chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; LONG HAULERS COVID-19; This spontaneous report received from a patient concerned a 64 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: 041A21A, and expiry: 19-SEP-2021) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination (dose number series 1). No concomitant medications were reported.  On 17-NOV-2021, the patient reported that her physician diagnosed her as long haulers covid-19 and suspected clinical vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from long haulers covid-19, and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number 90000207750.; Sender's Comments: V0 20211240696-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: DROPPED DEAD OF BLOOD CLOTS; This spontaneous report received from a consumer via social media  via company representative concerned a 4 decade old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, therapy start date was not reported 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 an unspecified date, reporter said that "my coworker was a healthy woman in her 30's and dropped dead of blood clots two weeks later". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211242178-COVID-19 VACCINE AD26.COV2.S-Dropped dead of blood clots. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: BLOOD CLOTS
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via company representative via social media 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 (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 total dose, therapy start date were not reported 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 an unspecified date, the patient died after one shot and it was reported by the consumer that "yeah my dad was one of em. And he died after one shot. So feel free to take as much as you want but I'm good. I don't need it". The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death); Sender's Comments: V0: 20211244541-Covid-19 vaccine ad26.cov2.s-Died. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: BACK PAIN; SHOULDER PAIN; This spontaneous report received from a patient via social media from a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26. cov2.s (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series 1), for prophylactic vaccination. It was reported that the patient "did not have any problem nor any pain or flu " following covid-19 vaccine ad26. cov2. s. (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was not reported) dose, start therapy date were not reported, 1 total administered (dose number in series 2) 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 an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced back pain, and shoulder pain. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shoulder pain and back pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN THIGH; This spontaneous report received from a consumer via social media through a company representative concerned a male of unspecified age, race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of administration not reported , batch number: Unknown and expiry date: Unknown) dose, start therapy date were not reported, 01 total administered 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 an unspecified date, the patient experienced mysterious blood clot in his thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in thigh. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211245900 and 20211245964.; Sender's Comments: V0: 20211245023- COVID-19 VACCINE AD26.COV2.S- blood clot in thigh. 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).
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hormone level abnormal, Thrombosis
Clinical narrative: BLOOD CLOT IN RIGHT SHOULDER UNDER CLAVICLE; HORMONAL CHANGES; This spontaneous report received from a consumer concerned a 29 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: 1808982, and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-JUN-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On an unspecified date, the patient experienced hormonal changes in her body ever since got the vaccine and had blood clot in right shoulder under her clavicle. The patient was in the hospital for a week.  The patient underwent blood test and she tested negative for everything autoimmune. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hormonal changes and blood clot in right shoulder under clavicle was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211245202-covid-19 vaccine ad26.cov2.s-Blood clot in right shoulder under clavicle and Hormonal changes. 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).
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: ONGOING RAPID HEARTBEAT; This spontaneous report received from a parent 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced ongoing rapid heartbeat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ongoing rapid heartbeat. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Headache, Palpitations
Clinical narrative: HEART FLUTTERING; VERY DIZZY; PALPITATIONS; SEVERE HEADACHE; This spontaneous report received from a patient via social media via company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 (dose series number 1) (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 01 total administered 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 an unspecified date, the patient experienced an adverse reaction, was very dizzy 15 minutes after inoculation, severe headache and palpitations followed. This lasted a couple of days, from then had been experiencing heart fluttering almost everyday, was so anxious to get a booster shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very dizzy, palpitations, and severe headache, and had not recovered from heart fluttering. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211245426-Covid-19 vaccine ad26.cov2.s- Heart fluttering. 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).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: VACCINE KILLED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 (Dose series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered 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 an unspecified date, the patient died from an unknown cause of death after vaccination. It was unknown if an autopsy was performed. The consumer reported as "Your vaccine killed my friend". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause of death on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20211245706- COVID-19 VACCINE AD26.COV2.S- vaccine killed. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART DAMAGE; This spontaneous report received from a consumer 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, and batch number were not reported) 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 patient experienced heart damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart damage was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: FULL BODY PARALYSIS FOR TWO MONTHS (FACE IS STILL PARTIALLY PARALYZED); This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age, race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered 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 an unspecified date, reporter stated that patient experienced full body paralysis for two months and his face was still partially paralyzed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from full body paralysis for two months (face is still partially paralyzed). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211246280- COVID-19 VACCINE AD26.COV2.S- full body paralysis for two months (face is still partially paralyzed). 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).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a 65 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 19-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: HAS NOT BEEN WELL THE WHOLE TIME; This spontaneous report received from a consumer 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced has not been well the whole time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of has not been well the whole time was not reported. This report was non-serious.
