chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fear, Feeding disorder, Hallucination, Hyperhidrosis
Clinical narrative: feel weak; this one really scared me; bone pain; Dizzy; arm is still painful; I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened; Joint pain; Achy, body pain; worst experience, I was in coma for 2 days; hallucinated; was sweating all over; Did not eat in two days; not woke up, just sleep; This spontaneous case was reported by a consumer and describes the occurrence of COMA (worst experience, I was in coma for 2 days) and HALLUCINATION (hallucinated) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE and Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine and PNEUMOCOCCAL VACCINE.    On 05-May-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced COMA (worst experience, I was in coma for 2 days) (seriousness criterion medically significant), HALLUCINATION (hallucinated) (seriousness criterion medically significant), HYPERHIDROSIS (was sweating all over), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep), BONE PAIN (bone pain), DIZZINESS (Dizzy), PAIN IN EXTREMITY (arm is still painful), CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened), ARTHRALGIA (Joint pain) and MYALGIA (Achy, body pain). On 07-May-2021, the patient experienced FEAR (this one really scared me) and ASTHENIA (feel weak). On 07-May-2021, COMA (worst experience, I was in coma for 2 days), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep) and CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened) had resolved. At the time of the report, HALLUCINATION (hallucinated), HYPERHIDROSIS (was sweating all over), FEAR (this one really scared me), DIZZINESS (Dizzy) and MYALGIA (Achy, body pain) outcome was unknown and BONE PAIN (bone pain), ASTHENIA (feel weak), PAIN IN EXTREMITY (arm is still painful) and ARTHRALGIA (Joint pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The patient did not receive any treatment medication. No concomitant medication was reported.   The patient spoke to his doctor about not getting the 2nd shot.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Myalgia, Pain in extremity
Clinical narrative: feel weak; this one really scared me; bone pain; Dizzy; arm is still painful; I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened; Joint pain; Achy, body pain; worst experience, I was in coma for 2 days; hallucinated; was sweating all over; Did not eat in two days; not woke up, just sleep; This spontaneous case was reported by a consumer and describes the occurrence of COMA (worst experience, I was in coma for 2 days) and HALLUCINATION (hallucinated) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE and Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine and PNEUMOCOCCAL VACCINE.    On 05-May-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced COMA (worst experience, I was in coma for 2 days) (seriousness criterion medically significant), HALLUCINATION (hallucinated) (seriousness criterion medically significant), HYPERHIDROSIS (was sweating all over), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep), BONE PAIN (bone pain), DIZZINESS (Dizzy), PAIN IN EXTREMITY (arm is still painful), CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened), ARTHRALGIA (Joint pain) and MYALGIA (Achy, body pain). On 07-May-2021, the patient experienced FEAR (this one really scared me) and ASTHENIA (feel weak). On 07-May-2021, COMA (worst experience, I was in coma for 2 days), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep) and CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened) had resolved. At the time of the report, HALLUCINATION (hallucinated), HYPERHIDROSIS (was sweating all over), FEAR (this one really scared me), DIZZINESS (Dizzy) and MYALGIA (Achy, body pain) outcome was unknown and BONE PAIN (bone pain), ASTHENIA (feel weak), PAIN IN EXTREMITY (arm is still painful) and ARTHRALGIA (Joint pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The patient did not receive any treatment medication. No concomitant medication was reported.   The patient spoke to his doctor about not getting the 2nd shot.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Electrocardiogram, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (Pain in the chest) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included LISINOPRIL and ATORVASTATIN. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria medically significant and life threatening), CHEST PAIN (Pain in the chest) (seriousness criterion life threatening), LETHARGY (Lethargic), DYSPEPSIA (Heart ache) and FATIGUE (Tired). On an unknown date, the patient experienced HEADACHE (Headache). On 14-Apr-2021, MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (Pain in the chest) outcome was unknown. At the time of the report, LETHARGY (Lethargic) and FATIGUE (Tired) had not resolved, DYSPEPSIA (Heart ache) was resolving and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Electrocardiogram: abnormal Showed mild Heart Attack. His doctor gave him nitroglycerin which he could not take due to headache and full aspirin. His cardiologist appointment is coming up on 25MAY2021. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested. This case was linked to MOD-2021-114362 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Myocardial infarction
