chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Body temperature, Chills, Decreased appetite
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (equilibrium was off), SOMNOLENCE (slept for 24hs), DECREASED APPETITE (did not have appetite), ARTHRALGIA (joint pain) and PYREXIA (fever of 100°F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 17-Mar-2021.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced BALANCE DISORDER (equilibrium was off), SOMNOLENCE (slept for 24hs), DECREASED APPETITE (did not have appetite), ARTHRALGIA (joint pain), PYREXIA (fever of 100°F) and CHILLS (chills). On 31-Jan-2021, BALANCE DISORDER (equilibrium was off), SOMNOLENCE (slept for 24hs), DECREASED APPETITE (did not have appetite), ARTHRALGIA (joint pain), PYREXIA (fever of 100°F) and CHILLS (chills) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 100°f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was unknown by the reporter. Treatment medication included ibuprofen   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received on 05 May 2021n contain PCP removed as primary reporter.; Sender's Comments:  MOD-2021-019789:Same reporter/different patient (wife). PCP is not a valid reporter or husband.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (equilibrium was off), SOMNOLENCE (slept for 24hs), DECREASED APPETITE (did not have appetite), ARTHRALGIA (joint pain) and PYREXIA (fever of 100°F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 17-Mar-2021.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced BALANCE DISORDER (equilibrium was off), SOMNOLENCE (slept for 24hs), DECREASED APPETITE (did not have appetite), ARTHRALGIA (joint pain), PYREXIA (fever of 100°F) and CHILLS (chills). On 31-Jan-2021, BALANCE DISORDER (equilibrium was off), SOMNOLENCE (slept for 24hs), DECREASED APPETITE (did not have appetite), ARTHRALGIA (joint pain), PYREXIA (fever of 100°F) and CHILLS (chills) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 100°f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was unknown by the reporter. Treatment medication included ibuprofen   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received on 05 May 2021n contain PCP removed as primary reporter.; Sender's Comments:  MOD-2021-019789:Same reporter/different patient (wife). PCP is not a valid reporter or husband.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Rash, Rash pruritic
Clinical narrative: rash itches; sore arm; scarlett red rash down both arms,entire trunk of body, and both legs; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash itches), PAIN IN EXTREMITY (sore arm), RASH (scarlett red rash down both arms,entire trunk of body, and both legs) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 30-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 RASH PRURITIC (rash itches), PAIN IN EXTREMITY (sore arm), RASH (scarlett red rash down both arms,entire trunk of body, and both legs) and CHILLS (chills). At the time of the report, RASH PRURITIC (rash itches), PAIN IN EXTREMITY (sore arm), RASH (scarlett red rash down both arms,entire trunk of body, and both legs) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness which is spreading; Redness which is spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness which is spreading) and VACCINATION SITE ERYTHEMA (Redness which is spreading) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness which is spreading) and VACCINATION SITE ERYTHEMA (Redness which is spreading). At the time of the report, VACCINATION SITE PRURITUS (Itchiness which is spreading) and VACCINATION SITE ERYTHEMA (Redness which is spreading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: left breast pain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (left breast pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concurrent medical conditions included Hypertension. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-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 BREAST PAIN (left breast pain). At the time of the report, BREAST PAIN (left breast pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included High Blood Pressure medication, acid reflux medication, Cranberry supplement and Cinnamon supplement. Treatment medication were not provided/unknown.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: mild case of nausea; This spontaneous case was reported by a nurse and describes the occurrence of NAUSEA (mild case of nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced NAUSEA (mild case of nausea). On 02-Feb-2021, NAUSEA (mild case of nausea) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: vaccination site rash; A spontaneous report was received from a consumer concerning a 69-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event vaccination site rash.  The patient's medical history was not provided. Current condition include lupus. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) in the right arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced the event rashes which started on her right arm and by the end of the day have spread out to her trunk. Treatment details included Benadryl. The rashes resolved in one and a half days.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event, rashes was resolved on 21 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 event, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Itchiness at the injection site; She started experiencing Hives at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE URTICARIA (She started experiencing Hives at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE URTICARIA (She started experiencing Hives at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE URTICARIA (She started experiencing Hives at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Red and puffy; Red spot; Sore arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Sore arm), VACCINATION SITE SWELLING (Red and puffy) and VACCINATION SITE ERYTHEMA (Red spot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included PARACETAMOL (TYLENOL), OXYCODONE HYDROCHLORIDE (OXICODONE ACCORD), TRAMADOL and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    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 VACCINATION SITE PAIN (Sore arm). On 03-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Red and puffy) and VACCINATION SITE ERYTHEMA (Red spot). On 27-Jan-2021, VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, VACCINATION SITE SWELLING (Red and puffy) and VACCINATION SITE ERYTHEMA (Red spot) outcome was unknown. Not Provided      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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Chills, Pyrexia
