chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic, Vaccination site erythema
Clinical narrative: arm was red like the size of a baseball and it itched; itching a little bit; red spot with a circle around where got injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (arm was red like the size of a baseball and it itched), PRURITUS (itching a little bit) and VACCINATION SITE ERYTHEMA (red spot with a circle around where got injection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 19-Jan-2021, the patient experienced RASH PRURITIC (arm was red like the size of a baseball and it itched), PRURITUS (itching a little bit) and VACCINATION SITE ERYTHEMA (red spot with a circle around where got injection).   The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency.    At the time of the report, RASH PRURITIC (arm was red like the size of a baseball and it itched) and PRURITUS (itching a little bit) had resolved and VACCINATION SITE ERYTHEMA (red spot with a circle around where got injection) had not 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.   Concomitant product use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: redness; pain in the injection site; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), ERYTHEMA (redness) and PAIN (pain in the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-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 24-Jan-2021, the patient experienced PRURITUS (itchiness). On an unknown date, the patient experienced ERYTHEMA (redness) and PAIN (pain in the injection site). At the time of the report, PRURITUS (itchiness), ERYTHEMA (redness) and PAIN (pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Heart rate increased, Heart rate irregular
Clinical narrative: Erythema; Dizziness; Developed, within 20 minutes, quick, fast heartbeat up to 120 beats per minute; Had some irregularity; This spontaneous case was reported by a physician and describes the occurrence of HEART RATE INCREASED (Developed, within 20 minutes, quick, fast heartbeat up to 120 beats per minute), HEART RATE IRREGULAR (Had some irregularity), ERYTHEMA (Erythema) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021 at 10:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEART RATE INCREASED (Developed, within 20 minutes, quick, fast heartbeat up to 120 beats per minute) and HEART RATE IRREGULAR (Had some irregularity). On 17-Feb-2021, the patient experienced ERYTHEMA (Erythema) and DIZZINESS (Dizziness). At the time of the report, HEART RATE INCREASED (Developed, within 20 minutes, quick, fast heartbeat up to 120 beats per minute), HEART RATE IRREGULAR (Had some irregularity), ERYTHEMA (Erythema) and DIZZINESS (Dizziness) 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.   No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: No specific follow-up information recorded.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 32 hours later, broke out in rash on my chest between the nipples; small rash between my nipples like a pimple; This spontaneous case was reported by a consumer and describes the occurrence of RASH (32 hours later, broke out in rash on my chest between the nipples) and RASH (small rash between my nipples like a pimple) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN (ZOCOR) and RIVAROXABAN (XARELTO) 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 an unknown date, the patient experienced RASH (32 hours later, broke out in rash on my chest between the nipples) and RASH (small rash between my nipples like a pimple). At the time of the report, RASH (32 hours later, broke out in rash on my chest between the nipples) and RASH (small rash between my nipples like a pimple) 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 HEADACHE (Severe Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Severe Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Oral pain
Clinical narrative: Feeling hot; diarrhea; cramping; Chills; headache; Teeth hurting; Sore arm; a lot of itching; red mark(size of a quarter) at injection site; A spontaneous report (United States) was received from a consumer concerning a 88-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site, diarrhea, cramping.  The patient's medical history was not provided. Concomitant medications reported were HBP Medication, Allergy Medication, Antianxiety Medication ,vitamins(centrum silver),vitamin D,calcium+Z 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: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event(s) chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site. On 4 Feb 2021, the patient experienced the event(s) diarrhea, cramping.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site  was unknown and the event diarrhea, cramping was resolving.  Based on MSA comment Feeling hot coded to Vaccination site warm, Pain in extremity coded to Vaccination site pain and Injection site erythema coded to Vaccination site erythema
