chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Taste disorder
Clinical narrative: WEIRD SENSE OF SMELL; WEIRD SENSE OF TASTE; RUNNY NOSE; COUGH; SORENESS ON THE LEFT ARM; BURNING PAIN ON THE LEFT ARM; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure (152/80), and chronic obstructive pulmonary disease (copd). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-AUG-2021, the subject experienced burning pain on the left arm. On 03-AUG-2021, the subject experienced weird sense of smell. On 03-AUG-2021, the subject experienced weird sense of taste. On 03-AUG-2021, the subject experienced runny nose. On 03-AUG-2021, the subject experienced cough. On 03-AUG-2021, the subject experienced soreness on the left arm. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 152/80 (High). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning pain on the left arm on 03-AUG-2021, and had not recovered from soreness on the left arm, weird sense of smell, weird sense of taste, runny nose, and cough. This report was non-serious.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Oropharyngeal pain, Pain, Upper-airway cough syndrome
Clinical narrative: BODY ACHES; SORE THROAT; FELT WARM BUT NOT FEVERISH; OCCASIONAL DRIP FROM NOSE; This spontaneous report received from a patient concerned a 73 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-AUG-2021, the subject experienced body aches. On 02-AUG-2021, the subject experienced sore throat. On 02-AUG-2021, the subject experienced felt warm but not feverish. On 02-AUG-2021, the subject experienced occasional drip from nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, sore throat, felt warm but not feverish, and occasional drip from nose. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; LOW GRADE FEVER; 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 subject experienced body aches, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches and low grade fever was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Injection site pain, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOTS IN LEGS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoking on a daily basis, and abstains from alcohol. The patient had no known allergies and drug abuse or illicit drug usage and was not comfortable disclosing other medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry date: unknown) dose was not reported, 1 total, administered on 31-MAR-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the patient experienced injection site pain and pain and swelling in both the legs, knee cap, ankle and feet. The patient went to a doctor the same day where they performed blood works (blood test, result was not reported) and ultrasound scan (sonogram imaging) which showed blood clots in legs. The patient was prescribed a blood thinner pradaxa (dabigatran etexilate mesilate). The patient was using walker to ambulate. Patient scheduled with another sonogram on 04-AUG-2021 The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and had not recovered from blood clots in legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210805948 - Covid-19 vaccine ad26.cov2.s - BLOOD CLOTS IN LEGS. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Generalised anxiety disorder, Mucosal haemorrhage, Pain in extremity
Clinical narrative: BLOODY MUCOUS WHEN BLOWING NOSE/BLOODY SNOT ON NOSE; GENERALIZED ANXIETY DISORDER / ANXIETY SPIRAL (HEAVY BREATHING, COULD NOT SLEEP); LOOKED LIKE BRUISE ON LEG; PAIN IN ARM/ARM STARTED TO HURT BADLY IN THE AREA ABOUT THE SIZE OF A PALM; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight was 256 pounds, and height was 67 inches. The patient's concurrent conditions included very rare alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no past medical history. the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with metoclopramide hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced pain in arm/arm started to hurt badly in the area about the size of a palm. On 29-MAY-2021, the subject experienced generalized anxiety disorder / anxiety spiral (heavy breathing, could not sleep). On 29-MAY-2021, the subject experienced looked like bruise on leg. On JUN-2021, the subject experienced bloody mucous when blowing nose/bloody snot on nose. Treatment medications (dates unspecified) included: escitalopram oxalate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody mucous when blowing nose/bloody snot on nose on 21-JUL-2021, and pain in arm/arm started to hurt badly in the area about the size of a palm on 09-JUN-2021, had not recovered from generalized anxiety disorder / anxiety spiral (heavy breathing, could not sleep), and the outcome of looked like bruise on leg was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; 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 subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pruritus, Skin mass
Clinical narrative: LUMPS COME UP, LAST LUMP WAS BEHIND THE RIGHT EAR; KNOTS UNDER SKIN; ITCHING; This spontaneous report received from a patient concerned an 82 year old female. 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: 1808978, expiry: 11-SEP-2021) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: calamine, and hydrocortisone. On 21-JUL-2021, the subject experienced itching. On 21-JUL-2021, the subject experienced knots under skin. On an unspecified date, the subject experienced lumps come up, last lump was behind the right ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, and knots under skin, and the outcome of lumps come up, last lump was behind the right ear was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY PAIN; FEVER; This spontaneous report received from a patient via a company representative from 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 subject experienced body pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body pain and fever was not reported. This report was non-serious.
