chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First shot one year ago, second one yesterday; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose almost (exactly) one year ago).   On 7th March 2022, the patient received the 2nd dose of Shingrix. On 7th March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix day before the reporting after a full year, later than the recommended interval, which led to lengthening of vaccination schedule. The patient asked that the vaccine would work or did he/she need to start over. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Shingrix shot about 3 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago of reporting date).   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. The reporter asked, if they need to restart the series or just 2nd dose needed. This case has been linked to US2022AMR044662, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR044662:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Shingrix shot about 3 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago of reporting date).   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. The reporter asked, if they need to restart the series or just 2nd dose needed. This case has been linked to US2022AMR044658, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR044658:Same reporter.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Lymphadenopathy, Rash
Clinical narrative: enlarged lymph nodes; rashes on chest and back; This case was reported by a consumer and described the occurrence of enlargement of lymph nodes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ELASOMERAN (MODERNA COVID 19 BOOSTER) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and MODERNA COVID 19 BOOSTER. On an unknown date, several weeks after receiving Shingrix, the patient experienced enlargement of lymph nodes and rash. On an unknown date, the outcome of the enlargement of lymph nodes and rash were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes and rash to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received Shingrix shot and a few weeks later she had a Moderna Covid booster shot.  Since then the patient experienced enlarged lymph nodes and skin rashes on her chest and back.  The reporter asked was there a possibility that her symptoms were related to these events. It was unknown if the reporter considered the enlargement of lymph nodes and rash to be Moderna Covid 19 Booster vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm is still swollen; arm is still painful; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2022, the patient received Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received Shingrix shot on Sunday and his/her arm was still swollen and painful till the time of reporting. No other information was reported. .
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Off label use, Pain in extremity, Restless legs syndrome
Clinical narrative: Worsened leg pain; Restless Leg Syndrome; Sleeplessness; Vaccine administration with an on going case of shingles; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (was diagnosed with shingles in hospital) and leg pain (was hospitalized for leg pain).   On 13th January 2022, the patient received the 1st dose of Shingrix. On 13th January 2022, unknown after receiving Shingrix, the patient experienced off label use in unapproved indication. On an unknown date, the patient experienced leg pain, restless legs syndrome and sleeplessness. The patient was treated with gabapentin. On an unknown date, the outcome of the leg pain, restless legs syndrome and sleeplessness were not recovered/not resolved and the outcome of the off label use in unapproved indication was unknown.   It was unknown if the reporter considered the leg pain, restless legs syndrome and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient was hospitalized for leg pain and was diagnosed with shingles. The patient stated that he was given a dose of Shingrix vaccine during this  hospitalization with an on going case of shingles, which led to off label use in unapproved indication. The patient stated that between 1 and 2 months, after receiving the vaccination, since his discharge from the hospital, the pain in his legs had worsened, and he had developed restless leg syndrome that caused sleeplessness. The patient was now taking Gabapentin as result. It was unknown if the MD was trying to treat shingles with the vaccine. The patient was given medical disclaimer and was provided information as per package insert content. The patient provided medical informer phone number for health care professional reference. Offered after call survey. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: her second dose was late; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 to 4 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient stated that, she got her Shingrix vaccinations about 3 to 4 years ago from the date of reporting, unsure of the exact dates. At the 2nd dose of Shingrix, none of the pharmacies had Shingrix in stock and therefore her second dose was late.  The patient would locate her records to see if she could find the dates of the vaccinations and call back with follow up information.  The patient called to inquire if there was a third dose needed or booster for Shingrix.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Jan2021, never came for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2021, batch number 9h234, expiry date 27th August 2022).   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 provided as follows: This case was reported by the registered pharmacist. The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Havrix adult dose, pediatric patient; Havrix adult dose, pediatric patient; This case was reported by a physician via call center representative and described the occurrence of overdose in a 18-month-old female patient who received HAV (Havrix adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th January 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 20th January 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The physician reported that an adult dose of Havrix was administered into a 18 months old patient, which led to overdose and adult product administered to child. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 12/2020, never received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 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 reported were as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received the second dose 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired if the patient needed to restart the series or get the second dose of Shingrix. The reporter unable to provide vaccine and the patient details.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose was not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 14th July 2021, batch number:BA5GK,expiry date:4th November 2022).   On an unknown date, the patient received 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 provided as follows: The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Administered after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number z9mz2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 medical assistant stated about administration of Kinrix after expiration date, which led to expired vaccine used. The reporter consented for follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccinated with expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   On 9th March 2022, the patient received Havrix. On 9th March 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The registered nurse reported a patient being vaccinated on the day of reporting with Havrix which was already expired in 26th February 2022, which led to expired vaccine used. The health care professional did not give consent to follow up or provided any information regarding the patient. Also, health care professional was not aware if it was the first dose or the booster.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 months old received kinrix; 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 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, 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 reporter was a pharmacy student. The reporter reported that a 4 months old patient received a Kinrix dose, which led to inappropriate age at vaccine administration. Consented to follow up was provided. .