Clinical narrative: This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (Pain in the chest) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included LISINOPRIL and ATORVASTATIN. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria medically significant and life threatening), CHEST PAIN (Pain in the chest) (seriousness criterion life threatening), LETHARGY (Lethargic), DYSPEPSIA (Heart ache) and FATIGUE (Tired). On an unknown date, the patient experienced HEADACHE (Headache). On 14-Apr-2021, MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (Pain in the chest) outcome was unknown. At the time of the report, LETHARGY (Lethargic) and FATIGUE (Tired) had not resolved, DYSPEPSIA (Heart ache) was resolving and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Electrocardiogram: abnormal Showed mild Heart Attack. His doctor gave him nitroglycerin which he could not take due to headache and full aspirin. His cardiologist appointment is coming up on 25MAY2021. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested. This case was linked to MOD-2021-114362 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cutaneous vasculitis, Fatigue, Insomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukocytoclastic vasculitis (had that earlier couple years ago after I came back from vacation but it was on both the legs). Concurrent medical conditions included Migraine. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (didn't sleep all night), NAUSEA (nauseous) and VACCINATION SITE PAIN (injection site pain). On 02-May-2021, the patient experienced MIGRAINE (migraine), MALAISE (Not feeling great), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). On 03-May-2021, the patient experienced CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis) (seriousness criterion medically significant), PRURITUS (leg were itching) and RASH (had little red dots everywhere on right legs). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage), VACCINATION SITE BRUISING (Vaccination site bruising) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis), INSOMNIA (didn't sleep all night), MIGRAINE (migraine), PRURITUS (leg were itching), MALAISE (Not feeling great), VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage), VACCINATION SITE BRUISING (Vaccination site bruising), RASH (had little red dots everywhere on right legs), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), NAUSEA (nauseous), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Inconclusive) 99.9. No relevant concomitant medications were reported. Treatment for the events included acetaminophen, Excedrin and ice pack. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-114413 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Nausea, Pruritus, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukocytoclastic vasculitis (had that earlier couple years ago after I came back from vacation but it was on both the legs). Concurrent medical conditions included Migraine. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (didn't sleep all night), NAUSEA (nauseous) and VACCINATION SITE PAIN (injection site pain). On 02-May-2021, the patient experienced MIGRAINE (migraine), MALAISE (Not feeling great), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). On 03-May-2021, the patient experienced CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis) (seriousness criterion medically significant), PRURITUS (leg were itching) and RASH (had little red dots everywhere on right legs). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage), VACCINATION SITE BRUISING (Vaccination site bruising) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis), INSOMNIA (didn't sleep all night), MIGRAINE (migraine), PRURITUS (leg were itching), MALAISE (Not feeling great), VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage), VACCINATION SITE BRUISING (Vaccination site bruising), RASH (had little red dots everywhere on right legs), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), NAUSEA (nauseous), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Inconclusive) 99.9. No relevant concomitant medications were reported. Treatment for the events included acetaminophen, Excedrin and ice pack. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-114413 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukocytoclastic vasculitis (had that earlier couple years ago after I came back from vacation but it was on both the legs). Concurrent medical conditions included Migraine. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (didn't sleep all night), NAUSEA (nauseous) and VACCINATION SITE PAIN (injection site pain). On 02-May-2021, the patient experienced MIGRAINE (migraine), MALAISE (Not feeling great), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). On 03-May-2021, the patient experienced CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis) (seriousness criterion medically significant), PRURITUS (leg were itching) and RASH (had little red dots everywhere on right legs). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage), VACCINATION SITE BRUISING (Vaccination site bruising) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis), INSOMNIA (didn't sleep all night), MIGRAINE (migraine), PRURITUS (leg were itching), MALAISE (Not feeling great), VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage), VACCINATION SITE BRUISING (Vaccination site bruising), RASH (had little red dots everywhere on right legs), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), NAUSEA (nauseous), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Inconclusive) 99.9. No relevant concomitant medications were reported. Treatment for the events included acetaminophen, Excedrin and ice pack. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-114413 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Headache, Hypertension, Migraine
