chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Eye pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th December 2021, the patient received the 1st dose of Shingrix .5 ml. In December 2021, less than a week after receiving Shingrix, the patient experienced back pain. On 20th December 2021, the patient experienced eye pain. On an unknown date, the outcome of the eye pain was not recovered/not resolved and the outcome of the back pain was unknown. It was unknown if the reporter considered the eye pain and back pain to be related to Shingrix. Additional details were provided as follows: The patient stated that almost immediately after administration of the Shingrix vaccine she got a pain in left eye on the socket part towards the outer corner of the eye. The pain was still present at the time of reporting, but the patient stated she wasn't having any vision loss or blurriness. She also reported back pain, but was not sure if it could be attributed to the vaccine entirely. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021264521:Same reporter. US-GLAXOSMITHKLINE-US2021264519:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the date of reporting, the patient did not receive second dose of Shingrix, which lead to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Coombs negative haemolytic anaemia, Coombs test negative, Haematocrit decreased
Clinical narrative: experienced coombs negative hemolysis; progressive hematocrit decline; This case was reported by a physician via call center representative and described the occurrence of coombs negative haemolytic anaemia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced coombs negative haemolytic anaemia (serious criteria GSK medically significant) and hematocrit decreased. On an unknown date, the outcome of the coombs negative haemolytic anaemia and hematocrit decreased were unknown.   It was unknown if the reporter considered the coombs negative haemolytic anaemia and hematocrit decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient experienced coombs negative hemolysis with progressive hematocrit decline after vaccination with Shingirx. The health care professional (HCP) did not provide demographics, patient initials or date of birth, lot number or expiration date. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of overdose in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 9377F, expiry date 25th March 2023) for prophylaxis. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX). On 24th November 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 24th November 2021, unknown after receiving Shingrix and, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown. Additional details were reported as follows: The nurse stated that patient received two doses of Shingrix. Both doses were from the same lot number. One dose was given in the right deltoid and the other dose was given in the left deltoid which led to overdose. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-year-old female patient who received HBV (ENGERIX B adult) (batch number K329E, expiry date 24th April 2023) for prophylaxis. On 23rd December 2021, the patient received the 3rd dose of ENGERIX B adult. On 23rd December 2021, unknown after receiving ENGERIX B adult, the patient experienced inappropriate age at vaccine administration and overdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and overdose were unknown. Additional details were reported as follows: As an adolescent patient received an adult dose of ENGERIX B as a third dose of the hepatitis B vaccination series which led to medication error of inappropriate age at vaccine administration and overdose. The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 23rd December 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The nurse reported that a 4 month old patient inadvertently received a dose of Kinrix which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old male patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (1st and 2nd dose received on an unknown date.). On 5th November 2021, the patient received the 3rd dose of Engerix B. On 5th November 2021, unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: The pharmacist reported that, the patient received the third dose of Engerix-B two months early which led to drug dose administration interval too short. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; INAPPROPRIATE SCHEDULE OF VACCINATION; OFF-LABEL USE; This spontaneous report received from a patient via a company representative via social media concerned a 69-year-old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26.cov2.s (form of admin, route of admin and batch number were not reported ,expiry: unknown), 1 in total, dose was not reported, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination(Dose number in series 2). 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 had a mild case of Covid (suspected covid-19 infection) which is due to inappropriate schedule of vaccination and off label use were (all events dose number in series 2). As per the report "The booster was the same. I just went to a pharmacy and got a J and J like it was my first. At 69, I wasn't waiting for another week for approval.  Now I have a mild case of Covid thanks to someone who worked in a small salon and did not wear a mask. I was to babysit her child and my grandkids. No one knew she did not wear a mask. Pretty sure my 2 year old grandchild".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, inappropriate schedule of vaccination and off label use were not reported. This report was non-serious. This report was associated with a product quality complaint: 90000207824, 90000207825. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria as reported complaints were adverse events). based on the PQC evaluation/investigation performed.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain in extremity
