moderna Bivalent Vaccine.  No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: ; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt under the weather for 2 days) and VACCINATION SITE PAIN (sore left arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine)  No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FEELING ABNORMAL (felt under the weather for 2 days) and VACCINATION SITE PAIN (sore left arm). On 18-Feb-2021, FEELING ABNORMAL (felt under the weather for 2 days) had resolved and VACCINATION SITE PAIN (sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Feeling hot, Migraine
Clinical narrative: warm for like 15 minutes; migraine for 12 hours; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL FEELING HOT (warm for like 15 minutes) and MIGRAINE (migraine for 12 hours) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On an unknown date, the patient received third 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 FEELING ABNORMAL, FEELING HOT (warm for like 15 minutes) and MIGRAINE (migraine for 12 hours). At the time of the report, FEELING ABNORMAL, FEELING HOT (warm for like 15 minutes) and MIGRAINE (migraine for 12 hours) had resolved.            The concomitant medication was reported as antidepressant and sleeping pill.  The patient had second dose of Moderna.  No treatment medications were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid/not much symptoms of Covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tested positive for Covid/not much symptoms of Covid) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE, METOPROLOL and IRBESARTAN (AVAPRO) for Hypertension.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (tested positive for Covid/not much symptoms of Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at a dose of for 5 days. At the time of the report, COVID-19 (tested positive for Covid/not much symptoms of Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No allergies (medications, food and other products) were reported. The patient did not experience a similar event in the past.   This case was linked to MOD-2022-667741 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two bivalent Moderna Covid-19 vaccines within 2 weeks of each other; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received two bivalent Moderna Covid-19 vaccines within 2 weeks of each other) and NO ADVERSE EVENT (No adverse event) in a 91-year-old 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, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received two bivalent Moderna Covid-19 vaccines within 2 weeks of each other) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received two bivalent Moderna Covid-19 vaccines within 2 weeks of each other) 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 assessment was provided for EXTRA DOSE ADMINISTERED (Patient received two bivalent Moderna Covid-19 vaccines within 2 weeks of each other).    No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Balance disorder, Dizziness, Dyspnoea
Clinical narrative: Shortness of breath; No taste; Dizziness; Loss of balance; Occasional inability to walk; Loss of energy; I have symptoms related to covid; Chronic fatigue; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), AGEUSIA (No taste), DIZZINESS (Dizziness), BALANCE DISORDER (Loss of balance) and GAIT INABILITY (Occasional inability to walk) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (hospitalized for double pneumonia in April 2021). Concurrent medical conditions included Myelodysplasia since October 2021.    On 27-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 DYSPNOEA (Shortness of breath), AGEUSIA (No taste), DIZZINESS (Dizziness), BALANCE DISORDER (Loss of balance), GAIT INABILITY (Occasional inability to walk), ASTHENIA (Loss of energy), SUSPECTED COVID-19 (I have symptoms related to covid) and FATIGUE (Chronic fatigue). At the time of the report, DYSPNOEA (Shortness of breath), AGEUSIA (No taste), DIZZINESS (Dizziness), BALANCE DISORDER (Loss of balance), GAIT INABILITY (Occasional inability to walk), ASTHENIA (Loss of energy), SUSPECTED COVID-19 (I have symptoms related to covid) and FATIGUE (Chronic fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Negative.         No concomitant medications were reported. No treatment medications were reported.    This spontaneous case concerns a patient (age and gender not specified) with no relevant medical history reported, who experienced unexpected non-serious  which occurred on an unknown date after the third dose of mRNA-1273 vaccination in covid -19 vaccination series. Patient is currently suffering from shortness of breath, chronic fatigue, dizziness, loss of balance, occasional inability to walk and loss of energy. SARS-CoV-2 test reported as Negative on an unknown date in 2022. Patient has been examined and treated by primary care physician, cardiologist, pulmonary physician, infectious disease doctor and oncologist. No further information of definitive diagnosis and treatment of the symptoms is available. The outcome of the events was reported as unknown. The benefit -risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Shortness of breath; No taste; Dizziness; Loss of balance; Occasional inability to walk; Loss of energy; I have symptoms related to covid; Chronic fatigue; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), AGEUSIA (No taste), DIZZINESS (Dizziness), BALANCE DISORDER (Loss of balance) and GAIT INABILITY (Occasional inability to walk) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (hospitalized for double pneumonia in April 2021). Concurrent medical conditions included Myelodysplasia since October 2021.    On 27-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 DYSPNOEA (Shortness of breath), AGEUSIA (No taste), DIZZINESS (Dizziness), BALANCE DISORDER (Loss of balance), GAIT INABILITY (Occasional inability to walk), ASTHENIA (Loss of energy), SUSPECTED COVID-19 (I have symptoms related to covid) and FATIGUE (Chronic fatigue). At the time of the report, DYSPNOEA (Shortness of breath), AGEUSIA (No taste), DIZZINESS (Dizziness), BALANCE DISORDER (Loss of balance), GAIT INABILITY (Occasional inability to walk), ASTHENIA (Loss of energy), SUSPECTED COVID-19 (I have symptoms related to covid) and FATIGUE (Chronic fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Negative.         