chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: LOW PLATELETS; This spontaneous report received from a patient concerned a 90 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: transcatheter aortic valve replacement, and stoke, and concurrent conditions included: minor history of clotting, and other pre-existing medical conditions included: The patient had a strong immune system. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 04-AUG-2021) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. Concomitant medications included cannabidiol. On an unspecified date, the patient experienced low platelets. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low platelets was not reported. This report was non-serious.
Age: 90.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: LOW PLATELETS; This spontaneous report received from a patient concerned a 90 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: transcatheter aortic valve replacement, and stoke, and concurrent conditions included: minor history of clotting, and other pre-existing medical conditions included: The patient had a strong immune system. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 04-AUG-2021) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. Concomitant medications included cannabidiol. On an unspecified date, the patient experienced low platelets. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low platelets was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: HUGE RED RASH ABOVE LEFT KNEE; This spontaneous report received from a consumer concerned a 67 year old male. 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 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 huge red rash above left knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of huge red rash above left knee was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Illness, Pyrexia
Clinical narrative: DEATHLY ILL FOR A WEEK; EVERYTHING; RAN A FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced deathly ill for a week, ran a fever, and everything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deathly ill for a week, and the outcome of ran a fever and everything was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISING IN LEGS AND FEET; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had a family history of Idiopathic thrombocytopenic purpura (ITP), and a genetic disposition toward bruising, mild blood disorder. 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 bruising in legs and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising in legs and feet was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: THROWING UP; NAUSEA; This spontaneous report received from a pharmacist 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, and batch number were not reported) 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 throwing up, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throwing up, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Lacrimation increased
Clinical narrative: SWEATING; EYES TEARING UP; UNCONTROLLABLE CHILLS; MUSCLE WEAKNESS; HEADACHE; FEVER; EXHAUSTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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 was not reported, administered on 30-AUG-2021 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 sweating, eyes tearing up, uncontrollable chills, muscle weakness, headache, fever, and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sweating, uncontrollable chills, eyes tearing up, headache, muscle weakness and exhaustion was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: SWEATING; EYES TEARING UP; UNCONTROLLABLE CHILLS; MUSCLE WEAKNESS; HEADACHE; FEVER; EXHAUSTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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 was not reported, administered on 30-AUG-2021 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 sweating, eyes tearing up, uncontrollable chills, muscle weakness, headache, fever, and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sweating, uncontrollable chills, eyes tearing up, headache, muscle weakness and exhaustion was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 47 year old male. The patient's weight was 180 pounds, and height was 69 inches. The patient's concurrent conditions included: blood pressure, and back, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included meloxicam for back, and lisinopril for blood pressure.  On 31-AUG-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine suspension for injection, route of admin not reported, batch number Unknown dose was not reported, administered on 26-AUG-2021 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 AUG-2021, the patient experienced body wobble. On AUG-2021, the patient experienced feel shook literally from the cells out. On AUG-2021, the patient experienced down hard with ache. On AUG-2021, the patient experienced sudden menstruation. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced odd headache. On 31-AUG-2021, the patient experienced heart palpitations. The action taken with covid-19 vaccine was not applicable. The patient recovered from fatigue on AUG-2021, and the outcome of down hard with ache, chills, odd headache, sudden menstruation, heart palpitations, body wobble, and feel shook literally from the cells out was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pain, Palpitations