Clinical narrative: SORE ARM; EXTREMELY COLD AND COULDN'T GET WARM FOR ABOUT TWO AND  HALF HOURS; 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: severe latex allergy and drug allergy (lidocaine). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, on left arm (dose number in series was 1) administered on 09-APR-2021 around 15:00 for prophylactic vaccination. On 10-APR-2021, About 12 hours later, around 2:00, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced freezing for a good hour/extremely cold feeling/couldn't get warm for about two and half hours. She was awake for that hour, then it went away and she went back to sleep. On 12-APR-2021 (on day 4 from primary shot), the patient experienced sore arm (dose number in series was 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1855191, and expiry: 11-APR-2022) dose was not reported, on right arm (dose number in series was 2), 01 total, administered on 18-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-DEC-2021, about 36 hours after the booster shot, the patient experienced extremely cold and could not get warm for about two and half hours. On 21-DEC-2021, her arm got sore on day 4 from the booster (dose number in series was 2). She had extremely mild side effects, exactly same symptoms that happened after the first shot (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extremely cold and couldn't get warm for about two and half hours on DEC-2021, and had not recovered from sore arm (dose number in series was 2), This report was non-serious. This case, involving the same patient is linked to 20211235748 (dose number in series was 1).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: FATIGUE; NO ENERGY/LETHARGY; This spontaneous report received from a patient concerned a 66 year male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 1)(suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 17-MAR-2021 into left arm for prophylactic vaccination. On 18-MAR-2021, the patient had fatigue the next day for around 24 hours or less. The next day patient woke up fine (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2)(suspension for injection, route of admin not reported, batch number: 1855194, expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-OCT-2021, the patient experienced no energy/lethargy. On 30-OCT-2021, the patient experienced fatigue. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no energy/lethargy, and fatigue on 31-OCT-2021. This report was non-serious. This case, involving the same patient is linked to 20211247378 (Dose number in series 1 case).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned an over 18 years old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number and expiry not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. No adverse events reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 22-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-DEC-2021, the pharmacist administered an expired Janssen covid-19 vaccine (booster dose) to the patient (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211250793.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness
Clinical narrative: FELT LIKE FLU WITH LOW GRADE FEVER; This spontaneous report received from a patient via a representative, concerned a patient of unspecified age and sex. 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 (dose number in series 1). 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 experienced felt like flu with low grade fever for about 48 hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from felt like flu with low grade fever (dose number in series 1). This report was non-serious. This case, involving the same patient is linked to 20211253778.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN LUNGS; This spontaneous report received from a consumer via social media  through a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown), dose not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: Unknown, expiry: unknown) dose not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 2). 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, It was reported that "Our neighbor got his second shot and ended up with blood clots in his lungs." (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211254462-covid-19 vaccine ad26.cov2.s-Blood clots in lungs. 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: Arthralgia, Tearfulness
Clinical narrative: WAS IN TEARS; JOINT PAIN; This spontaneous report received from a consumer via a representative concerned a female of unspecified age. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, 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 was in tears, and joint pain. The action taken with covid-19 vaccine was not applicable. The outcome of the joint pain and was in tears was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Impaired work ability, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; COULD NOT WORK AT JOB; WAS IN INTENSIVE CARE UNIT NEAR DEATH; This spontaneous report received from a parent via social media via a company representative concerned a female of unspecified age, race and ethnic origin. Initial information was processed along with additional information on 26-Dec-2021 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 is 1) (suspension for injection, route of admin were not reported, batch: unknown, expiry: unknown) dose, 1 total, administered on APR-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 an unspecified date in MAY-2021 the patient was in intensive care unit near death. On an unspecified date, patient experienced confirmed covid-19 infection, confirmed clinical vaccination failure and could not work at job. The patient got hospitalized for an unspecified days. The patient visited emergency room. The reporter stated that "My daughter had the JnJ in April 2021 one month later was in ICU near death and is still having affects from covid. No there was not. A lot of other people plus myself feel the vaccine caused it. She can't even work at her job she had for years and absolutely." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure, was in intensive care unit near death and could not work at job was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000208728.; Sender's Comments: V0: 20211256702-COVID-19 VACCINE AD26.COV2.S- confirmed covid-19 infection. 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). 20211256702-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination 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: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BOUT OF BELL'S PALSY; This spontaneous report received from a patient via social media through 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose (dose number in series:1), 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 bout of bell's palsy. The consumer reported as "I had a bout of Bell's palsy after being vaccinated ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bout of bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211258411-Covid-19 vaccine ad26.cov2.s-Bout of bell's palsy . 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: Thrombosis
Clinical narrative: BLOOD CLOTS AND DEVELOPED A FIBER; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethic 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 s (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 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.  The patient stated that "I got J and J covid shot. Ended up in ICU for 8 days with blood clots and developed a fiber which is now an on going issue," (Dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots and developed a fiber. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211258481-COVID-19 VACCINE AD26.COV2.S-blood clots and developed a fiber . 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: Inappropriate schedule of product administration, Off label use