No concomitant medications were reported. No treatment medications were reported.    This spontaneous case concerns a patient (age and gender not specified) with no relevant medical history reported, who experienced unexpected non-serious  which occurred on an unknown date after the third dose of mRNA-1273 vaccination in covid -19 vaccination series. Patient is currently suffering from shortness of breath, chronic fatigue, dizziness, loss of balance, occasional inability to walk and loss of energy. SARS-CoV-2 test reported as Negative on an unknown date in 2022. Patient has been examined and treated by primary care physician, cardiologist, pulmonary physician, infectious disease doctor and oncologist. No further information of definitive diagnosis and treatment of the symptoms is available. The outcome of the events was reported as unknown. The benefit -risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Needle issue, No adverse event
Clinical narrative: Administration error: while administering bivalent vaccine, needle was not good and vaccine came out; Administration error: while administering bivalent vaccine, needle was not good and vaccine came out; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: while administering bivalent vaccine, needle was not good and vaccine came out), NEEDLE ISSUE (Administration error: while administering bivalent vaccine, needle was not good and vaccine came out) and NO ADVERSE EVENT (No adverse event) 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)) for COVID-19 vaccination.     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 ACCIDENTAL UNDERDOSE (Administration error: while administering bivalent vaccine, needle was not good and vaccine came out), NEEDLE ISSUE (Administration error: while administering bivalent vaccine, needle was not good and vaccine came out) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: while administering bivalent vaccine, needle was not good and vaccine came out), NEEDLE ISSUE (Administration error: while administering bivalent vaccine, needle was not good and vaccine came out) 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 ACCIDENTAL UNDERDOSE (Administration error: while administering bivalent vaccine, needle was not good and vaccine came out) and NEEDLE ISSUE (Administration error: while administering bivalent vaccine, needle was not good and vaccine came out).    Concomitant medications were not reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect route of product administration, Maternal exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was not given into the normal deltoid muscle area on the upper center part of the arm/I do not think it was injected into a muscle), MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant) and NO ADVERSE EVENT (No adverse event) 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 vaccination.     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. Last menstrual period and estimated date of delivery were not provided. On 02-Nov-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was not given into the normal deltoid muscle area on the upper center part of the arm/I do not think it was injected into a muscle) and MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 02-Nov-2022, MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was not given into the normal deltoid muscle area on the upper center part of the arm/I do not think it was injected into a muscle) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant and treatment medications were reported.  Patient reported that the vaccine was not given into the normal deltoid muscle area on the upper center part of the arm, and was given a few inches more around towards the very back of her arm and she does not think it was injected into a muscle.   Patient was pregnant and concerned whether any adverse reactions or complications would arise from this.  Company comment.  This spontaneous case concerns a female patient (unknown age), with no medical history reported, who experienced maternal exposure during pregnancy with no adverse events associated, after a booster dose of mRNA-1273.222 vaccine (Original/Omicron BA.4/5); no information about previous immunization schedule was provided. Gestational age, last menstrual period and estimated date of delivery were not reported. Pregnancy outcome not available. No further clinical information was provided for medical reviewing. Additionally, inappropriate route of vaccination was considered in the case since patient mentioned she did not think it was injected into a muscle. The benefit-risk relationship of the mRNA-1273.222 (Original/Omicron BA.4/5) is not affected by this report.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event). On 01-Nov-2022, EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022).    No concomitant medications were reported. It was reported that total 6 patients of age 6 Months to 5 years of age were administered with the expired dose of vaccine, One patient on 31-Oct-2022 and 5 patients on 01-Nov-2022. There were 2 vials of size 2.5 mL of Monovalent doses. The vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursions. No treatment details were reported.  No Adverse events were reported.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022; No adverse event; dose administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022).    No concomitant medications were provided. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursion. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-668207, US-MODERNATX, INC.-MOD-2022-668172, US-MODERNATX, INC.-MOD-2022-668074, US-MODERNATX, INC.-MOD-2022-668208, US-MODERNATX, INC.-MOD-2022-668215 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668207:Same reporter US-MODERNATX, INC.-MOD-2022-668074:Same reporter US-MODERNATX, INC.-MOD-2022-668172:Same reporter US-MODERNATX, INC.-MOD-2022-668208:Same reporter US-MODERNATX, INC.-MOD-2022-668215:Same reporter