Age: 48.0
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 patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and drug abuse or illicit drug usage. 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 19-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-AUG-2021, the subject experienced covid-19 test positive. Laboratory data included: COVID-19 virus 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.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POSSIBLE MULTIPLE POTENTIAL ADMINISTRATION ERROR; MULTIPLE FREEZING TEMPERATURE EXCURSIONS POSSIBLY MORE THAN 20 UNPUNCTURED VIALS; This spontaneous report received from a patient 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, and batch number: 041A21A expiry: 19-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced possible multiple potential administration error. On 29-APR-2021, the subject experienced multiple freezing temperature excursions possibly more than 20 unpunctured vials. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible multiple potential administration error and multiple freezing temperature excursions possibly more than 20 unpunctured vials was not reported. This report was non-serious. This case, from the same reporter is linked to 20210807547.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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: 1808609 expiry: 1-JUN-2021) dose was not reported, administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye pain, Headache, Nausea, Pyrexia
Clinical narrative: EYES HURT; SEVERE MIGRAINE LIKE HEADACHES; VERY NAUSEATED; FEVER OF 102F; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug or non-drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the subject experienced eyes hurt. On 04-AUG-2021, the subject experienced severe migraine like headaches. On 04-AUG-2021, the subject experienced very nauseated. On 04-AUG-2021, the subject experienced fever of 102f. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine like headaches, eyes hurt, very nauseated, and fever of 102f. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pain
Clinical narrative: SORENESS; SWEATS; CHILLS; FEVER; WORST HEADACHE; FATIGUE; 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: 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 subject experienced soreness, sweats, chills, fever, worst headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, sweats, chills, fever, worst headache, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORENESS; SWEATS; CHILLS; FEVER; WORST HEADACHE; FATIGUE; 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: 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 subject experienced soreness, sweats, chills, fever, worst headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, sweats, chills, fever, worst headache, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHOEA; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhoea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhoea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: HIGH FEVER; SEVERE 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. the company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced high fever, and severe headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever and severe headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HIGH FEVER; EXTREME HEADACHE; This spontaneous report received from a consumer 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: 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 subject experienced high fever, and extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, and extreme headache. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood pressure measurement, Body temperature, Dizziness
Clinical narrative: PANIC ATTACK; KNEE PAIN; PAIN AROUND THE BRA STRAP IN THE BACK; SLEPT ALL DAY; ARM HURTING FROM THE INJECTION; FLU LIKE SYMPTOMS; DIZZINESS/FELT DIZZY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included antibiotic allergy, and metal allergy, and other pre-existing medical conditions included patient is allergic to pain medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the subject experienced dizziness/felt dizzy. On 29-JUL-2021, the subject experienced flu like symptoms. Laboratory data included: Blood pressure (NR: not provided) normal, 98/58 mmHg, and Body temperature (NR: not provided) 99 F. On 30-JUL-2021, the subject experienced slept all day. On 30-JUL-2021, the subject experienced arm hurting from the injection. Treatment medications included: ibuprofen. On 03-AUG-2021, treatment medications included: ondansetron. On 05-AUG-2021, the subject experienced pain around the bra strap in the back. On 05-AUG-2021, the subject experienced knee pain. On an unspecified date, the subject experienced panic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms, panic attack, knee pain, and pain around the bra strap in the back, and the outcome of dizziness/felt dizzy, arm hurting from the injection and slept all day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210810461.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Influenza like illness, Pain in extremity, Panic attack
Clinical narrative: PANIC ATTACK; KNEE PAIN; PAIN AROUND THE BRA STRAP IN THE BACK; SLEPT ALL DAY; ARM HURTING FROM THE INJECTION; FLU LIKE SYMPTOMS; DIZZINESS/FELT DIZZY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included antibiotic allergy, and metal allergy, and other pre-existing medical conditions included patient is allergic to pain medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the subject experienced dizziness/felt dizzy. On 29-JUL-2021, the subject experienced flu like symptoms. Laboratory data included: Blood pressure (NR: not provided) normal, 98/58 mmHg, and Body temperature (NR: not provided) 99 F. On 30-JUL-2021, the subject experienced slept all day. On 30-JUL-2021, the subject experienced arm hurting from the injection. Treatment medications included: ibuprofen. On 03-AUG-2021, treatment medications included: ondansetron. On 05-AUG-2021, the subject experienced pain around the bra strap in the back. On 05-AUG-2021, the subject experienced knee pain. On an unspecified date, the subject experienced panic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms, panic attack, knee pain, and pain around the bra strap in the back, and the outcome of dizziness/felt dizzy, arm hurting from the injection and slept all day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210810461.
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Pain in extremity
Clinical narrative: FLU SYMPTOMS; HURT IN ARM; 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 ad26.cov2.s (suspension for injection, route of admin 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 subject experienced flu symptoms, and hurt in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms, and hurt in arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: EXPECTED VACCINE SIDE EFFECTS; This spontaneous report received from a consumer 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 subject experienced expected vaccine side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expected vaccine side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210810385.
Sex: U
Vaccine: COVID19
Symptoms: Injection site bruising, Pyrexia
Clinical narrative: FELT LIKE BRUISED ON INJECTION SITE; FEVER; 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 was not reported, administered on 03-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 04-AUG-2021, the subject experienced felt like bruised on injection site. On 04-AUG-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and felt like bruised on injection site. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye irritation, Eye pain, Fatigue, Headache
Clinical narrative: SCRATCHY EYES; ACHY EYES; JOINT ACHES; GENERAL MALAISE; FATIGUE; HEADACHES; MINOR SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 52 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: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-AUG-2021, the subject experienced scratchy eyes. On 04-AUG-2021, the subject experienced achy eyes. On 04-AUG-2021, the subject experienced joint aches. On 04-AUG-2021, the subject experienced general malaise. On 04-AUG-2021, the subject experienced fatigue. On 04-AUG-2021, the subject experienced headaches. On 04-AUG-2021, the subject experienced minor soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint aches, general malaise, fatigue, headaches, minor soreness at injection site, scratchy eyes, and achy eyes. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Malaise
Clinical narrative: SCRATCHY EYES; ACHY EYES; JOINT ACHES; GENERAL MALAISE; FATIGUE; HEADACHES; MINOR SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 52 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: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-AUG-2021, the subject experienced scratchy eyes. On 04-AUG-2021, the subject experienced achy eyes. On 04-AUG-2021, the subject experienced joint aches. On 04-AUG-2021, the subject experienced general malaise. On 04-AUG-2021, the subject experienced fatigue. On 04-AUG-2021, the subject experienced headaches. On 04-AUG-2021, the subject experienced minor soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint aches, general malaise, fatigue, headaches, minor soreness at injection site, scratchy eyes, and achy eyes. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: MILD INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient takes blood pressure medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced mild injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild injection site soreness on 05-JUN-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: FEVER OF 104.7F; HEADACHE; This spontaneous report received from a patient 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: Unknown) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 05-AUG-2021, the subject experienced fever of 104.7f. On 05-AUG-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 104.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 104.7f, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: POSITIVE SIDE AFFECTS (GLUTEN ISSUE AND VITILIGO RASH AND PIGMENT IN SKIN WAS CLEAR); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included rash, and vitiligo, and concurrent conditions included gluten issue. 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. No concomitant medications were reported. On an unspecified date, the subject experienced positive side affects (gluten issue and vitiligo rash and pigment in skin was clear). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive side affects (gluten issue and vitiligo rash and pigment in skin was clear) was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: wrong vaccine administered; This spontaneous report received from a health care professional concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. Concomitant medications included epinephrine for allergies, and bnt 162.  On 05-AUG-2021, the subject experienced wrong vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wrong vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210811474.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Fatigue, Injection site pain, Lethargy
Clinical narrative: SKIN SENSITIVITY OVER RUBBING OR TOUCHING CLOTHES; LOWER BACK PAIN; FEELS LETHARGIC; STIFF MUSCLES FEELS LIKE PUTTING EXTRA LABOR TO MOVE ARMS; LOW ENERGY; VERY BAD BODY ACHES; GENERAL FATIGUE (FEEL VERY TIRED); PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included myocarditis, and concurrent conditions included chronic migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 19:00 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced general fatigue (feel very tired). On 29-JUL-2021, the subject experienced pain at site of injection. On 30-JUL-2021, the subject experienced very bad body aches. On 02-AUG-2021, the subject experienced skin sensitivity over rubbing or touching clothes. On 02-AUG-2021, the subject experienced lower back pain. On 02-AUG-2021, the subject experienced feels lethargic. On 02-AUG-2021, the subject experienced stiff muscles feels like putting extra labor to move arms. On 02-AUG-2021, the subject experienced low energy. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from general fatigue (feel very tired), very bad body aches., skin sensitivity over rubbing or touching clothes, lower back pain, feels lethargic, stiff muscles feels like putting extra labor to move arms, pain at site of injection, and low energy. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Sensitive skin
Clinical narrative: SKIN SENSITIVITY OVER RUBBING OR TOUCHING CLOTHES; LOWER BACK PAIN; FEELS LETHARGIC; STIFF MUSCLES FEELS LIKE PUTTING EXTRA LABOR TO MOVE ARMS; LOW ENERGY; VERY BAD BODY ACHES; GENERAL FATIGUE (FEEL VERY TIRED); PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included myocarditis, and concurrent conditions included chronic migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 19:00 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced general fatigue (feel very tired). On 29-JUL-2021, the subject experienced pain at site of injection. On 30-JUL-2021, the subject experienced very bad body aches. On 02-AUG-2021, the subject experienced skin sensitivity over rubbing or touching clothes. On 02-AUG-2021, the subject experienced lower back pain. On 02-AUG-2021, the subject experienced feels lethargic. On 02-AUG-2021, the subject experienced stiff muscles feels like putting extra labor to move arms. On 02-AUG-2021, the subject experienced low energy. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from general fatigue (feel very tired), very bad body aches., skin sensitivity over rubbing or touching clothes, lower back pain, feels lethargic, stiff muscles feels like putting extra labor to move arms, pain at site of injection, and low energy. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Vaccination site mass, Vaccination site pain
Clinical narrative: hearing loss (couple of months later); bump at injection site; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss (couple of months later)) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Alzheimer's disease.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (bump at injection site) and VACCINATION SITE PAIN (soreness at injection site). On an unknown date, the patient experienced DEAFNESS (hearing loss (couple of months later)) (seriousness criterion medically significant). At the time of the report, DEAFNESS (hearing loss (couple of months later)) outcome was unknown and VACCINATION SITE MASS (bump at injection site) and VACCINATION SITE PAIN (soreness at injection site) had resolved.            Concomitant products were not provided. Patient reported that her husband received his second Moderna vaccine on 11-Mar-2021.  Initially, he had a bump and soreness at the injection site that went away. Then, a couple of months later, he developed hearing loss. Patient's husband also suffers from Alzheimer's.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, regarding the event of deafness, very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, regarding the event of deafness, very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Neutrophil count, Platelet count, Skin discolouration
Clinical narrative: skin discoloration/has "circular skin color changes."; This is a spontaneous report from a contactable pharmacist (parent) reported for patient (daughter). A 12-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8736), via an unspecified route of administration, administered in left arm on 16May2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient was reported as none. The concomitant medications of the patient were not reported. The additional vaccines administered on same date of the Pfizer Suspect and Prior Vaccinations within 4 weeks list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were reported as none. The AE(s) following prior vaccinations and family medical history relevant to AE(s) were reported as none. On 20May2021, the patient experienced skin discoloration/has circular skin color changes. Parent of patient, also pharmacist, called to see if Pfizer had any information regarding the Pfizer COVID-19 Vaccine and any association with skin discoloration. She stated that she already filed a report reference. Mother and father have tried to search on their end as HCP however had not been successful in finding anything similar to their case. They however found information more so releated to COVID arm skin erruptions which did not met the same clinical presentation. She stated her daughter has circular skin color changes. One on the right hand, which was her 1st reaction after the 1st injection. The second notable skin color changed was located on her left pointer finger, more so on top of the finger between main knuckle and joint down. She noted it to be elongated and uniform in pattern. Not irregular. No jagged borders, it was an oval. These reactions occurred 4 days after the 1st dose, noticed a skin discoloration spot on her right hand. It was slightly red, grown darker over time more like a brownish color. There were no changes to the skin, just pure discoloration. Did had to go to a dermatologist. Was not sure. Was advised by Dermatologist and pediatrician to just watch and wait. Could it be related, pediatrician and dermatologist had not seen anything related. They were just watching it. It was a discolored spot. was not anywhere else. Nothing else was abnormal or associated with those two marks. Dermatologist initially said it was a bug bite. The event led to the physician office video visits since they were away on vacation. The event was reported as non-serious. The outcome of the events was reported as resolving.