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Feeling hot; diarrhea; cramping; Chills; headache; Teeth hurting; Sore arm; a lot of itching; red mark(size of a quarter) at injection site; A spontaneous report (United States) was received from a consumer concerning a 88-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site, diarrhea, cramping.  The patient's medical history was not provided. Concomitant medications reported were HBP Medication, Allergy Medication, Antianxiety Medication ,vitamins(centrum silver),vitamin D,calcium+Z 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: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event(s) chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site. On 4 Feb 2021, the patient experienced the event(s) diarrhea, cramping.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site  was unknown and the event diarrhea, cramping was resolving.  Based on MSA comment Feeling hot coded to Vaccination site warm, Pain in extremity coded to Vaccination site pain and Injection site erythema coded to Vaccination site erythema
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: A redness at the injection site; It is raised at the injection site; it is itchy at the injection site; Feeling hot; A spontaneous report was received from a consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccination site erythema, vaccination site pruritus ans vaccination site swelling.   The patient's medical history was not provided. No relevant concomitant medications were provided.  On 23 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route in right hip for prophylaxis of COVID-19 infection.  On the next day 24 Jan 2021 patient developed  a redness at the injection site, it was raised and  itchy .  No treatment details were reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), redness at the injection site, it was raised and  itchy were considered as not recovered.  Based on MSA comment, Feeling hot coded as Vaccination site warmth
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Erythema, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: it's warm to the touch; there's still some hardness to it; it was bright red; their arm was 2 by 3 inches red; it was raised; it was painful; did not feet well; chest was tight; it was itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PRURITUS (it was itchy), PAIN IN EXTREMITY (it was painful) and MALAISE (did not feet well) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included FENOFIBRATE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (it was itchy), MALAISE (did not feet well) and CHEST DISCOMFORT (chest was tight). On 28-Jan-2021, the patient experienced ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PAIN IN EXTREMITY (it was painful) and VACCINATION SITE ERYTHEMA (it was bright red). On an unknown date, the patient experienced VACCINATION SITE WARMTH (it's warm to the touch) and VACCINATION SITE INDURATION (there's still some hardness to it). At the time of the report, ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PRURITUS (it was itchy), PAIN IN EXTREMITY (it was painful), MALAISE (did not feet well), CHEST DISCOMFORT (chest was tight) and VACCINATION SITE ERYTHEMA (it was bright red) had not resolved and VACCINATION SITE WARMTH (it's warm to the touch) and VACCINATION SITE INDURATION (there's still some hardness to it) 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.   In treatment Topical steroid cream and increased the dosing of Sertac.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: it's warm to the touch; there's still some hardness to it; it was bright red; their arm was 2 by 3 inches red; it was raised; it was painful; did not feet well; chest was tight; it was itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PRURITUS (it was itchy), PAIN IN EXTREMITY (it was painful) and MALAISE (did not feet well) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included FENOFIBRATE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (it was itchy), MALAISE (did not feet well) and CHEST DISCOMFORT (chest was tight). On 28-Jan-2021, the patient experienced ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PAIN IN EXTREMITY (it was painful) and VACCINATION SITE ERYTHEMA (it was bright red). On an unknown date, the patient experienced VACCINATION SITE WARMTH (it's warm to the touch) and VACCINATION SITE INDURATION (there's still some hardness to it). At the time of the report, ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PRURITUS (it was itchy), PAIN IN EXTREMITY (it was painful), MALAISE (did not feet well), CHEST DISCOMFORT (chest was tight) and VACCINATION SITE ERYTHEMA (it was bright red) had not resolved and VACCINATION SITE WARMTH (it's warm to the touch) and VACCINATION SITE INDURATION (there's still some hardness to it) 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.   In treatment Topical steroid cream and increased the dosing of Sertac.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: A little hard at injection site; A little itchy at injection site; A little sore where the injection site was; little red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (A little hard at injection site), INJECTION SITE PRURITUS (A little itchy at injection site), INJECTION SITE PAIN (A little sore where the injection site was) and INJECTION SITE ERYTHEMA (little red at injection site) in a 79-year-old female patient 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 16-Feb-2021, the patient experienced INJECTION SITE INDURATION (A little hard at injection site), INJECTION SITE PRURITUS (A little itchy at injection site), INJECTION SITE PAIN (A little sore where the injection site was) and INJECTION SITE ERYTHEMA (little red at injection site). At the time of the report, INJECTION SITE INDURATION (A little hard at injection site), INJECTION SITE PRURITUS (A little itchy at injection site), INJECTION SITE PAIN (A little sore where the injection site was) and INJECTION SITE ERYTHEMA (little red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that it was a little red where the injection site occurred, it was little itchy where the injection site occurred, and  it was little hard where the injection site occurred.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR Received: patient she says she is all good and doesn't want frutherfollow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: body aches; weakness; chills; headaches; fever of 102.5; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), ASTHENIA (weakness), CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever of 102.5) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (body aches), ASTHENIA (weakness), CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever of 102.5). At the time of the report, PAIN (body aches), ASTHENIA (weakness), CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever of 102.5) outcome was unknown.        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.   Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache and fever are consistent with the known safety profile of mRNA-1273.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache and fever are consistent with the known safety profile of mRNA-1273.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Fatigue, Rash, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Diarrhea; Rash; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), DIARRHOEA (Diarrhea), RASH (Rash) and FATIGUE (Fatigue) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included COVID-19 since 16-Feb-2021 and No adverse event.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), RASH (Rash) and FATIGUE (Fatigue). On 16-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On 18-Feb-2021, DIARRHOEA (Diarrhea), RASH (Rash) and FATIGUE (Fatigue) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-096144 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Not specified On 29-Apr-2021: contact information updated
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: big, itchy patches all over both of my legs; site of the injection was really hot, red, and itchy; site of the injection was really hot, red, and itchy; site of the injection was really hot, red, and itchy; Little lump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (Little lump), PRURITUS (big, itchy patches all over both of my legs), VACCINATION SITE WARMTH (site of the injection was really hot, red, and itchy), VACCINATION SITE PRURITUS (site of the injection was really hot, red, and itchy) and VACCINATION SITE ERYTHEMA (site of the injection was really hot, red, and itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE MASS (Little lump). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (site of the injection was really hot, red, and itchy), VACCINATION SITE PRURITUS (site of the injection was really hot, red, and itchy) and VACCINATION SITE ERYTHEMA (site of the injection was really hot, red, and itchy). On an unknown date, the patient experienced PRURITUS (big, itchy patches all over both of my legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 22-Feb-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Little lump), VACCINATION SITE WARMTH (site of the injection was really hot, red, and itchy), VACCINATION SITE PRURITUS (site of the injection was really hot, red, and itchy) and VACCINATION SITE ERYTHEMA (site of the injection was really hot, red, and itchy) outcome was unknown and PRURITUS (big, itchy patches all over both of my legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-096058 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: The event pruritis outcome was changed from unknown to not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: fever; chills; achy all over; painful arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (achy all over) and VACCINATION SITE PAIN (painful arm at the injection site) in a 68-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 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 19-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (achy all over) and VACCINATION SITE PAIN (painful arm at the injection site).   At the time of the report, PYREXIA (fever), CHILLS (chills), PAIN (achy all over) and VACCINATION SITE PAIN (painful arm at the injection site) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Somnolence
Clinical narrative: Patient felt sleepy; fever (100F); chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient felt sleepy), PYREXIA (fever (100F)), CHILLS (chills) and FATIGUE (fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced SOMNOLENCE (Patient felt sleepy), PYREXIA (fever (100F)), CHILLS (chills) and FATIGUE (fatigue). On 25-Feb-2021, PYREXIA (fever (100F)) had resolved. At the time of the report, SOMNOLENCE (Patient felt sleepy), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 f (High) 100 F.         Action taken with mRNA 1273 in response to event was not applicable. No concomitant medications reported.  No treatment medications were provided
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Arthralgia, Lacrimation increased, Suspected COVID-19, Vaccination site erythema
