chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Dehydration, Headache, Hot flush
Clinical narrative: Felt dehydrated; Hot flashes; Lower back pain; Nausea; Chills; Terrible headache; A spontaneous report was received from a 28 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a terrible headache, felt dehydrated, chills, hot flashes, nausea and lower back pain.   The patient's medical history, as provided by the reporter, included no history of headache. No relevant concomitant medications were reported.   On 31 Dec 2020, approximately 30 minutes prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 31 Dec 2020, 30 minutes after being vaccinated, the patient experienced a terrible headache and felt dehydrated. Later in the day, she started to feel chills, hot flashes, nausea and lower back pain. She had no fever and no medical history of headache. She stated she felt miserable and was asking if these were common adverse reaction symptoms. On 03 Jan 2021, the patient tested negative for COVID-19 and the flu.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event, terrible headache, was not reported. The event, felt dehydrated, was resolved the evening of 31 Dec 2020. The events, chills, nausea, and lower back pain, were resolved on 01 Jan 2021. and the event, hot flashes, was resolved on 03 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza virus test, Nausea, SARS-CoV-2 test
Clinical narrative: Felt dehydrated; Hot flashes; Lower back pain; Nausea; Chills; Terrible headache; A spontaneous report was received from a 28 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a terrible headache, felt dehydrated, chills, hot flashes, nausea and lower back pain.   The patient's medical history, as provided by the reporter, included no history of headache. No relevant concomitant medications were reported.   On 31 Dec 2020, approximately 30 minutes prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 31 Dec 2020, 30 minutes after being vaccinated, the patient experienced a terrible headache and felt dehydrated. Later in the day, she started to feel chills, hot flashes, nausea and lower back pain. She had no fever and no medical history of headache. She stated she felt miserable and was asking if these were common adverse reaction symptoms. On 03 Jan 2021, the patient tested negative for COVID-19 and the flu.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event, terrible headache, was not reported. The event, felt dehydrated, was resolved the evening of 31 Dec 2020. The events, chills, nausea, and lower back pain, were resolved on 01 Jan 2021. and the event, hot flashes, was resolved on 03 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Disorientation, Dizziness, Flushing, Hot flush
Clinical narrative: Covid like symptoms with positive Covid test
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Rash, Rash erythematous, Rash macular
Clinical narrative: Covid like symptoms with positive Covid test
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test positive
Clinical narrative: Covid like symptoms with positive Covid test
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Blood alkaline phosphatase increased, Blood creatine phosphokinase normal, Chest X-ray normal
Clinical narrative: intense pain like childbirth; cramps; her arm and hand feel numb; pins or needles in her arm; itchy at the vaccination site; red spot size of her mobile phone; it started to swell; pain similar to flu vaccine, later itchy at the vaccination site; pain up to the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb) and PARAESTHESIA (pins or needles in her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder). At the time of the report, VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include High blood pressure medication. Treatment details included Ibuprofen. 2 Tylenol 500mg. At Urgent Care she was given lidocaine, a cream with Diclofenac.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Outcome of the events updated to Not recovered
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eosinophil count normal, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: intense pain like childbirth; cramps; her arm and hand feel numb; pins or needles in her arm; itchy at the vaccination site; red spot size of her mobile phone; it started to swell; pain similar to flu vaccine, later itchy at the vaccination site; pain up to the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb) and PARAESTHESIA (pins or needles in her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder). At the time of the report, VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include High blood pressure medication. Treatment details included Ibuprofen. 2 Tylenol 500mg. At Urgent Care she was given lidocaine, a cream with Diclofenac.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Outcome of the events updated to Not recovered
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Ultrasound Doppler normal, White blood cell count normal
Clinical narrative: intense pain like childbirth; cramps; her arm and hand feel numb; pins or needles in her arm; itchy at the vaccination site; red spot size of her mobile phone; it started to swell; pain similar to flu vaccine, later itchy at the vaccination site; pain up to the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb) and PARAESTHESIA (pins or needles in her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder). At the time of the report, VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include High blood pressure medication. Treatment details included Ibuprofen. 2 Tylenol 500mg. At Urgent Care she was given lidocaine, a cream with Diclofenac.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Outcome of the events updated to Not recovered
