chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Sore arm went back and forth/sore shoulder; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm went back and forth/sore shoulder) and HEADACHE (Headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN and TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm went back and forth/sore shoulder) and HEADACHE (Headache). At the time of the report, MYALGIA (Sore arm went back and forth/sore shoulder) and HEADACHE (Headache) outcome was unknown.            No treatment medication details was provided. Concomitants includes Flu shot on 19Oct2021 , Heart medication   This case was linked to MOD-2021-373613 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Durolane Hyaluronic Acid injection (Dermal filler-Durolane injection in her knee) in 2019 and Flu shot (Flu shot 3 weeks ago) in 2021. Past adverse reactions to the above products included No adverse event with Durolane Hyaluronic Acid injection and Flu shot.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling). At the time of the report, PARAESTHESIA (Tingling) outcome was unknown.            No concomitant medication was provided. No treatment medication was provided. Patient had been experiencing tingling on and off for more than a month
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chills, Heart rate irregular, Lethargy, Malaise
Clinical narrative: Angina pectoris; Heart rate irregular; Lethargy; Malaise; Chills; Pyrexia; This case was received via the Regulatory Authority (Reference number: 1592143) on 02-Nov-2021 and was forwarded to Moderna on 02-Nov-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ANGINA PECTORIS (Angina pectoris) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, FUROSEMIDE (LASIX [FUROSEMIDE]) and GABAPENTIN for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ANGINA PECTORIS (Angina pectoris) (seriousness criterion medically significant), HEART RATE IRREGULAR (Heart rate irregular), LETHARGY (Lethargy), MALAISE (Malaise), CHILLS (Chills) and PYREXIA (Pyrexia). At the time of the report, ANGINA PECTORIS (Angina pectoris), HEART RATE IRREGULAR (Heart rate irregular), LETHARGY (Lethargy), MALAISE (Malaise), CHILLS (Chills) and PYREXIA (Pyrexia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab test included Holter monitor in June and Electrocardiogram ambulatory in 06 Mar 2021 and results was not provided. Medical history included heart. It was reported that, patient experienced fever chills heart pain irregular heartbeat ongoing lethargy Increase in heart medications needed as abnormal lack of wellness continued through June.; Sender's Comments: This case concerns a  81-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Angina pectoris. The events occurred approximately 1 day after the unknown dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna Covid-19 Vaccine, is not affected by this report.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Angina pectoris; Heart rate irregular; Lethargy; Malaise; Chills; Pyrexia; This case was received via the Regulatory Authority (Reference number: 1592143) on 02-Nov-2021 and was forwarded to Moderna on 02-Nov-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ANGINA PECTORIS (Angina pectoris) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, FUROSEMIDE (LASIX [FUROSEMIDE]) and GABAPENTIN for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ANGINA PECTORIS (Angina pectoris) (seriousness criterion medically significant), HEART RATE IRREGULAR (Heart rate irregular), LETHARGY (Lethargy), MALAISE (Malaise), CHILLS (Chills) and PYREXIA (Pyrexia). At the time of the report, ANGINA PECTORIS (Angina pectoris), HEART RATE IRREGULAR (Heart rate irregular), LETHARGY (Lethargy), MALAISE (Malaise), CHILLS (Chills) and PYREXIA (Pyrexia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab test included Holter monitor in June and Electrocardiogram ambulatory in 06 Mar 2021 and results was not provided. Medical history included heart. It was reported that, patient experienced fever chills heart pain irregular heartbeat ongoing lethargy Increase in heart medications needed as abnormal lack of wellness continued through June.; Sender's Comments: This case concerns a  81-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Angina pectoris. The events occurred approximately 1 day after the unknown dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna Covid-19 Vaccine, is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Only one menstrual cycle since April when had first dose; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Only one menstrual cycle since April when had first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced MENSTRUATION IRREGULAR (Only one menstrual cycle since April when had first dose). At the time of the report, MENSTRUATION IRREGULAR (Only one menstrual cycle since April when had first dose) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are not provided. Treatment information does not provided. The patient had only one menstrual cycle since April when had first dose.   This case was linked to MOD-2021-372632 (Parent-Child Link).   See case MOD-2021-372632 for details regarding the child case.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Tremor
Clinical narrative: feeling cold; shaking; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold) and TREMOR (shaking) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042620A and 025D21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation (Patient had Atrial fibrillation and has been under control for the last 2 years.) since 2019.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING COLD (feeling cold) and TREMOR (shaking). At the time of the report, FEELING COLD (feeling cold) and TREMOR (shaking) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-372783 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia oral, Speech disorder
Clinical narrative: had wobbly leg not walking steadily bumping in to things not walking as us; speeches are little splitting; felt like someone numbed the whole mouth; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (had wobbly leg not walking steadily bumping in to things not walking as us), SPEECH DISORDER (speeches are little splitting) and HYPOAESTHESIA ORAL (felt like someone numbed the whole mouth) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced GAIT DISTURBANCE (had wobbly leg not walking steadily bumping in to things not walking as us), SPEECH DISORDER (speeches are little splitting) and HYPOAESTHESIA ORAL (felt like someone numbed the whole mouth). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (had wobbly leg not walking steadily bumping in to things not walking as us), SPEECH DISORDER (speeches are little splitting) and HYPOAESTHESIA ORAL (felt like someone numbed the whole mouth) outcome was unknown.            Concomitant medication information was not provided by the reporter.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Inappropriate schedule of product administration, Pain, Rash, Rash erythematous
Clinical narrative: sores on his scalp, face, legs, back and abdomen; She stated that it is extra red; seems like this shot has now flared up his eczema; next week it was completely flared up, with swelling; very bad rash/ it was completely flared up; He got his 2nd dose two weeks apart because that is what his pharmacy told him to do.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sores on his scalp, face, legs, back and abdomen), RASH ERYTHEMATOUS (She stated that it is extra red), ECZEMA (seems like this shot has now flared up his eczema), SWELLING (next week it was completely flared up, with swelling) and RASH (very bad rash/ it was completely flared up) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eczema (Patient was born with eczema.).   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PAIN (sores on his scalp, face, legs, back and abdomen), RASH ERYTHEMATOUS (She stated that it is extra red), ECZEMA (seems like this shot has now flared up his eczema), SWELLING (next week it was completely flared up, with swelling), RASH (very bad rash/ it was completely flared up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his 2nd dose two weeks apart because that is what his pharmacy told him to do.). The patient was treated with CORTISOL [HYDROCORTISONE] for Adverse event, at an unspecified dose and frequency. In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his 2nd dose two weeks apart because that is what his pharmacy told him to do.) had resolved. At the time of the report, PAIN (sores on his scalp, face, legs, back and abdomen), RASH ERYTHEMATOUS (She stated that it is extra red), ECZEMA (seems like this shot has now flared up his eczema), SWELLING (next week it was completely flared up, with swelling) and RASH (very bad rash/ it was completely flared up) had not resolved.            No concomitant medications were reported  It was reported that he got the 1st dose of the Moderna COVID 19 vaccine approximately at the end of August - 28th, 29th or 30th.  He had no reactions  It was reported events still ongoing.  It was reported that he  hasn't been treated for it since doctors did not  know what was going on. Three doctors in their area refused to treat him because they did not  know what to do. Only one dermatologist gave him a cortisol shot.  It was reported that the patient was born with eczema. He was not taking any medication for it, it has been under complete control for more than 10 years
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: sores on his scalp, face, legs, back and abdomen; She stated that it is extra red; seems like this shot has now flared up his eczema; next week it was completely flared up, with swelling; very bad rash/ it was completely flared up; He got his 2nd dose two weeks apart because that is what his pharmacy told him to do.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sores on his scalp, face, legs, back and abdomen), RASH ERYTHEMATOUS (She stated that it is extra red), ECZEMA (seems like this shot has now flared up his eczema), SWELLING (next week it was completely flared up, with swelling) and RASH (very bad rash/ it was completely flared up) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eczema (Patient was born with eczema.).   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PAIN (sores on his scalp, face, legs, back and abdomen), RASH ERYTHEMATOUS (She stated that it is extra red), ECZEMA (seems like this shot has now flared up his eczema), SWELLING (next week it was completely flared up, with swelling), RASH (very bad rash/ it was completely flared up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his 2nd dose two weeks apart because that is what his pharmacy told him to do.). The patient was treated with CORTISOL [HYDROCORTISONE] for Adverse event, at an unspecified dose and frequency. In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his 2nd dose two weeks apart because that is what his pharmacy told him to do.) had resolved. At the time of the report, PAIN (sores on his scalp, face, legs, back and abdomen), RASH ERYTHEMATOUS (She stated that it is extra red), ECZEMA (seems like this shot has now flared up his eczema), SWELLING (next week it was completely flared up, with swelling) and RASH (very bad rash/ it was completely flared up) had not resolved.            No concomitant medications were reported  It was reported that he got the 1st dose of the Moderna COVID 19 vaccine approximately at the end of August - 28th, 29th or 30th.  He had no reactions  It was reported events still ongoing.  It was reported that he  hasn't been treated for it since doctors did not  know what was going on. Three doctors in their area refused to treat him because they did not  know what to do. Only one dermatologist gave him a cortisol shot.  It was reported that the patient was born with eczema. He was not taking any medication for it, it has been under complete control for more than 10 years
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure before pregnancy
Clinical narrative: Vaccine exposure before pregnancy; Patient received vaccine after expiry date; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) and MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved. At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) and MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) to be possibly related.    The pharmacist stated in the questionnaire that the patient stated yes for could be pregnant or become pregnant in the next month. The pharmacist was unaware if the patient was taking medication and if the patient had the side effects. No concomitant and treatment medication were provided Company Comment: This is a case of expired product administered for this 28-year-old, female patient with no relevant medical history, who experienced maternal exposure before pregnancy following administration of the third dose of the Moderna COVID-19 Vaccine. No associated adverse event was reported. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This is a case of expired product administered for this 28-year-old, female patient with no relevant medical history, who experienced maternal exposure before pregnancy following administration of the third dose of the Moderna COVID-19 Vaccine. No associated adverse event was reported. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 patients were given the Moderna COVID 19 vaccine 16.5 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients were given the Moderna COVID 19 vaccine 16.5 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients were given the Moderna COVID 19 vaccine 16.5 hours post puncture). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (8 patients were given the Moderna COVID 19 vaccine 16.5 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.  The vial was initially stored in the refrigerator on 1 NOV 2021. Date and time vial was first punctured on 1 NOV 2021 at 5pm. Date of administration of vaccine was 2 NOV 2021 between 9am and 9:30am.  Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F)which was probably like 10 to 15 minutes.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received as no adverse event reported from patient.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Headache, Nausea, Pyrexia
Clinical narrative: Stomach ache  after 2nd shot; Headache after 2nd shot; Nausea  after 2nd shot; Low grade Fever 100F  after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache  after 2nd shot), HEADACHE (Headache after 2nd shot), NAUSEA (Nausea  after 2nd shot) and PYREXIA (Low grade Fever 100F  after 2nd shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache  after 2nd shot), HEADACHE (Headache after 2nd shot), NAUSEA (Nausea  after 2nd shot) and PYREXIA (Low grade Fever 100F  after 2nd shot). On 08-Feb-2021, ABDOMINAL PAIN UPPER (Stomach ache  after 2nd shot), HEADACHE (Headache after 2nd shot), NAUSEA (Nausea  after 2nd shot) and PYREXIA (Low grade Fever 100F  after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) Low grade Fever 100F for 2 days.         No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-373647, MOD-2021-373660 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms, Nausea
Clinical narrative: Diarrhea; Very crampy; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MUSCLE SPASMS (Very crampy) and NAUSEA (Nauseous) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), MUSCLE SPASMS (Very crampy) and NAUSEA (Nauseous). On 24-Jan-2021, DIARRHOEA (Diarrhea), MUSCLE SPASMS (Very crampy) and NAUSEA (Nauseous) had resolved.            No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-373701 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever for a day after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever for a day after the second vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PYREXIA (Fever for a day after the second vaccine). In March 2021, PYREXIA (Fever for a day after the second vaccine) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-373761, MOD-2021-373777 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Feeling intense sensation like "jackhammering in every joint"; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Feeling intense sensation like "jackhammering in every joint") and FATIGUE (Exhausted) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced ARTHRALGIA (Feeling intense sensation like "jackhammering in every joint") and FATIGUE (Exhausted). On 31-Oct-2021, ARTHRALGIA (Feeling intense sensation like "jackhammering in every joint") and FATIGUE (Exhausted) had resolved.            No concomitant medication reported. No treatment information was provided.  Patient stayed home to rest all day, and reported symptoms were cleared by 31-OC-2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: She ran a temperature for that 1st day; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (She ran a temperature for that 1st day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BODY TEMPERATURE INCREASED (She ran a temperature for that 1st day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (She ran a temperature for that 1st day) outcome was unknown.            No concomitant medications were reported   This case was linked to MOD-2021-366478 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: received booster dose from  expired vial; sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) and EXPIRED PRODUCT ADMINISTERED (received booster dose from  expired vial) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient has tested for COVID-19 positive on Sep-2021) in September 2021. Concurrent medical conditions included Sulfonamide allergy (allergy to Sulfa drugs), Hypothyroidism, Hypertension, Impaired fasting glucose and Gout. Concomitant products included ALLOPURINOL for Gout, SPIRONOLACTONE for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 29-Oct-2021 at 2:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster dose from  expired vial). In 2021, PAIN IN EXTREMITY (sore arm) had resolved. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received booster dose from  expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided. The sore arm had resolved within 24 hours.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: follow up received contains updated reporter type, patient demographic details, medical history, added concomitant medications and added events
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache
Clinical narrative: headache above right eye; my nose/right nostril blood started pouring out. Hard time getting it under control; felt tired; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection; Lot number: EW0185, Expiry date: Not reported), via an unknown route of administration into left arm on 21Jul2021 at 11:15 AM as dose 1 single (Age at vaccination: 65-year-old) for COVID-19 immunization. The patient did not receive any other vaccine in four weeks of covid vaccine. The patient was neither diagnosed with Covid prior to vaccination nor tested for Covid post vaccination. Medical history included: PVC (Premature ventricular contractions), Seasonal Allergies and Known allergies to Penicillin. Concomitant medications included (within two weeks of vaccination): IC Flecainide Acetate tablet at 50 mg twice a day and magnesium lactate, pyridoxine hydrochloride (IC MAGNES). On 22Jul2021 around 7 pm, the blood started pouring out from nose/right nostril and had Hard time getting it under control. About 5 minutes later, it was under control and felt tired. On 23Jul2021, the patient had no bleeding but had headache above right eye. The patient stated that she does have seasonal allergies and they have been bad this year and mentioned of having headache above right eye when she went for vaccine. The patient reported that she never had a nosebleed before. Heavy blood. The patient was feeling ok today and was having just headache. The patient was ready to go to the ED (emergency department) when got it under control. The patient did not receive any treatment for reported events. Outcome of nosebleed was recovered on 23Jul2021. Outcome for tiredness and headache was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Tenderness
Clinical narrative: Light headache; Flushed cheeks; Tenderness near my heart; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 31-year-old female patient received bnt162b2 (Pfizer/BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EW0171) intramuscularly, administered in right arm on 29Apr2021 12:50 (at the age of 31-year-old) as dose 1, single for covid-19 immunization. Medical history reported as none and family history included Diabetes, High blood pressure, cancer (reported as Diabetes, high blood pressure, cancer run in her family) from an unknown date and unknown if ongoing. Concomitant medications reported as none. Prior vaccination reported as none. On an unspecified date in 2021 the patient experienced light headache, flushed cheeks, tenderness near her heart. Outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizzy; Fever; This is a spontaneous report received from a contactable consumer (wife).  A 39-year-old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: FA6780) via an unspecified route of administration on 21Jul2021 ;9:30 as (At the age of 39 year) dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EW0196) via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunization. On 21July2021 the patient had experienced fever. On 22july2021 about 36 hours after the vaccination patient had experienced dizzy. Reporter stated, yesterday at 9:30 in the morning his husband and Reporter received our second dose of the Pfizer COVID-19 vaccination, and his husband got a strong reaction at night he had a fever (distorted voice and incomplete sentence). When paraphrased the concern, reporter stated, yes, and about 36 hours after the vaccination he is now dizzy and concerned that he is dizzy. When confirmed if the reporter had the reaction? Reporter stated, I said, I am fine I had no reaction. When asked to probe further questions, Reporter stated, I just would like to know before all of that if there is anything I can do to help him. It was reported that Treatment: Reporter stated, He took two Tylenols. Therapeutic measures were taken for the AE and treatment was given with two Tylenols. The clinical outcome of the event fever was unknown and outcome of event dizzy was Not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity
Clinical narrative: after the first dose she experience side effect like hypersensitivity and pain arm as well and that's it.; after the first dose she experience side effect like hypersensitivity and pain arm as well and that's it.; This is a spontaneous report from a contactable consumer (herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Jun2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and medications were not reported. The patient experienced after the first dose she experience side effect like hypersensitivity and pain arm as well and that's it on Jun2021. Consumer stated, He told her guys would be able to tell her if she needs to go to the doctors about it or if she needs to like go to the hospital or not. The clinical outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Extreme soreness in right arm/shoulder area immediately after first shot,lasted for about four days; Extreme soreness in right arm/shoulder area immediately after first shot, lasted for about four days; This is a spontaneous report from a non-contactable consumer (patient). A 46-years-old no -pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0167), via an unspecified route of administration, administered in Arm Right on 22May2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. No known allergies. The patient did not take no other vaccine in four weeks. The patient medical history was not reported. Concomitant medications included colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; zinc taken for an unspecified indication, start and stop date were not reported; probiotics taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced extreme soreness in right arm/shoulder area immediately after first shot, lasted for about four days. No COVID prior vaccination, and no COVID tested post vaccination. The patient did not receive any treatment. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fever; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 46-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0185, Expiration Date: was not reported), via an unspecified route of administration, administered in right arm, on 14Jun2021 at 08:00 (at the age of 46 year), as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Vitamin-D taken for an unspecified indication, start and stop date were not reported; Zinc taken for an unspecified indication, start and stop date were not reported; Probiotics taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0167, Expiration Date: was not reported), via an unspecified route of administration, administered in right arm, on 22May2021 at 13:30 (at the age of 46 year), as dose 1, single for COVID-19 immunization and the patient experienced extreme soreness in right arm (shoulder area) immediately after first shot which lasted for about four days. The patient was not pregnant. The patient was not received other vaccine in four weeks. The patient received other medication in two weeks were Vitamin D, Zinc, Probiotics. The adverse event was not resulted in emergency room or physician office visit. Prior to vaccination, the patient was not infected to COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient had no known allergies. On 14Jun2021 at 20:00 (12 hours after getting the second vaccine dose), the patient experienced fever, chills, and fatigue kicked in and lasted for about 48 hours. The patient was not received treatment for the adverse events. The outcome of fever, chills, fatigue was recovered on 16-JUN-2021 at 20:00.  No Follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose; Cough; Fever; This is a spontaneous report from a contactable consumer or other non-health professional. A 63-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EW0185)), dose 1 via an unspecified route of administration on 12Jul2021 (age at the time of vaccination was 63-year-old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, on the fifth day patient started having runny nose, fever and cough. Patient was trying to report a side effect and was not sure it was side effect or something else, but patient have runny nose, and cough and it has been 2 weeks since patient got the first dose of Pfizer. 26Jul2021 (Today), so it was 7 days. The patient informed about the role of Pfizer drug safety department and confirmed it was the Pfizer Covid19 vaccine. The patient was informed that Pfizer has a legal and ethical responsibility to report every problem to . Also, we maintain accurate safety profile of the drug which ultimately helps others using this product. When informed about Pfizer medical information department for the concern, consumer stated, "I should call them because it was impossible to talk. You are breaking up a lot. The fever went away in 3 days and runny nose and coughing was continues. Patient asked whether it was normal or should go and test for COVID-19. Maybe patient was not affected and if it was so where will they go, should go to any clinic or pharmacy or what was the procedure. The outcome of the event fever was recovered on an unspecified date in 2021, while all other events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: extreme fatigue/tiredness; body soreness; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration in Left Arm on 03Apr2021 (Lot Number: Ew0120) as Dose 2, Single (age at vaccination: 26-years-old) for Covid-19 immunisation. Medical history included testis cancer (History of testicular cancer) and known allergies: Sulfa. Concomitant medication(s) included famotidine, lysine and calcium carbonate (TUMS [CALCIUM CARBONATE]). Historical vaccine included bnt162b2 (PFIZER-(BIONTECH COVID -19 VACCINE, formulation: solution for injection, via an unspecified route of administration in Left Arm on 09Mar2021 (Lot Number: EN6199) as Dose 1, Single at the age of 26-years-old for Covid-19 immunisation and experienced Alopecia areata, and Sudden hair loss in patches on scalp and beard. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had received other medications within 2 weeks prior to the vaccination includes Famotidine, lysine, tums. The patient was not diagnosed with covid-19 before and tested post vaccination. On 04Apr2021 (1 day after the vaccination), the patient experienced extreme fatigue/tiredness, and body soreness. On 20Apr2021 the patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: Negative. The events resulted in emergency room visit/ Physician office visit. Therapeutic measures were taken as a result of extreme fatigue/tiredness, and body soreness includes steroid cream. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Antibody test, Asthenia, Blood immunoglobulin G, Body temperature
Clinical narrative: she had covid after the 2 doses and before the booster dose; she had covid after the 2 doses and before the booster dose; hot in the area; redness from flu shout and covid; burring eyes; She was sick in June and July; intermittent pressure at the back of the head; stuffiness; weakness; fever; nausea; could not taste anything; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient herself).  A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 07Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history included autoimmune disease but no transplant. The concomitant medications were not reported. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 17Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced covid after the 2 doses (4 weeks later) and before the booster dose, weakness, fever, stuffiness (with different food something her heard gets like this), intermittent pressure at the back of the head, headache, nausea, burring eyes, she was sick in June and July, could not taste anything, redness from flu shout and covid, hot in the area (full blown symptoms like when she received the shots) on an unspecified date in 2021. The patient underwent lab tests and procedures which included body temperature: 97 on an unspecified date, blood immunoglobulin g: positive on 09Sep2021, Quantitative test (investigation): 459.1 on 07Oct2021 (and 11Oct2021 result value 459.1- antibodies were detected) and antibody test: unknown, sars-cov-2 test (covid): positive result, serology test: 400 (in the last 3 to 6months) on 11Oct2021. she will be seeing her rheumatology. Patient was also interested in plasma donation. she did not specifically ask for the lab test that was ordered but is now wishing to have a better understanding of the lab results. She wanted to know if that meant she potentially had a breakthrough case, like her friend's parents and friend's husband. She reported she attempted to reach Lab, but they are not answer; her primary doctor is out for the weekend. She wanted to know if taking booster too soon could have caused the symptoms as she did test positive to covid after the 2 doses. The patient was administered with booster received on 26Oct2021 at 13:30. She wanted to know should she even gotten the booster dose since she had covid and with high antibodies. The clinical outcome of events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.