Clinical narrative: my shoulder blew up; it hurt when I touched it; had an allergic reaction to the shot; I can almost feel a little bit of hardness.; Past weekend, I woke up with something in my eye. My nose and my eyes tearing. I went through; 5 days after the shot, I felt symptoms of COVID.; it is sensitive to touch; arm was swelled, injection site swelled up for 2 weeks; red, not blood red but pink red. It was 2.5 inch below the injection site; Med Info Agent: Update to case number MOD21-16065  Per the contact on 22JUL2021,  She has received 2 phone calls but was unable to understand the caller. She recognized the call was from moderna and received a number "MOD021-0256." Today they called back again, it was staff, she said she wanted to send me some kind of a form by email, but did not have my address.  She received the both doses of the moderna covid-19 vaccine by injection to the left arm on 8JAN2021 (lot number 025J20A) and 5FEB2021 (lot number 028L20A).   She originally called after the first dose because she had questions after she took the first shot. Swelling in her arm for a while, and it looked like an egg. She took the second shot and everything was fine. Her shoulder blew up, got swollen. It hurt when she touched it. It was like half of a ping pong ball. She thought she possibly had an allergic reaction to the shot and was worried about getting the second dose. The swelling did not go down until 1 month later. A doctor friend of her told her not to worry. She has a history of immune problems.  Consented to follow up by safety. Caller does not want any additional personal information shared to anyone outside Moderna. Discussed sending information to the FDA and CDC through the VAERS program which she consented to as long as name and email are not included.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hyperaesthesia, Vaccination site induration, Vaccination site joint swelling, Vaccination site swelling
Clinical narrative: my shoulder blew up; it hurt when I touched it; had an allergic reaction to the shot; I can almost feel a little bit of hardness.; Past weekend, I woke up with something in my eye. My nose and my eyes tearing. I went through; 5 days after the shot, I felt symptoms of COVID.; it is sensitive to touch; arm was swelled, injection site swelled up for 2 weeks; red, not blood red but pink red. It was 2.5 inch below the injection site; Med Info Agent: Update to case number MOD21-16065  Per the contact on 22JUL2021,  She has received 2 phone calls but was unable to understand the caller. She recognized the call was from moderna and received a number "MOD021-0256." Today they called back again, it was staff, she said she wanted to send me some kind of a form by email, but did not have my address.  She received the both doses of the moderna covid-19 vaccine by injection to the left arm on 8JAN2021 (lot number 025J20A) and 5FEB2021 (lot number 028L20A).   She originally called after the first dose because she had questions after she took the first shot. Swelling in her arm for a while, and it looked like an egg. She took the second shot and everything was fine. Her shoulder blew up, got swollen. It hurt when she touched it. It was like half of a ping pong ball. She thought she possibly had an allergic reaction to the shot and was worried about getting the second dose. The swelling did not go down until 1 month later. A doctor friend of her told her not to worry. She has a history of immune problems.  Consented to follow up by safety. Caller does not want any additional personal information shared to anyone outside Moderna. Discussed sending information to the FDA and CDC through the VAERS program which she consented to as long as name and email are not included.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Pain in extremity, Swelling
Clinical narrative: pain in arm; No appetite for a couple of days.; Swelling from my elbow to my shoulder; Entire site is hot; Angry red patch an inch below the injection site; chills; vaccination site swelling; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in arm), DECREASED APPETITE (No appetite for a couple of days.), SWELLING (Swelling from my elbow to my shoulder), VACCINATION SITE WARMTH (Entire site is hot) and VACCINATION SITE ERYTHEMA (Angry red patch an inch below the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041l20a and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included B12 deficiency anemia and Angioplasty (HEART ANGIOPLASTY) on 19-Mar-2019. Previously administered products included for an unreported indication: B12 1000 SR on 02-Dec-2020. Concurrent medical conditions included Tetanus, Milk allergy, Allergy NOS (OFF INSECT SPRAY) and Blood pressure high since 15-Mar-2019. Concomitant products included LOSARTAN from 19-Mar-2019 to an unknown date and METOPROLOL from 19-Mar-2019 to an unknown date for Blood pressure high, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 19-Mar-2021 to an unknown date for Heart disorder, PARACETAMOL (TYLENOL) and FLUTICASONE for an unknown indication.   On 30-Dec-2020 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), DECREASED APPETITE (No appetite for a couple of days.), SWELLING (Swelling from my elbow to my shoulder), VACCINATION SITE WARMTH (Entire site is hot), VACCINATION SITE ERYTHEMA (Angry red patch an inch below the injection site), CHILLS (chills) and VACCINATION SITE SWELLING (vaccination site swelling). On 02-Feb-2021, SWELLING (Swelling from my elbow to my shoulder) and VACCINATION SITE WARMTH (Entire site is hot) had resolved. On 10-Feb-2021, PAIN IN EXTREMITY (pain in arm), DECREASED APPETITE (No appetite for a couple of days.), VACCINATION SITE ERYTHEMA (Angry red patch an inch below the injection site), CHILLS (chills) and VACCINATION SITE SWELLING (vaccination site swelling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 101.4 f High.         Treatment medications included Tylenol   This case was linked to MOD21-15908, MOD-2021-025534 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up received on 07-APR-2021 and added Med History updated and outcome of events updated
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: pain in arm; No appetite for a couple of days.; Swelling from my elbow to my shoulder; Entire site is hot; Angry red patch an inch below the injection site; chills; vaccination site swelling; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in arm), DECREASED APPETITE (No appetite for a couple of days.), SWELLING (Swelling from my elbow to my shoulder), VACCINATION SITE WARMTH (Entire site is hot) and VACCINATION SITE ERYTHEMA (Angry red patch an inch below the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041l20a and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included B12 deficiency anemia and Angioplasty (HEART ANGIOPLASTY) on 19-Mar-2019. Previously administered products included for an unreported indication: B12 1000 SR on 02-Dec-2020. Concurrent medical conditions included Tetanus, Milk allergy, Allergy NOS (OFF INSECT SPRAY) and Blood pressure high since 15-Mar-2019. Concomitant products included LOSARTAN from 19-Mar-2019 to an unknown date and METOPROLOL from 19-Mar-2019 to an unknown date for Blood pressure high, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 19-Mar-2021 to an unknown date for Heart disorder, PARACETAMOL (TYLENOL) and FLUTICASONE for an unknown indication.   On 30-Dec-2020 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), DECREASED APPETITE (No appetite for a couple of days.), SWELLING (Swelling from my elbow to my shoulder), VACCINATION SITE WARMTH (Entire site is hot), VACCINATION SITE ERYTHEMA (Angry red patch an inch below the injection site), CHILLS (chills) and VACCINATION SITE SWELLING (vaccination site swelling). On 02-Feb-2021, SWELLING (Swelling from my elbow to my shoulder) and VACCINATION SITE WARMTH (Entire site is hot) had resolved. On 10-Feb-2021, PAIN IN EXTREMITY (pain in arm), DECREASED APPETITE (No appetite for a couple of days.), VACCINATION SITE ERYTHEMA (Angry red patch an inch below the injection site), CHILLS (chills) and VACCINATION SITE SWELLING (vaccination site swelling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 101.4 f High.         Treatment medications included Tylenol   This case was linked to MOD21-15908, MOD-2021-025534 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up received on 07-APR-2021 and added Med History updated and outcome of events updated
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: swollen under his armpit (on the same arm of the injection); Felt tired; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Felt tired) and LYMPHADENOPATHY (swollen under his armpit (on the same arm of the injection)) in a 47-year-old male patient 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) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced FATIGUE (Felt tired). On 28-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen under his armpit (on the same arm of the injection)). At the time of the report, FATIGUE (Felt tired) and LYMPHADENOPATHY (swollen under his armpit (on the same arm of the injection)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided. Concomitant medications not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: No new information added
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Patient experienced redness at the injection site after her first vaccine done; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Patient experienced redness at the injection site after her first vaccine done) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No relevant medical history was reported. No relevant concomitant medications reported.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE ERYTHEMA (Patient experienced redness at the injection site after her first vaccine done). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Patient experienced redness at the injection site after her first vaccine done) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medication include antihistamine and Tylenol.   This case was linked to MOD-2021-026810 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram, Dizziness, Nausea
Clinical narrative: severe dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event 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) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DIZZINESS (severe dizziness) and NAUSEA (nausea). On 14-Feb-2021, DIZZINESS (severe dizziness) and NAUSEA (nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Blood test normal: normal. On 14-Feb-2021, Computerised tomogram: Normal.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema
Clinical narrative: Arm broke out on what looks like a sunburnt, it's red from the injection site down to the elbow; Shortness of breath; A spontaneous report was received from a consumer concerning a 87 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath/dyspnoea and arm broke out on what looks like a sunburnt, it's red from the injection site down to the elbow/erythema.  The patient's medical history was not provided by the reporter. Concomitant medications included blood pressure medication and vitamins.  On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) via an unknown route in the left arm for prophylaxis of COVID-19 infection.   On 31 Jan 2021, fifth day of injection, the patient started experiencing shortness of breath that lasted two days. On 05 Feb 2021, tenth day of injection the patient's arm broke out on what looks like a sunburnt, it's red from the injection site down to the elbow.  Treatment for the events were reported as none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event shortness of breath was reported as resolved on 02 Feb 2021. The outcome of the event arm broke out on what looks like a sunburnt, it's red from the injection site down to the elbow was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal skin infection, Vaccination site pain, Vaccination site rash
Clinical narrative: Fungal infection/Rash/ large rash under right breast; Small rash at injection site; Arm was sore; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FUNGAL SKIN INFECTION (Fungal infection/Rash/ large rash under right breast), VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE RASH (Small rash at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 25-Jan-2021, the patient experienced FUNGAL SKIN INFECTION (Fungal infection/Rash/ large rash under right breast) and VACCINATION SITE RASH (Small rash at injection site). At the time of the report, FUNGAL SKIN INFECTION (Fungal infection/Rash/ large rash under right breast) had resolved and VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE RASH (Small rash at injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE RASH (Small rash at injection site) to be possibly related. No further causality assessments were provided for FUNGAL SKIN INFECTION (Fungal infection/Rash/ large rash under right breast) and VACCINATION SITE PAIN (Arm was sore).    Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: updated medically confirmed to yes, patient medical history, suspect product details and event details.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Nausea all night long; headache; feels weak; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea all night long), HEADACHE (headache) and FATIGUE (feels weak) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 25-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 25-Feb-2021, the patient experienced NAUSEA (Nausea all night long), HEADACHE (headache) and FATIGUE (feels weak). At the time of the report, NAUSEA (Nausea all night long), HEADACHE (headache) and FATIGUE (feels weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-027674 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027674:FU completed on both crosslinked cases
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain
Clinical narrative: Soreness around the injection site with pressure; Headache; Soreness; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness around the injection site with pressure, headache  The patient's medical history covid-19, stroke were provided by the reporter. Concomitant medications metoprolol 50 mg, gabapentin 600mg, lodopine 5mg, atorvastatin 40mg, clopidogrel bisulfate, hydrochlorothiazide, losartan 100 mg were reported.  On 25 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 006M20A) via unknown route in his left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the events soreness on arm injected with pressure and headaches. Treatment included calcium, woman's multi vitamin, bare aspirin 81mg , ibuprofen was provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, soreness on arm injected with pressure and headaches were unknown at the time of this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal discomfort, Throat clearing
Clinical narrative: clearing his throat constantly; pressure in the bridge of his nose; This spontaneous case was reported by a consumer and describes the occurrence of THROAT CLEARING (clearing his throat constantly) and NASAL DISCOMFORT (pressure in the bridge of his nose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) 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 THROAT CLEARING (clearing his throat constantly) and NASAL DISCOMFORT (pressure in the bridge of his nose). At the time of the report, THROAT CLEARING (clearing his throat constantly) and NASAL DISCOMFORT (pressure in the bridge of his nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: Red and raised bump on tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Red and raised bump on tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced TONGUE DISORDER (Red and raised bump on tongue). At the time of the report, TONGUE DISORDER (Red and raised bump on tongue) outcome was unknown.            no concomitant medications are provided. treatment to the event not reported.  she went to the doctor and it was a blood blister on the tongue. Action taken with mRNA-1273 in response to the event was not applicable.  She advised that no further follow-up is needed.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information is received it does not contain any new information.