chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Vision blurred
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Body chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever). On 28-Feb-2021, the patient experienced BACK PAIN (Backache), MYALGIA (Body aches), CHILLS (Body chills) and HEADACHE (Headache). The patient was treated with LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]) at an unspecified dose and frequency and LISINOPRIL at an unspecified dose and frequency. On 26-Feb-2021, VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever) had resolved. On 14-Mar-2021, BACK PAIN (Backache) outcome was unknown and MYALGIA (Body aches), CHILLS (Body chills) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 150/85 mmHg (Inconclusive) increased and 92/50 mmHg (Inconclusive) decreased. 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. 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. Further information has been requested. This case was linked to MOD-2021-213956. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-2021: vaccine information, treatment medications, event details and event outcome were updated.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Blood pressure measurement, Chills, Dizziness, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Body chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever). On 28-Feb-2021, the patient experienced BACK PAIN (Backache), MYALGIA (Body aches), CHILLS (Body chills) and HEADACHE (Headache). The patient was treated with LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]) at an unspecified dose and frequency and LISINOPRIL at an unspecified dose and frequency. On 26-Feb-2021, VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever) had resolved. On 14-Mar-2021, BACK PAIN (Backache) outcome was unknown and MYALGIA (Body aches), CHILLS (Body chills) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 150/85 mmHg (Inconclusive) increased and 92/50 mmHg (Inconclusive) decreased. 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. 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. Further information has been requested. This case was linked to MOD-2021-213956. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-2021: vaccine information, treatment medications, event details and event outcome were updated.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash macular, Vision blurred
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Body chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever). On 28-Feb-2021, the patient experienced BACK PAIN (Backache), MYALGIA (Body aches), CHILLS (Body chills) and HEADACHE (Headache). The patient was treated with LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]) at an unspecified dose and frequency and LISINOPRIL at an unspecified dose and frequency. On 26-Feb-2021, VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever) had resolved. On 14-Mar-2021, BACK PAIN (Backache) outcome was unknown and MYALGIA (Body aches), CHILLS (Body chills) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 150/85 mmHg (Inconclusive) increased and 92/50 mmHg (Inconclusive) decreased. 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. 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. Further information has been requested. This case was linked to MOD-2021-213956. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-2021: vaccine information, treatment medications, event details and event outcome were updated.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Blood pressure measurement, Chills, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Body chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever). On 28-Feb-2021, the patient experienced BACK PAIN (Backache), MYALGIA (Body aches), CHILLS (Body chills) and HEADACHE (Headache). The patient was treated with LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]) at an unspecified dose and frequency and LISINOPRIL at an unspecified dose and frequency. On 26-Feb-2021, VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever) had resolved. On 14-Mar-2021, BACK PAIN (Backache) outcome was unknown and MYALGIA (Body aches), CHILLS (Body chills) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 150/85 mmHg (Inconclusive) increased and 92/50 mmHg (Inconclusive) decreased. 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. 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. Further information has been requested. This case was linked to MOD-2021-213956. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-2021: vaccine information, treatment medications, event details and event outcome were updated.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Body chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever). On 28-Feb-2021, the patient experienced BACK PAIN (Backache), MYALGIA (Body aches), CHILLS (Body chills) and HEADACHE (Headache). The patient was treated with LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]) at an unspecified dose and frequency and LISINOPRIL at an unspecified dose and frequency. On 26-Feb-2021, VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever) had resolved. On 14-Mar-2021, BACK PAIN (Backache) outcome was unknown and MYALGIA (Body aches), CHILLS (Body chills) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 150/85 mmHg (Inconclusive) increased and 92/50 mmHg (Inconclusive) decreased. 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. 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. Further information has been requested. This case was linked to MOD-2021-213956. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-2021: vaccine information, treatment medications, event details and event outcome were updated.; 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. Further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Mobility decreased
Clinical narrative: I can hardly raise it above my head.; My arm started aching really badly; My arm was sore at the injection site/injection site arm is still very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site/injection site arm is still very sore), MYALGIA (My arm started aching really badly) and VACCINATION SITE MOVEMENT IMPAIRMENT (I can hardly raise it above my head.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site/injection site arm is still very sore). On 22-May-2021, the patient experienced MYALGIA (My arm started aching really badly). On 01-Jun-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I can hardly raise it above my head.). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site/injection site arm is still very sore), MYALGIA (My arm started aching really badly) and VACCINATION SITE MOVEMENT IMPAIRMENT (I can hardly raise it above my head.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided No  Concomitant medications were provided
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: I can hardly raise it above my head.; My arm started aching really badly; My arm was sore at the injection site/injection site arm is still very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site/injection site arm is still very sore), MYALGIA (My arm started aching really badly) and VACCINATION SITE MOVEMENT IMPAIRMENT (I can hardly raise it above my head.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site/injection site arm is still very sore). On 22-May-2021, the patient experienced MYALGIA (My arm started aching really badly). On 01-Jun-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I can hardly raise it above my head.). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site/injection site arm is still very sore), MYALGIA (My arm started aching really badly) and VACCINATION SITE MOVEMENT IMPAIRMENT (I can hardly raise it above my head.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided No  Concomitant medications were provided
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Blood thyroid stimulating hormone, Fibrin D dimer normal, Full blood count, Haemoglobin normal
Clinical narrative: NEPHROPATHY; BACK PAIN; MOBILITY ISSUES (NO LONGER CAPABLE OF RUNNING/JUMPING); VISION PROBLEMS; CHALLENGES SLEEPING; DIMINISHED ENERGY; FATIGUE; SLIGHT LOSS OF SENSATION TO NUMB FINGERS; SOME PAIN; TOTAL BODY WEAKNESS; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the patient experienced slight loss of sensation to numb fingers. On 21-JUN-2021, the patient experienced some pain. On 21-JUN-2021, the patient experienced total body weakness. On 21-JUN-2021, the patient experienced fatigue. On an unspecified date, the patient experienced nephropathy, back pain, mobility issues (no longer capable of running/jumping), vision problems, challenges sleeping, and diminished energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight loss of sensation to numb fingers, some pain, total body weakness, fatigue, nephropathy, back pain, mobility issues (no longer capable of running/jumping), vision problems, diminished energy and challenges sleeping was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lipids normal, Metabolic function test, Sensory loss, Vitamin B12 normal
Clinical narrative: NEPHROPATHY; BACK PAIN; MOBILITY ISSUES (NO LONGER CAPABLE OF RUNNING/JUMPING); VISION PROBLEMS; CHALLENGES SLEEPING; DIMINISHED ENERGY; FATIGUE; SLIGHT LOSS OF SENSATION TO NUMB FINGERS; SOME PAIN; TOTAL BODY WEAKNESS; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the patient experienced slight loss of sensation to numb fingers. On 21-JUN-2021, the patient experienced some pain. On 21-JUN-2021, the patient experienced total body weakness. On 21-JUN-2021, the patient experienced fatigue. On an unspecified date, the patient experienced nephropathy, back pain, mobility issues (no longer capable of running/jumping), vision problems, challenges sleeping, and diminished energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight loss of sensation to numb fingers, some pain, total body weakness, fatigue, nephropathy, back pain, mobility issues (no longer capable of running/jumping), vision problems, diminished energy and challenges sleeping was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Back pain, Fatigue, Mobility decreased, Nephropathy
Clinical narrative: NEPHROPATHY; BACK PAIN; MOBILITY ISSUES (NO LONGER CAPABLE OF RUNNING/JUMPING); VISION PROBLEMS; CHALLENGES SLEEPING; DIMINISHED ENERGY; FATIGUE; SLIGHT LOSS OF SENSATION TO NUMB FINGERS; SOME PAIN; TOTAL BODY WEAKNESS; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the patient experienced slight loss of sensation to numb fingers. On 21-JUN-2021, the patient experienced some pain. On 21-JUN-2021, the patient experienced total body weakness. On 21-JUN-2021, the patient experienced fatigue. On an unspecified date, the patient experienced nephropathy, back pain, mobility issues (no longer capable of running/jumping), vision problems, challenges sleeping, and diminished energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight loss of sensation to numb fingers, some pain, total body weakness, fatigue, nephropathy, back pain, mobility issues (no longer capable of running/jumping), vision problems, diminished energy and challenges sleeping was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Sensory loss, Sleep disorder, Visual impairment
Clinical narrative: NEPHROPATHY; BACK PAIN; MOBILITY ISSUES (NO LONGER CAPABLE OF RUNNING/JUMPING); VISION PROBLEMS; CHALLENGES SLEEPING; DIMINISHED ENERGY; FATIGUE; SLIGHT LOSS OF SENSATION TO NUMB FINGERS; SOME PAIN; TOTAL BODY WEAKNESS; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the patient experienced slight loss of sensation to numb fingers. On 21-JUN-2021, the patient experienced some pain. On 21-JUN-2021, the patient experienced total body weakness. On 21-JUN-2021, the patient experienced fatigue. On an unspecified date, the patient experienced nephropathy, back pain, mobility issues (no longer capable of running/jumping), vision problems, challenges sleeping, and diminished energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight loss of sensation to numb fingers, some pain, total body weakness, fatigue, nephropathy, back pain, mobility issues (no longer capable of running/jumping), vision problems, diminished energy and challenges sleeping was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Pain, Sensory loss