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine suspension for injection, route of admin not reported, batch number Unknown dose was not reported, administered on 26-AUG-2021 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 AUG-2021, the patient experienced body wobble. On AUG-2021, the patient experienced feel shook literally from the cells out. On AUG-2021, the patient experienced down hard with ache. On AUG-2021, the patient experienced sudden menstruation. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced odd headache. On 31-AUG-2021, the patient experienced heart palpitations. The action taken with covid-19 vaccine was not applicable. The patient recovered from fatigue on AUG-2021, and the outcome of down hard with ache, chills, odd headache, sudden menstruation, heart palpitations, body wobble, and feel shook literally from the cells out was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON LEG THAT IS SPREADING; This spontaneous report received from a health care professional concerned a 7 decade old male. 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-AUG-2021, the patient experienced rash on leg that is spreading. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on leg that is spreading. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Headache
Clinical narrative: BRUISES OCCURRED EASILY; HEADACHE; This spontaneous report received from a health care professional 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 was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced bruises occurred easily, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and bruises occurred easily was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: SENSATION OF PRESSURE IN EYE; This spontaneous report received from a patient concerned a 55 year old female. The patient's pre-existing medical conditions included: Patient had no known allergies and no relevant medical history. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-JUL-2021 for propylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for moderate to severe adult crohn's disease. On 06-AUG-2021, the patient experienced sensation of pressure in eye. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from sensation of pressure in eye. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Skin irritation
Clinical narrative: Itchy and irritating rash; Itchy and irritating rash; The rash is on my left forearm, left hand, right abdomen and right breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy and irritating rash), SKIN IRRITATION (Itchy and irritating rash) and RASH (The rash is on my left forearm, left hand, right abdomen and right breast) 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.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced RASH PRURITIC (Itchy and irritating rash), SKIN IRRITATION (Itchy and irritating rash) and RASH (The rash is on my left forearm, left hand, right abdomen and right breast). At the time of the report, RASH PRURITIC (Itchy and irritating rash), SKIN IRRITATION (Itchy and irritating rash) and RASH (The rash is on my left forearm, left hand, right abdomen and right breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Memory impairment, Somnolence
Clinical narrative: Feeling wobbly, shaky and sleepy; sleep a lot; forget a lot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling wobbly, shaky and sleepy), SOMNOLENCE (sleep a lot) and MEMORY IMPAIRMENT (forget a lot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling wobbly, shaky and sleepy), SOMNOLENCE (sleep a lot) and MEMORY IMPAIRMENT (forget a lot). At the time of the report, FEELING ABNORMAL (Feeling wobbly, shaky and sleepy), SOMNOLENCE (sleep a lot) and MEMORY IMPAIRMENT (forget a lot) outcome was unknown.            Relevant concomitant medications were not reported.  It was reported that the patient was not feeling right ever since the patient got the second shot of vaccine.  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: follow up : added dose number of vaccine and events (somnolence and memory impairment).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Illness, Myalgia, Vaccination site warmth
Clinical narrative: arm hot and sore/Notice my left arm aches/upper right arm aches and late at night it really starts aching; sick; arm hot and sore; hot to the touch where the vaccines; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), FEELING HOT (arm hot and sore), VACCINATION SITE WARMTH (hot to the touch where the vaccines) and MYALGIA (arm hot and sore/Notice my left arm aches/upper right arm aches and late at night it really starts aching) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes in August 2018 and Asthma in 1975. Concomitant products included INSULIN, HYDROCODONE, PANTOPRAZOLE, DICLOFENAC and VITAMIN E NOS for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ILLNESS (sick), FEELING HOT (arm hot and sore) and VACCINATION SITE WARMTH (hot to the touch where the vaccines). On 01-May-2021, the patient experienced MYALGIA (arm hot and sore/Notice my left arm aches/upper right arm aches and late at night it really starts aching). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) for Pain in arm, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, PARACETAMOL (EXCEDRIN BACK & BODY) for Pain in arm, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), FEELING HOT (arm hot and sore) and VACCINATION SITE WARMTH (hot to the touch where the vaccines) outcome was unknown and MYALGIA (arm hot and sore/Notice my left arm aches/upper right arm aches and late at night it really starts aching) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow-up received and updated Reporter information, medical history and outcome of event body ache to not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in a very aggressive rash on legs, arms, back, backside, hands, and upper arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broke out in a very aggressive rash on legs, arms, back, backside, hands, and upper arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 RASH (Broke out in a very aggressive rash on legs, arms, back, backside, hands, and upper arms). At the time of the report, RASH (Broke out in a very aggressive rash on legs, arms, back, backside, hands, and upper arms) had not resolved.            No concomitant medications were  reported.  