Clinical narrative: blood pressure that was at 229/147; a terrible headache that continued to the next day to a migraine; terrible headache that continued to the next day to a migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure that was at 229/147) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MIGRAINE (a terrible headache that continued to the next day to a migraine) and HEADACHE (terrible headache that continued to the next day to a migraine). On 31-Jan-2021, the patient experienced HYPERTENSION (blood pressure that was at 229/147) (seriousness criterion intervention required). On 31-Jan-2021, HYPERTENSION (blood pressure that was at 229/147) had resolved. At the time of the report, MIGRAINE (a terrible headache that continued to the next day to a migraine) and HEADACHE (terrible headache that continued to the next day to a migraine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure abnormal: 229/147 (abnormal) 229/147.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  On 31-Jan-2021, the patient went to urgent care due headache changing into a migraine. The reporter stated, urgent care would not provide treatment due to how high the blood pressure was and advised the patient to go to the emergency department. The patient went to the emergency department around 6:00 pm and was treated for elevated blood pressure of 229/147. The patient was not admitted nut was advised to follow up with a primary care physician.  Treatment details were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-114821 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-114821:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Surgery
Clinical narrative: Pre-scheduled surgery; Missed second dose time window due to surgery; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SURGERY (Pre-scheduled surgery) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SURGERY (Pre-scheduled surgery) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose time window due to surgery). At the time of the report, SURGERY (Pre-scheduled surgery) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose time window due to surgery) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported.   No treatment information was provided. Patient received the first dose of the Moderna COVID-19 vaccine on 06Mar2021. The patient was then hospitalized for a surgery that was believe to be pre-scheduled. Due to this surgery, the patient did not receive their second dose of the vaccine and is now outside of the allowed time window. The patient is looking to receive this second dose of the vaccine on 11May2021. No other side effects were reported from the first dose of the vaccine.  This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 027A21A  and an AE of Surgery. Based on the current available information and temporal association between the use of the product and the start date of the event of Surgery, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 027A21A  and an AE of Surgery. Based on the current available information and temporal association between the use of the product and the start date of the event of Surgery, a causal relationship cannot be excluded.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Myalgia, Vaccination complication, Wrong product administered
Clinical narrative: Not feeling well; Feels hot; Achiness all over; Chills; inadvertently given the Moderna vaccine  (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well), FEELING HOT (Feels hot), MYALGIA (Achiness all over) and CHILLS (Chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently given the Moderna vaccine  (2nd dose)). On 11-May-2021, the patient experienced VACCINATION COMPLICATION (Not feeling well) (seriousness criterion medically significant), FEELING HOT (Feels hot) (seriousness criterion medically significant), MYALGIA (Achiness all over) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 10-May-2021, WRONG PRODUCT ADMINISTERED (inadvertently given the Moderna vaccine  (2nd dose)) had resolved. At the time of the report, VACCINATION COMPLICATION (Not feeling well), FEELING HOT (Feels hot), MYALGIA (Achiness all over) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and lab values were reported. No treatment related information has been reported. This report refers to a case of wrong product administered for mRNA -1273, lot # 044B21A with AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of wrong product administered for mRNA -1273, lot # 044B21A with AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Fall
Clinical narrative: fell and broke her ankle; fell; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (fell and broke her ankle) and FALL (fell) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANKLE FRACTURE (fell and broke her ankle) (seriousness criterion medically significant) and FALL (fell) (seriousness criterion medically significant). The patient was treated with Surgery for Ankle fracture. At the time of the report, ANKLE FRACTURE (fell and broke her ankle) and FALL (fell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment for ankle fracture included surgery.  Company Comment  Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: contact information provided; serious criteria updated for events; Sender's Comments: Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus inadequate control, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (Out of Control Blood Sugar (320 mg/dL)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LOSARTAN for Prevention, INSULIN LISPRO (HUMALOG) for Type 1 diabetes mellitus. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced INJECTION SITE PAIN (A little injection site pain). On 11-May-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Out of Control Blood Sugar (320 mg/dL)) (seriousness criteria medically significant). On 11-May-2021, INJECTION SITE PAIN (A little injection site pain) had resolved. At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Out of Control Blood Sugar (320 mg/dL)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Blood glucose: slightly high blood glucose mg/dl (Inconclusive) Slightly high blood glucose. On 12-May-2021, Blood glucose: 320 mg/dl (High) High blood glucose. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The night of vaccination, she had slightly high blood glucose, but it got worse as the days went by.  On 12-May-2021, her blood glucose reading was 320 mg/dl. It's high even when she is not eating. She increased her insulin dose triple fold to control her blood glucose. She called her Doctor and waited for him to call back. She stated that she had a very good control over her blood glucose. She knew that the uncontrolled blood glucose was caused by the vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue, Thrombosis