Clinical narrative: INAPPROPRIATE SCHEDULED OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a pharmacist concerned an elderly of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have an autoimmune disease or any other notable diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021, and dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested (for second dose). No concomitant medications were reported. On 06-MAY-2021, the patient experienced inappropriate scheduled of vaccine administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate scheduled of vaccine administered and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Respiratory tract congestion
Clinical narrative: CHEST CONGESTION; SHORTNESS OF BREATH; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patients 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 patients experienced chest congestion, and shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest congestion and shortness of breath was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via a 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 (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered for prophylactic vaccination (Dose number in series 1). 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 stroke (dose number in series 1). The reporter stated that, "my brother also". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211248907 and 20211258956.; Sender's Comments: V0: 20211258812-COVID-19 VACCINE AD26.COV2.S-Stroke. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: JUST GOT SICK LIKE HAD THE FLU; This spontaneous report received from a patient concerned a 34 year old female. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced just got sick like had the flu. The action taken with covid-19 vaccine was not applicable. The patient recovered from just got sick like had the flu. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54 year 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 (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-DEC-2021, patient has been testing negative Saturday and Sunday with the rapid test since he was exposed to his wife who tested positive on Saturday 25-DEC-2021. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. On 26-DEC-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. On 27-DEC-2021, the patient tested positive with a rapid home kit test for COVID-19 (suspected clinical vaccination failure, and suspected covid-19 infection), patient reports a little bit of joint and muscle fatigue and some tightness in chest and reports being relatively well. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211258883-COVID-19 VACCINE AD26.COV2.S- suspected covid-19 infection. 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). 20211258883-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination 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: Adverse drug reaction, Inappropriate schedule of product administration, Off label use
Clinical narrative: UNSPECIFIED ADVERSE EVENTS; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; 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, start therapy date were not reported (first dose), and dose, start therapy date were not reported (second dose) 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 unspecified adverse events, inappropriate schedule of vaccine administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unspecified adverse events, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of consciousness
Clinical narrative: DID NOT THINK I WAS GOING TO THE SHOULDER BEFORE PASSING OUT; WHILE DRIVING ON A 6 LANE HIGHWAY HAD WHAT FELT LIKE A STROKE; This spontaneous report received from a patient via a 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 number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total was administered 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. It was reported by the reporter that, on an unspecified date, "two days later while driving on a 6 lane highway had what felt like a stroke did not think I was going to the shoulder before passing out. No more for me I'll take my chances with covid" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the did not think i was going to the shoulder before passing out and while driving on a 6 lane highway had what felt like a stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211259090- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Did not think I was going to the shoulder before passing out. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: Antibody test, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history 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 was 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 10-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient had an antibody test in NOV-2021, which was negative. After vaccination on 24-DEC-2021, the patient again had an antibody test which negative as well, hence suspected immunological vaccine failure. The patient asked that, did he had protection from the vaccine, or did the antibody test not recognize the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0:20211259113-COVID-19 VACCINE AD26.COV2.S-Suspected immunological 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: M
Vaccine: COVID19
Symptoms: Dysstasia, Musculoskeletal stiffness
Clinical narrative: COULD NOT STAND; VERY STIFF; This spontaneous report received from a patient concerned a 7 decade old male. The patient's past medical history included hemorrhaged after surgery, cataract, cataract surgery, and concurrent conditions included legal blindness, crippled in hands, and Parkinson's disease. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number was 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. Non-company suspect drugs included HUMIRA (solution for injection in pre-filled syringe, subcutaneous, batch number: 1151530, 1154832) 40 mg, 1 time every 2 weeks, therapy dates were not reported for rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced could not stand, and very stiff. The action taken with covid-19 vaccine was not applicable, and action taken with HUMIRA was not reported. The outcome of the could not stand and very stiff was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: MI (HEART ATTACK); This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known pre-existing conditions and was a very healthy man. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown ) dose, start therapy date were not reported, (dose number in series was 1), 01 total administered 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.  It was reported that, on an unspecified date, the patient got the vaccine and stayed at the clinic for the required time, while walking across the parking lot he had a Myocardial infarction (MI) (heart attack), if a nurse had not been walking towards her car he would be dead. The nurse gave him Cardiopulmonary resuscitation (CPR) (dose number in was series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of MI (heart attack) was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211258726.; Sender's Comments: V0 20211259197-COVID-19 VACCINE AD26.COV2.S-MI (heart attack). 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: Dizziness, Feeling abnormal, Laboratory test, Lyme disease, Malaise
