chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Protein S
Clinical narrative: His arm also hurt; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His arm also hurt) and HEADACHE (Slight headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 004M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (His arm also hurt) and HEADACHE (Slight headache). At the time of the report, PAIN IN EXTREMITY (His arm also hurt) and HEADACHE (Slight headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Protein S: 1732 (High) Antibody test showed an S-protein count of 1732. On 18-Nov-2021, Protein S: 142 (Low) S-protein count of 142.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient did not take any treatments   This case was linked to MOD-2021-396060, MOD-2021-396043 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Non Significant follow-up appended
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Impaired work ability, Laboratory test, Seizure
Clinical narrative: Patient has also been unable to work because his license was taken away due to his seizures; Weak; Dizzy; Severe seizure/he had three severe seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Severe seizure/he had three severe seizures) and IMPAIRED WORK ABILITY (Patient has also been unable to work because his license was taken away due to his seizures) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021 at 2:30 AM, the patient experienced SEIZURE (Severe seizure/he had three severe seizures) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (Patient has also been unable to work because his license was taken away due to his seizures) (seriousness criteria disability and medically significant), ASTHENIA (Weak) and DIZZINESS (Dizzy). At the time of the report, SEIZURE (Severe seizure/he had three severe seizures), IMPAIRED WORK ABILITY (Patient has also been unable to work because his license was taken away due to his seizures), ASTHENIA (Weak) and DIZZINESS (Dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, Laboratory test: abnormal (abnormal) seem to think it was the vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had three severe seizures. He had the seizures on 12-May-2021, 2:30 am, 24-Jun-2021, 11:30 pm, and 14-Nov-2021 in afternoon. Patient's wife called emergency services and patient was taken to the Emergency room. The Emergency room ran several tests and seem to think it was the vaccine. Patient was under a Neurologists care and on different medications. The medication had altered his personality and everyday health.  Company comment: This case concerns a 58-year-old, male patient with no previous relevant medical reported, who experienced the unexpected events of seizure and impaired work ability. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 58-year-old, male patient with no previous relevant medical reported, who experienced the unexpected events of seizure and impaired work ability. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Myalgia, Oropharyngeal discomfort, Pyrexia
Clinical narrative: sensation of throat closing; Allergic reaction in the hands (red spots); body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (sensation of throat closing), HYPERSENSITIVITY (Allergic reaction in the hands (red spots)), MYALGIA (body aches) and PYREXIA (Fever) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (using medications.).    On 22-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced OROPHARYNGEAL DISCOMFORT (sensation of throat closing), HYPERSENSITIVITY (Allergic reaction in the hands (red spots)), MYALGIA (body aches) and PYREXIA (Fever). At the time of the report, OROPHARYNGEAL DISCOMFORT (sensation of throat closing), HYPERSENSITIVITY (Allergic reaction in the hands (red spots)), MYALGIA (body aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include inhaler used for asthma.  Treatment medication include patient asthma medication helped a little to alleviate the respiratory symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Dizziness, Pruritus, Vaccination site pain
Clinical narrative: round cyst like area sized shaped like a pea/ middle of the left armpit; under her left armpit started itching; sore left arm; feeling dizzy/ dizziness comes and goes/dizziness occurred while walking; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy/ dizziness comes and goes/dizziness occurred while walking), CYST (round cyst like area sized shaped like a pea/ middle of the left armpit), PRURITUS (under her left armpit started itching) and VACCINATION SITE PAIN (sore left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 014M20A and 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced DIZZINESS (feeling dizzy/ dizziness comes and goes/dizziness occurred while walking), PRURITUS (under her left armpit started itching) and VACCINATION SITE PAIN (sore left arm). On 23-Nov-2021, the patient experienced CYST (round cyst like area sized shaped like a pea/ middle of the left armpit). At the time of the report, DIZZINESS (feeling dizzy/ dizziness comes and goes/dizziness occurred while walking) had not resolved and CYST (round cyst like area sized shaped like a pea/ middle of the left armpit), PRURITUS (under her left armpit started itching) and VACCINATION SITE PAIN (sore left arm) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-396228 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Computerised tomogram, Dyspepsia, Electrocardiogram