The treatment medication included a steroid injection and that calmed the patient's rash down.  Patient had been given with  creams, pills and one injection, to alleviate his side effects.  Patient had consulted  4 dermatologists, his primary care doctor and an infectious disease doctor.The patient had done a biopsy advised by a dermatologist. The rash on stomach ,head, torso,been to an infectious disease doctor ,been to three dermatologists, doctors reported, when steroids are stopped rash comes back. The patient was still suffering ,felt vaccine caused him aggravation,uncomfortable,scratching all the time ,marks on his body ,had to cover up as much as he can, he used Duplixent  injection to help treat this.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow up received on 19-Aug-2021,treatment details added. Event outcome updated from unknown to not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Walking aid user
Clinical narrative: Young women with canes and problems with their knees after the shot; Young women with canes and problems with their knees after the shot; This spontaneous case was reported by a consumer and describes the occurrence of WALKING AID USER (Young women with canes and problems with their knees after the shot) and ARTHRALGIA (Young women with canes and problems with their knees after the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WALKING AID USER (Young women with canes and problems with their knees after the shot) and ARTHRALGIA (Young women with canes and problems with their knees after the shot). At the time of the report, WALKING AID USER (Young women with canes and problems with their knees after the shot) and ARTHRALGIA (Young women with canes and problems with their knees after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by the reporter No treatment medication reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow-up received on 23-AUG-2021 contains significant information: confirms product as Moderna COVID-19 vaccine
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: It has been more than 35 days after first dose and has not received the second dose; Got COVID-19 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days after first dose and has not received the second dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) 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 02-Apr-2021, the patient experienced COVID-19 (Got COVID-19 after first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days after first dose and has not received the second dose). The patient was treated with MONOCLONAL ANTIBODIES, GRANULOCYTE at an unspecified dose and frequency. At the time of the report, COVID-19 (Got COVID-19 after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days after first dose and has not received the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.         He was told not to get the second dose for 90 days after having COVID. Now he is about to get the second dose. No concomitant medications were mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: document received and contains no new information.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lip swelling, Mouth swelling
Clinical narrative: he started to get really dizzy; Mouth swollen.; Lips were swollen; Nose swollen; Feeling really tired; Next day he reported a fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, MOUTH SWELLING, LIP SWELLING, SWELLING, and FATIGUE in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IRON for an unknown indication.   On 21-Jun-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 an unknown date, the patient experienced DIZZINESS, MOUTH SWELLING, LIP SWELLING, SWELLING, FATIGUE, PYREXIA, and HEADACHE. At the time of the report, DIZZINESS, MOUTH SWELLING, LIP SWELLING, SWELLING, FATIGUE, PYREXIA, and HEADACHE outcome was unknown.            Concomitant products includes Blood pressure medication and Diabetes medication was also reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above on 26-Aug-2021, the follow up received contains non significant information that is contact information updated.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: he started to get really dizzy; Mouth swollen.; Lips were swollen; Nose swollen; Feeling really tired; Next day he reported a fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, MOUTH SWELLING, LIP SWELLING, SWELLING, and FATIGUE in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IRON for an unknown indication.   On 21-Jun-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 an unknown date, the patient experienced DIZZINESS, MOUTH SWELLING, LIP SWELLING, SWELLING, FATIGUE, PYREXIA, and HEADACHE. At the time of the report, DIZZINESS, MOUTH SWELLING, LIP SWELLING, SWELLING, FATIGUE, PYREXIA, and HEADACHE outcome was unknown.            Concomitant products includes Blood pressure medication and Diabetes medication was also reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above on 26-Aug-2021, the follow up received contains non significant information that is contact information updated.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Paraesthesia, Skin burning sensation, Vaccination site mass