Clinical narrative: CHRONIC LYME DISEASE; PATCHES OF PSORIASIS (SYMPTOMS RETURNED); MIGRAINE HEADACHE; DIZZINESS; FELT LIKE GONNA DIE; OVERALL FEELING OF SICKNESS; This spontaneous report received from a patient via a company representative concerned an adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: Chronic Lyme disease and concurrent conditions included: moderate to severe chronic plaque psoriasis and other pre-existing medical conditions included: Patient had not reported medical history. Patient was treated with MS medications at a specialized Lyme/oncology center for Chronic Lyme disease in childhood and believed that disease was dormant at that point. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total (1 in 1 once), start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  Consumer reported that on an unspecified date, the patient was at 99 percent clear, late took the dose of risankizumab medication by two weeks and symptoms started to return and not subsided. on an unspecified date, patient was itchy all over all of the time and some patches of psoriasis (psoriasis flare-up). Doctor was considered changing medications. On an unspecified date, patient took covid-19 vaccine and within minutes had a migraine headache, dizziness, and overall feeling of sickness. The patient felt like she was going die and likened it to had to take MS shots that she was given to treat Lyme disease. Laboratory data (dates unspecified) included: Lab test (NR: not provided) with result of Chronic Lyme Disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic lyme disease, and patches of psoriasis (symptoms returned), and the outcome of migraine headache, dizziness, overall feeling of sickness and felt like gonna die was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211259244-COVID-19 VACCINE AD26.COV2.S- Chronic Lyme Disease. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Psoriasis
Clinical narrative: CHRONIC LYME DISEASE; PATCHES OF PSORIASIS (SYMPTOMS RETURNED); MIGRAINE HEADACHE; DIZZINESS; FELT LIKE GONNA DIE; OVERALL FEELING OF SICKNESS; This spontaneous report received from a patient via a company representative concerned an adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: Chronic Lyme disease and concurrent conditions included: moderate to severe chronic plaque psoriasis and other pre-existing medical conditions included: Patient had not reported medical history. Patient was treated with MS medications at a specialized Lyme/oncology center for Chronic Lyme disease in childhood and believed that disease was dormant at that point. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total (1 in 1 once), start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  Consumer reported that on an unspecified date, the patient was at 99 percent clear, late took the dose of risankizumab medication by two weeks and symptoms started to return and not subsided. on an unspecified date, patient was itchy all over all of the time and some patches of psoriasis (psoriasis flare-up). Doctor was considered changing medications. On an unspecified date, patient took covid-19 vaccine and within minutes had a migraine headache, dizziness, and overall feeling of sickness. The patient felt like she was going die and likened it to had to take MS shots that she was given to treat Lyme disease. Laboratory data (dates unspecified) included: Lab test (NR: not provided) with result of Chronic Lyme Disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic lyme disease, and patches of psoriasis (symptoms returned), and the outcome of migraine headache, dizziness, overall feeling of sickness and felt like gonna die was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211259244-COVID-19 VACCINE AD26.COV2.S- Chronic Lyme Disease. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (FEVER, COUGH, BODY ACHE AND CHILLS); DIZZINESS; This spontaneous report received from a patient concerned a 43 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 administration not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, (dose number in series was 1), 01 total, administered on 10-JUN-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 27-DEC-2021, the patient experienced suspected covid-19 infection as had fever, cough, body ache and chills (suspected clinical vaccination failure). on the same day, laboratory data included: Covid-19 virus test (home test) which resulted positive. On DEC-2021, the patient experienced dizziness (dose number in series was 1). He also stated that no other issues after receiving vaccine on 10-JUN-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection (fever, cough, body ache and chills), and dizziness, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000209085.; Sender's Comments: V0:20211259381 covid-19 vaccine ad26.cov2.s - suspected clinical vaccination 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: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a consumer via a representative concerned multiple patients.  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,(Dose number series: 1) 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 side effects. The action taken with covid-19 vaccine was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: SEVERE ALLERGIC REACTION; This spontaneous report received from a patient by a Business partner (Pfizer Consumer Healthcare, 202101813326) was received on 23-DEC-2021 and 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, expiry date: Unknown) dose, start therapy date were not reported for prophylactic vaccination (dose series no- 0). The batch number was not reported and has been requested. Concomitant medications included malic acid. On an unspecified date, the patient experienced severe allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe allergic reaction was not reported. This report was non-serious.