chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity
Clinical narrative: left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cyanotic heart disease.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm soreness). At the time of the report, PAIN IN EXTREMITY (left arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 97.1-97.9 f 97.1-97.9 F but that's normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication taken was Aspirin for Cyanotic heart disease. No treatment medication was reported.   This case was linked to MOD-2021-097104.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Headache, Vaccination site pain
Clinical narrative: Headache; Pain Injection Site Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Antibody test: Patient mentioned she has antibodies..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: Vomited; Felt fatigued; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomited), FATIGUE (Felt fatigued) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomited), FATIGUE (Felt fatigued) and HEADACHE (Headache). At the time of the report, VOMITING (Vomited), FATIGUE (Felt fatigued) and HEADACHE (Headache) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site pain
Clinical narrative: Dry itchy red spots on buttocks; sore right where they gave me the shot; Red rash on Buttocks/rash higher up on the right side of my behind; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on Buttocks/rash higher up on the right side of my behind), RASH PRURITIC (Dry itchy red spots on buttocks) and VACCINATION SITE PAIN (sore right where they gave me the shot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on Buttocks/rash higher up on the right side of my behind) and VACCINATION SITE PAIN (sore right where they gave me the shot). On 16-Feb-2021, the patient experienced RASH PRURITIC (Dry itchy red spots on buttocks). At the time of the report, RASH ERYTHEMATOUS (Red rash on Buttocks/rash higher up on the right side of my behind), RASH PRURITIC (Dry itchy red spots on buttocks) and VACCINATION SITE PAIN (sore right where they gave me the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain, Pruritus, Vaccination site pain
Clinical narrative: all muscles hurt; itchy over upper arm and very large area 3 to 6 inches; pain at the injection site; redness; little pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy over upper arm and very large area 3 to 6 inches), VACCINATION SITE PAIN (pain at the injection site), ERYTHEMA (redness), MYALGIA (all muscles hurt) and PAIN (little pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025T20A or 025G20A not sure and 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug reaction (patient medical history was not reported). Concomitant products included CARVEDILOL for Heart attack, PREGABALIN (LYRICA) for Pain.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (little pain). On 12-Feb-2021, the patient experienced PRURITUS (itchy over upper arm and very large area 3 to 6 inches), VACCINATION SITE PAIN (pain at the injection site) and ERYTHEMA (redness). On 16-Feb-2021, the patient experienced MYALGIA (all muscles hurt). At the time of the report, PRURITUS (itchy over upper arm and very large area 3 to 6 inches), VACCINATION SITE PAIN (pain at the injection site), ERYTHEMA (redness), MYALGIA (all muscles hurt) and PAIN (little pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Excessive itching and burning especially wrist up; Excessive itching and burning especially wrist up; hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (Excessive itching and burning especially wrist up) and BURNING SENSATION (Excessive itching and burning especially wrist up) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011LA20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Glaucoma and Hyperlipidemia. Concomitant products included OMEPRAZOLE, ROSUVASTATIN and LISINOPRIL for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced URTICARIA (hives). On an unknown date, the patient experienced PRURITUS (Excessive itching and burning especially wrist up) and BURNING SENSATION (Excessive itching and burning especially wrist up). At the time of the report, URTICARIA (hives) had not resolved and PRURITUS (Excessive itching and burning especially wrist up) and BURNING SENSATION (Excessive itching and burning especially wrist up) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Soreness in her arm; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm) and DIZZINESS (Dizziness) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included MELOXICAM for Arthritis.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in her arm) and DIZZINESS (Dizziness). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Vaccination site pain; Vaccination site warmth; Vaccination site erythema; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (rVaccination site erythema), the first episode of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE WARMTH (Vaccination site warmth) and the second episode of VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (rVaccination site erythema), the first episode of VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE WARMTH (Vaccination site warmth). On an unknown date, the patient experienced the second episode of VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE ERYTHEMA (rVaccination site erythema), VACCINATION SITE WARMTH (Vaccination site warmth) and the last episode of VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1Drink/week). Concomitant products included VITAMIN B6 and MACROGOL 3350 (GAVILAX) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. The patient's last menstrual period was on 05-Oct-2020 and the estimated date of delivery was 12-Jul-2021. On 16-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan normal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1Drink/week). Concomitant products included VITAMIN B6 and MACROGOL 3350 (GAVILAX) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. The patient's last menstrual period was on 05-Oct-2020 and the estimated date of delivery was 12-Jul-2021. On 16-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan normal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment: No treatment was provided.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cough, Dyspnoea, Impaired work ability, Insomnia
Clinical narrative: difficulty in breathing; cough; hot air he feels in the throat; Swelling of hands; swollen  wrists; pain on wrists/hands; could barely move the wrists; could not work; back pain; difficulty to sleep due to back pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of hands), JOINT SWELLING (swollen  wrists), PAIN (pain on wrists/hands), JOINT RANGE OF MOTION DECREASED (could barely move the wrists) and IMPAIRED WORK ABILITY (could not work) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling of hands), JOINT SWELLING (swollen  wrists), PAIN (pain on wrists/hands), JOINT RANGE OF MOTION DECREASED (could barely move the wrists), IMPAIRED WORK ABILITY (could not work), BACK PAIN (back pain), INSOMNIA (difficulty to sleep due to back pain) and THROAT IRRITATION (hot air he feels in the throat). On an unknown date, the patient experienced DYSPNOEA (difficulty in breathing) and COUGH (cough). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (Swelling of hands), JOINT SWELLING (swollen  wrists), PAIN (pain on wrists/hands), JOINT RANGE OF MOTION DECREASED (could barely move the wrists), IMPAIRED WORK ABILITY (could not work), BACK PAIN (back pain), INSOMNIA (difficulty to sleep due to back pain), DYSPNOEA (difficulty in breathing), COUGH (cough) and THROAT IRRITATION (hot air he feels in the throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medicine and cholesterol medicine.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up document was received. Patient initials, gender, adverse event outcome  was updated from unknown to recovered. It contains significant information.
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Joint swelling, Pain, Peripheral swelling, Throat irritation
Clinical narrative: difficulty in breathing; cough; hot air he feels in the throat; Swelling of hands; swollen  wrists; pain on wrists/hands; could barely move the wrists; could not work; back pain; difficulty to sleep due to back pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of hands), JOINT SWELLING (swollen  wrists), PAIN (pain on wrists/hands), JOINT RANGE OF MOTION DECREASED (could barely move the wrists) and IMPAIRED WORK ABILITY (could not work) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling of hands), JOINT SWELLING (swollen  wrists), PAIN (pain on wrists/hands), JOINT RANGE OF MOTION DECREASED (could barely move the wrists), IMPAIRED WORK ABILITY (could not work), BACK PAIN (back pain), INSOMNIA (difficulty to sleep due to back pain) and THROAT IRRITATION (hot air he feels in the throat). On an unknown date, the patient experienced DYSPNOEA (difficulty in breathing) and COUGH (cough). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (Swelling of hands), JOINT SWELLING (swollen  wrists), PAIN (pain on wrists/hands), JOINT RANGE OF MOTION DECREASED (could barely move the wrists), IMPAIRED WORK ABILITY (could not work), BACK PAIN (back pain), INSOMNIA (difficulty to sleep due to back pain), DYSPNOEA (difficulty in breathing), COUGH (cough) and THROAT IRRITATION (hot air he feels in the throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medicine and cholesterol medicine.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up document was received. Patient initials, gender, adverse event outcome  was updated from unknown to recovered. It contains significant information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Pruritus; Erythema; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Pruritus) and ERYTHEMA (Erythema) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PRURITUS (Pruritus) and ERYTHEMA (Erythema). At the time of the report, PRURITUS (Pruritus) and ERYTHEMA (Erythema) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Asthenia
Clinical narrative: Alk Phos raised; ALT High; AST High; Feeling bad with nerve pain; feeling bad; tiredness; Felt weak; Low BP; Felt like passing out; bad headache; Headache kept on getting worse; temp of 99 that went to 101, rose to 102.6; nausea; achiness; sore arm; A spontaneous report was received from a 69-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced sore arm, achiness, feeling badly, tiredness, weakness, nerve pain, elevated liver enzymes of ALT, AST and ALK Phos, a temperature of 99 that went to 101, rose to 102.6, headache, nausea, low blood pressure, and felt like passing out.  The patient's medical history included anxiety. Products known to have been used by the patient, within two weeks prior to the event, included clonazepam and progesterone/estrogen.  On 06 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Feb 2021, the patient experienced a sore arm. On 08 Feb 2021, the patient developed achiness. On 09 Feb 2021, the patient's temperature went from 99 to 101, she had a bad headache, nausea, low blood pressure, felt like passing out, and felt weak. On 11 Feb 2021, the patient started feeling bad with nerve pain and tiredness. On 13 Feb 2021, the patient took ibuprofen to help with her headache and ended up going to the emergency room (ER). At the ER, the patient was given fluids. A blood test was performed and showed elevated liver enzymes- ALK Phos 188, ALT 249, and AST 110. A sonogram on the liver was performed, but came back as normal. A COVID-19 test was performed and was negative. The patient was released on 13 Feb 2021 with prescribed medications of Toradol and Benadryl. On 15 Feb 2021, the patient's headache was worse and her temperature rose to 102.6. She took the Toradol and Benadryl with no relief. That evening, the patient went to the ER again. Another blood test was completed and showed her liver enzymes elevated- ALK Phos 207, ALT 302, and AST 158. The patient was given fluids and a "migraine cocktail". A computerized tomogram head scan was performed and came out normal. Another COVID-19 test was performed and was negative. On 15 Feb 2021, the patient reported that she was still feeling bad, still had a headache, and temperature keeps coming back to 101.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The events, headache, feeling bad, and body temperature increased, were considered not recovered/ not resolved. The outcomes of the events, sore arm, achiness, tired, nerve pain, nausea, low blood pressure, felt like passing out, and felt weak, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase, Blood alkaline phosphatase increased, Computerised tomogram, Fatigue, Feeling abnormal
Clinical narrative: Alk Phos raised; ALT High; AST High; Feeling bad with nerve pain; feeling bad; tiredness; Felt weak; Low BP; Felt like passing out; bad headache; Headache kept on getting worse; temp of 99 that went to 101, rose to 102.6; nausea; achiness; sore arm; A spontaneous report was received from a 69-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced sore arm, achiness, feeling badly, tiredness, weakness, nerve pain, elevated liver enzymes of ALT, AST and ALK Phos, a temperature of 99 that went to 101, rose to 102.6, headache, nausea, low blood pressure, and felt like passing out.  The patient's medical history included anxiety. Products known to have been used by the patient, within two weeks prior to the event, included clonazepam and progesterone/estrogen.  On 06 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Feb 2021, the patient experienced a sore arm. On 08 Feb 2021, the patient developed achiness. On 09 Feb 2021, the patient's temperature went from 99 to 101, she had a bad headache, nausea, low blood pressure, felt like passing out, and felt weak. On 11 Feb 2021, the patient started feeling bad with nerve pain and tiredness. On 13 Feb 2021, the patient took ibuprofen to help with her headache and ended up going to the emergency room (ER). At the ER, the patient was given fluids. A blood test was performed and showed elevated liver enzymes- ALK Phos 188, ALT 249, and AST 110. A sonogram on the liver was performed, but came back as normal. A COVID-19 test was performed and was negative. The patient was released on 13 Feb 2021 with prescribed medications of Toradol and Benadryl. On 15 Feb 2021, the patient's headache was worse and her temperature rose to 102.6. She took the Toradol and Benadryl with no relief. That evening, the patient went to the ER again. Another blood test was completed and showed her liver enzymes elevated- ALK Phos 207, ALT 302, and AST 158. The patient was given fluids and a "migraine cocktail". A computerized tomogram head scan was performed and came out normal. Another COVID-19 test was performed and was negative. On 15 Feb 2021, the patient reported that she was still feeling bad, still had a headache, and temperature keeps coming back to 101.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The events, headache, feeling bad, and body temperature increased, were considered not recovered/ not resolved. The outcomes of the events, sore arm, achiness, tired, nerve pain, nausea, low blood pressure, felt like passing out, and felt weak, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypotension, Nausea, Neuralgia, Pain
Clinical narrative: Alk Phos raised; ALT High; AST High; Feeling bad with nerve pain; feeling bad; tiredness; Felt weak; Low BP; Felt like passing out; bad headache; Headache kept on getting worse; temp of 99 that went to 101, rose to 102.6; nausea; achiness; sore arm; A spontaneous report was received from a 69-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced sore arm, achiness, feeling badly, tiredness, weakness, nerve pain, elevated liver enzymes of ALT, AST and ALK Phos, a temperature of 99 that went to 101, rose to 102.6, headache, nausea, low blood pressure, and felt like passing out.  The patient's medical history included anxiety. Products known to have been used by the patient, within two weeks prior to the event, included clonazepam and progesterone/estrogen.  On 06 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Feb 2021, the patient experienced a sore arm. On 08 Feb 2021, the patient developed achiness. On 09 Feb 2021, the patient's temperature went from 99 to 101, she had a bad headache, nausea, low blood pressure, felt like passing out, and felt weak. On 11 Feb 2021, the patient started feeling bad with nerve pain and tiredness. On 13 Feb 2021, the patient took ibuprofen to help with her headache and ended up going to the emergency room (ER). At the ER, the patient was given fluids. A blood test was performed and showed elevated liver enzymes- ALK Phos 188, ALT 249, and AST 110. A sonogram on the liver was performed, but came back as normal. A COVID-19 test was performed and was negative. The patient was released on 13 Feb 2021 with prescribed medications of Toradol and Benadryl. On 15 Feb 2021, the patient's headache was worse and her temperature rose to 102.6. She took the Toradol and Benadryl with no relief. That evening, the patient went to the ER again. Another blood test was completed and showed her liver enzymes elevated- ALK Phos 207, ALT 302, and AST 158. The patient was given fluids and a "migraine cocktail". A computerized tomogram head scan was performed and came out normal. Another COVID-19 test was performed and was negative. On 15 Feb 2021, the patient reported that she was still feeling bad, still had a headache, and temperature keeps coming back to 101.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The events, headache, feeling bad, and body temperature increased, were considered not recovered/ not resolved. The outcomes of the events, sore arm, achiness, tired, nerve pain, nausea, low blood pressure, felt like passing out, and felt weak, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Alk Phos raised; ALT High; AST High; Feeling bad with nerve pain; feeling bad; tiredness; Felt weak; Low BP; Felt like passing out; bad headache; Headache kept on getting worse; temp of 99 that went to 101, rose to 102.6; nausea; achiness; sore arm; A spontaneous report was received from a 69-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced sore arm, achiness, feeling badly, tiredness, weakness, nerve pain, elevated liver enzymes of ALT, AST and ALK Phos, a temperature of 99 that went to 101, rose to 102.6, headache, nausea, low blood pressure, and felt like passing out.  The patient's medical history included anxiety. Products known to have been used by the patient, within two weeks prior to the event, included clonazepam and progesterone/estrogen.  On 06 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Feb 2021, the patient experienced a sore arm. On 08 Feb 2021, the patient developed achiness. On 09 Feb 2021, the patient's temperature went from 99 to 101, she had a bad headache, nausea, low blood pressure, felt like passing out, and felt weak. On 11 Feb 2021, the patient started feeling bad with nerve pain and tiredness. On 13 Feb 2021, the patient took ibuprofen to help with her headache and ended up going to the emergency room (ER). At the ER, the patient was given fluids. A blood test was performed and showed elevated liver enzymes- ALK Phos 188, ALT 249, and AST 110. A sonogram on the liver was performed, but came back as normal. A COVID-19 test was performed and was negative. The patient was released on 13 Feb 2021 with prescribed medications of Toradol and Benadryl. On 15 Feb 2021, the patient's headache was worse and her temperature rose to 102.6. She took the Toradol and Benadryl with no relief. That evening, the patient went to the ER again. Another blood test was completed and showed her liver enzymes elevated- ALK Phos 207, ALT 302, and AST 158. The patient was given fluids and a "migraine cocktail". A computerized tomogram head scan was performed and came out normal. Another COVID-19 test was performed and was negative. On 15 Feb 2021, the patient reported that she was still feeling bad, still had a headache, and temperature keeps coming back to 101.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The events, headache, feeling bad, and body temperature increased, were considered not recovered/ not resolved. The outcomes of the events, sore arm, achiness, tired, nerve pain, nausea, low blood pressure, felt like passing out, and felt weak, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles ) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history was  not reported).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced HERPES ZOSTER (Shingles ). At the time of the report, HERPES ZOSTER (Shingles ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm). On 21-Jan-2021, PAIN IN EXTREMITY (Soreness in arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-015356 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Arm swelled down to her elbow; Arm had a rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled down to her elbow) and RASH (Arm had a rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swelled down to her elbow) and RASH (Arm had a rash). At the time of the report, PERIPHERAL SWELLING (Arm swelled down to her elbow) and RASH (Arm had a rash) outcome was unknown. Not Provided          No concomitant medications were reported No treatments were reported.  Moderna lot 025L20A Patient reported at her second Moderna vaccine shot that her arm swelled down to her elbow and arm had a rash. Patient reports that this lasted 1 week.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy at injection site; Arm pain at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE PAIN (Arm pain at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE PAIN (Arm pain at injection site). At the time of the report, VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE PAIN (Arm pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Movement disorder, Swelling face
Clinical narrative: Swelling in the face; Slow hands  movement; Headache; A spontaneous report was received from a consumer concerning a 37 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events slow hands movement/ movement disorder, swelling in the face/swelling face, and headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30-Dec-2020, about two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13-Jan-2021, the patient experienced the events headache and anaphylactic reactions which were characterized by slow hands movement and swelling in the face. Treatment included Benadryl and steroids and the symptoms disappeared.   Action taken with mRNA-1273 in response to the events was not applicable.   The events slow hands movement, swelling in the face, and headache, were resolved on unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: knee pain; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (knee pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included CORTISONE for Arthritis.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (knee pain). At the time of the report, ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Tenderness
Clinical narrative: tenderness; pain on the left arm; swollen lymph nodes of left hand; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), PAIN IN EXTREMITY (pain on the left arm) and LYMPHADENOPATHY (swollen lymph nodes of left hand) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on the left arm) and LYMPHADENOPATHY (swollen lymph nodes of left hand). On an unknown date, the patient experienced TENDERNESS (tenderness). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, TENDERNESS (tenderness), PAIN IN EXTREMITY (pain on the left arm) and LYMPHADENOPATHY (swollen lymph nodes of left hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Follow-up information included patient demographic details. causality updated and treatment details were updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia, Pain, Pyrexia
Clinical narrative: Body ache; Lethargy; Aches; Fever of; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), PAIN (Aches), PYREXIA (Fever of), HEADACHE (Headache) and MYALGIA (Body ache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargy), PAIN (Aches), PYREXIA (Fever of), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, LETHARGY (Lethargy), PAIN (Aches), PYREXIA (Fever of), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Paraesthesia, Vaccination site pain
Clinical narrative: Pain in back of neck; Tingling in her extremities; Tingling in her fingers; Tingling in her toes; Pain in her shoulders; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in back of neck), ARTHRALGIA (Pain in her shoulders) and VACCINATION SITE PAIN (Soreness at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes, Hypothyroidism, Blood pressure high, Breast cancer, Ovarian cancer and Brain cancer metastatic. Concomitant products included METFORMIN, PRAVASTATIN, LEVOTHYROXINE, LISINOPRIL, CYCLOBENZAPRINE and GABAPENTIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NECK PAIN (Pain in back of neck), ARTHRALGIA (Pain in her shoulders) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, NECK PAIN (Pain in back of neck), ARTHRALGIA (Pain in her shoulders) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Tinnitus
Clinical narrative: Tinnitus; Really bad headache on the front head, going down the back of her neck; Itching on the hand and arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), PRURITUS (Itching on the hand and arm) and HEADACHE (Really bad headache on the front head, going down the back of her neck) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (Itching on the hand and arm). On 11-Feb-2021, the patient experienced TINNITUS (Tinnitus) and HEADACHE (Really bad headache on the front head, going down the back of her neck). At the time of the report, TINNITUS (Tinnitus) had not resolved, PRURITUS (Itching on the hand and arm) had resolved and HEADACHE (Really bad headache on the front head, going down the back of her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information include Lipo flavonoid plus for the Tinnitus.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: additional info-significant info - Outcome of event reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eczema, Pharyngeal swelling, Pruritus, Throat tightness
Clinical narrative: Whole body developed hives; Burning behind the backs of her knees and arms; Head and chest became itchy; Throat was tight; Throat swelled up; Triggered their eczema; This spontaneous case was reported by a health care professional and describes the occurrence of PHARYNGEAL SWELLING (Throat swelled up), ECZEMA (Triggered their eczema), URTICARIA (Whole body developed hives), BURNING SENSATION (Burning behind the backs of her knees and arms) and PRURITUS (Head and chest became itchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelled up) and ECZEMA (Triggered their eczema). On an unknown date, the patient experienced URTICARIA (Whole body developed hives), BURNING SENSATION (Burning behind the backs of her knees and arms), PRURITUS (Head and chest became itchy) and THROAT TIGHTNESS (Throat was tight). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at a dose of UNK dosage form. At the time of the report, PHARYNGEAL SWELLING (Throat swelled up), ECZEMA (Triggered their eczema), URTICARIA (Whole body developed hives), BURNING SENSATION (Burning behind the backs of her knees and arms), PRURITUS (Head and chest became itchy) and THROAT TIGHTNESS (Throat was tight) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. Treatment included cream.