Clinical narrative: NEPHROPATHY; BACK PAIN; MOBILITY ISSUES (NO LONGER CAPABLE OF RUNNING/JUMPING); VISION PROBLEMS; CHALLENGES SLEEPING; DIMINISHED ENERGY; FATIGUE; SLIGHT LOSS OF SENSATION TO NUMB FINGERS; SOME PAIN; TOTAL BODY WEAKNESS; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the patient experienced slight loss of sensation to numb fingers. On 21-JUN-2021, the patient experienced some pain. On 21-JUN-2021, the patient experienced total body weakness. On 21-JUN-2021, the patient experienced fatigue. On an unspecified date, the patient experienced nephropathy, back pain, mobility issues (no longer capable of running/jumping), vision problems, challenges sleeping, and diminished energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight loss of sensation to numb fingers, some pain, total body weakness, fatigue, nephropathy, back pain, mobility issues (no longer capable of running/jumping), vision problems, diminished energy and challenges sleeping was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: admitted with fevers, chills, malaise. Patient had a cough and was started on 2L oxygen. Patient still undergoing treatment in hospital.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Malaise, Pyrexia
Clinical narrative: admitted with fevers, chills, malaise. Patient had a cough and was started on 2L oxygen. Patient still undergoing treatment in hospital.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Extreme high fever 99.5+-100 about 10 hours after shot given lasting for a solid week around the clock requiring 8 Tylenol?s per day just to be barely tolerable. Extreme fatigue and high fever in evenings requiring cool-cold showers to break fever. Insomnia and unable to sleep. Frightening
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fear, Insomnia, Pyrexia
Clinical narrative: Extreme high fever 99.5+-100 about 10 hours after shot given lasting for a solid week around the clock requiring 8 Tylenol?s per day just to be barely tolerable. Extreme fatigue and high fever in evenings requiring cool-cold showers to break fever. Insomnia and unable to sleep. Frightening
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Erythema, Oral pruritus, Peripheral swelling, Pruritus
Clinical narrative: started to develop generalized itching about 30 minutes after receiving vaccine.  Started to feel anxious.  No problems swallowing.  No swelling noted.  Gave her 50 mg of liquid Benadryl.  Two nurses  talked with her for 20 minutes. Did not need to use an epi pen.  We drove her to the ER for an evaluation.  a 5minute drive from our office.  They gave her some steroids and observed her for one hour and then discharged her  with two doses of steroids to take for the next two days.  She did not need an epi pen in the ER. No other complications.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Throat irritation, Tinnitus
Clinical narrative: started to develop generalized itching about 30 minutes after receiving vaccine.  Started to feel anxious.  No problems swallowing.  No swelling noted.  Gave her 50 mg of liquid Benadryl.  Two nurses  talked with her for 20 minutes. Did not need to use an epi pen.  We drove her to the ER for an evaluation.  a 5minute drive from our office.  They gave her some steroids and observed her for one hour and then discharged her  with two doses of steroids to take for the next two days.  She did not need an epi pen in the ER. No other complications.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Pruritus
Clinical narrative: started to develop generalized itching about 30 minutes after receiving vaccine.  Started to feel anxious.  No problems swallowing.  No swelling noted.  Gave her 50 mg of liquid Benadryl.  Two nurses  talked with her for 20 minutes. Did not need to use an epi pen.  We drove her to the ER for an evaluation.  a 5minute drive from our office.  They gave her some steroids and observed her for one hour and then discharged her  with two doses of steroids to take for the next two days.  She did not need an epi pen in the ER. No other complications.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Arm is still really sore and muscles still hurt nowshe keeps getting muscle cramps
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Arm is still really sore and muscles still hurt nowshe keeps getting muscle cramps
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Headache, Photosensitivity reaction, Pruritus
Clinical narrative: Patient received vaccine and 30 mins after admin, she reported a frontal headache and photosensitivity. No respiratory distress. Pulse ox 99%, BP an pulse WNL. Encouraged fluids, snack and rest. She was monitored in a staff office where she was allowed to rest in the dark. Around 1030 MD checked in on her and she then was reporting general pruritis and rash. She was given oral benadryl and observed, vital signs remained stable. She then reported chest tightness and MD at that time recommended she report to ER out of extreme caution.   She denied known allergy to Pfizer vaccine ingredients.   Per ED Provider note:  23 y.o. female who presented to the emergency department for allergic reaction, onset 1000 hours. Further complains of headache, mild shortness of breath, itchiness, generalized rash, and nausea. Patient received the first dose of the COVID-19 vaccine at 0930 hours and began experiencing these symptoms 30 minutes following the vaccine. She was given benadryl and calamine lotion at Specialty Clinic prior to arrival at ED. She noted having allergic reactions to vaccines in the past. When patient was a child, she experienced arm swelling following IM flu shot and nose bleed with nasal spray vaccine. Also has a history of hypertension. NKDA. Denies chest pain, abdominal pain, and vomiting. Further complains of headache, mild shortness of breath, itchiness, generalized rash, and nausea. No rashes appreciated upon clinical exam.   DDx: appears to have significant anxiety overlay to this.w symptom amplification.  Patient discharged in stable condition
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Headache, Nausea
Clinical narrative: Patient received vaccine and 30 mins after admin, she reported a frontal headache and photosensitivity. No respiratory distress. Pulse ox 99%, BP an pulse WNL. Encouraged fluids, snack and rest. She was monitored in a staff office where she was allowed to rest in the dark. Around 1030 MD checked in on her and she then was reporting general pruritis and rash. She was given oral benadryl and observed, vital signs remained stable. She then reported chest tightness and MD at that time recommended she report to ER out of extreme caution.   She denied known allergy to Pfizer vaccine ingredients.   Per ED Provider note:  23 y.o. female who presented to the emergency department for allergic reaction, onset 1000 hours. Further complains of headache, mild shortness of breath, itchiness, generalized rash, and nausea. Patient received the first dose of the COVID-19 vaccine at 0930 hours and began experiencing these symptoms 30 minutes following the vaccine. She was given benadryl and calamine lotion at Specialty Clinic prior to arrival at ED. She noted having allergic reactions to vaccines in the past. When patient was a child, she experienced arm swelling following IM flu shot and nose bleed with nasal spray vaccine. Also has a history of hypertension. NKDA. Denies chest pain, abdominal pain, and vomiting. Further complains of headache, mild shortness of breath, itchiness, generalized rash, and nausea. No rashes appreciated upon clinical exam.   DDx: appears to have significant anxiety overlay to this.w symptom amplification.  Patient discharged in stable condition
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Photosensitivity reaction, Pruritus, Rash
Clinical narrative: Patient received vaccine and 30 mins after admin, she reported a frontal headache and photosensitivity. No respiratory distress. Pulse ox 99%, BP an pulse WNL. Encouraged fluids, snack and rest. She was monitored in a staff office where she was allowed to rest in the dark. Around 1030 MD checked in on her and she then was reporting general pruritis and rash. She was given oral benadryl and observed, vital signs remained stable. She then reported chest tightness and MD at that time recommended she report to ER out of extreme caution.   She denied known allergy to Pfizer vaccine ingredients.   Per ED Provider note:  23 y.o. female who presented to the emergency department for allergic reaction, onset 1000 hours. Further complains of headache, mild shortness of breath, itchiness, generalized rash, and nausea. Patient received the first dose of the COVID-19 vaccine at 0930 hours and began experiencing these symptoms 30 minutes following the vaccine. She was given benadryl and calamine lotion at Specialty Clinic prior to arrival at ED. She noted having allergic reactions to vaccines in the past. When patient was a child, she experienced arm swelling following IM flu shot and nose bleed with nasal spray vaccine. Also has a history of hypertension. NKDA. Denies chest pain, abdominal pain, and vomiting. Further complains of headache, mild shortness of breath, itchiness, generalized rash, and nausea. No rashes appreciated upon clinical exam.   DDx: appears to have significant anxiety overlay to this.w symptom amplification.  Patient discharged in stable condition
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Echocardiogram, Pericardial effusion, Pericarditis
Clinical narrative: Approximately 2 weeks after vaccine administration patient started developing shortness of breath, fluid retention, lightheadedness with movement, and chest pain. Patient was seen for their symptoms diagnosed with pericarditis and hospitalized. Patient is now on isosorbide and metoprolol suc for maintenece treatment.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Fluid retention, Pericarditis
Clinical narrative: Approximately 2 weeks after vaccine administration patient started developing shortness of breath, fluid retention, lightheadedness with movement, and chest pain. Patient was seen for their symptoms diagnosed with pericarditis and hospitalized. Patient is now on isosorbide and metoprolol suc for maintenece treatment.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient developed erythema multiforme rash of both palms and both feet. Rash started 8/18/21, ten days after Moderna vaccine. Patient had previously received two doses  of vaccine on May 14, 2021 and June 9, 2021.  Rash worsened on 8/21/21 and started to improve on 8/23/21, but was not completely resolved.   Patient had a fever for one day after receiving Moderna and headache for two days. Both of those symptoms had resolved when rash started.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema multiforme, Headache, Pyrexia, Rash
Clinical narrative: Patient developed erythema multiforme rash of both palms and both feet. Rash started 8/18/21, ten days after Moderna vaccine. Patient had previously received two doses  of vaccine on May 14, 2021 and June 9, 2021.  Rash worsened on 8/21/21 and started to improve on 8/23/21, but was not completely resolved.   Patient had a fever for one day after receiving Moderna and headache for two days. Both of those symptoms had resolved when rash started.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swollen around where they put me the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen around where they put me the shot) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen around where they put me the shot). At the time of the report, VACCINATION SITE SWELLING (swollen around where they put me the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not receive 2nd dose as scheduled; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose as scheduled) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery on 14-Apr-2021.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose as scheduled). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose as scheduled) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       . Patient missed second shot of vaccine as in the interim he had triple bypass surgery. No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant at the time of administration; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of administration) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of administration). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment medications reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Myalgia
Clinical narrative: body discomfort; Arm pain,Body discomfort; A little of headache; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (body discomfort), MYALGIA (Arm pain,Body discomfort) and HEADACHE (A little of headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided.) for COVID-19 vaccination.     No medical history was provided by the reporter.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 DISCOMFORT (body discomfort), MYALGIA (Arm pain,Body discomfort) and HEADACHE (A little of headache). The patient was treated with PARACETAMOL (PANADOL) for Muscle pain, at a dose of 1 UNK. At the time of the report, DISCOMFORT (body discomfort), MYALGIA (Arm pain,Body discomfort) and HEADACHE (A little of headache) outcome was unknown.            concomitant drug include muscle pain medication eventof positive coronavirus antigen test
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: not able to receive dose 2 within the recommended time frame; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not able to receive dose 2 within the recommended time frame) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not able to receive dose 2 within the recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not able to receive dose 2 within the recommended time frame) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose 125 days after first; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 125 days after first) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 125 days after first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 125 days after first) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia, Rash, Swelling
Clinical narrative: neck lump; cough; rash; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (neck lump), COUGH (cough), RASH (rash), PYREXIA (fever) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (neck lump), COUGH (cough), RASH (rash), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (neck lump), COUGH (cough), RASH (rash), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No treatment medication provided. No concomitant medication provided.   This case was linked to MOD-2021-176266 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Severe stomach pains; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach pains) and VOMITING (Vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, QUETIAPINE FUMARATE (SEROQUEL), LEVETIRACETAM, SYNODRIN, LAMOTRIGINE (LAMICTAL) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 26-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach pains) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach pains) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication includes supplements.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpatations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpatations) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpatations). At the time of the report, PALPITATIONS (heart palpatations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Headache, Lymphadenopathy
Clinical narrative: Pretty aggressive inflammation in my sinuses; I lost my taste/smell; I lost my taste/smell; swollen lymph nodes; chills; fever; body aches; headaches; smelling smoke(campfire, not cigarette); This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (smelling smoke(campfire, not cigarette)), SINUSITIS (Pretty aggressive inflammation in my sinuses), AGEUSIA (I lost my taste/smell), ANOSMIA (I lost my taste/smell) and LYMPHADENOPATHY (swollen lymph nodes) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine and Levaquin).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAROSMIA (smelling smoke(campfire, not cigarette)), CHILLS (chills), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches). On an unknown date, the patient experienced SINUSITIS (Pretty aggressive inflammation in my sinuses), AGEUSIA (I lost my taste/smell), ANOSMIA (I lost my taste/smell) and LYMPHADENOPATHY (swollen lymph nodes). On 14-Mar-2021, PAROSMIA (smelling smoke(campfire, not cigarette)), CHILLS (chills), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches) had resolved. At the time of the report, SINUSITIS (Pretty aggressive inflammation in my sinuses), AGEUSIA (I lost my taste/smell) and ANOSMIA (I lost my taste/smell) had not resolved and LYMPHADENOPATHY (swollen lymph nodes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: (Positive) tested positive for COVID-19. In January 2021, SARS-CoV-2 test: (Positive) tested positive for COVID-19.         No treatment information was provided.   This case was linked to MOD-2021-046849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: added patient medical history , updated product tab , added events