Clinical narrative: Pain; left forearm started burning and tingling; Bumps appear inside left forearm; Bumps appeared inside my left elbow; Tingling in left forearm/expanded over left torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling in left forearm/expanded over left torso), VACCINATION SITE MASS (Bumps appear inside left forearm), HERPES ZOSTER (Bumps appeared inside my left elbow), PAIN (Pain) and SKIN BURNING SENSATION (left forearm started burning and tingling) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 019B21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC), VITAMIN D NOS and FISH OIL for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced PARAESTHESIA (Tingling in left forearm/expanded over left torso). On 24-May-2021, the patient experienced VACCINATION SITE MASS (Bumps appear inside left forearm) and HERPES ZOSTER (Bumps appeared inside my left elbow). On an unknown date, the patient experienced PAIN (Pain) and SKIN BURNING SENSATION (left forearm started burning and tingling). On 15-Aug-2021, HERPES ZOSTER (Bumps appeared inside my left elbow) had resolved. At the time of the report, PARAESTHESIA (Tingling in left forearm/expanded over left torso) and VACCINATION SITE MASS (Bumps appear inside left forearm) was resolving and PAIN (Pain) and SKIN BURNING SENSATION (left forearm started burning and tingling) outcome was unknown.            No treatment medications were reported. The event of Shingles was confirmed by two separate doctors according to the reporter.  Patient was on prolon diet(fast mimicking diet) from 17/05/2021 to 20/05/2021   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 and included contact information was updated. On 22-Aug-2021: Follow-up received: Pt. age, height, weight added. Added concomitant medication, new events (Pain, Skin burning sensation)were added, outcome of event updated, and narrative updated accordingly.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received 1st dose 31 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received 1st dose 31 hours after puncture) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C2A) for COVID-19 vaccination.     Concurrent medical conditions included GERD since 17-May-2021 and Hypotension since 17-May-2021. Concomitant products included OMEPRAZOLE from 17-May-2021 to an unknown date for GERD, BENAZEPRIL from 17-May-2021 to an unknown date for Hypotension.    On 14-Jul-2021 at 2:42 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received 1st dose 31 hours after puncture). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received 1st dose 31 hours after puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Patient Race and ethnicity added, Concomitant medications updated, Medical history updated, facility details and Reporter details.
Sex: F
Vaccine: COVID19
Symptoms: Incontinence, Urinary incontinence
Clinical narrative: Vaccine causing incontinence; dribble; This spontaneous case was reported by a consumer and describes the occurrence of INCONTINENCE (Vaccine causing incontinence) and URINARY INCONTINENCE (dribble) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 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 INCONTINENCE (Vaccine causing incontinence) and URINARY INCONTINENCE (dribble). At the time of the report, INCONTINENCE (Vaccine causing incontinence) had not resolved and URINARY INCONTINENCE (dribble) outcome was unknown. Not Provided          No concomitant medications were provided by reporter. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 28 Jul 2021: Added new event
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: Before the vaccine the patient suffered from fatigue and hot flushes from her menopause, which totally went away after the 2nd dose/the shots were good and made her feel great; Hot flashes returned; This spontaneous case was reported by a nurse and describes the occurrence of HOT FLUSH (Hot flashes returned) and THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine the patient suffered from fatigue and hot flushes from her menopause, which totally went away after the 2nd dose/the shots were good and made her feel great) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fatigue (fatigue and hot flushes from her menopause), Hot flushes (fatigue and hot flushes from her menopause) from January 2020 to March 2020 and COVID-19 on 23-Dec-2020. Concurrent medical conditions included Menopause (fatigue and hot flushes from her menopause) since January 2020. Concomitant products included IRON and MULTIVITAMIN [VITAMINS NOS] from 07-Jul-2006 to an unknown date for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. In March 2021, the patient experienced HOT FLUSH (Hot flashes returned). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine the patient suffered from fatigue and hot flushes from her menopause, which totally went away after the 2nd dose/the shots were good and made her feel great). At the time of the report, HOT FLUSH (Hot flashes returned) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine the patient suffered from fatigue and hot flushes from her menopause, which totally went away after the 2nd dose/the shots were good and made her feel great) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was available.  Patient informed that after receiving her Moderna 2nd shot, hot flashes were completely gone for three months. However, hot flashes had returned at the time of this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Patient demographics, Concomitant medicine( multivitamin), medical history, event, lab data added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Neoplasm, Vaccination site mass
Clinical narrative: she had a bump the side of a gulf ball on her arm at the injection site; tumor; sick in bed for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (she had a bump the side of a gulf ball on her arm at the injection site), NEOPLASM (tumor) and ILLNESS (sick in bed for 24 hours) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M210A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis since 31-Oct-2018, Allergy to antibiotic (Cipro), Penicillin allergy (Penicillin), Drug allergy (macrobide), Iodine allergy (iodine) and Shellfish allergy (shellfish). Concomitant products included OCRELIZUMAB (OCREVUS) from 15-Mar-2019 to an unknown date for Multiple sclerosis.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 VACCINATION SITE MASS (she had a bump the side of a gulf ball on her arm at the injection site), NEOPLASM (tumor) and ILLNESS (sick in bed for 24 hours). At the time of the report, VACCINATION SITE MASS (she had a bump the side of a gulf ball on her arm at the injection site) had not resolved and NEOPLASM (tumor) and ILLNESS (sick in bed for 24 hours) outcome was unknown.            Diagnostic results: On an unknown date, Antibody test-negative.  No treatment information was provided by the reporter   This case was linked to MOD-2021-031333.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Significant follow up appended: Event addition illness, height, weight, lab data On 17-Aug-2021: Follow up received contain non significant information