Clinical narrative: lump about the size of the baseball under the armpit/ arm where she received the vaccine; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump about the size of the baseball under the armpit/ arm where she received the vaccine), CHILLS (chills) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN and LORAZEPAM (ATIVAN) for an unknown indication.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced AXILLARY MASS (lump about the size of the baseball under the armpit/ arm where she received the vaccine), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, AXILLARY MASS (lump about the size of the baseball under the armpit/ arm where she received the vaccine), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the drug was not applicable.; 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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pyrexia, Urinary incontinence
Clinical narrative: weak; peeing himself; dizzy; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), URINARY INCONTINENCE (peeing himself), DIZZINESS (dizzy) and PYREXIA (fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.    The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included VITAMIN D2, ACETYLSALICYLIC ACID (ASPIRIN EC), CARVEDILOL, CALCITRIOL, GABAPENTIN, ALLOPURINOL, AMLODIPINE, CITALOPRAM and ATORVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ASTHENIA (weak), URINARY INCONTINENCE (peeing himself), DIZZINESS (dizzy) and PYREXIA (fever). At the time of the report, ASTHENIA (weak), URINARY INCONTINENCE (peeing himself), DIZZINESS (dizzy) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Vaccination site pain
Clinical narrative: just wasn't with it; arm was sore; she begun to have the chills this morning and every part of her body was cold; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (just wasn't with it), CHILLS (she begun to have the chills this morning and every part of her body was cold), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026620A and 027620A) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced CHILLS (she begun to have the chills this morning and every part of her body was cold) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (just wasn't with it) and VACCINATION SITE PAIN (arm was sore). At the time of the report, FEELING ABNORMAL (just wasn't with it), CHILLS (she begun to have the chills this morning and every part of her body was cold), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore) outcome was unknown.            No concomitants or treatment medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Headache, Nausea, Pyrexia
Clinical narrative: Got very, very ill; Weakness to where it was hard to get out of bed; Trouble breathing; Fever of 103 F; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got very, very ill), ASTHENIA (Weakness to where it was hard to get out of bed), DYSPNOEA (Trouble breathing), PYREXIA (Fever of 103 F) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported).    On 28-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 COMPLICATION (Got very, very ill), ASTHENIA (Weakness to where it was hard to get out of bed), DYSPNOEA (Trouble breathing), PYREXIA (Fever of 103 F), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (Got very, very ill), ASTHENIA (Weakness to where it was hard to get out of bed), DYSPNOEA (Trouble breathing), PYREXIA (Fever of 103 F), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Got very, very ill; Weakness to where it was hard to get out of bed; Trouble breathing; Fever of 103 F; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got very, very ill), ASTHENIA (Weakness to where it was hard to get out of bed), DYSPNOEA (Trouble breathing), PYREXIA (Fever of 103 F) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported).    On 28-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 COMPLICATION (Got very, very ill), ASTHENIA (Weakness to where it was hard to get out of bed), DYSPNOEA (Trouble breathing), PYREXIA (Fever of 103 F), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (Got very, very ill), ASTHENIA (Weakness to where it was hard to get out of bed), DYSPNOEA (Trouble breathing), PYREXIA (Fever of 103 F), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe pain on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain on injection arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00M00A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Severe pain on injection arm). At the time of the report, VACCINATION SITE PAIN (Severe pain on injection arm) outcome was unknown.        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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching near injection site; Rash near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching near injection site) and VACCINATION SITE RASH (Rash near injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history). Concomitant products included LISINOPRIL, ZINC, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching near injection site) and VACCINATION SITE RASH (Rash near injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching near injection site) had resolved and VACCINATION SITE RASH (Rash near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Really tired; Pain on the injection site; Swelling on the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site) and FATIGUE (Really tired) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection site) and VACCINATION SITE SWELLING (Swelling on the injection site). On an unknown date, the patient experienced FATIGUE (Really tired). At the time of the report, VACCINATION SITE PAIN (Pain on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site) and FATIGUE (Really tired) outcome was unknown.        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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Feeling abnormal, Feeling jittery, Taste disorder
Clinical narrative: Feeling was just odd; Feeling Jittery; Different taste in my mouth; Dryness in my mouth; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling was just odd), FEELING JITTERY (Feeling Jittery), TASTE DISORDER (Different taste in my mouth), DRY MOUTH (Dryness in my mouth) and DIZZINESS (Light headedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling was just odd), FEELING JITTERY (Feeling Jittery), TASTE DISORDER (Different taste in my mouth) and DRY MOUTH (Dryness in my mouth). On an unknown date, the patient experienced DIZZINESS (Light headedness). At the time of the report, FEELING ABNORMAL (Feeling was just odd), FEELING JITTERY (Feeling Jittery), TASTE DISORDER (Different taste in my mouth), DRY MOUTH (Dryness in my mouth) and DIZZINESS (Light headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Nervous system disorder, Vaccination site pain
Clinical narrative: had a sore arm; woke up and was about to fall on the floor; had a mini nerve attack; A spontaneous report  was received from a consumer concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced woke up and was about to fall on the floor, had a mini nerve attack, and sore arm.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 18 Jan 2021, approximately same day prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 18 Jan 2021, after receiving mRNA-1273, the patient woke up in the middle of that night experiencing "mini nerve attack". The patient stated "was about to fall on the floor but didn't and sat back down" on bed and was able to go back to sleep. The patient woke up again and was given two Tylenols by the nurse. At 0700am, the patient wasn't feeling normal and had a sore arm. Patient was then given Norco to relieve the pain. Treatment for the events included acetaminophen, Narco was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The events, woke up and was about to fall on the floor, had a mini nerve attack, and sore arm were considered resolved on an 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 events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site that resolved), INJECTION SITE PAIN (sore arm at the injection site), CHILLS (chills), NAUSEA (nausea) and HEADACHE (mild headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm at the injection site that resolved), INJECTION SITE PAIN (sore arm at the injection site), CHILLS (chills), NAUSEA (nausea) and HEADACHE (mild headache). On 02-Feb-2021, INJECTION SITE PAIN (sore arm at the injection site that resolved), INJECTION SITE PAIN (sore arm at the injection site), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, HEADACHE (mild headache) outcome was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Fever of 102F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102F) and HEADACHE (Headache) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 28-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 PYREXIA (Fever of 102F) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever of 102F) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), NAUSEA (nausea) and HEADACHE (headache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (Chills), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Red Spots (Injection Site); Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red Spots (Injection Site)) and VACCINATION SITE SWELLING (Swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 18-Jan-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE RASH (Red Spots (Injection Site)) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE RASH (Red Spots (Injection Site)) and VACCINATION SITE SWELLING (Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-063831 (E2B Linked Report).
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Tremor, Vaccination site pain, Vomiting
Clinical narrative: Extreme shakiness; was unable to walk well; vomiting; pain injection site/soreness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Extreme shakiness), GAIT INABILITY (was unable to walk well), VOMITING (vomiting) and VACCINATION SITE PAIN (pain injection site/soreness around injection site) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain injection site/soreness around injection site). On 05-Feb-2021, the patient experienced TREMOR (Extreme shakiness), GAIT INABILITY (was unable to walk well) and VOMITING (vomiting). At the time of the report, TREMOR (Extreme shakiness), GAIT INABILITY (was unable to walk well), VOMITING (vomiting) and VACCINATION SITE PAIN (pain injection site/soreness around injection site) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus
Clinical narrative: it's going down the inside of the arm now; it started to itch in that area; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it's going down the inside of the arm now) and VACCINATION SITE PRURITUS (it started to itch in that area) 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 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PRURITUS (it's going down the inside of the arm now) and VACCINATION SITE PRURITUS (it started to itch in that area). At the time of the report, PRURITUS (it's going down the inside of the arm now) and VACCINATION SITE PRURITUS (it started to itch in that area) outcome was unknown.            Treatment and concomitant medications were not reported. Action taken in response to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: process with initial
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Experienced flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Experienced flu like symptoms) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Experienced flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Experienced flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A202A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy.   On 07-Jan-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little sore at injection site). At the time of the report, VACCINATION SITE PAIN (Little sore at injection site) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products included Blood Pressure and Cholesterol medications.  No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Added second dosage regimen.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 28-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 PAIN (SORE ARM). At the time of the report, VACCINATION SITE PAIN (SORE ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Headache, Myalgia, Vaccination site pain
Clinical narrative: can not get out of bed; muscle pain; Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (can not get out of bed), MYALGIA (muscle pain), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included COVID-19 on 13-Jan-2021.    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 BEDRIDDEN (can not get out of bed), MYALGIA (muscle pain), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm). At the time of the report, BEDRIDDEN (can not get out of bed), MYALGIA (muscle pain), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Pink around the injection site; It itches; Patient's injection site became raised and swollen, the size of a lemon; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pink around the injection site), VACCINATION SITE PRURITUS (It itches) and VACCINATION SITE SWELLING (Patient's injection site became raised and swollen, the size of a lemon) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (It itches) and VACCINATION SITE SWELLING (Patient's injection site became raised and swollen, the size of a lemon). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Pink around the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Pink around the injection site), VACCINATION SITE PRURITUS (It itches) and VACCINATION SITE SWELLING (Patient's injection site became raised and swollen, the size of a lemon) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Peripheral swelling, Vaccination site pruritus
Clinical narrative: sugar levels went very low; itchiness on injection site; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), BLOOD GLUCOSE DECREASED (sugar levels went very low) and VACCINATION SITE PRURITUS (itchiness on injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D13L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE PRURITUS (itchiness on injection site). On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (sugar levels went very low). At the time of the report, PERIPHERAL SWELLING (Swollen arm), BLOOD GLUCOSE DECREASED (sugar levels went very low) and VACCINATION SITE PRURITUS (itchiness on injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: low (Low) Low.         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.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Added a new event (blood glucose decreased).; 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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Skin feels warm; Skin feels hard; Skin itching; Red rash on site of administration; A spontaneous report was received from a  consumer concerning herself a 85 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red rash on site of administration/vaccination site rash, skin itching/vaccination site pruritus, skin feels warm/vaccination site warmth and skin feels hard/vaccination site induration.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced red rash on site of administration and skin itching. She also says that her skin feels warm and hard. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, red rash on site of administration, skin itching, skin feels warm and skin feels hard were unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Rash
Clinical narrative: Missed second dose; Itching; big rash on his chest/got a horrible rash all over their entire body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), RASH (big rash on his chest/got a horrible rash all over their entire body) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 30-Jan-2021, the patient experienced PRURITUS (Itching) and RASH (big rash on his chest/got a horrible rash all over their entire body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). The patient was treated with PREDNISONE (oral) for Rash and Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) outcome was unknown, RASH (big rash on his chest/got a horrible rash all over their entire body) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included injectable steroids. No concomitant medication was provided. On an unknown date, Biopsy and Throat culture was performed, but result was not available.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Updated event - Product dose omission issue.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Disturbance in attention, Feeling abnormal, Panic attack
Clinical narrative: Anxiety; Panic attack; Confusion; Unusual sensations on the brain; Problems to concentrate; This spontaneous case was reported by an other health care professional and describes the occurrence of ANXIETY (Anxiety), PANIC ATTACK (Panic attack), CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Unusual sensations on the brain) and DISTURBANCE IN ATTENTION (Problems to concentrate) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ANXIETY (Anxiety), PANIC ATTACK (Panic attack), CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Unusual sensations on the brain) and DISTURBANCE IN ATTENTION (Problems to concentrate). At the time of the report, ANXIETY (Anxiety), PANIC ATTACK (Panic attack), CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Unusual sensations on the brain) and DISTURBANCE IN ATTENTION (Problems to concentrate) outcome was unknown. Not Provided      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.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity
Clinical narrative: In lot of pain; Shoulder blade pain; Back pain; Left arm extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PAIN IN EXTREMITY (Left arm extremely sore), PAIN (In lot of pain) and ARTHRALGIA (Shoulder blade pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer and Cancer surgery (Lung cancer surgery). Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced BACK PAIN (Back pain), PAIN IN EXTREMITY (Left arm extremely sore) and ARTHRALGIA (Shoulder blade pain). On an unknown date, the patient experienced PAIN (In lot of pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPRIN) for Pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain), PAIN IN EXTREMITY (Left arm extremely sore), PAIN (In lot of pain) and ARTHRALGIA (Shoulder blade pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient is on radiation therapy Radiation therapy.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Added current condition (Radiation). New event (In lot of pain) added. On 21-May-2021: Follow-up information received on 21-MAY-2021 contains non-significant information ("The patient reported that the reaction had nothing to do with the vaccine").