chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Gastritis.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (body pain) and HEADACHE (headache). At the time of the report, PAIN (body pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fall, Muscular weakness, Nausea, Pallor
Clinical narrative: nausea; arm pain; weakness in arms and legs; shortness of breath; Pale; Fell down and couldnt move; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in arms and legs), DYSPNOEA (shortness of breath), PALLOR (Pale), FALL (Fell down and couldnt move) and NAUSEA (nausea) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neurological disorder NOS (has neurological condition that cause weakness in legs).   On 14-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 10-Feb-2021, the patient experienced MUSCULAR WEAKNESS (weakness in arms and legs), DYSPNOEA (shortness of breath), PALLOR (Pale), FALL (Fell down and couldnt move) and VACCINATION SITE PAIN (arm pain). On 11-Feb-2021, the patient experienced NAUSEA (nausea). At the time of the report, MUSCULAR WEAKNESS (weakness in arms and legs), DYSPNOEA (shortness of breath), PALLOR (Pale), FALL (Fell down and couldnt move), NAUSEA (nausea) and VACCINATION SITE PAIN (arm pain) outcome was unknown.            Treatment information include tylenol, benadryl and Gatorade, which patient refused to take The outcome of events, arm pain, weakness in arms and legs, shortness of breath, pale, fell down and couldnt move, nausea was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: nausea; arm pain; weakness in arms and legs; shortness of breath; Pale; Fell down and couldnt move; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in arms and legs), DYSPNOEA (shortness of breath), PALLOR (Pale), FALL (Fell down and couldnt move) and NAUSEA (nausea) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neurological disorder NOS (has neurological condition that cause weakness in legs).   On 14-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 10-Feb-2021, the patient experienced MUSCULAR WEAKNESS (weakness in arms and legs), DYSPNOEA (shortness of breath), PALLOR (Pale), FALL (Fell down and couldnt move) and VACCINATION SITE PAIN (arm pain). On 11-Feb-2021, the patient experienced NAUSEA (nausea). At the time of the report, MUSCULAR WEAKNESS (weakness in arms and legs), DYSPNOEA (shortness of breath), PALLOR (Pale), FALL (Fell down and couldnt move), NAUSEA (nausea) and VACCINATION SITE PAIN (arm pain) outcome was unknown.            Treatment information include tylenol, benadryl and Gatorade, which patient refused to take The outcome of events, arm pain, weakness in arms and legs, shortness of breath, pale, fell down and couldnt move, nausea was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: dental issue; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (dental issue) 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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced TOOTH DISORDER (dental issue). At the time of the report, TOOTH DISORDER (dental issue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the left arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in the left arm). At the time of the report, VACCINATION SITE PAIN (Pain in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 011A21A) 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 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm). At the time of the report, PAIN IN EXTREMITY (pain in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood pressure pills.  No treatment information was provided.   This case was linked to MOD-2021-025150, MOD-2021-026665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information included no new information, FU received for Daughter case.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Area feels warm to the touch; Itching around injection site 1 week after 1st dose; Redness around injection site. Area has gotten larger; Area is slightly tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area feels warm to the touch), VACCINATION SITE PRURITUS (Itching around injection site 1 week after 1st dose), VACCINATION SITE ERYTHEMA (Redness around injection site. Area has gotten larger) and VACCINATION SITE PAIN (Area is slightly tender to touch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around injection site 1 week after 1st dose), VACCINATION SITE ERYTHEMA (Redness around injection site. Area has gotten larger) and VACCINATION SITE PAIN (Area is slightly tender to touch). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Area feels warm to the touch). At the time of the report, VACCINATION SITE WARMTH (Area feels warm to the touch), VACCINATION SITE PRURITUS (Itching around injection site 1 week after 1st dose), VACCINATION SITE ERYTHEMA (Redness around injection site. Area has gotten larger) and VACCINATION SITE PAIN (Area is slightly tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include ice twice.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: intense arm pain; severe chills; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (intense arm pain) and CHILLS (severe chills) in a 75-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (intense arm pain) and CHILLS (severe chills). At the time of the report, VACCINATION SITE PAIN (intense arm pain) and CHILLS (severe chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Nausea; Running fever; Woke up shaking really bad; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Woke up shaking really bad), NAUSEA (Nausea) and PYREXIA (Running fever) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Woke up shaking really bad). On an unknown date, the patient experienced NAUSEA (Nausea) and PYREXIA (Running fever). At the time of the report, CHILLS (Woke up shaking really bad), NAUSEA (Nausea) and PYREXIA (Running fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. Patient treatment information was not provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Pollakiuria
Clinical narrative: Constant urination; Weakness; chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Constant urination), ASTHENIA (Weakness), CHILLS (chills) and MYALGIA (Body aches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced POLLAKIURIA (Constant urination), ASTHENIA (Weakness), CHILLS (chills) and MYALGIA (Body aches). On 15-Feb-2021, POLLAKIURIA (Constant urination), ASTHENIA (Weakness), CHILLS (chills) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: GOT VACCINE THAT WAS 5MINUTES PAST 6 HOURS EXPIRATION OUTSIDE REFRIGERATOR; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (GOT VACCINE THAT WAS 5MINUTES PAST 6 HOURS EXPIRATION OUTSIDE REFRIGERATOR) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (GOT VACCINE THAT WAS 5MINUTES PAST 6 HOURS EXPIRATION OUTSIDE REFRIGERATOR). On 25-Feb-2021, EXPIRED PRODUCT ADMINISTERED (GOT VACCINE THAT WAS 5MINUTES PAST 6 HOURS EXPIRATION OUTSIDE REFRIGERATOR) had 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: fallow up was received and contains no new information