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizziness; Having Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PYREXIA (Having Fever) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and PYREXIA (Having Fever). At the time of the report, DIZZINESS (Dizziness) and PYREXIA (Having Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not reported.  No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Significant follow up received. Having Fever a new Event added.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Tinnitus
Clinical narrative: Pulsating tinnitus/can hear her heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Pulsating tinnitus/can hear her heartbeat) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tetracycline). Concomitant products included SPIRONOLACTONE (SPIRONOLACTON) for Female pattern baldness, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation, SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]), CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (GLUCOSAMIN CHONDR), COLECALCIFEROL (D3), BIOTIN from 2018 to an unknown date and UBIDECARENONE (COQ-10) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced TINNITUS (Pulsating tinnitus/can hear her heartbeat). At the time of the report, TINNITUS (Pulsating tinnitus/can hear her heartbeat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Nothing of any consequence has been found.. On an unknown date, Magnetic resonance imaging: normal (normal) Nothing of any consequence has been found..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant products included biotin tablet (2018), bone support (2020), coq-10 (30 mg) capsule (1987), selenium plus capsule at lunch (2020).  Laboratory details included, X-Rays done and reported with no results.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow-up received contains additional details of patient demographics, medical history, lab details, suspected drug- start date and batch number, concomitant medications and event details updated.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Missed second dose date; 90 days since first dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (90 days since first dose) and PRODUCT DOSE OMISSION ISSUE (Missed second dose date) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0UU21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (90 days since first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose date). On 30-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (90 days since first dose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported by the porter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow up appended for document attachment contains no new information. On 18-Aug-2021: Follow up information contains event: Missed second dose date.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 13th-may-21 and second dsoe on 6th-jun-21; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 13th-may-21 and second dsoe on 6th-jun-21) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C121A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021 at 1:45 AM, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 13th-may-21 and second dsoe on 6th-jun-21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 13th-may-21 and second dsoe on 6th-jun-21) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported by patient.  Patient reported no adverse events with second dose of moderna vaccine.   This case was linked to MOD-2021-249067 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Interchange of vaccine products, Pain in extremity, Pyrexia
Clinical narrative: Soreness in arm; Minor fever; Fatigue; Got pfizer vaccine 3rd dose after Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Minor fever), FATIGUE (Fatigue) and INTERCHANGE OF VACCINE PRODUCTS (Got pfizer vaccine 3rd dose after Moderna) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 041L20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got pfizer vaccine 3rd dose after Moderna). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Minor fever) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Minor fever) and FATIGUE (Fatigue) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Got pfizer vaccine 3rd dose after Moderna) outcome was unknown.            Concomitant medications, Lab data details and Treatment information, if any,  were  not provided.   One day after the second dose patient had minor arm pain and a mild fever that lasted about two days and also have some fatigue for 2-3 days.   Patient received one dose of the Pfizer vaccine and did not have any symptoms after Pfizer vaccine. So roughly in 3 month time period patient had 3 separate COVID 19 vaccines with no major incidents and was planning on taking a 4th (booster) vaccine in the next few months.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Included additional event, facility Information updated. Lot No. of Pfizer vaccine dose updated, event outcome updated
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: 6000 patients reported paresthesia; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (6000 patients reported paresthesia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (6000 patients reported paresthesia). At the time of the report, PARAESTHESIA (6000 patients reported paresthesia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.