Clinical narrative: Hospitalization involving some serious health conditions; blood clot removed from legs; second dose has passed over 28 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalization involving some serious health conditions) and THROMBOSIS (blood clot removed from legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac transplant in 2004. Concomitant products included TACROLIMUS and MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Prophylaxis against heart transplant rejection, APIXABAN (ELIQUIS) for Thrombosis prophylaxis.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization involving some serious health conditions) (seriousness criterion hospitalization), THROMBOSIS (blood clot removed from legs) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (second dose has passed over 28 days). The patient was treated with Surgery (blood clot removed) for Thrombosis. At the time of the report, HOSPITALISATION (Hospitalization involving some serious health conditions) and THROMBOSIS (blood clot removed from legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose has passed over 28 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.  It was reported that, the patient missed an appointment for his second dose due to hospitalization involving some serious health conditions. The patient was in the hospital for extended period and underwent surgery to get blood clot removed from legs during the hospitalization.  Very limited information has been provided for the event at this time. However, details of hospitalization and compliance with anti-coagulant therapy is required for further evaluation. This report also This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.; Sender's Comments: Very limited information has been provided for the event at this time. However, details of hospitalization and compliance with anti-coagulant therapy is required for further evaluation. This report also This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Nausea, Vomiting
Clinical narrative: Fast heart rate; dizziness; Nausea; vomiting; This is a spontaneous report from a contactable other hcp (Patient herself). A 37-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 16:30 (age at the time of vaccination was 37-year-old) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included cyclic vomiting syndrome, Peanut allergy, Allergy to nuts from an unknown date and unknown if ongoing. Other medications in two weeks Concomitant medication(s) included nystatin (NYSTATIN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took compazine [prochlorperazine edisylate], reglan [metoclopramide] , betadine [povidone-iodine] and experienced drug hypersensitivity. The patient has no COVID prior to vaccination. The patient has no other vaccine in 4 weeks.The patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included heart rate: 185 on Fast heart rate. 185 BPM when lying  down.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of fast heart rate (heart rate increased), nausea (nausea), dizziness (dizziness), vomiting (vomiting). As a result patient was in [Emergency room/department or urgent care]. Treatment received yes with IV fluids and Phenergan 12.5 mg. On 14Jan2021 18:00 The patient experienced fast heart rate (medically significant), nausea (medically significant) , dizziness (medically significant), vomiting (medically significant). The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the temporal association, there is a reasonable possibility that the administration of vaccination with BNT162B2 played a contributory role in triggering the onset of the events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Caller indicates he takes "epifen 10mg and no hematoma formation".; This is a spontaneous report from a contactable consumer or other non hcp.  A 71-years-old male patient received dose 1 of bnt162b2 (BNT162B2, Solution for injection, (Batch/Lot Number: EL3302), via an unspecified route of administration on an unspecified date as SINGLE DOSE for an unspecified indication. Medical history included disability from an unknown date and unknown if ongoing. Concomitant medications included epinephrine (EPIPEN) taken for an unspecified indication, naproxen sodium (ALEVE), Aleve (Lot no NAA92FK expiry:Jun2023) taken for disability. Patient was responded by caller when vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection. He just wanted to find out if the things he did affect the potency. He said he did take a blood thinner. Secondly, the local station said one should not take any over the counter medication or pain killer, pain relief pills like aspirin, Ibuprofen, and it did not mention Aleve. The patient had asked whether he could antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. He was responded, recently too the Pfizer vaccine tuesday saw the warnings on the news channel all the things he should have done or not done, daily habits included Aleve, Norco. He was responded the interim ACIP guidelines note that Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms was not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses was not available at this time and If you were a patient, you should discuss this with your healthcare provider. The patient took Epifen 10mg and no hematoma formation. The outcome of the event was unknown.  Follow-up attempts were completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Muscle spasms
