chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear infection, Ear pain, Pain, Pyrexia
Clinical narrative: pain; chills; fever; ear infection; stabbing pain on it's ears; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (ear infection), EAR PAIN (stabbing pain on it's ears), PAIN (pain), CHILLS (chills) and PYREXIA (fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 03AK20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced EAR INFECTION (ear infection) and EAR PAIN (stabbing pain on it's ears). On 02-Mar-2021, the patient experienced PAIN (pain), CHILLS (chills) and PYREXIA (fever). On 04-Mar-2021, PAIN (pain), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, EAR INFECTION (ear infection) and EAR PAIN (stabbing pain on it's ears) had resolved.            Concomitant medication not provided. No treatment but doctor prescribed Tylenol and did not clarified if took it or not.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Rash, Skin exfoliation
Clinical narrative: full body rash; angry red; pain; skin to peel; itching; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (full body rash), ERYTHEMA (angry red), PAIN (pain), SKIN EXFOLIATION (skin to peel) and PRURITUS (itching) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L28) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 29-Jan-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (full body rash), ERYTHEMA (angry red), PAIN (pain), SKIN EXFOLIATION (skin to peel) and PRURITUS (itching). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency and PREDNISONE at a dose of UNK mg. At the time of the report, RASH (full body rash) had not resolved and ERYTHEMA (angry red), PAIN (pain), SKIN EXFOLIATION (skin to peel) and PRURITUS (itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-048001 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a non-health professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient 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 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Sep-2020 and the estimated date of delivery was 06-Jul-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Worse headache; Chills; Fever; Body ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Worse headache), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Cholesterol. Concomitant products included PRAVASTATIN for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue). On 15-Mar-2021 at 4:00 AM, the patient experienced HEADACHE (Worse headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 2 Advil. On 14-Mar-2021, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue) had resolved. At the time of the report, HEADACHE (Worse headache) outcome was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Social drinks, 3-4 drinks a week-no alcohol durning pregnancies stop date - 2021) in 2006, Nicotine dependence (Got up to 3 packs a week Nicotine (cigarettes/cigars/vaporized)) from 2003 to 2011 and Pregnancy (Live, Full-term birth) on 17-May-2017. Concurrent medical conditions included Asthma (exacerbated by any respiratory infection, not chronic condition). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from an unknown date to 29-Jan-2021 and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) from 04-Feb-2021 to an unknown date for Allergy, PARACETAMOL (TYLENOL) for Pain, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 04-Feb-2021 to an unknown date for Supplementation therapy, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 28-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Pregnancy test: positive (Positive) Positive. On 05-Mar-2021, Ultrasound foetal: inconclusive (Inconclusive) ultrasound - 10 week establish there was a fetus..         Genetic blood test was scheduled on 25-Apr-2021. Ultrasound was scheduled on 21-May-2021.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received on 06-May-2021 contains information regarding the historical conditions, laboratory data, concomitant medications, pregnancy details of the patient.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: Diarrhea; Abdominal pain; Nausea; Vomiting; fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-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 PYREXIA (Fever) and CHILLS (Chills). On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (fatigue). On 13-Mar-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (fatigue) outcome was unknown.            Treatment using bismuth subsalicylate diarrhea and stomach pain was reported  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Diarrhea; Abdominal pain; Nausea; Vomiting; fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-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 PYREXIA (Fever) and CHILLS (Chills). On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (fatigue). On 13-Mar-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (fatigue) outcome was unknown.            Treatment using bismuth subsalicylate diarrhea and stomach pain was reported  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site rash, Vaccination site reaction
Clinical narrative: Itchy; Moderna arm; Rash on her arm that is about 2.5x2 inches; it is just a red spot; Rash kind of like a square; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), VACCINATION SITE REACTION (Moderna arm), VACCINATION SITE RASH (Rash on her arm that is about 2.5x2 inches), VACCINATION SITE ERYTHEMA (it is just a red spot) and VACCINATION SITE RASH (Rash kind of like a square) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included CLONIDINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DIAZEPAM (VALIUM) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (Itchy), VACCINATION SITE REACTION (Moderna arm), VACCINATION SITE RASH (Rash on her arm that is about 2.5x2 inches), VACCINATION SITE ERYTHEMA (it is just a red spot) and VACCINATION SITE RASH (Rash kind of like a square). At the time of the report, PRURITUS (Itchy), VACCINATION SITE REACTION (Moderna arm), VACCINATION SITE RASH (Rash on her arm that is about 2.5x2 inches), VACCINATION SITE ERYTHEMA (it is just a red spot) and VACCINATION SITE RASH (Rash kind of like a square) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise, Vaccination site pain
Clinical narrative: her hand was heavy; not comfortable; She experienced injection site pain the same as flu shot; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (her hand was heavy), MALAISE (not comfortable) and VACCINATION SITE PAIN (She experienced injection site pain the same as flu shot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Cholesterol.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced LIMB DISCOMFORT (her hand was heavy), MALAISE (not comfortable) and VACCINATION SITE PAIN (She experienced injection site pain the same as flu shot). The patient was treated with IBUPROFEN at a dose of 200 milligram. On 21-Feb-2021, LIMB DISCOMFORT (her hand was heavy), MALAISE (not comfortable) and VACCINATION SITE PAIN (She experienced injection site pain the same as flu shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included asthma and cholesterol medications.   This case was linked to MOD-2021-047975 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: TCR received and the reporter denied further follow up.; Sender's Comments:  MOD-2021-047975:
Sex: M
Vaccine: COVID19
Symptoms: Epicondylitis, Limb discomfort, Pain in extremity, Tendonitis
Clinical narrative: horrible pain in left arm; tendonitis; Tennis Elbow; Can't use Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (horrible pain in left arm), TENDONITIS (tendonitis), EPICONDYLITIS (Tennis Elbow) and LIMB DISCOMFORT (Can't use Arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (horrible pain in left arm), TENDONITIS (tendonitis), EPICONDYLITIS (Tennis Elbow) and LIMB DISCOMFORT (Can't use Arm). At the time of the report, PAIN IN EXTREMITY (horrible pain in left arm), TENDONITIS (tendonitis), EPICONDYLITIS (Tennis Elbow) and LIMB DISCOMFORT (Can't use Arm) outcome was unknown. Not Provided          No concomitant medication included.  No treatment medication included.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite
Clinical narrative: not eaten very much the past few days; feeling weak/not gotten up much; muscle ache from shoulders and down backside; chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (muscle ache from shoulders and down backside), CHILLS (chills), ASTHENIA (feeling weak/not gotten up much) and DECREASED APPETITE (not eaten very much the past few days) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ARTHRALGIA (muscle ache from shoulders and down backside) and CHILLS (chills). On 17-Mar-2021, the patient experienced ASTHENIA (feeling weak/not gotten up much). On an unknown date, the patient experienced DECREASED APPETITE (not eaten very much the past few days). The patient was treated with PARACETAMOL (TYLENOL) for Shoulder pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (muscle ache from shoulders and down backside), CHILLS (chills), ASTHENIA (feeling weak/not gotten up much) and DECREASED APPETITE (not eaten very much the past few days) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter.  The patient did not  eat  very much the past few days and stated that could also be why she felt weak.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: some liquid leaked out; some liquid leaked out and she is not sure that patient got enough dose or not?; A spontaneous report was received from a Pharmacist concerning an unspecified age and gender patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and some liquid leaked out/ device connection issue and she is not sure that patient got enough dose or not/ underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 March 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 045A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 17 March 2021, the patient received mRNA-1273 but had some liquid leaked out and underdose. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  On 17 March 2021, the outcome of the events was considered as recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy, Ultrasound foetal
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy, Alcohol use (Social drinks, 3-4 drinks a week-no alcohol durning pregnancies) in 2006 and Cigarette smoker (Got up to 3 packs a week) from 2003 to 2011. Concurrent medical conditions included Asthma (exacerbated by any respiratory infection, not chronic condition). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) from 04-Feb-2021 to an unknown date and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Nutritional supplement, PARACETAMOL (TYLENOL) for Pain, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 25-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 21-Feb-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Ultrasound foetal: establish there was a fetus. On 25-Apr-2021, Blood test: to be complete 23APR2021.   This case was linked to MOD-2021-048015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow-up was received on 06-may-2021, medical history and lab data were updated
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for an unknown indication.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Mobility decreased
Clinical narrative: Mobility decreased; Condition aggravated; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Mobility decreased), CONDITION AGGRAVATED (Condition aggravated) and COVID-19 (Covid-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) and TERIFLUNOMIDE (AUBAGIO) for an unknown indication.    In January 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 MOBILITY DECREASED (Mobility decreased), CONDITION AGGRAVATED (Condition aggravated) and COVID-19 (Covid-19). At the time of the report, MOBILITY DECREASED (Mobility decreased), CONDITION AGGRAVATED (Condition aggravated) and COVID-19 (Covid-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site hot to the touch; Injection site Hard; Injection Site became red; Injection site swelling; Injection site Itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site hot to the touch), INJECTION SITE INDURATION (Injection site Hard), INJECTION SITE ERYTHEMA (Injection Site became red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site Itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M204) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Hypertension. Concurrent medical conditions included Drug allergy (Vancomycin), Drug allergy (Piperacillin/tazobactam), Drug allergy (Linezolid) and Drug allergy (Trimethoprim/sulfamethoxazole). Concomitant products included DOXYCYCLINE for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE WARMTH (Injection site hot to the touch), INJECTION SITE INDURATION (Injection site Hard), INJECTION SITE ERYTHEMA (Injection Site became red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site Itching). At the time of the report, INJECTION SITE WARMTH (Injection site hot to the touch), INJECTION SITE INDURATION (Injection site Hard), INJECTION SITE ERYTHEMA (Injection Site became red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site Itching) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-012977 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: Not feeling well; Arm sore; Fever 103-101.5; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling well), PAIN IN EXTREMITY (Arm sore) and PYREXIA (Fever 103-101.5) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (Not feeling well), PAIN IN EXTREMITY (Arm sore) and PYREXIA (Fever 103-101.5). At the time of the report, FEELING ABNORMAL (Not feeling well), PAIN IN EXTREMITY (Arm sore) and PYREXIA (Fever 103-101.5) had not resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio decreased
Clinical narrative: INR dropped from a normal of 2.9 to 1.9; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTERNATIONAL NORMALISED RATIO DECREASED (INR dropped from a normal of 2.9 to 1.9) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement in 2004. Concurrent medical conditions included Fruit allergy (Allergy to strawberry), Drug allergy (Allergy to steroids), Penicillin allergy, Fruit allergy (Allergy to cranberry) and Drug allergy (Allergy to narcotics). Concomitant products included WARFARIN and VITAMINS NOS for an unknown indication.   On 05-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 11:35 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INTERNATIONAL NORMALISED RATIO DECREASED (INR dropped from a normal of 2.9 to 1.9). The patient was treated with LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) ongoing since an unknown date for INR decreased, at a dose of UNK, q12h. In March 2021, INTERNATIONAL NORMALISED RATIO DECREASED (INR dropped from a normal of 2.9 to 1.9) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, International normalised ratio: 1.9 (Low) 1.9. Normal is around 2.9. In March 2021, International normalised ratio: 2.9 (normal) 2nd week back to 2.9, 2.7 (Low) 3rd week 2.7 and 1.9 (Low) 4th week back down to 1.9. In April 2021, International normalised ratio: 3.0 (Low) 5th week 3.0, 2.4 (Low) 6th week 2.4, 3.2 (High) 7th week 3.2 and 4.9 (High) 8th week 4.9. In May 2021, International normalised ratio: 4.7 (High) 9th week 4.7 and 1.5 (Low) 10th week 1.5.         The patient 's cardiologist told her to take her INR weekly instead of every other week until her next dose of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up document received on 11-May-201 contains updated patient details, medical history, concomitant medications, lab data, treatment information and second dose details.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Vaccination complication, Vaccination site reaction
Clinical narrative: shingles; feeling lousy/kind of sick; really bad headache; little bit of reaction; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), VACCINATION COMPLICATION (feeling lousy/kind of sick), HEADACHE (really bad headache) and VACCINATION SITE REACTION (little bit of reaction) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 028L20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (Medical history was not reported).   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles), VACCINATION COMPLICATION (feeling lousy/kind of sick), HEADACHE (really bad headache) and VACCINATION SITE REACTION (little bit of reaction). At the time of the report, HERPES ZOSTER (shingles), VACCINATION COMPLICATION (feeling lousy/kind of sick), HEADACHE (really bad headache) and VACCINATION SITE REACTION (little bit of reaction) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-039293, MOD-2021-039117 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in his ears/ tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in his ears/ tinnitus) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 17-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 TINNITUS (Ringing in his ears/ tinnitus). At the time of the report, TINNITUS (Ringing in his ears/ tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Incorrect dose administered
Clinical narrative: Inadequate dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (Inadequate dose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Inadequate dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Inadequate dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) Negative.         Patient had no adverse events after both doses.  No concomitant medications were provided by the reporter.  No Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up information received on 23-Jul-2021 contains updated information of second dose and first and second dose outcomes.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: started to feel exteremely chilly; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (started to feel exteremely chilly) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (started to feel exteremely chilly). At the time of the report, CHILLS (started to feel exteremely chilly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking concomitant medications (name not specified).  No treatment was received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: extreme headaches; nausea; chills; body aches; fever; exhaustion and fatigue; felt like somebody had beat me up; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (extreme headaches), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus syndrome. Concomitant products included CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), DICLOFENAC, DULOXETINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FOLIC ACID, LEVOTHYROXINE, IBUPROFEN, ROPINIROLE, SUCRALFATE, SUMATRIPTAN, TIZANIDINE and VITAMIN D NOS.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (extreme headaches), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever), FATIGUE (exhaustion and fatigue) and FEELING ABNORMAL (felt like somebody had beat me up). The patient was treated with PANTOPRAZOLE ongoing since an unknown date at an unspecified dose and frequency. On 17-Mar-2021, HEADACHE (extreme headaches), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever), FATIGUE (exhaustion and fatigue) and FEELING ABNORMAL (felt like somebody had beat me up) had resolved.            Additional concomitant medications included Omega fish oil ,Benzoate, Hydrochloroquine   No treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: extreme headaches; nausea; chills; body aches; fever; exhaustion and fatigue; felt like somebody had beat me up; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (extreme headaches), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus syndrome. Concomitant products included CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), DICLOFENAC, DULOXETINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FOLIC ACID, LEVOTHYROXINE, IBUPROFEN, ROPINIROLE, SUCRALFATE, SUMATRIPTAN, TIZANIDINE and VITAMIN D NOS.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (extreme headaches), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever), FATIGUE (exhaustion and fatigue) and FEELING ABNORMAL (felt like somebody had beat me up). The patient was treated with PANTOPRAZOLE ongoing since an unknown date at an unspecified dose and frequency. On 17-Mar-2021, HEADACHE (extreme headaches), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever), FATIGUE (exhaustion and fatigue) and FEELING ABNORMAL (felt like somebody had beat me up) had resolved.            Additional concomitant medications included Omega fish oil ,Benzoate, Hydrochloroquine   No treatment was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Cold sweat, Dizziness, Nausea
Clinical narrative: Light-headed/Dizzy; Weakness/ no energy; Clammy; Stomach tied up in knots; Thirsty; Random episodes of nausea/Felt like he was going to pass out; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light-headed/Dizzy), ASTHENIA (Weakness/ no energy), COLD SWEAT (Clammy), ABDOMINAL PAIN UPPER (Stomach tied up in knots) and THIRST (Thirsty) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M2077) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Light-headed/Dizzy), ASTHENIA (Weakness/ no energy), COLD SWEAT (Clammy), ABDOMINAL PAIN UPPER (Stomach tied up in knots), THIRST (Thirsty) and NAUSEA (Random episodes of nausea/Felt like he was going to pass out). At the time of the report, DIZZINESS (Light-headed/Dizzy), ASTHENIA (Weakness/ no energy), COLD SWEAT (Clammy), ABDOMINAL PAIN UPPER (Stomach tied up in knots), THIRST (Thirsty) and NAUSEA (Random episodes of nausea/Felt like he was going to pass out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   These episode happened on 10-Mar-2021 and 16-Mar-2021.  Concomitant products known to be used by the patient were Blood pressure medication, Cholesterol medication, Arthritis medication.  No treatment medication was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Light-headed/Dizzy; Weakness/ no energy; Clammy; Stomach tied up in knots; Thirsty; Random episodes of nausea/Felt like he was going to pass out; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light-headed/Dizzy), ASTHENIA (Weakness/ no energy), COLD SWEAT (Clammy), ABDOMINAL PAIN UPPER (Stomach tied up in knots) and THIRST (Thirsty) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M2077) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Light-headed/Dizzy), ASTHENIA (Weakness/ no energy), COLD SWEAT (Clammy), ABDOMINAL PAIN UPPER (Stomach tied up in knots), THIRST (Thirsty) and NAUSEA (Random episodes of nausea/Felt like he was going to pass out). At the time of the report, DIZZINESS (Light-headed/Dizzy), ASTHENIA (Weakness/ no energy), COLD SWEAT (Clammy), ABDOMINAL PAIN UPPER (Stomach tied up in knots), THIRST (Thirsty) and NAUSEA (Random episodes of nausea/Felt like he was going to pass out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   These episode happened on 10-Mar-2021 and 16-Mar-2021.  Concomitant products known to be used by the patient were Blood pressure medication, Cholesterol medication, Arthritis medication.  No treatment medication was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in lower right arm -when use it  pain moved from lower right arm all the way to hand when use it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in lower right arm -when use it  pain moved from lower right arm all the way to hand when use it) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in lower right arm -when use it  pain moved from lower right arm all the way to hand when use it). At the time of the report, VACCINATION SITE PAIN (Pain in lower right arm -when use it  pain moved from lower right arm all the way to hand when use it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of pain in extremity (pain in leg), pain (achy all over and now has subsided), pain in extremity (her arm is sore but not horrible), arthralgia (pain in hips) and injection site pain (injection site pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional events detailed below. The patient's past medical history included no adverse event. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 9, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 9, 2021, patient experienced pain (achy all over and now has subsided), pain in extremity (her arm is sore but not horrible) and pyrexia (fever). On Feb 10, 2021, patient experienced pain in extremity (pain in leg), arthralgia (pain in hips) and injection site pain (injection site pain). At the time of the report, pain in extremity (pain in leg), pain in extremity (her arm is sore but not horrible), arthralgia (pain in hips) and injection site pain (injection site pain) outcome: unknown and pain (achy all over and now has subsided) and pyrexia (fever): resolving. Patient took Advil for her first dose and took 2 extra strength Tylenol after the second dose. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable. This case linked to MOD-2021-003479 (patient link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Stomach pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, ENALAPRIL MALEATE (ENAPRIL), OMEPRAZOLE, EZETIMIBE, LORATADINE (LORATADIN) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory data was provided.  No treatment information was provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; itching all over her chest, back, arms, legs, feet, everywhere; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and PRURITUS (itching all over her chest, back, arms, legs, feet, everywhere) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     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 12-Mar-2021, the patient experienced URTICARIA (hives) and PRURITUS (itching all over her chest, back, arms, legs, feet, everywhere). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and PRURITUS (itching all over her chest, back, arms, legs, feet, everywhere) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: Very cold; Body aches; Fever temperature of 101 F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Very cold), PAIN (Body aches), PYREXIA (Fever temperature of 101 F) and HEADACHE (Headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING COLD (Very cold), PAIN (Body aches), PYREXIA (Fever temperature of 101 F) and HEADACHE (Headache). At the time of the report, FEELING COLD (Very cold), PAIN (Body aches), PYREXIA (Fever temperature of 101 F) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient also mentioned that he has not had a temperature like this in years  Treatment details was not provided.