chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Horrible fever blisters; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Horrible fever blisters) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (Horrible fever blisters). At the time of the report, ORAL HERPES (Horrible fever blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia, Rash
Clinical narrative: Sore arm; Initially experiencing a headache; Rash on her chest, stomach, and back; Fever / temp was approximately 99.2F; A spontaneous report was received from a consumer concerning herself, a 66-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, sore arm / pain in extremity, rash on her chest, stomach and back / rash, fever, temp was approximately 99.2F / pyrexia.  The patient's medical history was not provided. Concomitant product use was not provided.  On 03 Feb 2021, prior to the onset of the events, the patient received their planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date the patient initially experienced headache and sore arm. On 09 Feb 2021, the patient experienced rash on her chest, stomach, and back. Patient also reported that her temp was approximately 99.2F and still has the rash.  Treatment information included diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.   The event rash was not resolved at the time of report. The outcome of the event, headache, sore arm, temp was approximately 99.2F was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: sugar spike about a half hour after the vaccine. He mentioned it was much higher than usual.; A spontaneous report was received from a consumer concerning a 63-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sugar spike about a half hour after the vaccine. he mentioned it was much higher than usual.  The patient's medical history was not provided. Concomitant medications reported were lantus insulin, humalog insulin, atorvastatin 20 mg, levothyroxine 88 mg, fenofibrate 54 mg, amlodipine 10 mg, benazepril mg, aspirin, prilosec for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029K20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) sugar spike about a half hour after the vaccine. he mentioned it was much higher than usual.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sugar spike about a half hour after the vaccine, he mentioned it was much higher than usual was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Rash pruritic
Clinical narrative: Bad Itchy rash on both Arms & Legs; Dizzy; A spontaneous report was received from a consumer concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizzy, bad itchy rash on both arms & legs.  The patient's medical history was not provided. He stopped Lipitor prior to vaccination and has not restarted it. Concomitant medications reported were esomeprazole magnesium.  On 17 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient felt a little dizzy for one day. On 19 Feb 2021, he developed an itchy rash on both arms and legs. On 20 Feb 2021, he went to the Hospital. The Emergency Room (ER) doctor administered one diphenhydramine injection to him, and discharged him the same day to continue diphenhydramine per oral at home. The rash lasted for five days. On 24 Feb 2021, the patient had very little symptoms. He took another diphenhydramine pill and it went away.  Treatment details included diphenhydramine Injection, diphenhydramine capsules.  Action taken with mRNA-1273 in response to the events was unknown.  Outcome for the event of dizzy and bad itchy rash on both arms and legs was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Tinnitus, Vaccination site pain
Clinical narrative: dizzy; trouble breathing; ears buzzing; little soreness; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dizziness (dizzy), Dysponea ( trouble breathing), Tinnittus (ears buzzing) and Vaccination site pain (little soreness).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event little soreness, ears buzzing, dizzy and trouble breathing. she also stated that this lasted for 15 minutes, but had not mentioned which event has lated for 15 minutes.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: her arm hurts to the touch; rash is hot to the touch; has a rash, a big red spot of 6 inches around; has a rash, a big red spot of 6 inches around; was achy; didn't feel really well, was achy; didn't feel really well; stomach hurt; her arm started to get a rash; arm was really sore; slightly sore arm; A spontaneous report was received from a consumer, a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was really sore, didn't feel really well, was achy, arm started to get a rash, stomach hurt, arm hurt, rash, a big red spot of 6 inches around that is hot to the touch. And arm hurts to the touch.  The patient's medical history was not provided. Concomitant products used included Vitamin D gummies.   On 02 Feb 2021, few hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: [021M20A] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Feb 2021, after few hours of vaccine administration the patient experienced slightly sore arm. After 8 days on 10 Feb 2021 patient experienced arm was really sore, didn't feel really well, was achy, arm started to get a rash, stomach hurt, arm hurt, rash, a big red spot of 6 inches around that is hot to the touch. And arm hurts to the touch. Treatment for the events included children's Tylenol.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, arm was really sore, didn't feel really well, was achy, arm started to get a rash, stomach hurt, arm hurt was resolved and rash, a big red spot of 6 inches around that is hot to the touch. And arm hurts to the touch was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: her arm hurts to the touch; rash is hot to the touch; has a rash, a big red spot of 6 inches around; has a rash, a big red spot of 6 inches around; was achy; didn't feel really well, was achy; didn't feel really well; stomach hurt; her arm started to get a rash; arm was really sore; slightly sore arm; A spontaneous report was received from a consumer, a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was really sore, didn't feel really well, was achy, arm started to get a rash, stomach hurt, arm hurt, rash, a big red spot of 6 inches around that is hot to the touch. And arm hurts to the touch.  