Clinical narrative: severe debilitating back spasms; he suffered from "debilitating back spasms" due to a "movement he made. He added he also "had these spasms in the past; massive lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via unspecified route of administration on 15Jan2021 as 1st dose, single for covid-19 immunisation. The patient medical history included spasms, in the past. The concomitant medication was not reported. The patient reported that, he got the first dose of the Pfizer BioNTech vaccine on 15Jan2021. On 26Jan2021, he had a massive lower back pain, he needs to take a metronidazole injection then went to a regular metronidazole. On 26Jan2021, he got severe debilitating back spasms due to a movement he made and went to ER/urgent care where they gave him a dexamethasone shot, methylprednisolone shot, and a 6-8 course of oral prednisone. Is not sure if he was going to finish it, he took the dose 6 and 5, but did not to the 4 yesterday. Wants to make sure it's not causing more problems to finish that. The dexamethasone he believes is long acting and the methylprednisolone may be similar to the regular prednisone. The patient was feeling better, and the muscle relaxers are helping, but he wants to be sure that these medications did not diminish the effectiveness of the vaccine. The hospital was wanting him back to work on the 05Feb2021 to get the second dose, but he wants to be sure these medicines has not affected or impacted the first dose. The outcome of the events was recovering. The patient specified that his symptoms were not related to the vaccine.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the reported "severe debilitating back spasms" and "condition aggravated" cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 10 days after the vaccine, I received a positive PCR Coronavirus test result; This is a spontaneous report from a contactable consumer or other non hcp.  A 70-years-old female patient first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had positive PCR Coronavirus test. It was reported that two days after first Pfizer Coronavirus vaccine patient was exposed to someone who had the virus and 10 days after the vaccine, the patient had positive PCR Coronavirus test result. The following day patient's physician set her up to receive the monoclonal antibody infusion and told that she cannot get the second dose of the Pfizer vaccine for 90 days from the date she received the infusion, but her physician says she may have to start the vaccine over again.  The outcome of event was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: her period came back in less than the usual 28 days and was very heavy. It started on 06Feb2021 and was still ongoing (03Mar2021); This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 04Feb2021 (Lot Number: EL3247) at the age of 32 years old as 2nd dose, single for COVID-19 immunisation. Medical history included anxiety. Concomitant medication included buspirone and etonogestrel (NEXPLANON). The patient previously received BNT162B2, via an unspecified route of administration on the right arm on 14Jan2021 09:30 (Lot Number: EL3247) at the age of 32 years old as 1st dose, single for COVID-19 immunisation. The patient had no other vaccines in 4 weeks and had no known allergies. The patient didn't have COVID prior to the vaccination. The patient was not COVID tested post vaccination. The patient stated that with etonogestrel (NEXPLANON), her period came back in less than the usual 28 days and was very heavy. It started on 06Feb2021 and was still ongoing (03Mar2021). No treatment was done for the adverse event. The outcome of the event was not recovered.  information about lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 15Feb2021 at 11:30 (Batch/Lot Number: EL9266) (at the age of 50-years-old) as 2nd dose, single for COVID-19 immunization. The vaccination facility type was nursing home. The patient's medical history was reported as none and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks and other medication in two weeks. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ENS358) on 25Jan2021 at 03:30 PM via an unspecified route of administration, administered in left arm for COVID-19 vaccination. The patient reported that she was 2 years post-menopausal. She had a full period for 6 days starting the night of 15Feb2021 at 07:00 PM on the same day she received her second dose of COVID vaccine. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment included pelvic and internal ultrasound and scheduled uterine (as reported). The outcome of the event was recovering. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatitis, Urinary retention
Clinical narrative: Swelling of prostate causing inability to urinate.; Swelling of prostate causing inability to urinate.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 10Mar2021 at 11:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and severe pollen allergy causing food allergy to melons and bananas. The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 14Mar2021 at 02:00, the patient experienced swelling of prostate causing inability to urinate. Therapeutic measures were taken as a result of adverse event and included visit to emergency room/department or urgent care and treatment with a catheter. The clinical outcome of swelling of prostate causing inability to urinate was recovering at the time of this report.  Follow-up (20May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.