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: tremendous headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (tremendous headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 014M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGGRENOX) for Clot blood, LUBIPROSTONE (AMITIZA), ACETYLSALICYLIC ACID (BABY ASPIRIN) and PRAVASTATIN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (tremendous headache). The patient was treated with ACETAMINOPHEN at a dose of morning. At the time of the report, HEADACHE (tremendous headache) outcome was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site cellulitis, Injection site hypersensitivity
Clinical narrative: Diarrhea; Arm looks like it has cellulitis; Moderna arm ( swollen , itchy and warm to the touch); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), INJECTION SITE CELLULITIS (Arm looks like it has cellulitis) and INJECTION SITE HYPERSENSITIVITY (Moderna arm ( swollen , itchy and warm to the touch)) in an 82-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 DIARRHOEA (Diarrhea), INJECTION SITE CELLULITIS (Arm looks like it has cellulitis) and INJECTION SITE HYPERSENSITIVITY (Moderna arm ( swollen , itchy and warm to the touch)). At the time of the report, DIARRHOEA (Diarrhea), INJECTION SITE CELLULITIS (Arm looks like it has cellulitis) and INJECTION SITE HYPERSENSITIVITY (Moderna arm ( swollen , itchy and warm to the touch)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: Skin reaction; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events skin reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event skin reaction.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, skin reaction was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: puffiness; pinkish arm 3inches by 2 inches wide; itchy; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (puffiness), VACCINATION SITE ERYTHEMA (pinkish arm 3inches by 2 inches wide), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE SWELLING (Swollen) in an 81-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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced SKIN SWELLING (puffiness), VACCINATION SITE ERYTHEMA (pinkish arm 3inches by 2 inches wide), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE SWELLING (Swollen). At the time of the report, SKIN SWELLING (puffiness), VACCINATION SITE ERYTHEMA (pinkish arm 3inches by 2 inches wide), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE SWELLING (Swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain in the left arm; A spontaneous report was received from a consumer concerning a 19-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain (pain in the left arm).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced pain in the left arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Arm for about a week, remained warm in that spot, as if I had a fever in that spot; Had a red patch, 3inches by 1inch, lasted whole time arm was warm; Muscle I had shot in was sore for a couple of day; A spontaneous report was received from a healthcare professional concerning a 70-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site erythema ( had a red patch, 3inches by 1inch), injection site pain ( muscle i had shot in was sore for a couple of day) and injection site warmth (remained warm in that spot, as if i had a fever in that spot).  The patient's medical history was not provided. Concomitant medications reported were Avapro,  Claritin, Crestor, Flonase,  Singulair, Synthroid, Zetia,  for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, on that evening the patient stated that her arm was warm and muscle was sore for 3 days at the injection site. she had redness that had not spreaded and had stayed localized. she also added that she felt like she had fever in that particular spot in arm. she reported that all this lasted for about 7-10 days and now they are completely gone an she is feeling fine.  Treatment details was not included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was reported to be recovered/ resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches for 3-4 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches for 3-4 days). At the time of the report, HEADACHE (headaches for 3-4 days) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medications were provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Additional information added on 08-Feb-2021 does not contain any new information. On 22-Apr-2021: Follow up received on 22-Apr-2021 had updated contact information of reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Tremor
Clinical narrative: dizzied; get really sick/felt really sick/ felt really sick; little shaken; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness (dizzied), illness (get really sick, felt really sick) and tremor (little shaken).  The patient's medical history was not provided. Concomitant medications reported were Synthroid for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient stated she was feeling really sick, was dizzied and little shaken  after receiving the shot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was reported to be unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Memory impairment, Pyrexia, Tremor
Clinical narrative: When she was standing up her knees kind of gave out; Hands are shaky; she could not think well and had a hard time recollecting her personal information; Body temperature reached 98.4°F today; A spontaneous report (United States) was received from a consumer concerning a 75 Years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events include when she was standing up her knees kind of gave out, hands are shaky, body temperature reached 98.4°F, she could not think well and had a hard time recollecting her personal information.  The patient's medical history includes she has mild allergies and an asthma patient. Concomitant medications used by the patient are tylenol, albuterol inhaler, vitamins, high blood pressure medication, medication for allergies.  On 24 FEB 2021, prior to the onset on events the patient received one of two planned doses of mRNA-1273 (Batch Number: 006M20A) via unspecified route for prophylaxis of COVID-19 infection.  On an unspecified date, when patient was standing up her knees kind of gave out, her hands were shaky and on 26 FEB 2021 she had 98.4°F of body temperature and patient could not think well and had a hard time recollecting her personal information.  Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided by the reporter.  The outcome of the listed events was said to be unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over their body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash all over their body) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced RASH (Rash all over their body). At the time of the report, RASH (Rash all over their body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment for the event included steroid injection.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Nausea, Pain, Peripheral swelling
Clinical narrative: Swollen a week after injection; Hot at injection site; Itches like crazy,itches around waist; feels nauseas; Legs are achy like flu; Legs are achy like flu; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen a week after injection), VACCINATION SITE WARMTH (Hot at injection site), PRURITUS (Itches like crazy,itches around waist), NAUSEA (feels nauseas) and PAIN (Legs are achy like flu) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen a week after injection), VACCINATION SITE WARMTH (Hot at injection site), PAIN (Legs are achy like flu), INFLUENZA (Legs are achy like flu) and HEADACHE (headaches). 06-Feb-2021, the patient experienced PRURITUS (Itches like crazy,itches around waist) and NAUSEA (feels nauseas). At the time of the report, PERIPHERAL SWELLING (Swollen a week after injection), VACCINATION SITE WARMTH (Hot at injection site), PRURITUS (Itches like crazy,itches around waist), NAUSEA (feels nauseas), PAIN (Legs are achy like flu), INFLUENZA (Legs are achy like flu) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site warmth
Clinical narrative: Swollen a week after injection; Hot at injection site; Itches like crazy,itches around waist; feels nauseas; Legs are achy like flu; Legs are achy like flu; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen a week after injection), VACCINATION SITE WARMTH (Hot at injection site), PRURITUS (Itches like crazy,itches around waist), NAUSEA (feels nauseas) and PAIN (Legs are achy like flu) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen a week after injection), VACCINATION SITE WARMTH (Hot at injection site), PAIN (Legs are achy like flu), INFLUENZA (Legs are achy like flu) and HEADACHE (headaches). 06-Feb-2021, the patient experienced PRURITUS (Itches like crazy,itches around waist) and NAUSEA (feels nauseas). At the time of the report, PERIPHERAL SWELLING (Swollen a week after injection), VACCINATION SITE WARMTH (Hot at injection site), PRURITUS (Itches like crazy,itches around waist), NAUSEA (feels nauseas), PAIN (Legs are achy like flu), INFLUENZA (Legs are achy like flu) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Nausea, Vomiting
Clinical narrative: chills; nausea; vomit; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), VOMITING (vomit) and DEHYDRATION (dehydration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Cancer and Diabetic.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced CHILLS (chills), NAUSEA (nausea), VOMITING (vomit) and DEHYDRATION (dehydration). At the time of the report, CHILLS (chills), NAUSEA (nausea), VOMITING (vomit) and DEHYDRATION (dehydration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Itching; swelling / felt kind of lumpy underneath, about 2 inches in diameter/reaction continued to increase in size; redness; swelling, felt kind of lumpy underneath, about 2 inches in diameter; very painful; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), VACCINATION SITE MASS (swelling / felt kind of lumpy underneath, about 2 inches in diameter/reaction continued to increase in size), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling, felt kind of lumpy underneath, about 2 inches in diameter) and VACCINATION SITE PAIN (very painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l29A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Plasma cell disorder and MGUS. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and COLECALCIFEROL (VITAMINS D3) for an unknown indication.   On 16-Jan-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE MASS (swelling / felt kind of lumpy underneath, about 2 inches in diameter/reaction continued to increase in size), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling, felt kind of lumpy underneath, about 2 inches in diameter) and VACCINATION SITE PAIN (very painful). On an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching), VACCINATION SITE MASS (swelling / felt kind of lumpy underneath, about 2 inches in diameter/reaction continued to increase in size), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling, felt kind of lumpy underneath, about 2 inches in diameter) and VACCINATION SITE PAIN (very painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were provided as Whole plant Multivitamins-100%, Plant calcium 905mg(oral route). No treatment details were provided. Patient stated that she did not experience any side effects after dose 2.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow-up received on 14-Jul-2021 contains concomitant medication information, details about both the doses of Moderna vaccine.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant patient received first dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of Moderna vaccine) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Jun-2020 and the estimated date of delivery was 28-Mar-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The date of positive pregnancy test was reported as Aug-2020.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: diarrhea; upset stomach; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea, upset stomach/abdominal discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Feb 2021, approximately 3 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 07 Feb 2021, the patient experienced the event(s) diarrhea, upset stomach.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), diarrhea, upset stomach was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Micturition urgency
Clinical narrative: increased frequency in urination; A spontaneous report was received from a consumer concerning a (patient age and gender: unknown) patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced increased frequency in urination/micturition urgency.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided. On an unknown date, prior to the onset of the event, the patient received their first of their two planned doses of mRNA-1273 (Lot number: unknown) through unknown route at unspecified site for prophylaxis of COVID-19 infection.  On an unknown date, reported about several people over age of 70 years experienced increased frequency in urination after receiving the first dose from Moderna's' COVID-19 vaccine.  Treatment activities for event was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, increased frequency in urination was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Oral discomfort