The patient's medical history was not provided. Concomitant products used included Vitamin D gummies.   On 02 Feb 2021, few hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: [021M20A] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Feb 2021, after few hours of vaccine administration the patient experienced slightly sore arm. After 8 days on 10 Feb 2021 patient experienced arm was really sore, didn't feel really well, was achy, arm started to get a rash, stomach hurt, arm hurt, rash, a big red spot of 6 inches around that is hot to the touch. And arm hurts to the touch. Treatment for the events included children's Tylenol.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, arm was really sore, didn't feel really well, was achy, arm started to get a rash, stomach hurt, arm hurt was resolved and rash, a big red spot of 6 inches around that is hot to the touch. And arm hurts to the touch was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Neck pain, Pyrexia
Clinical narrative: Neck pain; Fever; Headache; Chills; Redness; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events neck pain, fever/pyrexia, headache, chills, redness/erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010M20A) via unknown route for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient experienced the event(s) neck pain, fever, headache, chills, redness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), neck pain, fever, headache, chills, redness was unknown.
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 male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, 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). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia oral
Clinical narrative: Face, shoulders, top of arms, and neck turned red; Lips tingled; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face, shoulders, top of arms, and neck turned red) and PARAESTHESIA ORAL (Lips tingled) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Face, shoulders, top of arms, and neck turned red) and PARAESTHESIA ORAL (Lips tingled). At the time of the report, ERYTHEMA (Face, shoulders, top of arms, and neck turned red) and PARAESTHESIA ORAL (Lips tingled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Chills, Headache, Heart rate increased, Nausea
Clinical narrative: blood sugar level 204; fever; nausea; chills; headache; heart rate over 100; A spontaneous report was received from a consumer concerning a 74-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, nausea, chills, headache, heart rate over 100, blood sugar 204.  The patient's medical history was not provided. Concomitant medications reported were Chloratholidone, Omeprozole, Aspirin, Clonidine, Alprazolam, vitamin D3-400, Fish oil 400, Multivitamin, Magnesium, Colace, Proair HFR inhaler, Metformin, Carvedilol, Lovastatin, Pravastatin, Doxazosin, Potassium chloride unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) fever, nausea, chills, headache, heart rate over 100, blood sugar 204.Treatment medication include acetaminophen .  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever, nausea, chills, headache, heart rate over 100, blood sugar 204 was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: blood sugar level 204; fever; nausea; chills; headache; heart rate over 100; A spontaneous report was received from a consumer concerning a 74-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, nausea, chills, headache, heart rate over 100, blood sugar 204.  The patient's medical history was not provided. Concomitant medications reported were Chloratholidone, Omeprozole, Aspirin, Clonidine, Alprazolam, vitamin D3-400, Fish oil 400, Multivitamin, Magnesium, Colace, Proair HFR inhaler, Metformin, Carvedilol, Lovastatin, Pravastatin, Doxazosin, Potassium chloride unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) fever, nausea, chills, headache, heart rate over 100, blood sugar 204.Treatment medication include acetaminophen .  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever, nausea, chills, headache, heart rate over 100, blood sugar 204 was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Decreased appetite, Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Joint stiffness that got worse), DIZZINESS (Dizziness), DECREASED APPETITE (Loss of apetite), DIARRHEA (Diarrhea) and ANOSMIA (Loss of smell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced JOINT STIFFNESS (Joint stiffness that got worse), DIZZINESS (Dizziness), DECREASED APPETITE (Loss of apetite), DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell), SOMNOLENCE (I only want to sleep), AGEUSIA (Loss of taste) and PYREXIA (Low grade fever). On 09-Feb-2021, DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and PYREXIA (Low grade fever) had resolved. At the time of the report, JOINT STIFFNESS (Joint stiffness that got worse) had not resolved and DECREASED APPETITE (Loss of apetite), ANOSMIA (Loss of smell), SOMNOLENCE (I only want to sleep) and AGEUSIA (Loss of taste) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9-100.1 (High) 99.9-101.1. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Joint stiffness, Pyrexia, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Joint stiffness that got worse), DIZZINESS (Dizziness), DECREASED APPETITE (Loss of apetite), DIARRHEA (Diarrhea) and ANOSMIA (Loss of smell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced JOINT STIFFNESS (Joint stiffness that got worse), DIZZINESS (Dizziness), DECREASED APPETITE (Loss of apetite), DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell), SOMNOLENCE (I only want to sleep), AGEUSIA (Loss of taste) and PYREXIA (Low grade fever). On 09-Feb-2021, DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and PYREXIA (Low grade fever) had resolved. At the time of the report, JOINT STIFFNESS (Joint stiffness that got worse) had not resolved and DECREASED APPETITE (Loss of apetite), ANOSMIA (Loss of smell), SOMNOLENCE (I only want to sleep) and AGEUSIA (Loss of taste) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9-100.1 (High) 99.9-101.1. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Vaccination site haemorrhage
Clinical narrative: took the needle out of her arm, she noticed several big drops of blood that came out.; vaccine may have leaked and she may not have gotten the full dose; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site haemorrhage, and accidental underdose.  The patient's medical history, was not provided by the reporter.  No Concomitant medications were reported.  On 01 Mar 2021, the patient received their one of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   When the nurse took the needle out of her arm, the patient noticed several big drops of blood that came out. The patient felt that the vaccine may have leaked and she may not have gotten the full dose.  Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, were recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine received during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine received during pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 24-Sep-2021. On 10-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine received during pregnancy). On 10-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine received during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vulvovaginal pruritus
Clinical narrative: it feels like fire from her vagina to the rectal line and it itche; just initial rash and itchiness,rash has expanded to her entire back, scalp, under her breast; started with a rash, it looked like tiny bites , by that night she had a bad rash in her forehead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VULVOVAGINAL PRURITUS (it feels like fire from her vagina to the rectal line and it itche), RASH PRURITIC (just initial rash and itchiness,rash has expanded to her entire back, scalp, under her breast) and RASH (started with a rash, it looked like tiny bites , by that night she had a bad rash in her forehead) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Patient is on levothyroxine). Concomitant products included METFORMIN, ATORVASTATIN, LEVOTHYROXINE SODIUM (LEVOTHYROXIN), CALCIUM and VITAMIN D3 for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced RASH (started with a rash, it looked like tiny bites , by that night she had a bad rash in her forehead). On an unknown date, the patient experienced VULVOVAGINAL PRURITUS (it feels like fire from her vagina to the rectal line and it itche) and RASH PRURITIC (just initial rash and itchiness,rash has expanded to her entire back, scalp, under her breast). At the time of the report, VULVOVAGINAL PRURITUS (it feels like fire from her vagina to the rectal line and it itche), RASH PRURITIC (just initial rash and itchiness,rash has expanded to her entire back, scalp, under her breast) and RASH (started with a rash, it looked like tiny bites , by that night she had a bad rash in her forehead) 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.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in the arm and in the shoulder/Arm is very painful; Swollen; Difficulty of breathing; Arm completely red; Pain in the shoulder; A spontaneous report was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm completely red, pain in the arm and in the shoulder, very swollen, arm was very painful, difficulty of breathing.  The patient's medical history included chronic gastritis, allergies and high blood pressure. Concomitant medications reported were Omesartan, Modetine, Vitamin D, C, and antacids (for gastritis).  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013620A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced redness and swelling. The arm was very painful. Also she experienced difficulty in breathing and  pain in shoulder.Treatment details included ice on the arm and has taken several medications.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events - arm completely red, pain in the arm and in the shoulder, very swollen, arm was very painful, difficulty of breathing-were unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: fatigue; headache; violent vomiting; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, headache and vomiting (violent vomiting).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) through unknown route in the left arm for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced headache, violent vomiting and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Hyperhidrosis, Muscle spasms
Clinical narrative: Dizziness; Sweats; Diarrhea; Cramps; Nausea; Vomiting; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPERHIDROSIS (Sweats), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Dizziness), HYPERHIDROSIS (Sweats), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 01-Mar-2021, DIZZINESS (Dizziness), HYPERHIDROSIS (Sweats), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Dizziness; Sweats; Diarrhea; Cramps; Nausea; Vomiting; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPERHIDROSIS (Sweats), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Dizziness), HYPERHIDROSIS (Sweats), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 01-Mar-2021, DIZZINESS (Dizziness), HYPERHIDROSIS (Sweats), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Sweating; Injection site was sore; Fatigue; Chills; Nausea; Vomiting; Fever; Muscle pain; A spontaneous report was received from a consumer concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site was sore, fatigue, chills, nausea, vomiting, sweating, fever and muscle pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: B12M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced injection site soreness, fatigue, chills, nausea, vomiting, sweating, fever and muscle pain.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events injection site was sore, fatigue, chills, nausea, vomiting, sweating, fever, muscle pain were unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Sweating; Injection site was sore; Fatigue; Chills; Nausea; Vomiting; Fever; Muscle pain; A spontaneous report was received from a consumer concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site was sore, fatigue, chills, nausea, vomiting, sweating, fever and muscle pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: B12M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced injection site soreness, fatigue, chills, nausea, vomiting, sweating, fever and muscle pain.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events injection site was sore, fatigue, chills, nausea, vomiting, sweating, fever, muscle pain were unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Delayed reaction; arm was red and itchy near the site of the injection site; Described the itchiness as "not persistent, just a little subtle."; Headache and fatigue; Fatigue; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache and fatigue,delayed reaction, arm was red and itchy near the site of the injection site, described the itchiness as not persistent, just a little subtle.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events headache and fatigue. On 4 Feb 2021, the patient continued to experience fatigue. On 10 Feb 2021, the patient experienced a delayed reaction, arm was red and itchy near the site of the injection site, described the itchiness as not persistent, just a little subtle.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events headache and fatigue,delayed reaction, arm was red and itchy near the site of the injection site, described the itchiness as not persistent, just a little subtle were unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On an unknown date, the patient experienced CHILLS (chills), PAIN IN EXTREMITY (aches), INFLUENZA LIKE ILLNESS (felt like with flu), PYREXIA (fever 101) and PAIN IN EXTREMITY (body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), CHILLS (chills), PAIN IN EXTREMITY (aches), INFLUENZA LIKE ILLNESS (felt like with flu), PYREXIA (fever 101) and PAIN IN EXTREMITY (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: elevated (High) 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient reports taking High Blood Pressure medication (NOS), Cholesterol medication (NOS) and Diuretic medication (NOS).     This case was linked to MOD-2021-031372 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: swollen lymph node on neck on the opposite side of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swollen lymph node on neck on the opposite side of the injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph node on neck on the opposite side of the injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen lymph node on neck on the opposite side of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: He has sore arm; shoulder pain; headache; A spontaneous report was received from a consumer concerning himself an 86 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shoulder pain, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown  date, the  patient received first of two planned doses of mRNA-1273 (lot/batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection. On 10-feb-2021, prior to the onset of events which was experienced on unknown date, the patient received the second of the two planned doses of mRNA-1273 (lot/batch number : Unknown) through unknown route.  On an unknown date, the patient experienced the event(s) shoulder pain, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), shoulder pain, headache was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: her arm was sore, red, and swollen up./ a lump on her arm; A spontaneous report () was received from a consumer concerning a 74-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore, red, and swollen up, lump on her arm, red spot the size of a half dollar.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) arm was sore, red, and swollen up, lump on her arm, red spot the size of a half dollar.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm was sore, red, and swollen up, lump on her arm, red spot the size of a half dollar was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: swollen, red, itchy, and spreading/ progressing.; Swollen, red, itchy, and spreading/ progressing.; Rash on her left arm where the vaccination was given; Swollen, red, itchy, and spreading/ progressing.; Swollen, red, itchy, and spreading/ progressing.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (swollen, red, itchy, and spreading/ progressing.), VACCINATION SITE PRURITUS (Swollen, red, itchy, and spreading/ progressing.), VACCINATION SITE RASH (Rash on her left arm where the vaccination was given), VACCINATION SITE SWELLING (Swollen, red, itchy, and spreading/ progressing.) and VACCINATION SITE ERYTHEMA (Swollen, red, itchy, and spreading/ progressing.) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced RASH (swollen, red, itchy, and spreading/ progressing.), VACCINATION SITE PRURITUS (Swollen, red, itchy, and spreading/ progressing.), VACCINATION SITE RASH (Rash on her left arm where the vaccination was given), VACCINATION SITE SWELLING (Swollen, red, itchy, and spreading/ progressing.) and VACCINATION SITE ERYTHEMA (Swollen, red, itchy, and spreading/ progressing.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (swollen, red, itchy, and spreading/ progressing.), VACCINATION SITE PRURITUS (Swollen, red, itchy, and spreading/ progressing.), VACCINATION SITE RASH (Rash on her left arm where the vaccination was given), VACCINATION SITE SWELLING (Swollen, red, itchy, and spreading/ progressing.) and VACCINATION SITE ERYTHEMA (Swollen, red, itchy, and spreading/ progressing.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: light headed/dizzy; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed/dizzy) and FATIGUE (tired) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (light headed/dizzy) and FATIGUE (tired). On 27-Feb-2021, FATIGUE (tired) had resolved. At the time of the report, DIZZINESS (light headed/dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were  provided by Reporter. No Treatment Medications were  provided by Reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site urticaria
Clinical narrative: Hives on left arm and lower chest area; Hives on left arm and lower chest area; A spontaneous report was received from a consumer concerning a 65-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on left arm (vaccination site urticaria) and lower chest area (urticaria).  The patient's medical history was not provided. Concomitant medications were not provided by reporter.  On 8 Feb 2021, the patient received their planned dose of mRNA-1273 (Batch number: 007M20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 10 Feb 2021, reporter stated he developed hives on left arm (injection site) and lower left chest area. Treatment information not provided. Lab tests not provided.  Action taken with response to mRNA-1273 was not reported.  The outcome of the events, hives on left arm and lower chest area was considered unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash, Swelling
Clinical narrative: Itchiness; Swelling; Rash; Itchiness; Arm is hot to touch; A spontaneous report  was received from a consumer concerning a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling, rash, itchiness/pruritis, arm is hot to touch/feeling of warmth.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 31 Jan 2021, prior to the onset of the symptoms, the patient received first of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 7 Feb 2021, after vaccination, the patient experienced swelling, rash, itchiness and arm was hot to touch. On 11 Feb 2021, the patient felt itchness.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, swelling, rash, arm was hot to touch, were considered to be resolved on 09 Feb 2021. The outcome of the event, itchiness, was considered to be unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers), FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. NO medical history information was reported. On 02-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers). On 03-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers) was resolving and FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers), FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. NO medical history information was reported. On 02-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers). On 03-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness on face/Numbness on back of head/Numbness on fingers) was resolving and FEELING ABNORMAL (Feeling foggy) and PARAESTHESIA (Tingling on the back of the shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypertension, Nervousness, Paraesthesia
Clinical narrative: Felt tingly immediately after injection; heart and chest felt cold; Feeling shaky; High Blood Pressure; A spontaneous report was received from a consumer concerning a 79-year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt tingly immediately after injection, heart and chest felt cold immediately after injection, feeling shaky, high blood pressure.  The patient's medical history was not provided. Concomitant medications reported were Ranolazine, High Blood Pressure Medications, Synthroid, Baby Aspirin, Vitamin B12, Vitamin D3, Potassium Chloride, Calcium, Allopurinol for drug use for unknown indication.  No relevant lab data was provided by the reporter.  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: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the events, felt tingly immediately after injection. heart felt cold immediately after injection, chest felt cold immediately after injection, feeling shaky, high blood pressure.  Treatment details included Diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, felt tingly immediately after injection was unknown, heart and chest felt cold immediately after injection, feeling shaky, high blood pressure was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pharyngeal swelling, Swollen tongue, Tongue disorder
Clinical narrative: Tongue felt a little bit thicker; Numbness and tingling in my arm and hand and leg; Tingling; Throat and tongue started swelling; Tongue swelling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness and tingling in my arm and hand and leg), PARAESTHESIA (Tingling), PHARYNGEAL SWELLING (Throat and tongue started swelling), SWOLLEN TONGUE (Tongue swelling) and TONGUE DISORDER (Tongue felt a little bit thicker) in a 68-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 was not reported .     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness and tingling in my arm and hand and leg), PARAESTHESIA (Tingling), PHARYNGEAL SWELLING (Throat and tongue started swelling) and SWOLLEN TONGUE (Tongue swelling). On an unknown date, the patient experienced TONGUE DISORDER (Tongue felt a little bit thicker). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness and tingling in my arm and hand and leg), PARAESTHESIA (Tingling), PHARYNGEAL SWELLING (Throat and tongue started swelling), SWOLLEN TONGUE (Tongue swelling) and TONGUE DISORDER (Tongue felt a little bit thicker) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided