chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: CHANGE THE TEXTURE OF HIS SKIN; WARM TO THE TOUCH; ACHINESS; CHILLS; RASH; FEVER; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hives, and concurrent conditions included: acid reflux, and amoxicillin allergy, and other pre-existing medical conditions included: The patient had no trouble with his breathing. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced change the texture of his skin. On 16-SEP-2021, the patient experienced warm to the touch. On 16-SEP-2021, the patient experienced achiness. On 16-SEP-2021, the patient experienced chills. On 16-SEP-2021, the patient experienced rash. On 16-SEP-2021, the patient experienced fever. Treatment medications included: diphenhydramine hydrochloride, ibuprofen, and paracetamol.  The patient recovered from achiness, chills, and fever on 18-SEP-2021, had not recovered from rash, and the outcome of change the texture of his skin and warm to the touch was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia, Nausea, Panic attack
Clinical narrative: DIZZY; FELT TO GET A PANIC ATTACK (HYPERVENTILATE, TIGHTNESS OF CHEST, SHORTNESS OF BREATH); FINGERS STARTED TO GET NUMB (FEELING BECAME WORSE THEN BETTER AND NOT CONSTANT); VOMITING/ THREW UP; NAUSEOUS; FELT WEIRD (FEELING BECAME WORSE THEN BETTER AND NOT CONSTANT); This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included: brain injury, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-SEP-2021, the patient experienced felt weird (feeling became worse then better and not constant). On 14-SEP-2021, the patient experienced nauseous. On 17-SEP-2021, the patient experienced dizzy. On 17-SEP-2021, the patient experienced felt to get a panic attack (hyperventilate, tightness of chest, shortness of breath). On 17-SEP-2021, the patient experienced fingers started to get numb (feeling became worse then better and not constant). On 17-SEP-2021, the patient experienced vomiting/ threw up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nauseous, dizzy, vomiting/ threw up, fingers started to get numb (feeling became worse then better and not constant), felt weird (feeling became worse then better and not constant), and felt to get a panic attack (hyperventilate, tightness of chest, shortness of breath). This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DIZZY; FELT TO GET A PANIC ATTACK (HYPERVENTILATE, TIGHTNESS OF CHEST, SHORTNESS OF BREATH); FINGERS STARTED TO GET NUMB (FEELING BECAME WORSE THEN BETTER AND NOT CONSTANT); VOMITING/ THREW UP; NAUSEOUS; FELT WEIRD (FEELING BECAME WORSE THEN BETTER AND NOT CONSTANT); This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included: brain injury, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-SEP-2021, the patient experienced felt weird (feeling became worse then better and not constant). On 14-SEP-2021, the patient experienced nauseous. On 17-SEP-2021, the patient experienced dizzy. On 17-SEP-2021, the patient experienced felt to get a panic attack (hyperventilate, tightness of chest, shortness of breath). On 17-SEP-2021, the patient experienced fingers started to get numb (feeling became worse then better and not constant). On 17-SEP-2021, the patient experienced vomiting/ threw up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nauseous, dizzy, vomiting/ threw up, fingers started to get numb (feeling became worse then better and not constant), felt weird (feeling became worse then better and not constant), and felt to get a panic attack (hyperventilate, tightness of chest, shortness of breath). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: SERIOUS FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced serious fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from serious fever, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE REACTIONS; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reactions was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Peripheral swelling, Ultrasound scan
Clinical narrative: HAND SWELLING, FEET WERE SWELLING; LEG CRAMPS, RIGHT LEG CRAMPING DURING INTERACTION; THROBBING PAIN IN LEFT SHOULDER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high cholesterol, rheumatoid arthritis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced hand swelling, feet were swelling, leg cramps, right leg cramping during interaction, and throbbing pain in left shoulder. Laboratory data (dates unspecified) included: Ultrasound scan (NR: not provided) No blood clots. Treatment medications (dates unspecified) included: prednisone, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramps, right leg cramping during interaction, and the outcome of hand swelling, feet were swelling and throbbing pain in left shoulder was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815521.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Anxiety, Dyspnoea, Eructation, Fatigue
Clinical narrative: FELT HOT; ANXIOUS; SHORTWINDED; BLOATED; MORE BELCHING; TENDERNESS AND PAIN  AT INJECTION SITE; FELT TIRED AND FATIGUED; HEADACHE; SORE ARM/ ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: smallpox vaccination, polio vaccination, hepatitis a vaccination, hepatitis b vaccination, measles, mumps and rubella vaccination, pertussis vaccination, typhoid vaccination, and shingles vaccination, and concurrent conditions included: drug allergy, penicillin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had tons of allergies and she did not had any chronic conditions nor did she take any medications. The patient was taking an allergy pill, a probiotic, and vitamins regularly. The patient was previously treated with oseltamivir phosphate for drug allergy; and experienced drug allergy when treated with prednisone non-company for drug used for unknown indication, and drug allergy when treated with morphine non-company. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced sore arm/ arm pain. On 18-SEP-2021, the patient experienced felt hot. On 18-SEP-2021, the patient experienced anxious. On 18-SEP-2021, the patient experienced shortwinded. On 18-SEP-2021, the patient experienced bloated. On 18-SEP-2021, the patient experienced more belching. On 18-SEP-2021, the patient experienced tenderness and pain at injection site. On 18-SEP-2021, the patient experienced felt tired and fatigued. On 18-SEP-2021, the patient experienced headache. Treatment medications (dates unspecified) included: diethylamine salicylate/methyl nicotinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, anxious, shortwinded, bloated, more belching, felt tired and fatigued, and headache on 19-SEP-2021, and had not recovered from sore arm/ arm pain, and tenderness and pain at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Injection site pain, Pain in extremity
Clinical narrative: FELT HOT; ANXIOUS; SHORTWINDED; BLOATED; MORE BELCHING; TENDERNESS AND PAIN  AT INJECTION SITE; FELT TIRED AND FATIGUED; HEADACHE; SORE ARM/ ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: smallpox vaccination, polio vaccination, hepatitis a vaccination, hepatitis b vaccination, measles, mumps and rubella vaccination, pertussis vaccination, typhoid vaccination, and shingles vaccination, and concurrent conditions included: drug allergy, penicillin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had tons of allergies and she did not had any chronic conditions nor did she take any medications. The patient was taking an allergy pill, a probiotic, and vitamins regularly. The patient was previously treated with oseltamivir phosphate for drug allergy; and experienced drug allergy when treated with prednisone non-company for drug used for unknown indication, and drug allergy when treated with morphine non-company. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced sore arm/ arm pain. On 18-SEP-2021, the patient experienced felt hot. On 18-SEP-2021, the patient experienced anxious. On 18-SEP-2021, the patient experienced shortwinded. On 18-SEP-2021, the patient experienced bloated. On 18-SEP-2021, the patient experienced more belching. On 18-SEP-2021, the patient experienced tenderness and pain at injection site. On 18-SEP-2021, the patient experienced felt tired and fatigued. On 18-SEP-2021, the patient experienced headache. Treatment medications (dates unspecified) included: diethylamine salicylate/methyl nicotinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, anxious, shortwinded, bloated, more belching, felt tired and fatigued, and headache on 19-SEP-2021, and had not recovered from sore arm/ arm pain, and tenderness and pain at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic, Skin burning sensation
Clinical narrative: BURNING OF THE SKIN; RASH TO THE ANKLES WITH INTERNAL ITCHING THEN PROGRESSIVELY SPREAD TO THE THIGHS, BACK, BILATERAL SIDES AND SHOULDERS, RASH WAS RAISED, WARM, WELTED IN SOME AREAS AND EXTREMELY ITCHY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-SEP-2021, the patient experienced burning of the skin. On 01-SEP-2021, the patient experienced rash to the ankles with internal itching then progressively spread to the thighs, back, bilateral sides and shoulders, rash was raised, warm, welted in some areas and extremely itchy. Treatment medications (dates unspecified) included: triamcinolone, ibuprofen, diphenhydramine hydrochloride, methylprednisolone, fluticasone propionate, cortisone, and pseudoephedrine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rash to the ankles with internal itching then progressively spread to the thighs, back, bilateral sides and shoulders, rash was raised, warm, welted in some areas and extremely itchy, and burning of the skin. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: ALL SORTS OF COMPLICATIONS; This spontaneous report received from a consumer via a company representative concerned a 26 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced all sorts of complications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of all sorts of complications was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Sleep apnoea syndrome
Clinical narrative: SLEEP APNEA; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for rheumatoid arthritis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sleep apnea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from sleep apnea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: CARDIAC PROBLEMS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cardiac problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiac problems was not reported. This report was non-serious. This case, from the same reporter is linked to 20210920683.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Very mild symptoms like body pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Very mild symptoms like body pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced MYALGIA (Very mild symptoms like body pain). At the time of the report, MYALGIA (Very mild symptoms like body pain) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe pain in forearm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in forearm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (Severe pain in forearm). At the time of the report, PAIN IN EXTREMITY (Severe pain in forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pyrexia
Clinical narrative: Chest Pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain) and PYREXIA (Fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced PYREXIA (Fever). In July 2021, the patient experienced CHEST PAIN (Chest Pain). At the time of the report, CHEST PAIN (Chest Pain) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were reported.  No treatment information were reported.  Patient  went to the hospital on 5JUL2021 for the chest pains and he told that everything is fine at this time after routine tests and the patient was referred to a Cardiologist. Patient took second dose of vaccine on 19 Aug 2021(088B21A) intramuscularly and experienced the same side effects.   This case was linked to MOD-2021-308353 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Added reporter's state. Updated action taken and onset date for fever.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, SARS-CoV-2 test, Tinnitus
Clinical narrative: Hot flash; ringing in ear; Tinitus; hot flush; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flash), TINNITUS (ringing in ear), TINNITUS (Tinitus) and HOT FLUSH (hot flush) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jan-2021, the patient experienced TINNITUS (Tinitus) and HOT FLUSH (hot flush). On 22-Jan-2021, the patient experienced HOT FLUSH (Hot flash) and TINNITUS (ringing in ear). At the time of the report, HOT FLUSH (Hot flash) and TINNITUS (ringing in ear) outcome was unknown and TINNITUS (Tinitus) and HOT FLUSH (hot flush) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2020, SARS-CoV-2 test: positive (Positive) 3 days test nose swab.         No relevant concomitant medications were provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up document contain new event  were added and patient demographics was updated.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Red blotches all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches all over body) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 040A21A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced RASH MACULAR (Red blotches all over body). The patient was treated with TRIAMCINOLONE for Rash, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date for Rash, at a dose of 20 mg twice a day. At the time of the report, RASH MACULAR (Red blotches all over body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that the patient still has all red quarter size spots on his body, some days they are more clear, and some days they got very red. The Patient's doctor had said  that it might take about 6months for them to clear.   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Follow-up received added event details.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her arm where she was injected was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her arm where she was injected was a little sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091021A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced VACCINATION SITE PAIN (Her arm where she was injected was a little sore). On 21-Jul-2021, VACCINATION SITE PAIN (Her arm where she was injected was a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up contains significant information of second dose details
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Cold sweat, Dizziness
Clinical narrative: Trouble getting up; Fatigue; Chills; arm was swollen at injection site "little bigger than first one"; arm felt very painful; Fever for 3 days; in cold sweats; got hot really quickly; Taste Buds are off; Feeling dizzy; Smell was off; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (in cold sweats), FEELING HOT (got hot really quickly), AGEUSIA (Taste Buds are off), DIZZINESS (Feeling dizzy) and ANOSMIA (Smell was off) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced COLD SWEAT (in cold sweats), FEELING HOT (got hot really quickly), AGEUSIA (Taste Buds are off), DIZZINESS (Feeling dizzy), ANOSMIA (Smell was off), VACCINATION SITE SWELLING (arm was swollen at injection site "little bigger than first one"), VACCINATION SITE PAIN (arm felt very painful) and PYREXIA (Fever for 3 days). On an unknown date, the patient experienced SOMNOLENCE (Trouble getting up), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COLD SWEAT (in cold sweats), FEELING HOT (got hot really quickly), AGEUSIA (Taste Buds are off), DIZZINESS (Feeling dizzy), SOMNOLENCE (Trouble getting up), VACCINATION SITE SWELLING (arm was swollen at injection site "little bigger than first one"), VACCINATION SITE PAIN (arm felt very painful), PYREXIA (Fever for 3 days), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown and ANOSMIA (Smell was off) was resolving.            No concomitant medications were reported.   This case was linked to MOD-2021-262876 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up received includes Updated outcome of event Anosmia from unknown to recovering/resolving. pregnancy information updated to unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: Trouble getting up; Fatigue; Chills; arm was swollen at injection site "little bigger than first one"; arm felt very painful; Fever for 3 days; in cold sweats; got hot really quickly; Taste Buds are off; Feeling dizzy; Smell was off; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (in cold sweats), FEELING HOT (got hot really quickly), AGEUSIA (Taste Buds are off), DIZZINESS (Feeling dizzy) and ANOSMIA (Smell was off) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced COLD SWEAT (in cold sweats), FEELING HOT (got hot really quickly), AGEUSIA (Taste Buds are off), DIZZINESS (Feeling dizzy), ANOSMIA (Smell was off), VACCINATION SITE SWELLING (arm was swollen at injection site "little bigger than first one"), VACCINATION SITE PAIN (arm felt very painful) and PYREXIA (Fever for 3 days). On an unknown date, the patient experienced SOMNOLENCE (Trouble getting up), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COLD SWEAT (in cold sweats), FEELING HOT (got hot really quickly), AGEUSIA (Taste Buds are off), DIZZINESS (Feeling dizzy), SOMNOLENCE (Trouble getting up), VACCINATION SITE SWELLING (arm was swollen at injection site "little bigger than first one"), VACCINATION SITE PAIN (arm felt very painful), PYREXIA (Fever for 3 days), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown and ANOSMIA (Smell was off) was resolving.            No concomitant medications were reported.   This case was linked to MOD-2021-262876 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up received includes Updated outcome of event Anosmia from unknown to recovering/resolving. pregnancy information updated to unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Trouble getting up; Fatigue; Chills; arm was swollen at injection site "little bigger than first one"; arm felt very painful; Fever for 3 days; in cold sweats; got hot really quickly; Taste Buds are off; Feeling dizzy; Smell was off; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (in cold sweats), FEELING HOT (got hot really quickly), AGEUSIA (Taste Buds are off), DIZZINESS (Feeling dizzy) and ANOSMIA (Smell was off) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced COLD SWEAT (in cold sweats), FEELING HOT (got hot really quickly), AGEUSIA (Taste Buds are off), DIZZINESS (Feeling dizzy), ANOSMIA (Smell was off), VACCINATION SITE SWELLING (arm was swollen at injection site "little bigger than first one"), VACCINATION SITE PAIN (arm felt very painful) and PYREXIA (Fever for 3 days). On an unknown date, the patient experienced SOMNOLENCE (Trouble getting up), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COLD SWEAT (in cold sweats), FEELING HOT (got hot really quickly), AGEUSIA (Taste Buds are off), DIZZINESS (Feeling dizzy), SOMNOLENCE (Trouble getting up), VACCINATION SITE SWELLING (arm was swollen at injection site "little bigger than first one"), VACCINATION SITE PAIN (arm felt very painful), PYREXIA (Fever for 3 days), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown and ANOSMIA (Smell was off) was resolving.            No concomitant medications were reported.   This case was linked to MOD-2021-262876 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up received includes Updated outcome of event Anosmia from unknown to recovering/resolving. pregnancy information updated to unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got first dose on April, has not gotten second dose yet.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got first dose on April, has not gotten second dose yet.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 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 PRODUCT DOSE OMISSION ISSUE (Got first dose on April, has not gotten second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got first dose on April, has not gotten second dose yet.) had resolved.            The patient stated that I was already fully vaccinated.  No concomitants were reported. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up information include vaccine start date captured, Action taken updated to not applicable and narrative updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination complication
Clinical narrative: Delayed side effects; Pain in hands; tingling in feet and hands; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Delayed side effects), PARAESTHESIA (tingling in feet and hands) and PAIN IN EXTREMITY (Pain in hands) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (tingling in feet and hands). On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed side effects) and PAIN IN EXTREMITY (Pain in hands). At the time of the report, VACCINATION COMPLICATION (Delayed side effects) and PAIN IN EXTREMITY (Pain in hands) outcome was unknown and PARAESTHESIA (tingling in feet and hands) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.  No Treatment medications were provided by reporter. Vaccination facility type was Public health clinic.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up recieved contains no new information.. On 14-Aug-2021: Follow up recieved contains no new information. On 10-Sep-2021: Significant follow up received includes Patient demographic details, Patient's historical condition,  1st and 2nd dose  details, Vaccine facility information  and new events Tingling and pain in extremity are added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: two individuals received the Moderna vaccine dose #2 at day 21; received a Johnson & Johnson shot on 27/May/2021 and their first Moderna shot on 09/Jul/2021; first Moderna shot on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021); This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a Johnson & Johnson shot on 27/May/2021 and their first Moderna shot on 09/Jul/2021), EXPIRED PRODUCT ADMINISTERED (first Moderna shot on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two individuals received the Moderna vaccine dose #2 at day 21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced WRONG PRODUCT ADMINISTERED (received a Johnson & Johnson shot on 27/May/2021 and their first Moderna shot on 09/Jul/2021) and EXPIRED PRODUCT ADMINISTERED (first Moderna shot on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021)). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two individuals received the Moderna vaccine dose #2 at day 21). At the time of the report, WRONG PRODUCT ADMINISTERED (received a Johnson & Johnson shot on 27/May/2021 and their first Moderna shot on 09/Jul/2021), EXPIRED PRODUCT ADMINISTERED (first Moderna shot on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two individuals received the Moderna vaccine dose #2 at day 21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 27 May 2021, patient received the Johnson & Johnson COVID-19 vaccination. Concomitant information was not provided. Treatment information does not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: updated event two individuals received the Moderna vaccine dose #2 at day 21 On 09-Sep-2021: non significant Follow-up document received .
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Illness
Clinical narrative: Got sick; Every joint in body hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) and ARTHRALGIA (Every joint in body hurt) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick) and ARTHRALGIA (Every joint in body hurt). At the time of the report, ILLNESS (Got sick) and ARTHRALGIA (Every joint in body hurt) had resolved.            No concomitant medication information was provided. No treatment medication were provided. Patient took  shingrix  vaccine after 2 doses of Moderna vaccine
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Myalgia
Clinical narrative: ALLERGY SYMPTOMS; She is sore; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (ALLERGY SYMPTOMS) and MYALGIA (She is sore) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.  No treatment medication reported.     On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced ALLERGY TO VACCINE (ALLERGY SYMPTOMS) and MYALGIA (She is sore). At the time of the report, ALLERGY TO VACCINE (ALLERGY SYMPTOMS) and MYALGIA (She is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by reporter.  No concomitant medication reported.  No treatment medication reported   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: They have a patient who got their first dose on 28May2021 and has not gotten their 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (They have a patient who got their first dose on 28May2021 and has not gotten their 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-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 PRODUCT DOSE OMISSION ISSUE (They have a patient who got their first dose on 28May2021 and has not gotten their 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (They have a patient who got their first dose on 28May2021 and has not gotten their 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Myalgia
Clinical narrative: Back problem; My mother had sore arm for a week or two; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Back problem) and MYALGIA (My mother had sore arm for a week or two) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK DISORDER (Back problem) and MYALGIA (My mother had sore arm for a week or two). At the time of the report, BACK DISORDER (Back problem) outcome was unknown and MYALGIA (My mother had sore arm for a week or two) had resolved.            No concomitant medication information was provided.   Patient took treatment medication steroid daily for back problem
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Oropharyngeal pain, Pyrexia, Vaccination site pain
Clinical narrative: Sore throat; Chills; Sore injection site arm; Fever of 102 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), VACCINATION SITE PAIN (Sore injection site arm) and PYREXIA (Fever of 102 degrees Farenheight) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), VACCINATION SITE PAIN (Sore injection site arm) and PYREXIA (Fever of 102 degrees Farenheight). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), VACCINATION SITE PAIN (Sore injection site arm) and PYREXIA (Fever of 102 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) fever of 102 degrees Farenheight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: If she should vaccinate the patient today 17Aug2021 even though it is 42 days past the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (If she should vaccinate the patient today 17Aug2021 even though it is 42 days past the first dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (If she should vaccinate the patient today 17Aug2021 even though it is 42 days past the first dose). On 16-May-2021, PRODUCT DOSE OMISSION ISSUE (If she should vaccinate the patient today 17Aug2021 even though it is 42 days past the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Vomiting
Clinical narrative: vomiting repeatedly; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting repeatedly) and EXTRA DOSE ADMINISTERED (Extra dose administered) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 024M20A and 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 17-Aug-2021, the patient experienced VOMITING (vomiting repeatedly). On 15-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, VOMITING (vomiting repeatedly) outcome was unknown.            No Concomitant Medications were provided. No Treatment Medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported by the reporter.   No treatment medication were reported.