Clinical narrative: Intense chest pain on & off every 20 minutes after 2nd shot; Not sure if heartburn after 2nd shot; Chills after 2nd vaccine; Low Fever (Not measured) after 2nd vaccine; Muscle Spasm after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle Spasm after 2nd vaccine), CHEST PAIN (Intense chest pain on & off every 20 minutes after 2nd shot), DYSPEPSIA (Not sure if heartburn after 2nd shot), CHILLS (Chills after 2nd vaccine) and PYREXIA (Low Fever (Not measured) after 2nd vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced MUSCLE SPASMS (Muscle Spasm after 2nd vaccine), CHILLS (Chills after 2nd vaccine) and PYREXIA (Low Fever (Not measured) after 2nd vaccine). On 10-May-2021, the patient experienced DYSPEPSIA (Not sure if heartburn after 2nd shot). On 10-May-2021 at 10:00 AM, the patient experienced CHEST PAIN (Intense chest pain on & off every 20 minutes after 2nd shot). On 12-May-2021, MUSCLE SPASMS (Muscle Spasm after 2nd vaccine), CHEST PAIN (Intense chest pain on & off every 20 minutes after 2nd shot), DYSPEPSIA (Not sure if heartburn after 2nd shot), CHILLS (Chills after 2nd vaccine) and PYREXIA (Low Fever (Not measured) after 2nd vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Computerised tomogram: normal (normal) CT was normal. On 10-May-2021, Electrocardiogram: normal (normal) EKG was normal. On 10-May-2021, Enzyme level test: normal (normal) Enzyme level normal.         The evening of vaccination day after 2nd shot, patient had a low fever (not measured), chills and something similar to muscle spasm that she can not really describe. the next day, 10-May-2021, around 10am, she had intense chest pain that continued every 20 minutes on and off. On 10-may-2021 around 3:30pm, she visited the emergency room.  EKG and CT scan were normal. she stated that they did enzyme levels to see if there was inflammation and that was normal too. they could not find anything wrong. she was not sure if it was heartburn.  No concomitant medication were given.  No treatment information were given.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Enzyme level test, Muscle spasms, Pyrexia
Clinical narrative: Intense chest pain on & off every 20 minutes after 2nd shot; Not sure if heartburn after 2nd shot; Chills after 2nd vaccine; Low Fever (Not measured) after 2nd vaccine; Muscle Spasm after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle Spasm after 2nd vaccine), CHEST PAIN (Intense chest pain on & off every 20 minutes after 2nd shot), DYSPEPSIA (Not sure if heartburn after 2nd shot), CHILLS (Chills after 2nd vaccine) and PYREXIA (Low Fever (Not measured) after 2nd vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced MUSCLE SPASMS (Muscle Spasm after 2nd vaccine), CHILLS (Chills after 2nd vaccine) and PYREXIA (Low Fever (Not measured) after 2nd vaccine). On 10-May-2021, the patient experienced DYSPEPSIA (Not sure if heartburn after 2nd shot). On 10-May-2021 at 10:00 AM, the patient experienced CHEST PAIN (Intense chest pain on & off every 20 minutes after 2nd shot). On 12-May-2021, MUSCLE SPASMS (Muscle Spasm after 2nd vaccine), CHEST PAIN (Intense chest pain on & off every 20 minutes after 2nd shot), DYSPEPSIA (Not sure if heartburn after 2nd shot), CHILLS (Chills after 2nd vaccine) and PYREXIA (Low Fever (Not measured) after 2nd vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Computerised tomogram: normal (normal) CT was normal. On 10-May-2021, Electrocardiogram: normal (normal) EKG was normal. On 10-May-2021, Enzyme level test: normal (normal) Enzyme level normal.         The evening of vaccination day after 2nd shot, patient had a low fever (not measured), chills and something similar to muscle spasm that she can not really describe. the next day, 10-May-2021, around 10am, she had intense chest pain that continued every 20 minutes on and off. On 10-may-2021 around 3:30pm, she visited the emergency room.  EKG and CT scan were normal. she stated that they did enzyme levels to see if there was inflammation and that was normal too. they could not find anything wrong. she was not sure if it was heartburn.  No concomitant medication were given.  No treatment information were given.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: after first dose, her arm was tender for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (after first dose, her arm was tender for a day or two) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced TENDERNESS (after first dose, her arm was tender for a day or two). In January 2021, TENDERNESS (after first dose, her arm was tender for a day or two) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information reported after 1st dose.   This case was linked to MOD-2021-396344 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter.  No treatment medications were provided by the reporter.  The reported stated that a family got a COVID-19 vaccine possibly Moderna, but uncertain and had COVID-19, 4 months after. The reporter had very limited information.  This case concerns a male patient adult patient with no medical history, who experienced the unexpected event of COVID 19. The event occurred on an unknown date.  Administration date of a dose of mRNA-1273 was not provided however it was stated that the event occurred 4 months after a dose of COVID 19 vaccine. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient adult patient with no medical history, who experienced the unexpected event of COVID 19. The event occurred on an unknown date.  Administration date of a dose of mRNA-1273 was not provided however it was stated that the event occurred 4 months after a dose of COVID 19 vaccine. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Eye colour change
Clinical narrative: pink eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE COLOUR CHANGE (pink eye) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 20-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 an unknown date, the patient experienced EYE COLOUR CHANGE (pink eye). At the time of the report, EYE COLOUR CHANGE (pink eye) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other medications include high blood pressure medication.  No treatment medications were provided.   This case was linked to MOD-2021-396106 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pruritus, Pyrexia, Vaccination complication
Clinical narrative: The itching started before the booster dose/ this has been going on for about 6 months; Regular side effects for the other doses; Chills; slight fever; Sick for one day; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (The itching started before the booster dose/ this has been going on for about 6 months), VACCINATION COMPLICATION (Sick for one day), VACCINATION COMPLICATION (Regular side effects for the other doses), CHILLS (Chills) and PYREXIA (slight fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (well maintained, she is not on any medications for it.), Constipation and Legal blindness, as defined in U.S.A. (So she needs to take dilation drops). Concomitant products included SENNOSIDE A+B (SENOKOT) for Constipation, CYCLOPENTOLATE HYDROCHLORIDE (CYCLOGEL) for Legal blindness, as defined in U.S.A..   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-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 PRURITUS (The itching started before the booster dose/ this has been going on for about 6 months), VACCINATION COMPLICATION (Sick for one day), VACCINATION COMPLICATION (Regular side effects for the other doses), CHILLS (Chills) and PYREXIA (slight fever). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date for Itching, at a dose of UNK, qd. At the time of the report, PRURITUS (The itching started before the booster dose/ this has been going on for about 6 months) had not resolved, VACCINATION COMPLICATION (Sick for one day) had resolved and VACCINATION COMPLICATION (Regular side effects for the other doses), CHILLS (Chills) and PYREXIA (slight fever) outcome was unknown.            Patient had severe itching inside the body, it is not topical. The consumer reported that had been going on for about six months. She took a lot of labs and tests at her doctor's office, and she was concerned she could be allergic. She took Claritin every day, once the Claritin leaves its 24 hour cycle, the itching starts on the top of her feet, back, all over her body. The itching started before the booster dose.   This case was linked to MOD-2021-396227, MOD-2021-396265 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Pain in jaw, SARS-CoV-2 test
Clinical narrative: sinus headache for the past 2 weeks; My upper jaw is aching; I have a little bit of an earache; Earlier on I had fatigue.; It's a dull headache with no fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache for the past 2 weeks), HEADACHE (It's a dull headache with no fever), PAIN IN JAW (My upper jaw is aching), EAR PAIN (I have a little bit of an earache) and FATIGUE (Earlier on I had fatigue.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced SINUS HEADACHE (sinus headache for the past 2 weeks), HEADACHE (It's a dull headache with no fever), PAIN IN JAW (My upper jaw is aching), EAR PAIN (I have a little bit of an earache) and FATIGUE (Earlier on I had fatigue.). At the time of the report, SINUS HEADACHE (sinus headache for the past 2 weeks), HEADACHE (It's a dull headache with no fever), PAIN IN JAW (My upper jaw is aching), EAR PAIN (I have a little bit of an earache) and FATIGUE (Earlier on I had fatigue.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: sinus headache for the past 2 weeks; My upper jaw is aching; I have a little bit of an earache; Earlier on I had fatigue.; It's a dull headache with no fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache for the past 2 weeks), HEADACHE (It's a dull headache with no fever), PAIN IN JAW (My upper jaw is aching), EAR PAIN (I have a little bit of an earache) and FATIGUE (Earlier on I had fatigue.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced SINUS HEADACHE (sinus headache for the past 2 weeks), HEADACHE (It's a dull headache with no fever), PAIN IN JAW (My upper jaw is aching), EAR PAIN (I have a little bit of an earache) and FATIGUE (Earlier on I had fatigue.). At the time of the report, SINUS HEADACHE (sinus headache for the past 2 weeks), HEADACHE (It's a dull headache with no fever), PAIN IN JAW (My upper jaw is aching), EAR PAIN (I have a little bit of an earache) and FATIGUE (Earlier on I had fatigue.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: With the first shots, only felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (With the first shots, only felt tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Thyroiditis. Concomitant products included TAMOXIFEN for Breast cancer, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis NOS, VITAMINS NOS and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (With the first shots, only felt tired). At the time of the report, FATIGUE (With the first shots, only felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication use was reported.   This case was linked to MOD-2021-396274 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Tenderness
Clinical narrative: arm  was tender; sore; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (arm  was tender) and MYALGIA (sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (arm  was tender) and MYALGIA (sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, TENDERNESS (arm  was tender) outcome was unknown and MYALGIA (sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications information was reported.   This case was linked to MOD-2021-396212, MOD-2021-396344 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: ear infections two to three weeks after; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EAR INFECTION (ear infections two to three weeks after) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR INFECTION (ear infections two to three weeks after). At the time of the report, EAR INFECTION (ear infections two to three weeks after) 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.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: achy; head with headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (achy) and HEADACHE (head with headache) in a 68-year-old patient of an unknown gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (achy) and HEADACHE (head with headache). At the time of the report, MYALGIA (achy) and HEADACHE (head with headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had 'reactions'; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had 'reactions') in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had 'reactions'). At the time of the report, VACCINATION COMPLICATION (Had 'reactions') outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-399673 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) 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) 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds). At the time of the report, PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-396547, MOD-2021-396583 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) 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) 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds). At the time of the report, PRODUCT PREPARATION ISSUE (received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter said it feels it was more that a gentle swirl.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-396573 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Side effects/Report adverse event; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Side effects/Report adverse event) and PYREXIA (Fever) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects/Report adverse event) and PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (Side effects/Report adverse event) and PYREXIA (Fever) 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.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes with the Moderna Covid19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes with the Moderna Covid19 Vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes with the Moderna Covid19 Vaccine). At the time of the report, RASH (Rashes with the Moderna Covid19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided.   If the rashes did not resolve within 3 or 4 days patient was advised to take Benadryl by a pharmacist.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: body aches; terrible headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (body aches) and HEADACHE (terrible headache) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches) and HEADACHE (terrible headache). At the time of the report, MYALGIA (body aches) and HEADACHE (terrible headache) 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.   No concomitant medication was reported.  No treatment medication use was reported
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  Reported stated that this vaccine was then placed in a different freezer which experienced a temperature excursion on 19NOV2021, reaching a maximum of 10.8°F for 5 hours and 31 minutes.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: came into the pharmacy on morning of 11/23/2021 inquiring about flu and covid shots. Since appointments are required at this site, they made appointments online and stopped back that afternoon during a rush time. I saw them waiting and remembered our conversation earlier about covid vaccines. Therefore, I pushed paperwork forward for booster shots  after verifying eligibility and gave them to our nurse. After vaccinations, they were asked for their covid cards and it was then determined their appointments were made for flu shots. I immediately told them about the error and asked if they were experiencing any issues. I updated their covid cards to reflect booster doses given and will follow-up with them. They declined flu shots at that time because they wanted to space shots out. After they left, I contacted their doctor to alert them of the error.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature exersion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported. This is a case of product temperature excursion for this 57-year-old male patient with no relevant medical history, who had no adverse reactions reported. The product temperature excursion  occurred after the patient received a dose of mRNA-1273 (Batch/lot no.- 020F21A). The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a case of product temperature excursion for this 57-year-old male patient with no relevant medical history, who had no adverse reactions reported. The product temperature excursion  occurred after the patient received a dose of mRNA-1273 (Batch/lot no.- 020F21A). The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 38.0