Sex: F
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 74 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-NOV-2021, the patient 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. This case was associated with product quality complaint: 90000208145.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Muscle spasms, Muscular weakness
Clinical narrative: BRAIN FOG; DARK AND SWOLLEN ARM PITS; FOGGY VISION; MUSCLE CRAMPS; DARK ARMPIT; JOINT PAIN; MUSCLE WEAKNESS; MUSCLE PAIN; FATIGUE; RINGING IN EAR; TINGLING IN FEET; BUMP WITH FLUID, THAT LEFT A MARK; This spontaneous report received from a physician concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic pain due to trauma, hyperlipidemia, copd, hypertension, obesity, and carpal tunnel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine besilate for drug used for unknown indication, atorvastatin calcium for drug used for unknown indication, clopidogrel bisulfate for drug used for unknown indication, glyceryl trinitrate for drug used for unknown indication, lisinopril for drug used for unknown indication, metoprolol for drug used for unknown indication, tiotropium bromide for drug used for unknown indication, and tramadol for drug used for unknown indication. On 11-MAR-2021, the patient experienced bump with fluid, that left a mark. On 12-MAR-2021, the patient experienced brain fog, dark and swollen arm pits, foggy vision, muscle cramps, dark armpit, joint pain, muscle weakness, muscle pain, fatigue, ringing in ear, and tingling in feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bump with fluid, that left a mark, muscle pain, joint pain, fatigue, ringing in ear, muscle cramps, muscle weakness, tingling in feet, brain fog, dark and swollen arm pits, foggy vision and dark armpit was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Rash, Skin hyperpigmentation, Swelling
Clinical narrative: BRAIN FOG; DARK AND SWOLLEN ARM PITS; FOGGY VISION; MUSCLE CRAMPS; DARK ARMPIT; JOINT PAIN; MUSCLE WEAKNESS; MUSCLE PAIN; FATIGUE; RINGING IN EAR; TINGLING IN FEET; BUMP WITH FLUID, THAT LEFT A MARK; This spontaneous report received from a physician concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic pain due to trauma, hyperlipidemia, copd, hypertension, obesity, and carpal tunnel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine besilate for drug used for unknown indication, atorvastatin calcium for drug used for unknown indication, clopidogrel bisulfate for drug used for unknown indication, glyceryl trinitrate for drug used for unknown indication, lisinopril for drug used for unknown indication, metoprolol for drug used for unknown indication, tiotropium bromide for drug used for unknown indication, and tramadol for drug used for unknown indication. On 11-MAR-2021, the patient experienced bump with fluid, that left a mark. On 12-MAR-2021, the patient experienced brain fog, dark and swollen arm pits, foggy vision, muscle cramps, dark armpit, joint pain, muscle weakness, muscle pain, fatigue, ringing in ear, and tingling in feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bump with fluid, that left a mark, muscle pain, joint pain, fatigue, ringing in ear, muscle cramps, muscle weakness, tingling in feet, brain fog, dark and swollen arm pits, foggy vision and dark armpit was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: BRAIN FOG; DARK AND SWOLLEN ARM PITS; FOGGY VISION; MUSCLE CRAMPS; DARK ARMPIT; JOINT PAIN; MUSCLE WEAKNESS; MUSCLE PAIN; FATIGUE; RINGING IN EAR; TINGLING IN FEET; BUMP WITH FLUID, THAT LEFT A MARK; This spontaneous report received from a physician concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic pain due to trauma, hyperlipidemia, copd, hypertension, obesity, and carpal tunnel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine besilate for drug used for unknown indication, atorvastatin calcium for drug used for unknown indication, clopidogrel bisulfate for drug used for unknown indication, glyceryl trinitrate for drug used for unknown indication, lisinopril for drug used for unknown indication, metoprolol for drug used for unknown indication, tiotropium bromide for drug used for unknown indication, and tramadol for drug used for unknown indication. On 11-MAR-2021, the patient experienced bump with fluid, that left a mark. On 12-MAR-2021, the patient experienced brain fog, dark and swollen arm pits, foggy vision, muscle cramps, dark armpit, joint pain, muscle weakness, muscle pain, fatigue, ringing in ear, and tingling in feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bump with fluid, that left a mark, muscle pain, joint pain, fatigue, ringing in ear, muscle cramps, muscle weakness, tingling in feet, brain fog, dark and swollen arm pits, foggy vision and dark armpit was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 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 (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: HAD ISSUES MONTHS LATER; 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 (dose series 1) (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. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient had issues months later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had issues months later was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 56 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-DEC-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: CONSTANT PAIN IN ARM; 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, and batch number were not reported) dose was not reported, administered on OCT-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 OCT-2021, the patient experienced constant pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant pain in arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF A VACCINE THAT WAS 7 DAYS PAST ITS EXPIRATION DATE; This spontaneous report received from a health care professional 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 administration of a vaccine that was 7 days past its expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of a vaccine that was 7 days past its expiration date was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIGNIFICANT REACTION/NEGATIVE REACTIONS; This spontaneous report received from a patient via a company representative concerned a 62 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient was in great health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced significant reaction/negative reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of significant reaction/negative reactions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Blood pressure measurement