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Ophthalmic herpes zoster
Clinical narrative: hospitalized with eye shingles; first dose on 2019, in 2022 received second; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number A4D72, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2019, the patient received the 1st dose of Shingrix. In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced ophthalmic herpes zoster (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported that the patient received a dose of Shingrix and on an unknown date the patient was hospitalized with eye shingles. In January 2022, after reporting eye shingles, the patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 70 year old female. Initial information was processed along with the additional information received on 04-MAR-2022 and 09-MAR-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unspecified if the patient experienced any adverse event after vaccination with covid-19 vaccine ad26.cov2.s (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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient stated herself was trying to recover from Covid and have been very sick (suspected clinical vaccination failure, and suspected covid-19 infection) (dose number in series 2). patient had the J and J shot and booster, as the doctor said it could have been worse. The patient concomitantly received rivaroxaban (film-coated tablet, route of admin not reported, batch number: 1314754-10430 expiry: 27-OCT-2022) 20 mg, frequency, and therapy dates were not reported for an unspecified indication. The patient received a manufacture sealed 30 count bottle of Xarelto 20 mg, that was short of 2 tablets. she opened the bottle and counted the tablets and there were only 28 tablets in the bottle. She has not missed any days but wants something to be done about the missing tablets because they are so expensive 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). This report was associated with product quality complaint: 90000220076. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the RA evaluation/investigation performed. This case, from the same reporter is linked to 20220302858.; Sender's Comments: V0-20220304761-covid-19 vaccine ad26.cov2.s Suspected clinical vaccination failure. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity (case ID# 003592683). 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, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. The reporter stated "The media not honest or factual. Say it's not so. My wife died from the J&J vaccine. Would the media cover it. Nope. It did not fit their agenda. Yet, they report other countries censoring their media. JNJNews protect each other". On an unspecified date, the patient experienced death from an unknown cause. 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: 20220306247- Covid-19 vaccine ad26.cov2.s-Death. 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). Therefore, this event(s) is considered unassessable. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: MULTIPLE BLOOD CLOTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered 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 multiple blood clots, and was hospitalized on unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multiple blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220306318-Covid-19 vaccine ad26.cov2.s-Multiple blood clots. 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). Therefore, this event(s) is considered unassessable.
Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Inappropriate schedule of product administration, Off label use, Psoriasis, Therapeutic response shortened
Clinical narrative: PSORIASIS FLARE UP; WEARING OFF EFFECT; HEADACHE; OFF-LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis.  The patient received 2 doses of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination and dose was not reported, 1 total administered on an unspecified date and month in 2021 for prophylactic vaccination (which was off label use and inappropriate schedule of vaccine administration). The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the patient experienced plaque psoriasis flare up, itch for two or three days before injection with humira, headache and wearing off effect (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from psoriasis flare up, and wearing off effect, and the outcome of headache, off-label use and inappropriate schedule of vaccine administered was not reported. The patient received moderna covid-19 vaccine (dose number in series 2), (form of administration not reported, intramuscular, and batch number: unknown, expiry: unknown) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No adverse events were reported following administration of moderna covid-19 vaccine (dose number in series 2). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 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, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died. It was reported as "Patient my dad did too" (It was in response to the previously reported event, "My mom died 2 days after getting the vaccine"). It was unspecified if an autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). Sender's Comments: V0: 20220308262-Covid-19 vaccine ad26.cov2.s -Died. 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). Therefore, this event(s) is considered unassessable. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This spontaneous pregnancy report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was pregnant at the time of vaccination. The patient was gravida 1. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 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. On an unspecified date, the patient had vaccine exposure during pregnancy and lost baby (Miscarriage). The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a spontaneous abortion. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220312606- Covid-19 vaccine ad26.cov2.s-Miscarriage. 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). Therefore, this event(s) is considered unassessable. 20220312606- Covid-19 vaccine ad26.cov2.s- Vaccine exposure during pregnancy. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a 59 year old African American female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: In 2019, the patient got Covid-19, received an antibody infusion in JAN-2020, and concurrent conditions included: high blood pressure, alcohol user, non-smoker, and sciatic nerve. The patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol (Tylenol) and other anti-inflammatory drugs for sciatic nerve. On an unspecified date, the patient experienced scratchy throat and had tested positive in PCR (Polymerase chain reaction) test which indicated suspected Covid-19 infection (mild) and suspected clinical vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000220543, 90000220643. This case, involving the same patient is linked to 20220312273 (Dose number in series 2). Sender's Comments: V0:20220314408--COVID-19 VACCINE Ad26.COV2.S--suspected clinical vaccination failure. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fibromyalgia, Psoriatic arthropathy, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a consumer concerned a 67 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Covid-19 virus test positive, psoriatic arthritis. On DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The patient received adalimumab non-company (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 week, therapy dates were not reported, and dose was not reported, 1 time every 2 weeks, from an unspecified date to 28-FEB-2022 for psoriatic arthritis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported and expiry: unknown) dose was not reported, 1 total administered on 01-JUN-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, the patient experienced fibromyalgia, some pains when got up, worsening of pain in knee and psoriatic arthritis in neck and shoulders. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab non-company was not reported. The patient had not recovered from psoriatic arthritis in neck and shoulders, and the outcome of fibromyalgia was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220314806-COVID-19 VACCINE Ad26.COV2.S- Psoriatic arthritis in neck and shoulders. The event(s) has a unknown/unclear 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211a21a, expiry: UNKNOWN) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2022, the patient experienced suspected covid-19. On 07-MAR-2022, Laboratory data included: SARS-CoV-2 test (not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; 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 experienced arm was a little stiff when treated with influenza vaccine for prophylactic vaccination.  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 07-MAR-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, the patient experienced inappropriate dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate dose of vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Burning sensation, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: FEELS HORRIBLE; FACE AND EARS FEEL LIKE THEY ARE ON FIRE; SKIN SENSITIVITY; OTIS MEDIA OF LEFT EAR; ELEVATED BLOOD PRESSURE; TINNITUS/RINGING OF EARS; NUMBNESS; TINGLING OF EARS AND FACE/RINGING OF FACE; NAUSEA; DIARRHEA; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, asthma, sinusitis, and sting bee allergy, and other pre-existing medical conditions included: The patient is sensitive to non-sedating antihistamines. The patient was not taking any inhaler or medications. The patient had no known sources of allergy before/or immediately after immunization. The patient experienced rash, skin sensitivity and swollen arm when treated with influenza vaccine for prophylactic vaccination. 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 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Concomitant medications included valsartan for hypertension. On MAR-2021, the patient experienced nausea, diarrhea, and headache. On 24-MAR-2021, the patient experienced elevated blood pressure, tinnitus/ringing of ears, numbness, and tingling of ears and face/ringing of face. On MAR-2022, Laboratory data included: Blood pressure (NR: not provided) elevated. On an unspecified date, the patient experienced otis media of left ear, feels horrible, face and ears feel like they are on fire, and skin sensitivity. Treatment medications (dates unspecified) included: epinephrine, ibuprofen, triamcinolone acetonide, paracetamol, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, and numbness on 24-MAR-2021, had not recovered from tinnitus/ringing of ears, tingling of ears and face/ringing of face, nausea, diarrhea, headache, and feels horrible, and the outcome of face and ears feel like they are on fire, otis media of left ear and skin sensitivity was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Nausea, Otitis media, Paraesthesia
Clinical narrative: FEELS HORRIBLE; FACE AND EARS FEEL LIKE THEY ARE ON FIRE; SKIN SENSITIVITY; OTIS MEDIA OF LEFT EAR; ELEVATED BLOOD PRESSURE; TINNITUS/RINGING OF EARS; NUMBNESS; TINGLING OF EARS AND FACE/RINGING OF FACE; NAUSEA; DIARRHEA; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, asthma, sinusitis, and sting bee allergy, and other pre-existing medical conditions included: The patient is sensitive to non-sedating antihistamines. The patient was not taking any inhaler or medications. The patient had no known sources of allergy before/or immediately after immunization. The patient experienced rash, skin sensitivity and swollen arm when treated with influenza vaccine for prophylactic vaccination. 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 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Concomitant medications included valsartan for hypertension. On MAR-2021, the patient experienced nausea, diarrhea, and headache. On 24-MAR-2021, the patient experienced elevated blood pressure, tinnitus/ringing of ears, numbness, and tingling of ears and face/ringing of face. On MAR-2022, Laboratory data included: Blood pressure (NR: not provided) elevated. On an unspecified date, the patient experienced otis media of left ear, feels horrible, face and ears feel like they are on fire, and skin sensitivity. Treatment medications (dates unspecified) included: epinephrine, ibuprofen, triamcinolone acetonide, paracetamol, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, and numbness on 24-MAR-2021, had not recovered from tinnitus/ringing of ears, tingling of ears and face/ringing of face, nausea, diarrhea, headache, and feels horrible, and the outcome of face and ears feel like they are on fire, otis media of left ear and skin sensitivity was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Tinnitus
Clinical narrative: FEELS HORRIBLE; FACE AND EARS FEEL LIKE THEY ARE ON FIRE; SKIN SENSITIVITY; OTIS MEDIA OF LEFT EAR; ELEVATED BLOOD PRESSURE; TINNITUS/RINGING OF EARS; NUMBNESS; TINGLING OF EARS AND FACE/RINGING OF FACE; NAUSEA; DIARRHEA; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, asthma, sinusitis, and sting bee allergy, and other pre-existing medical conditions included: The patient is sensitive to non-sedating antihistamines. The patient was not taking any inhaler or medications. The patient had no known sources of allergy before/or immediately after immunization. The patient experienced rash, skin sensitivity and swollen arm when treated with influenza vaccine for prophylactic vaccination. 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 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Concomitant medications included valsartan for hypertension. On MAR-2021, the patient experienced nausea, diarrhea, and headache. On 24-MAR-2021, the patient experienced elevated blood pressure, tinnitus/ringing of ears, numbness, and tingling of ears and face/ringing of face. On MAR-2022, Laboratory data included: Blood pressure (NR: not provided) elevated. On an unspecified date, the patient experienced otis media of left ear, feels horrible, face and ears feel like they are on fire, and skin sensitivity. Treatment medications (dates unspecified) included: epinephrine, ibuprofen, triamcinolone acetonide, paracetamol, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, and numbness on 24-MAR-2021, had not recovered from tinnitus/ringing of ears, tingling of ears and face/ringing of face, nausea, diarrhea, headache, and feels horrible, and the outcome of face and ears feel like they are on fire, otis media of left ear and skin sensitivity was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: A REALLY GOOD SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 a really good side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a really good side effect was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Thrombosis
Clinical narrative: This spontaneous report received from a patient concerned a female 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 Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on SEP-2021 on left arm 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 blood clots, and smells like diesel. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and smells like diesel was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220322002-COVID-19 VACCINE AD26.COV2.S- Blood clots. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS; This spontaneous report received from a consumer 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 (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 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 It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine bnt 162 (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, start therapy date was not reported for prophylactic vaccination. On an unspecified date, following vaccination with booster of bnt 162, the patient experienced tinnitus. (Dose number in series 2). The action taken with bnt 162 was not applicable. The outcome of tinnitus was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Epstein-Barr virus test, Hypersomnia, Peripheral swelling
Clinical narrative: CAN'T BEND FINGERS; ARM WAS SWOLLEN/ ISSUES WITH ARM; ALL DO IS SLEEP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: ebv infection. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced can't bend fingers, arm was swollen/ issues with arm, and all do is sleep. Laboratory data (dates unspecified) included: Epstein-Barr virus test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can't bend fingers, arm was swollen/ issues with arm and all do is sleep was not reported. This report was non-serious.