Sex: M
Vaccine: FLUA4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Approximately 15 minutes after vaccination, began to experience. Tingling sensation in bottom of both of my feet. 10 hours later, sensation has grown more intense. Sharp pains in tips of my big toes. Additionally, I am now also feeling numbness and tingling  in my calves. No treatment yet, watching-and-waiting while keeping doctor?s office apprised. Plan is to go to ER if muscle weakness or any loss of motor control occurs.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: presented to the clinic to receive her first dose of Pediatric Pfizer (Lot FK5127-H). She received a dose at 0944 to her RD and moved to the observation area with her mother. At approximately 0950, she c/o nausea to the observation RN and had a small amount of emesis. RN alerted another RN to assist. At 0955, the client transferred to the cot and accepted water, drinking it without difficulty or further emesis. She reported that she felt better after laying down. SPO2 at 0955 was 95% on RA, HR was 84. She denied any sensation of itchiness, tingling, or difficulty breathing and showed no signs of facial/tongue/lip swelling or rashes. She reported that she had been very anxious about receiving the vaccine before injection and that she has a fear of needles.  At 1000, she sat up on the cot, denied nausea and reported that she felt ?90% normal.? SPO2 was 98% on RA, HR was 94. At 1004, she rose and transferred to a nearby chair without difficulty. Visual assessment of facial tissues continued to show no signs of swelling, no rashes noted on skin. The client and her mother were educated on s/s anaphylactic responses, what to watch for, and when to seek medical care. Aside from the brief episode of N/V, she exhibited no s/s of an allergic reaction. She remained under observation until 1019, at which point she reported she felt ?better than ever? and her SPO2 was 99% on RA with an HR of 83. She exited the facility at 1020 with her mother, to be monitored by her mother at home.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Urticaria
Clinical narrative: Two weeks after the 3rd dose of the Moderna vaccine, patient started having an outbreak of hives that would come and go and move to different parts of the body including legs, stomach, back, and arms. The hives appeared daily and would be mildly treated by Zyrtec. Patient started a Methylprednisolone treatment on November 29, which has reduced symptoms to itchiness on body at night and prickling/itchiness on palms and soles of feet.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Booster dose given to 15-year-old patient.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dyspnoea, Heavy menstrual bleeding, Thrombosis
Clinical narrative: Menstration problem. Severe Increase in bleeding and blood clots  Breathing problems- inhaler prescribed
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Acute kidney injury, Asymptomatic COVID-19, Blood glucose increased, Chest X-ray normal
Clinical narrative: 11/28/21 ED note: "Patient is 63-year-old female history of diabetes, hypertension, hyperlipidemia presents with abdominal pain, emesis.  She reports intermittent abdominal pain for the past 3 days.  She reports episodes of emesis tonight.  She denies diarrhea, constipation, melena, medic hematochezia.  She denies fever, chills, chest pain, shortness of breath. Reports sugars have been elevated at home. "11/29/21 resident's note: '63 y.o. year-old female with history of T2DM, HTN, HLD, and Gout who presented with elevated blood sugars and DKA. Patient is sitting up in the bedside chair saturating 99% on RA. Spoke to patient over the phone. She is feeling better than yesterday and is ambulating well in her room. She endorses increased frequency in urination and pain with urination. She denies HA, CP, SOB, N/V, diarrhea, or leg pain. PCR was positive for COVID 19 upon admission, but asymptomatic". 11/29/21 ID's note: "Acute COVID 19 infection in vaccinated patient w/ Moderna, s/p booster 11/2/21 - mild sx for 3 days, possible household exposure 21. Decompensated IDDM w/ DKA - has not taken her insulin for the past 3 days 3. AKI - likely from dehydration 4. Chr pancreatitis 5. Multiple comorbidities including CHF s/ p AICD, gout, HTN, DM etc. mAbs w/ casi/imde 600 mg/600 mg iv x1 since pt w/ multiple comorbidities, and at risk for progression Discussed with patient re: investigational use of casirivimab/imdevimab, explained the rationale of blocking SARS-CoV2 at the onset of disease and the benefits observed with less progression of disease and need for hospitalization; also explained the risk of infusion allergic reactions and the need for monitoring. Pt agreed to proceed"  .
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dehydration, Diabetic ketoacidosis, Dysuria, Pancreatitis chronic, Pollakiuria
Clinical narrative: 11/28/21 ED note: "Patient is 63-year-old female history of diabetes, hypertension, hyperlipidemia presents with abdominal pain, emesis.  She reports intermittent abdominal pain for the past 3 days.  She reports episodes of emesis tonight.  She denies diarrhea, constipation, melena, medic hematochezia.  She denies fever, chills, chest pain, shortness of breath. Reports sugars have been elevated at home. "11/29/21 resident's note: '63 y.o. year-old female with history of T2DM, HTN, HLD, and Gout who presented with elevated blood sugars and DKA. Patient is sitting up in the bedside chair saturating 99% on RA. Spoke to patient over the phone. She is feeling better than yesterday and is ambulating well in her room. She endorses increased frequency in urination and pain with urination. She denies HA, CP, SOB, N/V, diarrhea, or leg pain. PCR was positive for COVID 19 upon admission, but asymptomatic". 11/29/21 ID's note: "Acute COVID 19 infection in vaccinated patient w/ Moderna, s/p booster 11/2/21 - mild sx for 3 days, possible household exposure 21. Decompensated IDDM w/ DKA - has not taken her insulin for the past 3 days 3. AKI - likely from dehydration 4. Chr pancreatitis 5. Multiple comorbidities including CHF s/ p AICD, gout, HTN, DM etc. mAbs w/ casi/imde 600 mg/600 mg iv x1 since pt w/ multiple comorbidities, and at risk for progression Discussed with patient re: investigational use of casirivimab/imdevimab, explained the rationale of blocking SARS-CoV2 at the onset of disease and the benefits observed with less progression of disease and need for hospitalization; also explained the risk of infusion allergic reactions and the need for monitoring. Pt agreed to proceed"  .
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Type 1 diabetes mellitus, Vomiting
Clinical narrative: 11/28/21 ED note: "Patient is 63-year-old female history of diabetes, hypertension, hyperlipidemia presents with abdominal pain, emesis.  She reports intermittent abdominal pain for the past 3 days.  She reports episodes of emesis tonight.  She denies diarrhea, constipation, melena, medic hematochezia.  She denies fever, chills, chest pain, shortness of breath. Reports sugars have been elevated at home. "11/29/21 resident's note: '63 y.o. year-old female with history of T2DM, HTN, HLD, and Gout who presented with elevated blood sugars and DKA. Patient is sitting up in the bedside chair saturating 99% on RA. Spoke to patient over the phone. She is feeling better than yesterday and is ambulating well in her room. She endorses increased frequency in urination and pain with urination. She denies HA, CP, SOB, N/V, diarrhea, or leg pain. PCR was positive for COVID 19 upon admission, but asymptomatic". 11/29/21 ID's note: "Acute COVID 19 infection in vaccinated patient w/ Moderna, s/p booster 11/2/21 - mild sx for 3 days, possible household exposure 21. Decompensated IDDM w/ DKA - has not taken her insulin for the past 3 days 3. AKI - likely from dehydration 4. Chr pancreatitis 5. Multiple comorbidities including CHF s/ p AICD, gout, HTN, DM etc. mAbs w/ casi/imde 600 mg/600 mg iv x1 since pt w/ multiple comorbidities, and at risk for progression Discussed with patient re: investigational use of casirivimab/imdevimab, explained the rationale of blocking SARS-CoV2 at the onset of disease and the benefits observed with less progression of disease and need for hospitalization; also explained the risk of infusion allergic reactions and the need for monitoring. Pt agreed to proceed"  .
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Syncope, Tremor
Clinical narrative: Pt experience vasovagal syncope. Seconds after recieving the vaccine, the patient fainted, her eyes rolled back and she closed her eyes, tilted her head back, and started shaking. i assisted her to the floor so she can lay flat on the floor and she recovered consciousness. I remained with the patient for an additional 15 minutes. the patient stated she was feeling better and i assisted her to a chair where she sat for an additional 5 minutes. I assisted the patient to the car and followed up with them 30 minutes later over the phone to make sure they were feeling fine.