Clinical narrative: LOST SENSE OF SMELL; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and had no 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced lost sense of smell. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high-controlled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lost sense of smell was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Heart rate, Inappropriate schedule of product administration, Rash
Clinical narrative: vertigo; light headed, dizzy; very uncomfortable and he does not feel like himself; rash on his body; Inappropriate schedule of vaccine administered; sinus tachycardia; This spontaneous case was reported by a pharmacist and describes the occurrence of SINUS TACHYCARDIA (sinus tachycardia), VERTIGO (vertigo), DIZZINESS (light headed, dizzy), FEELING ABNORMAL (very uncomfortable and he does not feel like himself) and RASH (rash on his body) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (1st & 2nd Pfizer vaccine in early March) in March 2021. Past adverse reactions to the above products included Adverse event with Pfizer vaccine. Concurrent medical conditions included Blood pressure abnormal.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced SINUS TACHYCARDIA (sinus tachycardia). On 23-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced VERTIGO (vertigo), DIZZINESS (light headed, dizzy), FEELING ABNORMAL (very uncomfortable and he does not feel like himself) and RASH (rash on his body). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at an unspecified dose and frequency. On 23-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, SINUS TACHYCARDIA (sinus tachycardia), VERTIGO (vertigo), DIZZINESS (light headed, dizzy), FEELING ABNORMAL (very uncomfortable and he does not feel like himself) and RASH (rash on his body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 100 (normal) heart rate stabilized and went down to below 100 and 130 (High) heartrate up to 130. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported going to the ER and everything came out negative and he is referred to a neurologist and EENT doctor. Patient reported taking blood pressure medications for the past 10 years and aside from that being healthy.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus tachycardia, Vertigo
Clinical narrative: vertigo; light headed, dizzy; very uncomfortable and he does not feel like himself; rash on his body; Inappropriate schedule of vaccine administered; sinus tachycardia; This spontaneous case was reported by a pharmacist and describes the occurrence of SINUS TACHYCARDIA (sinus tachycardia), VERTIGO (vertigo), DIZZINESS (light headed, dizzy), FEELING ABNORMAL (very uncomfortable and he does not feel like himself) and RASH (rash on his body) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (1st & 2nd Pfizer vaccine in early March) in March 2021. Past adverse reactions to the above products included Adverse event with Pfizer vaccine. Concurrent medical conditions included Blood pressure abnormal.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced SINUS TACHYCARDIA (sinus tachycardia). On 23-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced VERTIGO (vertigo), DIZZINESS (light headed, dizzy), FEELING ABNORMAL (very uncomfortable and he does not feel like himself) and RASH (rash on his body). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at an unspecified dose and frequency. On 23-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, SINUS TACHYCARDIA (sinus tachycardia), VERTIGO (vertigo), DIZZINESS (light headed, dizzy), FEELING ABNORMAL (very uncomfortable and he does not feel like himself) and RASH (rash on his body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 100 (normal) heart rate stabilized and went down to below 100 and 130 (High) heartrate up to 130. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported going to the ER and everything came out negative and he is referred to a neurologist and EENT doctor. Patient reported taking blood pressure medications for the past 10 years and aside from that being healthy.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure before pregnancy, Maternal exposure during breast feeding, Pyrexia
Clinical narrative: little bit of a headache after second dose; little bit of a fever after second dose; Breastfeeding at time of her second Moderna dose.; Maternal exposure before pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of HEADACHE (little bit of a headache after second dose), PYREXIA (little bit of a fever after second dose), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding at time of her second Moderna dose.) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Feb-2022. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding at time of her second Moderna dose.) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). On an unknown date, the patient experienced HEADACHE (little bit of a headache after second dose) and PYREXIA (little bit of a fever after second dose). On 02-Feb-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding at time of her second Moderna dose.) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved. At the time of the report, HEADACHE (little bit of a headache after second dose) and PYREXIA (little bit of a fever after second dose) outcome was unknown.            No concomitant medications were provided No treatment medications were provided The  patient said that, the son she was breastfeeding was born on June 2020 , he was doing great and reaching all his milestone and had his regular check up. She is now 7 months pregnant (on Monday 20dec21 she will be 30 weeks pregnant), with due date on 28feb2022. Her LMP was, probably, on 24may2021.  The patient had a little bit of headache and fever like with any vaccine after second dose.   This case was linked to MOD-2021-418524 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Significant follow up received on 17-Dec-2021, second dose events were added and EDD was updated