Clinical narrative: soreness at injection site; burning of the lips; A spontaneous report was received from a consumer concerning a 84-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness at injection site/vaccination site pain, burning of the lips/ oral discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) soreness at injection site, burning of the lips.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness at injection site, burning of the lips was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: fatigue; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) 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 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test negative: negative (Negative) negative.      No relevant concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Age Requirement confused with Pfizer, Pediatric patient received the vaccine; A spontaneous report was received from a consumer regarding a 16 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25-FEB-2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 023J202A) intramuscularly for prophylaxis of COVID-19 infection.  On 25-FEB-2021, the patient received the vaccine in error as the event age requirement was confused with Pfizer's.   No treatment information for the events was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event was resolved on 25 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 023J20A) with no associated AEs reported.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headaches; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) and MYALGIA (Body aches) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches) and MYALGIA (Body aches). At the time of the report, HEADACHE (Headaches) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore left arm.  The patient's medical history was not provided. Concomitant medications reported were hydrocortisone 5-10mg, pain medicine, supplements, multivitamins for drug use for unknown indication.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011L220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event(s) sore left arm.  Treatment details included Two ibuprofen pills on 27Jan2021..  Action taken with mRNA-1273 in response to the events was not reported.  On 30 Jan 2021 the outcome of event(s), sore left arm was resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin exfoliation, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Itchy at injection site; Red at injection site; Arm looks bumpy/Arm is peeling; Arm was hard; Arm swell up to the size of a baseball/arm was the size of a softball; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchy at injection site, red at injection site, arm swell up to the size of a baseball, arm was the size of a softball, arm looks bumpy, arm is peeling, arm was hard.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Itchy at injection site, Red at injection site. On 5 Feb 2021, the patient experienced the event(s) arm swell up to the size of a baseball,On 6 Feb 2021, the patient experienced the event(s) arm was the size of a softball,arm was hard.On 9 Feb 2021, the patient experienced the event(s) arm looks bumpy, arm is peeling.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm swell up to the size of a baseball was resolved on 5 Feb 2021. The outcome of event(s), itchy at injection site, red at injection site, arm was the size of a softball, arm looks bumpy, arm is peeling, arm was hard was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Red splotch on left arm at injection site; Injection site is hot; Injection site is sore; headache; fatigued; Injection site is itchy; A spontaneous report (United States) was received from a Health care professional concerning a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy). at the time of the report, rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy)     The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.   On 29 Jan  2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A)  via  intramuscular route  on her left arm  for prophylaxis of COVID-19 infection.  Patient  developed a red splotch on the left arm at injection site and it feels hot, itchy and sore. She also had a severe headache  and feels fatigued like she had been ran over a truck . She had experienced these side effects for about 11 days. She expressed her frustrations about the side effects. Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy). at the time of the report, rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy) outcome was considered unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Red splotch on left arm at injection site; Injection site is hot; Injection site is sore; headache; fatigued; Injection site is itchy; A spontaneous report (United States) was received from a Health care professional concerning a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy). at the time of the report, rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy)     The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.   On 29 Jan  2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A)  via  intramuscular route  on her left arm  for prophylaxis of COVID-19 infection.  Patient  developed a red splotch on the left arm at injection site and it feels hot, itchy and sore. She also had a severe headache  and feels fatigued like she had been ran over a truck . She had experienced these side effects for about 11 days. She expressed her frustrations about the side effects. Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy). at the time of the report, rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy) outcome was considered unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pruritus
Clinical narrative: injection site is itchy; injection site has a 3 inch red spot.; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site is itchy, injection site has a 3 inch red spot,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 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 an unknown date, the patient experienced the event(s) injection site is itchy, injection site has a 3 inch red spot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), injection site is itchy, injection site has a 3 inch red spot,  was unknown.