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Consumer reported that he had another person who had flu-like symptoms (No age and gender provided). Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swelling under my armpit; it was kind of swollen and tender; This is a spontaneous report from a contactable consumer (Consumer). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Jun2021 (Batch/Lot number was not reported) as dose 1,single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. When probed for the concern, consumer stated," I went today to my local right now getting my second dose of Covid vaccine. I was explaining to the Pharmacist that when I took my first dose on the 26th of last month. I was telling him that the day after I had a swelling under my armpit, near I guess it was under my lymph node and my armpit, first of all I thought it was normal. It was kind of swollen and tender for like first two days and then on the third day, on the fourth day I believe it went away, it went down and at the time I believe that I was normal. So when I went to my Pharmacist because today is my two weeks now also and I have to take my second dose vaccine. I told him that and he said that is not normal and I should call this number to see what they would say."When probed to confirm if received Vaccine second dose today, consumer stated, "No, Pharmacist told me that it is best for me to not take it and call you guys to see what you say first." Consumer was informed about Pfizer Medical Information Department. Consumer was informed about the Roles of Pfizer Drug Safety. In response, consumer stated, "I would see, I just took the time to get (second dose) vaccine. I am actually here right for work." The outcome of the events were recovered on an unspecified date in 2021.  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Malaise, Migraine, Vertigo
Clinical narrative: Migraine; Vertigo; not feeling good; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8735) via unknown route in Apr2021 at 11:00 AM at an unknown dose, dose 1, single for COVID-19 immunisation. Medical history was none. The concomitant medications were not reported. Patient had no known allergies. Patient had no covid prior vaccination and patient had not tested positive after vaccination. On 23Apr2021, patient experienced migraine, vertigo and not feeling good. Patient stated that "I got my first Pfizer vaccine in April and ever since I got it I had migraine and vertigo and I had 2 doctor suggest that I get an MRI and I don't have Insurance at the time and my doctor told me that may you guys may be able to help me with it." It was reported that "I have been experiencing severe migraines since the vaccine as well as vertigo. It is interfering with my work. I have 4-5 weekly. Patient did not receive any treatment for the events. The events were not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea
Clinical narrative: Soreness; consumer just took her temp about five minutes ago and it was little bit higher than it was, initially, it was like 101 point consumer wanted to say 2/fever was slightly higher than it was earlier; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer. This consumer reported for a 15-year-old female patient (Reporter's daughter). A 15-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on 17Jul2021 (Lot Number: EW0171) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection) on an unknown date for covid 19 immunization. Patient just took her second dose of the vaccine yesterday (17Jul2021) and this morning (18Jul2021), she experienced some soreness, a fever and nausea and consumer have given her some medication, she ate, she did take some Tylenol (treatment) and she rested. Then, consumer just took her temp about five minutes ago and it was little bit higher than it was, initially, it was like 101 point consumer wanted to say 2 (event captured as per verbatim). When paraphrased the concern, reporter stated that It was for his daughter. After she took the Tylenol, this was earlier in the morning, this morning (sentence incomplete). Reporter further stated, that his concern was what to do for her fever, some hours later, we were off in to the night, it was about 5 minutes to 10 her time. Her fever was slightly higher than it was earlier that morning when she took the Tylenol (treatment). They were just trying to get some advice on what they need to do because they were concerned that she was still having the fever and she also experienced some chills as well and nausea and headache on 18Jul2021. Consumer understood those were the side effects but they were trying to see, was this normal or did she need to see her pediatrician. Expiration date: Reporter stated that did not have an expiration date on here, he just have the card. Reporter was informed about Pfizer Medical Information department and provided with the number. Further probing could not be initiated reporter hung up the call abruptly. Hence, other details were unknown and limited information was available over the call. Outcome of the event, consumer just took her temp about five minutes ago and it was little bit higher than it was, initially, it was like 101 point consumer wanted to say 2/fever was slightly higher than it was earlier was not recovered while for other events was unknown.