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray limb normal
Clinical narrative: intense pain like childbirth; cramps; her arm and hand feel numb; pins or needles in her arm; itchy at the vaccination site; red spot size of her mobile phone; it started to swell; pain similar to flu vaccine, later itchy at the vaccination site; pain up to the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb) and PARAESTHESIA (pins or needles in her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder). At the time of the report, VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include High blood pressure medication. Treatment details included Ibuprofen. 2 Tylenol 500mg. At Urgent Care she was given lidocaine, a cream with Diclofenac.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Outcome of the events updated to Not recovered
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Muscle spasms, Pain, Paraesthesia
Clinical narrative: intense pain like childbirth; cramps; her arm and hand feel numb; pins or needles in her arm; itchy at the vaccination site; red spot size of her mobile phone; it started to swell; pain similar to flu vaccine, later itchy at the vaccination site; pain up to the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb) and PARAESTHESIA (pins or needles in her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder). At the time of the report, VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include High blood pressure medication. Treatment details included Ibuprofen. 2 Tylenol 500mg. At Urgent Care she was given lidocaine, a cream with Diclofenac.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Outcome of the events updated to Not recovered
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: intense pain like childbirth; cramps; her arm and hand feel numb; pins or needles in her arm; itchy at the vaccination site; red spot size of her mobile phone; it started to swell; pain similar to flu vaccine, later itchy at the vaccination site; pain up to the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb) and PARAESTHESIA (pins or needles in her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder). At the time of the report, VACCINATION SITE BRUISING (red spot size of her mobile phone), PAIN (intense pain like childbirth), MUSCLE SPASMS (cramps), HYPOAESTHESIA (her arm and hand feel numb), PARAESTHESIA (pins or needles in her arm), VACCINATION SITE PRURITUS (itchy at the vaccination site), VACCINATION SITE SWELLING (it started to swell), VACCINATION SITE PAIN (pain similar to flu vaccine, later itchy at the vaccination site) and ARTHRALGIA (pain up to the shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include High blood pressure medication. Treatment details included Ibuprofen. 2 Tylenol 500mg. At Urgent Care she was given lidocaine, a cream with Diclofenac.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Outcome of the events updated to Not recovered
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: rash on the deltoid area; her deltoid turned red and Itchy/COVID arm; Itchy deltoid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy deltoid), VACCINATION SITE RASH (rash on the deltoid area) and VACCINATION SITE ERYTHEMA (her deltoid turned red and Itchy/COVID arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy deltoid) and VACCINATION SITE ERYTHEMA (her deltoid turned red and Itchy/COVID arm). On an unknown date, the patient experienced VACCINATION SITE RASH (rash on the deltoid area). At the time of the report, VACCINATION SITE PRURITUS (Itchy deltoid) and VACCINATION SITE ERYTHEMA (her deltoid turned red and Itchy/COVID arm) had not resolved and VACCINATION SITE RASH (rash on the deltoid area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history and concomitant medications were provided. Treatment medication incldued Benadryl to alleviate the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Follow up received with updated "Patient demographics and the vaccine received date on 23JAN2021. 8 days after, deltoid turned red and itchy that last till today and reported it as "COVID arm".Consent YES to Follow up
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash on the deltoid area; her deltoid turned red and Itchy/COVID arm; Itchy deltoid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy deltoid), VACCINATION SITE RASH (rash on the deltoid area) and VACCINATION SITE ERYTHEMA (her deltoid turned red and Itchy/COVID arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy deltoid) and VACCINATION SITE ERYTHEMA (her deltoid turned red and Itchy/COVID arm). On an unknown date, the patient experienced VACCINATION SITE RASH (rash on the deltoid area). At the time of the report, VACCINATION SITE PRURITUS (Itchy deltoid) and VACCINATION SITE ERYTHEMA (her deltoid turned red and Itchy/COVID arm) had not resolved and VACCINATION SITE RASH (rash on the deltoid area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history and concomitant medications were provided. Treatment medication incldued Benadryl to alleviate the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Follow up received with updated "Patient demographics and the vaccine received date on 23JAN2021. 8 days after, deltoid turned red and itchy that last till today and reported it as "COVID arm".Consent YES to Follow up
