chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 43 year old male. Initial information processed along with additional information received on 13-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1)(suspension for injection, route of admin, and batch number were not reported) dose was not reported 01 total administered to the left arm on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 42 years old. No concomitant medications were reported.  The patient additionally received non-company suspect vaccine: elasomeran (moderna covid-19 vaccine)(dose number in series 2)(form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination.  On an unspecified date, the patient experienced confirmed covid-19 infection (dose number in series 2) and had confirmed clinical vaccination failure (dose number in series 1). Laboratory data (dates unspecified) included: COVID-19 antigen test Positive, COVID-19 antigen test Negative. The patient received paxlovid (form of admin, route of admin, batch number were not reported), administered from 24-JUN-2022 to 29-JUN-2022 for treatment of Covid-19. The patient retested antigen positive for Covid-19 after 5 days of negative and 4 days after completing treating with Paxlovid The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint number.; Sender's Comments: V0-20220721597 -COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: COVID-19 SYMPTOMS; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 39 year old female. Initial information was processed with the additional information received on 13-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (no drug reported) and asthma, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 38 years old. Concomitant medications included ethinylestradiol/etonogestrel (Nuvaring)for birth control. The patient additionally received Moderna (spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin and batch number were not reported, expiry: unknown) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The patient received non company suspect Paxlovid (form of admin, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, administered on 24-JUN-2022 for covid-19 treatment. Patient received last dose of Paxlovid on 29-JUN-2022.  On an unspecified date in 2022, the patient experienced COVID symptoms again after being symptom free (dose number in series 2). She was symptom free on the 30-JUN-2022 (same day as finishing the pills). On 03-JUL-2022, symptoms relapsed and were worse than before.  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and action taken with Paxlovid was treatment discontinued. The patient had not recovered from covid-19 symptoms. This report was non-serious. This report was associated with product quality complaint number: 90000242158.; Sender's Comments: V0- Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: COVID-19 SYMPTOMS; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 39 year old female. Initial information was processed with the additional information received on 13-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (no drug reported) and asthma, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 38 years old. Concomitant medications included ethinylestradiol/etonogestrel (Nuvaring)for birth control. The patient additionally received Moderna (spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin and batch number were not reported, expiry: unknown) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The patient received non company suspect Paxlovid (form of admin, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, administered on 24-JUN-2022 for covid-19 treatment. Patient received last dose of Paxlovid on 29-JUN-2022.  On an unspecified date in 2022, the patient experienced COVID symptoms again after being symptom free (dose number in series 2). She was symptom free on the 30-JUN-2022 (same day as finishing the pills). On 03-JUL-2022, symptoms relapsed and were worse than before.  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and action taken with Paxlovid was treatment discontinued. The patient had not recovered from covid-19 symptoms. This report was non-serious. This report was associated with product quality complaint number: 90000242158.; Sender's Comments: V0- Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: SEVERE STOMACH CRAMPS; DIARRHEA; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-infectious intermediate, posterior and panuveitis, and other pre-existing medical conditions included: The patient had no known allergies, no concomitant drugs taken and no reported medical history. The patient received two doses of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with two doses of covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient additionally received booster dose of Moderna vaccine (elasomeran) (dose number in series 2) (form of admin unknown, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, administered on 23-JUN-2022 for covid-19 prophylaxis. Non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) 40 mg, 1 time every 2 weeks, from 25-JUN-2022 for non-infectious intermediate posterior and panuveitis. On 25-JUN-2022, the patient experienced stomach cramps, and diarrhea (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and dose of adalimumab was not changed. The outcome of the diarrhea and severe stomach cramps was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Herpes zoster, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SHINGLES ON HIS ARM; This spontaneous report received from a patient concerned a 70 year old male. 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, batch number and expiry date were not reported) dose was not reported, 1 total administered on 04-DEC-2021 to left arm for prophylactic vaccination. Age at time of vaccination 69 years old. The batch number was not reported and has been requested. No concomitant medications were reported. The patient had taken only primary dose. On an unspecified date in JUN-2022 after the shot (6 months or more), the patient got a rash caused by the virus of chickenpox on his left arm (shingles). He said it went away and came back. On 29-JUN-2022, the patient experienced confirmed covid-19 infection and had confirmed clinical vaccination failure. The patient reported that he was knocked out and had the symptoms of cold sweats, fever, cough, and felt like he was on death's door. He was feeling better at the time of reporting with a bit of flu-like symptoms left, real mild now. He did not went to work yet. Laboratory data included: COVID-19 antigen test Positive at home. On 12-JUL-2022, Laboratory data included: COVID-19 antigen test Positive at home. The patient had not visited to any doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and shingles on his arm was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220726100-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-APR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000242092.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ear pain, Lymphadenopathy, SARS-CoV-2 test, Sinusitis
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; PAIN IN EARS; SINUS INFECTION; ELEVATED LYMPH NODES; This spontaneous report received from a patient concerned a patient of unspecified age female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: unknown) dose was not reported, 1 total, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that after receiving the vaccine patient contracted COVID-19 on first July (year not specified) (confirmed covid-19 infection and confirmed clinical vaccination failure). Patient did a rapid antigen test and her symptoms included body aches, several general headaches, cough, fever. All of the symptoms were resolved on fifth July (year not specified) except the sinus infection. Also had pain in ears and elevated lymph nodes. Patient had a virtual appointment with a Telo-doc physician on fifth July (year not specified) and was prescribed with antibiotics for a sinus infection. Patient had to call them back on 11 July (year not specified) since the medication not worked. Laboratory data (dates unspecified) included: COVID-19 antigen test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and elevated lymph nodes, had not recovered from sinus infection, and the outcome of pain in ears and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint.; Sender's Comments: V0- 20220726291- covid-19 vaccine ad26.cov2.s Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; PAIN IN EARS; SINUS INFECTION; ELEVATED LYMPH NODES; This spontaneous report received from a patient concerned a patient of unspecified age female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: unknown) dose was not reported, 1 total, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that after receiving the vaccine patient contracted COVID-19 on first July (year not specified) (confirmed covid-19 infection and confirmed clinical vaccination failure). Patient did a rapid antigen test and her symptoms included body aches, several general headaches, cough, fever. All of the symptoms were resolved on fifth July (year not specified) except the sinus infection. Also had pain in ears and elevated lymph nodes. Patient had a virtual appointment with a Telo-doc physician on fifth July (year not specified) and was prescribed with antibiotics for a sinus infection. Patient had to call them back on 11 July (year not specified) since the medication not worked. Laboratory data (dates unspecified) included: COVID-19 antigen test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and elevated lymph nodes, had not recovered from sinus infection, and the outcome of pain in ears and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint.; Sender's Comments: V0- 20220726291- covid-19 vaccine ad26.cov2.s Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE; This spontaneous report received from a patient 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 was not reported, administered on 14-JUL-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUL-2022, the patient experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 14-JUL-2022. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Mammogram
Clinical narrative: LUMP UNDER LEFT ARM; This spontaneous report received from a patient 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 not reported, batch number: 1809878 expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On JUL-2021, Laboratory data included: Mammogram everything was normal. On 01-JUL-2021, the patient experienced lump under left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lump under left arm on 2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient (health care professional) via other manufacturer (Pfizer) concerned an adult male. The patient's height and weight were not reported. The patient was a health care professional. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total administered for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 in total, administered on 14-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient was treated with Paxlovid (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 20-JUN-2022 to 25-JUN-2022 for treatment of COVID-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. On 28-JUN-2022, Laboratory data included: COVID-19 virus test Negative. On 29-JUN-2022, the patient was rebounded with covid-19 which was coded as confirmed covid-19 infection which led to confirmed clinical vaccination failure (dose number in series 2). On 30-JUN-2022, Laboratory data included: COVID-19 virus test Positive with return of symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number requested.; Sender's Comments: V0: 20220729874-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: MUSCLE CRAMPS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was an lifelong athlete. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced muscle cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle cramps. This report was non-serious.
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: During that call, he mentioned that two dermatologist would like for him to get the GARDASIL 9 vaccine but he cannot afford it and it is not covered by his insurance since he is over the age of 45; No additional adverse event reported; This spontaneous report was received from a consumer and refers to a male patient over 45-year-old concerning himself.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.    On an unknown date, two dermatologist told the patient to get  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, , administered for skin papilloma (reported as "warts) (strength, dose description, lot #, expiry date, and route of administration were not provided) (product prescribing issue), but he cannot afford it and it is not covered by his insurance. At the time of reporting, the patient had not received any vaccine and no adverse event was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021); This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 003C21A) for COVID-19 vaccination.     Patient was not tested positive or diagnosed for COVID-19.  Concurrent medical conditions included Drug allergy, Chronic kidney disease, COPD and Insomnia. Concomitant products included TRAZODONE for Insomnia, BUPRENORPHINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), LISINOPRIL, GABAPENTIN and METHOCARBAMOL for an unknown indication.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not seek any medical care. Treatment information was not provided.   This case was linked to MOD-2022-600713 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2022: Follow up received. Patient demographic added.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster beyond  30-day Use By Date in the refrigerator/15 adult patients (>18-year-old) received expired booster Moderna COVID-19 vaccine on 05JUL2022 through 07JUL2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster beyond  30-day Use By Date in the refrigerator/15 adult patients (>18-year-old) received expired booster Moderna COVID-19 vaccine on 05JUL2022 through 07JUL2022.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A and 066H21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy, Chronic pain on 17-Jan-2019, Hypertension on 21-Jan-2021, Type 2 diabetes mellitus on 21-Jan-2021, Hypothyroidism on 18-Oct-2017 and Depression on 08-Dec-2015. Concomitant products included MORPHINE SULFATE from 25-Mar-2022 to an unknown date for Chronic pain, CITALOPRAM from 12-Jan-2022 to an unknown date and BUPROPION HYDROBROMIDE (BUPROPION SANDOZ [BUPROPION HYDROBROMIDE]) from 12-Jan-2022 to an unknown date for Depression, LISINOPRIL from 11-Jan-2022 to an unknown date for Hypertension, LEVOTHYROXINE from 22-Mar-2022 to an unknown date for Hypothyroidism, INFLUENZA VACCINE (INFLUENZA VACCIN).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 millilitre per kilogram. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Jan-2022 at 3:24 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 05-Jul-2022 at 2:28 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster beyond  30-day Use By Date in the refrigerator/15 adult patients (>18-year-old) received expired booster Moderna COVID-19 vaccine on 05JUL2022 through 07JUL2022.). On 07-Jul-2022, EXPIRED PRODUCT ADMINISTERED (Received expired booster beyond  30-day Use By Date in the refrigerator/15 adult patients (>18-year-old) received expired booster Moderna COVID-19 vaccine on 05JUL2022 through 07JUL2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient height was given as 67 inches. On 02JUN2022, the vial was initially stored in the refrigerator. No vial doesnot undergo any temperature excursions. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2022: Significant follow up appended contains patient details,dose details, medical history and concomitant medication updated
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: Got COVID Disease 8 months after first booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got COVID Disease 8 months after first booster) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904 and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Got COVID Disease 8 months after first booster). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Got COVID Disease 8 months after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Negative) Negative. On 21-Jun-2022, Body temperature: 101.6 101.6 F. On 22-Jun-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  Company comment: This is a spontaneous case concerning a 69-year-old male  patient with no reported medical history, who experienced the serious unexpected event of COVID-19 (AESI), approximately 8 months after receiving the third dose of mRNA-1273 vaccine.  Patient had fever and sickness, SARS-CoV-2 test was performed with positive result and was treated with Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-606589 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a 69-year-old male  patient with no reported medical history, who experienced the serious unexpected event of COVID-19 (AESI), approximately 8 months after receiving the third dose of mRNA-1273 vaccine.  Patient had fever and sickness, SARS-CoV-2 test was performed with positive result and was treated with Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a dose given from a vial with the lot # 057M21A  today 7/12/22 when the BUD sticker was 7/9/22 of 30 days in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose given from a vial with the lot # 057M21A  today 7/12/22 when the BUD sticker was 7/9/22 of 30 days in the fridge) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose given from a vial with the lot # 057M21A  today 7/12/22 when the BUD sticker was 7/9/22 of 30 days in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose given from a vial with the lot # 057M21A  today 7/12/22 when the BUD sticker was 7/9/22 of 30 days in the fridge) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  A dose given from a vial with the lot (057M21A) today 7/12/22 when the BUD sticker was 7/9/22 of 30 days in the fridge.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Breast feeding.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. In 2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) 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.   Concomitant and treatment medications were not reported. Patient was still breastfeeding then after receiving booster.  Company comment: This is a spontaneous retrospective pregnancy case that reported the occurrence of Maternal exposure during pregnancy in a female patient of an unknown age who received an unspecified dose of mRNA-1273. Very limited information had been reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous retrospective pregnancy case that reported the occurrence of Maternal exposure during pregnancy in a female patient of an unknown age who received an unspecified dose of mRNA-1273. Very limited information had been reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Breast mass, Immunisation reaction, Lymphadenopathy, Mass, Swelling
Clinical narrative: had side effects; Nodules in my chest and breast area; extreme swelling; Nodules in my chest and breast area; lymph nodes were swollen and he needed a biopsy.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had side effects), MASS (Nodules in my chest and breast area), SWELLING (extreme swelling), BREAST MASS (Nodules in my chest and breast area) and LYMPHADENOPATHY (lymph nodes were swollen and he needed a biopsy.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergic reaction to antibiotics.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had side effects), MASS (Nodules in my chest and breast area), SWELLING (extreme swelling), BREAST MASS (Nodules in my chest and breast area) and LYMPHADENOPATHY (lymph nodes were swollen and he needed a biopsy.). At the time of the report, IMMUNISATION REACTION (had side effects), MASS (Nodules in my chest and breast area), SWELLING (extreme swelling), BREAST MASS (Nodules in my chest and breast area) and LYMPHADENOPATHY (lymph nodes were swollen and he needed a biopsy.) outcome was unknown.            Patient's height was reported as 5'9". Patient had his first and second Moderna COVID-19 vaccinations as well as the first booster at the facility in contact 2. He had side effects to the first doses. No concomitant medication were provided. No treatment medication were provided.   Reporter did not allow further contact
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: a 16 year old patient received the full adult dose of 100mcg (0.5ml) of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (a 16 year old patient received the full adult dose of 100mcg (0.5ml) of the Moderna Covid-19 Vaccine) in a 16-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 05-May-2022, the patient experienced ACCIDENTAL OVERDOSE (a 16 year old patient received the full adult dose of 100mcg (0.5ml) of the Moderna Covid-19 Vaccine). At the time of the report, ACCIDENTAL OVERDOSE (a 16 year old patient received the full adult dose of 100mcg (0.5ml) of the Moderna Covid-19 Vaccine) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.  It was reported that, the patient has not received their 2nd dose yet but will be receiving Pfizer because that's what their practice is giving moving forward.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Immunisation reaction, Myalgia
Clinical narrative: Brain fog; Covid arm; Body aches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A(4), 032B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allegra, Compazine and sulfa antibiotics).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches). At the time of the report, FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches) outcome was unknown.            Lot number (058E21A(4)) of 1st booster dose was not written well on the card as per patient. Patient never had COVID test or diagnosis. No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-607747 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergic sinusitis, Blood iron decreased, C-reactive protein, Fatigue, Feeling abnormal
Clinical narrative: Brain fog; Covid arm; Body aches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A(4), 032B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allegra, Compazine and sulfa antibiotics).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches). At the time of the report, FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches) outcome was unknown.            Lot number (058E21A(4)) of 1st booster dose was not written well on the card as per patient. Patient never had COVID test or diagnosis. No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-607747 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Muscle spasms, Muscle twitching, Myalgia, Pain
Clinical narrative: Brain fog; Covid arm; Body aches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A(4), 032B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allegra, Compazine and sulfa antibiotics).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches). At the time of the report, FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches) outcome was unknown.            Lot number (058E21A(4)) of 1st booster dose was not written well on the card as per patient. Patient never had COVID test or diagnosis. No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-607747 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pyrexia, Red blood cell sedimentation rate, SARS-CoV-2 test
Clinical narrative: Brain fog; Covid arm; Body aches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A(4), 032B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allegra, Compazine and sulfa antibiotics).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches). At the time of the report, FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches) outcome was unknown.            Lot number (058E21A(4)) of 1st booster dose was not written well on the card as per patient. Patient never had COVID test or diagnosis. No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-607747 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: Brain fog; Covid arm; Body aches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A(4), 032B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allegra, Compazine and sulfa antibiotics).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches). At the time of the report, FEELING ABNORMAL (Brain fog), IMMUNISATION REACTION (Covid arm) and MYALGIA (Body aches) outcome was unknown.            Lot number (058E21A(4)) of 1st booster dose was not written well on the card as per patient. Patient never had COVID test or diagnosis. No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-607747 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Immunisation reaction, Night sweats, Pain
Clinical narrative: Aches mostly in her upper legs but also a little in her arms; Extreme feeling reaction like her muscles or bones were petrifying; Night sweats; Achiness; Headache; Slight fever, fever of 102 degree F; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Aches mostly in her upper legs but also a little in her arms), IMMUNISATION REACTION (Extreme feeling reaction like her muscles or bones were petrifying), NIGHT SWEATS (Night sweats), PAIN (Achiness) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII (before 1st booster in the fall). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Drug allergy (codeine and derivates), Hypercholesterolaemia (Started 35 or 40 years ago, no change in status such as improvement or worsening), Esophageal reflux (Started 25 or 30 years ago, no change in status such as improvement or worsening) and Asthma (Started 25 or 30 years ago, no change in status such as improvement or worsening). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Esophageal reflux, SIMVASTATIN for High cholesterol, FLUOXETINE HYDROCHLORIDE (PROZAC), PRIMIDONE, CALCIUM and VITAMINS NOS for an unknown indication.    On 09-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced PAIN IN EXTREMITY (Aches mostly in her upper legs but also a little in her arms), IMMUNISATION REACTION (Extreme feeling reaction like her muscles or bones were petrifying), NIGHT SWEATS (Night sweats), PAIN (Achiness), HEADACHE (Headache) and PYREXIA (Slight fever, fever of 102 degree F). On 10-Apr-2022, NIGHT SWEATS (Night sweats), PAIN (Achiness), HEADACHE (Headache) and PYREXIA (Slight fever, fever of 102 degree F) had resolved. At the time of the report, PAIN IN EXTREMITY (Aches mostly in her upper legs but also a little in her arms) and IMMUNISATION REACTION (Extreme feeling reaction like her muscles or bones were petrifying) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2022, Body temperature: 102 102°F.   No treatment was given   This case was linked to MOD-2022-607733 (Patient Link).