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Influenza like illness, Suspected COVID-19, Taste disorder
Clinical narrative: some mild congestion and flu like symptoms; sick as having Covid; bone burning uncontrollable; Immediately felt a strange taste; This spontaneous case was reported by a pharmacist and describes the occurrence of SUSPECTED COVID-19 (sick as having Covid), TASTE DISORDER (Immediately felt a strange taste), BONE PAIN (bone burning uncontrollable) and INFLUENZA LIKE ILLNESS (some mild congestion and flu like symptoms) 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 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced TASTE DISORDER (Immediately felt a strange taste). On 16-Sep-2021, the patient experienced BONE PAIN (bone burning uncontrollable). On 17-Sep-2021, the patient experienced SUSPECTED COVID-19 (sick as having Covid). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (some mild congestion and flu like symptoms). At the time of the report, SUSPECTED COVID-19 (sick as having Covid), TASTE DISORDER (Immediately felt a strange taste), BONE PAIN (bone burning uncontrollable) and INFLUENZA LIKE ILLNESS (some mild congestion and flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter. Company Comment:  This case concerns patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of suspected COVID-19 (sick as having Covid), with concurrent taste disorder and influenza like illness. The event occurred approximately 3 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of suspected COVID-19 (sick as having Covid), with concurrent taste disorder and influenza like illness. The event occurred approximately 3 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Ocular discomfort, Ocular hyperaemia, Vaccination site paraesthesia
Clinical narrative: My right eye is red right now; Inappropriate schedule of vaccine administered; shivers; I had the tingling thing around my arm; difficult to open my right eye, because of crusty stuff around it/It felt like when you put a dirty contact in/it had crusty stuff around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (I had the tingling thing around my arm), OCULAR DISCOMFORT (difficult to open my right eye, because of crusty stuff around it/It felt like when you put a dirty contact in/it had crusty stuff around it), OCULAR HYPERAEMIA (My right eye is red right now), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (shivers) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer Biontech Covid-19 vaccine on 11-Mar-2021 and Pfizer Biontech Covid-19 vaccine on 01-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine and Pfizer Biontech Covid-19 vaccine.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced VACCINATION SITE PARAESTHESIA (I had the tingling thing around my arm), OCULAR DISCOMFORT (difficult to open my right eye, because of crusty stuff around it/It felt like when you put a dirty contact in/it had crusty stuff around it), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (shivers). On 30-Nov-2021, the patient experienced OCULAR HYPERAEMIA (My right eye is red right now). On 29-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE PARAESTHESIA (I had the tingling thing around my arm), OCULAR DISCOMFORT (difficult to open my right eye, because of crusty stuff around it/It felt like when you put a dirty contact in/it had crusty stuff around it), OCULAR HYPERAEMIA (My right eye is red right now) and CHILLS (shivers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity, Rash, Vaccination complication
Clinical narrative: Arm hurting a bit after 1 week; had some side effects not severe ones; Interchange of vaccine products; weird side effect, rash all over the torso; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurting a bit after 1 week), RASH (weird side effect, rash all over the torso), VACCINATION COMPLICATION (had some side effects not severe ones) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER on 04-Apr-2021 and pfizer on 25-Apr-2021. Past adverse reactions to the above products included No adverse reaction with PFIZER and pfizer.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced RASH (weird side effect, rash all over the torso). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurting a bit after 1 week), VACCINATION COMPLICATION (had some side effects not severe ones) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 27-Nov-2021, RASH (weird side effect, rash all over the torso) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurting a bit after 1 week) had not resolved and VACCINATION COMPLICATION (had some side effects not severe ones) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination complication, Wound
Clinical narrative: Cellulitis in his legs; Sores on his feet/feet have open sores; lot of problems; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis in his legs), WOUND (Sores on his feet/feet have open sores) and VACCINATION COMPLICATION (lot of problems) in a 94-year-old male patient 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 CELLULITIS (Cellulitis in his legs), WOUND (Sores on his feet/feet have open sores) and VACCINATION COMPLICATION (lot of problems). At the time of the report, CELLULITIS (Cellulitis in his legs), WOUND (Sores on his feet/feet have open sores) and VACCINATION COMPLICATION (lot of problems) had not resolved.            Concomitant medications were not reported by the reporter.   No treatment information was provided.  Patient had appointment to get the booster dose on 08-DEC-2021.  This case concerns a 94-year-old male patient with no medical history, who experienced the unexpected event of Cellulitis. The event occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. No treatment or other clinical details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow-up received contains no new information. Sender's Comments: This case concerns a 94-year-old male patient with no medical history, who experienced the unexpected event of Cellulitis. The event occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. No treatment or other clinical details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.