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypersensitivity, Lip swelling, Swelling face, Throat irritation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Face felt odd), SWELLING FACE (Puffy face), PRURITUS (Itchy face) and ERYTHEMA (Red face) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The patient's past medical history included Thyroid disorder NOS in 2000, Heart valve operation (Open heart surgery to repair mitral valve and tricuspid valve) on 27-Apr-2017, Cholecystectomy (30 years ago) and Appendectomy (30 years ago). Concurrent medical conditions included Allergy to antibiotic (Avalox), Drug allergy (Allergic to prednisone), Allergy to antibiotic (Biaxin XL), Allergy to topical drugs (Allergy to face cream which caused  the face to swell and turn red about 15 years ago), Acid reflux (esophageal) since 1993 and Cataract. Concomitant products included LEVOTHYROXINE, METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]), ATORVASTATIN, VITAMIN D3, LUTEIN [XANTOFYL], APIXABAN (ELIQUIS) and FUROSEMIDE for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced FACIAL PAIN (Face felt odd), SWELLING FACE (Puffy face), PRURITUS (Itchy face) and ERYTHEMA (Red face). The patient was treated with OLOPATADINE HYDROCHLORIDE (PATANOL) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 18-Feb-2021, FACIAL PAIN (Face felt odd), SWELLING FACE (Puffy face), PRURITUS (Itchy face) and ERYTHEMA (Red face) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Patient height and weight updated, Concomitant medications doses were updated, concomitants added, medical history was added. Allergies were added.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Facial pain, Pruritus, Swelling face
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Face felt odd), SWELLING FACE (Puffy face), PRURITUS (Itchy face) and ERYTHEMA (Red face) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The patient's past medical history included Thyroid disorder NOS in 2000, Heart valve operation (Open heart surgery to repair mitral valve and tricuspid valve) on 27-Apr-2017, Cholecystectomy (30 years ago) and Appendectomy (30 years ago). Concurrent medical conditions included Allergy to antibiotic (Avalox), Drug allergy (Allergic to prednisone), Allergy to antibiotic (Biaxin XL), Allergy to topical drugs (Allergy to face cream which caused  the face to swell and turn red about 15 years ago), Acid reflux (esophageal) since 1993 and Cataract. Concomitant products included LEVOTHYROXINE, METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]), ATORVASTATIN, VITAMIN D3, LUTEIN [XANTOFYL], APIXABAN (ELIQUIS) and FUROSEMIDE for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced FACIAL PAIN (Face felt odd), SWELLING FACE (Puffy face), PRURITUS (Itchy face) and ERYTHEMA (Red face). The patient was treated with OLOPATADINE HYDROCHLORIDE (PATANOL) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 18-Feb-2021, FACIAL PAIN (Face felt odd), SWELLING FACE (Puffy face), PRURITUS (Itchy face) and ERYTHEMA (Red face) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Patient height and weight updated, Concomitant medications doses were updated, concomitants added, medical history was added. Allergies were added.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Face went numb on right side below the lip; Nose area also became numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA and HYPOAESTHESIA in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 16-Feb-2021, the patient experienced HYPOAESTHESIA and HYPOAESTHESIA. The patient was treated with BENADRYL at an unspecified dose and frequency. On 23-Feb-2021, HYPOAESTHESIA and HYPOAESTHESIA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The consumer stated that the Benadryl didn't help. She stated that she took levothyroxine daily to treat hypothyroidism. She stated that she has no known medication allergies.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Face went numb on right side below the lip; Nose area also became numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA and HYPOAESTHESIA in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 16-Feb-2021, the patient experienced HYPOAESTHESIA and HYPOAESTHESIA. The patient was treated with BENADRYL at an unspecified dose and frequency. On 23-Feb-2021, HYPOAESTHESIA and HYPOAESTHESIA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The consumer stated that the Benadryl didn't help. She stated that she took levothyroxine daily to treat hypothyroidism. She stated that she has no known medication allergies.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itching; Swelling; red looking like a rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SWELLING (Swelling) and RASH (red looking like a rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PRURITUS (Itching), SWELLING (Swelling) and RASH (red looking like a rash). At the time of the report, PRURITUS (Itching), SWELLING (Swelling) and RASH (red looking like a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional info-1
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Itching; Swelling; red looking like a rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SWELLING (Swelling) and RASH (red looking like a rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PRURITUS (Itching), SWELLING (Swelling) and RASH (red looking like a rash). At the time of the report, PRURITUS (Itching), SWELLING (Swelling) and RASH (red looking like a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional info-1
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Swollen lymph nodes, pain at injection site, suffered a stroke.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Injection site pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes, pain at injection site, suffered a stroke.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Injection site pruritus, Lip swelling, Muscle spasms
