chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm due to injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm due to injection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Lumbar Spine) on 29-Mar-1993 and Surgery (Lumbar Spine) on 23-Jan-2004. Concurrent medical conditions included Osteoarthritis (symptoms began about 10 years ago), GERD (symptoms began 16years or so ago), Brain tumour (Inoperable (Cerebral bypass 22-MAR-2021)) and Hypertension (may be started 10 years ago). Concomitant products included LOSARTAN POTASSIUM for Blood pressure high, OMEPRAZOLE for GERD, VITAMIN D3 and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm due to injection). On 25-Jan-2021, VACCINATION SITE PAIN (sore arm due to injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.    This case was linked to MOD-2021-051546 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021 does not contain any new information. On 24-May-2021: Medical history, concomitant medications and outcome of event were added. Dechallenge and rechallenge changed.; Sender's Comments:  MOD-2021-051546:Second dose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: injection site was "very warm"; "red spot baseball size"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site was "very warm") and VACCINATION SITE ERYTHEMA ("red spot baseball size") in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A. and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site was "very warm") and VACCINATION SITE ERYTHEMA ("red spot baseball size"). At the time of the report, VACCINATION SITE WARMTH (injection site was "very warm") and VACCINATION SITE ERYTHEMA ("red spot baseball size") outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. No treatment was provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Warmth; Diarrhea; Nausea; Fatigue; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth), DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmth), DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE WARMTH (Warmth), DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up was received on 19-may-2021 and no significant information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Warmth; Diarrhea; Nausea; Fatigue; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth), DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmth), DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE WARMTH (Warmth), DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up was received on 19-may-2021 and no significant information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: fever; Chills; Nausea; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included COVID-19 (Fisrt week of January 2021). Concurrent medical conditions included Kidney stone. Concomitant products included HYDROCODONE from 16-Mar-2021 to an unknown date, CEFDINIR from 16-Mar-2021 to an unknown date, ANTIBIOTICS and ONDANSETRON from 16-Mar-2021 to an unknown date for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Feb-2021, PYREXIA (fever) and CHILLS (Chills) had resolved. On 27-Feb-2021, NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking blood pressure and cholesterol medications on regular basis
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dyspnea (difficulty breathing) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 010A21A) for COVID-19 immunization. No medical history reported. On Mar 19, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 19, 2021, patient experienced dyspnea (difficulty breathing). At the time of the report, dyspnea (difficulty breathing) outcome: unknown. No concomitant medications or treatment information reported. The patient went to the emergency department.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rash, Rash macular
Clinical narrative: Blotches in both arms; Rash in torso/Blotches in torso; Rash in both arms; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotches in both arms), RASH MACULAR (Rash in torso/Blotches in torso), RASH (Rash in both arms) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 039K20-2A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MIRTAZAPINE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 27-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 1 dosage form. On 27-Feb-2021, the patient experienced RASH MACULAR (Blotches in both arms), RASH MACULAR (Rash in torso/Blotches in torso), RASH (Rash in both arms) and CHILLS (chills). At the time of the report, RASH MACULAR (Blotches in both arms), RASH MACULAR (Rash in torso/Blotches in torso), RASH (Rash in both arms) and CHILLS (chills) 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 laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Swollen lymph node; Not feeling well; Feeling tired; achy; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Not feeling well), FATIGUE (Feeling tired), MYALGIA (achy) and LYMPHADENOPATHY (Swollen lymph node) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced MALAISE (Not feeling well), FATIGUE (Feeling tired) and MYALGIA (achy). On 06-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MALAISE (Not feeling well), FATIGUE (Feeling tired) and MYALGIA (achy) outcome was unknown and LYMPHADENOPATHY (Swollen lymph node) had not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Vaccination site erythema
Clinical narrative: twitching and spasms in the left arm/in the right inner thigh; spasms in the left arm/in the right inner thigh; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at injection site), MUSCLE TWITCHING (twitching and spasms in the left arm/in the right inner thigh) and MUSCLE SPASMS (spasms in the left arm/in the right inner thigh) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 029L20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site). On 18-Feb-2021, the patient experienced MUSCLE TWITCHING (twitching and spasms in the left arm/in the right inner thigh) and MUSCLE SPASMS (spasms in the left arm/in the right inner thigh). On 28-Feb-2021, VACCINATION SITE ERYTHEMA (redness at injection site) had resolved. At the time of the report, MUSCLE TWITCHING (twitching and spasms in the left arm/in the right inner thigh) and MUSCLE SPASMS (spasms in the left arm/in the right inner thigh) outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   The side effect that he was most worried about and wanted to discuss was his twitch he developed in his left bicep, he explained that it was disconcerting and it wakes him at night. This began around 18 Fe b21. As it got worse, it would go from his elbow up to his bicep and the "spasms" would last up to 20 minutes each time. He reported having 40-50 spasms over the past two or three weeks. Starting this week, the caller reports a new location of spasms in his inner thigh of his right leg. He reports having two so far but still, "very foreign" as he has never experienced twitching or spasms of the muscle before.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching of hand; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching of hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching of hand). At the time of the report, PRURITUS (Itching of hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea) outcome was unknown. 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash
Clinical narrative: Sore arm; Severe rash all around area where shot was administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE RASH (Severe rash all around area where shot was administered) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high. Concomitant products included HYDROCHLOROTHIAZIDE, POTASSIUM, LEVOTHYROXINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE RASH (Severe rash all around area where shot was administered). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE RASH (Severe rash all around area where shot was administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included calcium blocker, statin for cholesterol.  No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Heart rate increased, Pyrexia
Clinical narrative: Increased Heart rate; Massive headache; Fever; Joint Pain; A spontaneous report was received from a consumer concerning a 64-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events massive headache, fever/pyrexia, joint pain/arthralgia, increased heart rate/heart rate increased.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) in the left arm for prophylaxis of COVID-19 infection.  On 19 Mar 2021, the patient experienced the events massive headache, fever, joint pain, increased heart rate and he was not doing well.  Treatment details included unspecified cold and flu medicine and regular medicine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events massive headache, fever, joint pain, increased heart rate was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: I got face numbness; Numbness on my lips, tongue, all the way to my left eye mostly in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (I got face numbness) and HYPOAESTHESIA ORAL (Numbness on my lips, tongue, all the way to my left eye mostly in my mouth) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HYPOAESTHESIA (I got face numbness) and HYPOAESTHESIA ORAL (Numbness on my lips, tongue, all the way to my left eye mostly in my mouth). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (I got face numbness) and HYPOAESTHESIA ORAL (Numbness on my lips, tongue, all the way to my left eye mostly in my mouth) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Vaccination site nodule
Clinical narrative: The patient had Back Ache; nodule on Injection Site; The patient had Chills; This spontaneous case was reported by a nurse and describes the occurrence of BACK PAIN (The patient had Back Ache), VACCINATION SITE NODULE (nodule on Injection Site) and CHILLS (The patient had Chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 03-Feb-2001, the patient experienced CHILLS (The patient had Chills). On 03-Feb-2021, the patient experienced BACK PAIN (The patient had Back Ache) and VACCINATION SITE NODULE (nodule on Injection Site). In February 2021, BACK PAIN (The patient had Back Ache), VACCINATION SITE NODULE (nodule on Injection Site) and CHILLS (The patient had Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication provided.  No treatment drugs were provided.   This case was linked to MOD21-058711, MOD21-058703, MOD21-049015, MOD21-058136, MOD21-058280, MOD21-058698, MOD21-058281, MOD21-058340, MOD21-058388, MOD21-058415, MOD21-058427, MOD21-058427, MOD21-058450, MOD21-058692, MOD21-058465, MOD21-058488, MOD21-058505, MOD21-058616, MOD21-058625, MOD21-058638, MOD21-058654, MOD21-058666, MOD21-058676 (E2B Linked Report).; Sender's Comments:  MOD21-058711: MOD21-058703: MOD21-049015: MOD21-058136: MOD21-058280: MOD21-058698: MOD21-058281: MOD21-058340: MOD21-058388: MOD21-058415: MOD21-058427: MOD21-058427: MOD21-058450: MOD21-058692: MOD21-058465: MOD21-058488: MOD21-058505: MOD21-058616: MOD21-058625: MOD21-058638: MOD21-058654: MOD21-058666: MOD21-058676:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Rash
Clinical narrative: Rash and its spreading, warm to the touch and its going on; Headache; Muscle pain; Tired for couple of days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash and its spreading, warm to the touch and its going on), HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Tired for couple of days) 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 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Tired for couple of days). On 17-Mar-2021, the patient experienced RASH (Rash and its spreading, warm to the touch and its going on). On 16-Mar-2021, HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Tired for couple of days) had resolved. At the time of the report, RASH (Rash and its spreading, warm to the touch and its going on) had not resolved.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-064623 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Urinary tract infection
Clinical narrative: body ache; Urinary tract infection; Chills; Tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), URINARY TRACT INFECTION (Urinary tract infection), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (headache) in a 38-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body ache), URINARY TRACT INFECTION (Urinary tract infection), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (headache). At the time of the report, PAIN (body ache), URINARY TRACT INFECTION (Urinary tract infection), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received on 09-May-2021,TCR Added
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Erythema, Fatigue, Myalgia
Clinical narrative: photosensitivity reaction; face was terrible red; progressively worse; very sore arm; red blotchy spot at the injection site; chills; very tired; muscle aches; aches; red blotchy spot in her face/ neck/ chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotchy spot in her face/ neck/ chest), PHOTOSENSITIVITY REACTION (photosensitivity reaction), ERYTHEMA (face was terrible red), PAIN (aches) and CONDITION AGGRAVATED (progressively worse) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02921A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced RASH MACULAR (red blotchy spot in her face/ neck/ chest), PAIN (aches), PAIN IN EXTREMITY (very sore arm), VACCINATION SITE ERYTHEMA (red blotchy spot at the injection site), CHILLS (chills), FATIGUE (very tired) and MYALGIA (muscle aches). On 15-Mar-2021, the patient experienced CONDITION AGGRAVATED (progressively worse). On an unknown date, the patient experienced PHOTOSENSITIVITY REACTION (photosensitivity reaction) and ERYTHEMA (face was terrible red). On 15-Mar-2021, PAIN (aches), PAIN IN EXTREMITY (very sore arm), CHILLS (chills) and MYALGIA (muscle aches) had resolved, FATIGUE (very tired) outcome was unknown. At the time of the report, RASH MACULAR (red blotchy spot in her face/ neck/ chest), PHOTOSENSITIVITY REACTION (photosensitivity reaction), ERYTHEMA (face was terrible red), CONDITION AGGRAVATED (progressively worse) and VACCINATION SITE ERYTHEMA (red blotchy spot at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  Treatment Prednisone for two weeks, a steroid cream for her face, 3 mg Benadryl 3 times a day for two week   This case was linked to MOD21-058418 (E2B Linked Report).; Sender's Comments:  MOD21-058418:Cross-Linked Case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Photosensitivity reaction, Rash macular, Vaccination site erythema
Clinical narrative: photosensitivity reaction; face was terrible red; progressively worse; very sore arm; red blotchy spot at the injection site; chills; very tired; muscle aches; aches; red blotchy spot in her face/ neck/ chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotchy spot in her face/ neck/ chest), PHOTOSENSITIVITY REACTION (photosensitivity reaction), ERYTHEMA (face was terrible red), PAIN (aches) and CONDITION AGGRAVATED (progressively worse) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02921A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced RASH MACULAR (red blotchy spot in her face/ neck/ chest), PAIN (aches), PAIN IN EXTREMITY (very sore arm), VACCINATION SITE ERYTHEMA (red blotchy spot at the injection site), CHILLS (chills), FATIGUE (very tired) and MYALGIA (muscle aches). On 15-Mar-2021, the patient experienced CONDITION AGGRAVATED (progressively worse). On an unknown date, the patient experienced PHOTOSENSITIVITY REACTION (photosensitivity reaction) and ERYTHEMA (face was terrible red). On 15-Mar-2021, PAIN (aches), PAIN IN EXTREMITY (very sore arm), CHILLS (chills) and MYALGIA (muscle aches) had resolved, FATIGUE (very tired) outcome was unknown. At the time of the report, RASH MACULAR (red blotchy spot in her face/ neck/ chest), PHOTOSENSITIVITY REACTION (photosensitivity reaction), ERYTHEMA (face was terrible red), CONDITION AGGRAVATED (progressively worse) and VACCINATION SITE ERYTHEMA (red blotchy spot at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  Treatment Prednisone for two weeks, a steroid cream for her face, 3 mg Benadryl 3 times a day for two week   This case was linked to MOD21-058418 (E2B Linked Report).; Sender's Comments:  MOD21-058418:Cross-Linked Case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain
Clinical narrative: very painful stomach pains; a really sharp pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (very painful stomach pains) and PAIN (a really sharp pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Drug allergy (montelukast). Concomitant products included ESTRADIOL, NORETHISTERONE ACETATE (ACTIVELLA), LOSARTAN, MONTELUKAST, MULTIVITAMIN & MINERAL, FISH OIL (OMEGA 3 FISH OILS), UBIDECARENONE (COQ10 [UBIDECARENONE]), VITAMIN C [ASCORBIC ACID] and COLLAGEN for an unknown indication.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (a really sharp pain). On 19-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (very painful stomach pains). At the time of the report, ABDOMINAL PAIN UPPER (very painful stomach pains) and PAIN (a really sharp pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pain in extremity, Rash, Urticaria
Clinical narrative: breaking out in hives; redness around the eye; thumb is in pain; Rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out in hives), OCULAR HYPERAEMIA (redness around the eye), PAIN IN EXTREMITY (thumb is in pain) and RASH (Rash on the arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (breaking out in hives), OCULAR HYPERAEMIA (redness around the eye), PAIN IN EXTREMITY (thumb is in pain) and RASH (Rash on the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, URTICARIA (breaking out in hives), OCULAR HYPERAEMIA (redness around the eye), PAIN IN EXTREMITY (thumb is in pain) and RASH (Rash on the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dermatitis contact, Fatigue, Muscle spasms
Clinical narrative: Bubble blisters, big rash that is inflammed, starting to spread and it's very itchy on my right forearm all the way to my bicept; Weak and crampy; (rash) started up as little dots and it starting to cluster, looks like poison ivy; Weak and crampy; Tired around noon the next day; Chills for about 3 hours; After shot hand felt tingly and numb for about 5 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (After shot hand felt tingly and numb for about 5 minutes), RASH VESICULAR (Bubble blisters, big rash that is inflammed, starting to spread and it's very itchy on my right forearm all the way to my bicept), ASTHENIA (Weak and crampy), DERMATITIS CONTACT ((rash) started up as little dots and it starting to cluster, looks like poison ivy) and MUSCLE SPASMS (Weak and crampy) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Prednisone). Concomitant products included TESTOSTERONE from 2018 to an unknown date for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PARAESTHESIA (After shot hand felt tingly and numb for about 5 minutes). On 16-Mar-2021, the patient experienced RASH VESICULAR (Bubble blisters, big rash that is inflammed, starting to spread and it's very itchy on my right forearm all the way to my bicept), ASTHENIA (Weak and crampy), DERMATITIS CONTACT ((rash) started up as little dots and it starting to cluster, looks like poison ivy), MUSCLE SPASMS (Weak and crampy), FATIGUE (Tired around noon the next day) and CHILLS (Chills for about 3 hours). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 15-Mar-2021, PARAESTHESIA (After shot hand felt tingly and numb for about 5 minutes) had resolved. On 17-Mar-2021, ASTHENIA (Weak and crampy), MUSCLE SPASMS (Weak and crampy), FATIGUE (Tired around noon the next day) and CHILLS (Chills for about 3 hours) had resolved. At the time of the report, RASH VESICULAR (Bubble blisters, big rash that is inflammed, starting to spread and it's very itchy on my right forearm all the way to my bicept) and DERMATITIS CONTACT ((rash) started up as little dots and it starting to cluster, looks like poison ivy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter contact detail was updated, relevant patient tab was updated, concomitant medication was added, event outcome was updated.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Rash vesicular
Clinical narrative: Bubble blisters, big rash that is inflammed, starting to spread and it's very itchy on my right forearm all the way to my bicept; Weak and crampy; (rash) started up as little dots and it starting to cluster, looks like poison ivy; Weak and crampy; Tired around noon the next day; Chills for about 3 hours; After shot hand felt tingly and numb for about 5 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (After shot hand felt tingly and numb for about 5 minutes), RASH VESICULAR (Bubble blisters, big rash that is inflammed, starting to spread and it's very itchy on my right forearm all the way to my bicept), ASTHENIA (Weak and crampy), DERMATITIS CONTACT ((rash) started up as little dots and it starting to cluster, looks like poison ivy) and MUSCLE SPASMS (Weak and crampy) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Prednisone). Concomitant products included TESTOSTERONE from 2018 to an unknown date for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PARAESTHESIA (After shot hand felt tingly and numb for about 5 minutes). On 16-Mar-2021, the patient experienced RASH VESICULAR (Bubble blisters, big rash that is inflammed, starting to spread and it's very itchy on my right forearm all the way to my bicept), ASTHENIA (Weak and crampy), DERMATITIS CONTACT ((rash) started up as little dots and it starting to cluster, looks like poison ivy), MUSCLE SPASMS (Weak and crampy), FATIGUE (Tired around noon the next day) and CHILLS (Chills for about 3 hours). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 15-Mar-2021, PARAESTHESIA (After shot hand felt tingly and numb for about 5 minutes) had resolved. On 17-Mar-2021, ASTHENIA (Weak and crampy), MUSCLE SPASMS (Weak and crampy), FATIGUE (Tired around noon the next day) and CHILLS (Chills for about 3 hours) had resolved. At the time of the report, RASH VESICULAR (Bubble blisters, big rash that is inflammed, starting to spread and it's very itchy on my right forearm all the way to my bicept) and DERMATITIS CONTACT ((rash) started up as little dots and it starting to cluster, looks like poison ivy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter contact detail was updated, relevant patient tab was updated, concomitant medication was added, event outcome was updated.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Dry throat, Fatigue, Lethargy
Clinical narrative: My throat is so dry; Hit bone very sore, seemed like I was hit by a car; Vomiting; Nausea; Tired; Lethargic and tired; Sore arm; Cold; Tingling; Temperature went up to 100.4°; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PARAESTHESIA (Tingling), LETHARGY (Lethargic and tired), BONE PAIN (Hit bone very sore, seemed like I was hit by a car) and DRY THROAT (My throat is so dry) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and s 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provide by the reporter.  Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) and RIBOFLAVIN (VITAMIN B2 INJEEL) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold), PARAESTHESIA (Tingling) and PYREXIA (Temperature went up to 100.4°). On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Mar-2021, the patient experienced LETHARGY (Lethargic and tired) and FATIGUE (Tired). On 17-Mar-2021, the patient experienced VOMITING (Vomiting) and NAUSEA (Nausea). On 18-Mar-2021, the patient experienced BONE PAIN (Hit bone very sore, seemed like I was hit by a car). On 19-Mar-2021, the patient experienced DRY THROAT (My throat is so dry). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), PARAESTHESIA (Tingling), LETHARGY (Lethargic and tired), BONE PAIN (Hit bone very sore, seemed like I was hit by a car), DRY THROAT (My throat is so dry), PAIN IN EXTREMITY (Sore arm), VOMITING (Vomiting), FATIGUE (Tired), NAUSEA (Nausea) and PYREXIA (Temperature went up to 100.4°) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.4 (High) 100.4°F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-114531 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow-up information received on 09-May-2021 included second dose details, concomitant medication and action taken updated.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: My throat is so dry; Hit bone very sore, seemed like I was hit by a car; Vomiting; Nausea; Tired; Lethargic and tired; Sore arm; Cold; Tingling; Temperature went up to 100.4°; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PARAESTHESIA (Tingling), LETHARGY (Lethargic and tired), BONE PAIN (Hit bone very sore, seemed like I was hit by a car) and DRY THROAT (My throat is so dry) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and s 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provide by the reporter.  Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) and RIBOFLAVIN (VITAMIN B2 INJEEL) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold), PARAESTHESIA (Tingling) and PYREXIA (Temperature went up to 100.4°). On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Mar-2021, the patient experienced LETHARGY (Lethargic and tired) and FATIGUE (Tired). On 17-Mar-2021, the patient experienced VOMITING (Vomiting) and NAUSEA (Nausea). On 18-Mar-2021, the patient experienced BONE PAIN (Hit bone very sore, seemed like I was hit by a car). On 19-Mar-2021, the patient experienced DRY THROAT (My throat is so dry). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), PARAESTHESIA (Tingling), LETHARGY (Lethargic and tired), BONE PAIN (Hit bone very sore, seemed like I was hit by a car), DRY THROAT (My throat is so dry), PAIN IN EXTREMITY (Sore arm), VOMITING (Vomiting), FATIGUE (Tired), NAUSEA (Nausea) and PYREXIA (Temperature went up to 100.4°) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.4 (High) 100.4°F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-114531 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow-up information received on 09-May-2021 included second dose details, concomitant medication and action taken updated.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: My throat is so dry; Hit bone very sore, seemed like I was hit by a car; Vomiting; Nausea; Tired; Lethargic and tired; Sore arm; Cold; Tingling; Temperature went up to 100.4°; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PARAESTHESIA (Tingling), LETHARGY (Lethargic and tired), BONE PAIN (Hit bone very sore, seemed like I was hit by a car) and DRY THROAT (My throat is so dry) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and s 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provide by the reporter.  Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) and RIBOFLAVIN (VITAMIN B2 INJEEL) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold), PARAESTHESIA (Tingling) and PYREXIA (Temperature went up to 100.4°). On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Mar-2021, the patient experienced LETHARGY (Lethargic and tired) and FATIGUE (Tired). On 17-Mar-2021, the patient experienced VOMITING (Vomiting) and NAUSEA (Nausea). On 18-Mar-2021, the patient experienced BONE PAIN (Hit bone very sore, seemed like I was hit by a car). On 19-Mar-2021, the patient experienced DRY THROAT (My throat is so dry). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), PARAESTHESIA (Tingling), LETHARGY (Lethargic and tired), BONE PAIN (Hit bone very sore, seemed like I was hit by a car), DRY THROAT (My throat is so dry), PAIN IN EXTREMITY (Sore arm), VOMITING (Vomiting), FATIGUE (Tired), NAUSEA (Nausea) and PYREXIA (Temperature went up to 100.4°) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.4 (High) 100.4°F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-114531 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow-up information received on 09-May-2021 included second dose details, concomitant medication and action taken updated.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.