Clinical narrative: Within 2 hours of injection:  Random jabbing/stabbing pains over whole body, random headaches of short duration < 5 minutes.  24 hours after injection:  lips/gums/roof of mouth become swollen and sensitive.  3 days after injection: Overall body itchiness.  Received Prednisone treatment in early March 2021 (~3/3 to 3/11) which was ineffective at mitigating symptoms but catalyzed a new symptom of large area burning sensations on the skin.  It is now 7 months from injection and I continue to experience all these symptoms with no improvement and only increase in severity.  I currently take 3 Benadryl and 1 Claritin per day in addition to supplements Turmeric, Quercetin, Omega-3 Fish Oil, Vitamin C, Vitamin D3, Vitamin B12, Biotin to accomplish a 50-75% mitigation of symptoms.  Without OTC antihistamines I experience vicious stabbing/jabbing pains, vicious skin burning sensations, and unbearable itchiness whole body.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Palatal swelling, Parosmia
Clinical narrative: Within 2 hours of injection:  Random jabbing/stabbing pains over whole body, random headaches of short duration < 5 minutes.  24 hours after injection:  lips/gums/roof of mouth become swollen and sensitive.  3 days after injection: Overall body itchiness.  Received Prednisone treatment in early March 2021 (~3/3 to 3/11) which was ineffective at mitigating symptoms but catalyzed a new symptom of large area burning sensations on the skin.  It is now 7 months from injection and I continue to experience all these symptoms with no improvement and only increase in severity.  I currently take 3 Benadryl and 1 Claritin per day in addition to supplements Turmeric, Quercetin, Omega-3 Fish Oil, Vitamin C, Vitamin D3, Vitamin B12, Biotin to accomplish a 50-75% mitigation of symptoms.  Without OTC antihistamines I experience vicious stabbing/jabbing pains, vicious skin burning sensations, and unbearable itchiness whole body.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Gingival swelling, Headache, Lip swelling, Pain
Clinical narrative: Within 2 hours of injection:  Random jabbing/stabbing pains over whole body, random headaches of short duration < 5 minutes.  24 hours after injection:  lips/gums/roof of mouth become swollen and sensitive.  3 days after injection: Overall body itchiness.  Received Prednisone treatment in early March 2021 (~3/3 to 3/11) which was ineffective at mitigating symptoms but catalyzed a new symptom of large area burning sensations on the skin.  It is now 7 months from injection and I continue to experience all these symptoms with no improvement and only increase in severity.  I currently take 3 Benadryl and 1 Claritin per day in addition to supplements Turmeric, Quercetin, Omega-3 Fish Oil, Vitamin C, Vitamin D3, Vitamin B12, Biotin to accomplish a 50-75% mitigation of symptoms.  Without OTC antihistamines I experience vicious stabbing/jabbing pains, vicious skin burning sensations, and unbearable itchiness whole body.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palatal swelling, Pruritus, Skin burning sensation
Clinical narrative: Within 2 hours of injection:  Random jabbing/stabbing pains over whole body, random headaches of short duration < 5 minutes.  24 hours after injection:  lips/gums/roof of mouth become swollen and sensitive.  3 days after injection: Overall body itchiness.  Received Prednisone treatment in early March 2021 (~3/3 to 3/11) which was ineffective at mitigating symptoms but catalyzed a new symptom of large area burning sensations on the skin.  It is now 7 months from injection and I continue to experience all these symptoms with no improvement and only increase in severity.  I currently take 3 Benadryl and 1 Claritin per day in addition to supplements Turmeric, Quercetin, Omega-3 Fish Oil, Vitamin C, Vitamin D3, Vitamin B12, Biotin to accomplish a 50-75% mitigation of symptoms.  Without OTC antihistamines I experience vicious stabbing/jabbing pains, vicious skin burning sensations, and unbearable itchiness whole body.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A spontaneous report was received from a healthcare professional concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was itchy, arm was a little bit swollen, arm was red. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced the event(s) arm was itchy, arm was a little bit swollen, arm was red. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), arm was itchy, arm was a little bit swollen, arm was red was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: A spontaneous report was received from a healthcare professional concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was itchy, arm was a little bit swollen, arm was red. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced the event(s) arm was itchy, arm was a little bit swollen, arm was red. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), arm was itchy, arm was a little bit swollen, arm was red was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: BILATERAL DEEP VEIN THROMBOSIS WITH RIGHT SIDED PE; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via a Regulatory Authority via Vaccine Adverse Event Reporting System (VAERS , reference 201760) concerned a 63 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included hypertension, hypercholesteromia, obstructive sleep apnea (OSA), cerebrovascular accident (CVA), and allergy to wasp sting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose not reported,1 total frequency, administered on 1-APR-2021 for prophylactic vaccination. All required follow-up attempts have been made. The batch number has not been provided. Concomitant medications included atorvastatin calcium for hypercholesteromia, and lisinopril for hypertension.  It was reported that within two days of receiving covid-19 vaccine ad26.cov2.s (also reported as on the same day), the patient experienced bilateral deep vein thrombosis with right sided pulmonary embolism (PE), and pulmonary embolism, was hospitalized for 2 days, and is now clinically stable. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from bilateral deep vein thrombosis with right sided PE and pulmonary embolism. This report was serious (Life Threatening and Hospitalization Caused / Prolonged).  Additional information was received on 03-AUG-2021. All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided.; Sender's Comments: V2:Additional information in this version updates -  All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided. This follow-up information does not alter the prior assessed causality of reported events.  20210441483-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis and pulmonary embolism. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram thorax abnormal, Deep vein thrombosis, Pulmonary embolism, Pulmonary infarction
Clinical narrative: BILATERAL DEEP VEIN THROMBOSIS WITH RIGHT SIDED PE; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via a Regulatory Authority via Vaccine Adverse Event Reporting System (VAERS , reference 201760) concerned a 63 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included hypertension, hypercholesteromia, obstructive sleep apnea (OSA), cerebrovascular accident (CVA), and allergy to wasp sting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose not reported,1 total frequency, administered on 1-APR-2021 for prophylactic vaccination. All required follow-up attempts have been made. The batch number has not been provided. Concomitant medications included atorvastatin calcium for hypercholesteromia, and lisinopril for hypertension.  It was reported that within two days of receiving covid-19 vaccine ad26.cov2.s (also reported as on the same day), the patient experienced bilateral deep vein thrombosis with right sided pulmonary embolism (PE), and pulmonary embolism, was hospitalized for 2 days, and is now clinically stable. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from bilateral deep vein thrombosis with right sided PE and pulmonary embolism. This report was serious (Life Threatening and Hospitalization Caused / Prolonged).  Additional information was received on 03-AUG-2021. All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided.; Sender's Comments: V2:Additional information in this version updates -  All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided. This follow-up information does not alter the prior assessed causality of reported events.  20210441483-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis and pulmonary embolism. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: BILATERAL DEEP VEIN THROMBOSIS WITH RIGHT SIDED PE; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via a Regulatory Authority via Vaccine Adverse Event Reporting System (VAERS , reference 201760) concerned a 63 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included hypertension, hypercholesteromia, obstructive sleep apnea (OSA), cerebrovascular accident (CVA), and allergy to wasp sting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose not reported,1 total frequency, administered on 1-APR-2021 for prophylactic vaccination. All required follow-up attempts have been made. The batch number has not been provided. Concomitant medications included atorvastatin calcium for hypercholesteromia, and lisinopril for hypertension.  It was reported that within two days of receiving covid-19 vaccine ad26.cov2.s (also reported as on the same day), the patient experienced bilateral deep vein thrombosis with right sided pulmonary embolism (PE), and pulmonary embolism, was hospitalized for 2 days, and is now clinically stable. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from bilateral deep vein thrombosis with right sided PE and pulmonary embolism. This report was serious (Life Threatening and Hospitalization Caused / Prolonged).  Additional information was received on 03-AUG-2021. All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided.; Sender's Comments: V2:Additional information in this version updates -  All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided. This follow-up information does not alter the prior assessed causality of reported events.  20210441483-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis and pulmonary embolism. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; HEAD AND NECK HOT; SENSITIVITY TO LIGHT; This spontaneous report received from a patient concerned a 44 year old female of unknown ethnicity. The patient's weight was 140 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user(socially), and non smoker. The patient had no known allergies and drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-AUG-2021 patient was working with her boss all day, and went into client doctors offices. On 05-AUG-2021 patient had experienced headache, chills, body aches, runny nose, sore throat, sensitivity to light, fatigue, and while she had no fever, her head and neck were hot. On 07-AUG-2021 patient had test positive for COVID-19 (Suspected clinical vaccination failure). Patient had not informed her health care provider. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccine failure, head and neck hot and sensitivity to light was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000189143.; Sender's Comments: V0:20210818569- covid-19 vaccine ad26.cov2.s-Suspected Clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS