chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: my arm is really sore; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th August 2021, the patient received the 2nd dose of Shingles vaccine. On 19th August 2021, immediately after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by patient himself or herself. The age at vaccination was not reported. It was reported that the patient just got 2nd dose of shingles vaccine and his/ her arm was really sore.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after the vaccine/ suspected vaccination failure; shingles twice; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter knows someone who got the shingles twice after the vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown. This case has been linked with the case US2021AMR176081, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176081:same reporter (flu vaccine case)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine. Got shingles 3 times/ Suspected Vaccination failure; Got shingles 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the vaccine and got shingles 3 times. The reporter wonder why it didn't work for him/her. The reporter was told there was a new 2 step one that would be better. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The vaccine can only guarantee a milder case/ I've had it twice/ suspected vaccination failure; I've had it twice; This case was reported by a consumer  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immunocompromised.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The reporter stated that the vaccine can only guarantee a milder case and not prevent it.  The reporter stated if they are immune compromised, they still could get shingles. The patient had shingles twice the first was brutal the second a little easier. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: deathly sick; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient received dose of Shingles vaccine and felt deathly sick for a couple weeks. For 2nd dose, refer case US2021AMR176128, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176129:Same reporter US-GLAXOSMITHKLINE-US2021AMR176128:Same reporter
Sex: M
Vaccine: TDAP
Symptoms: Underdose
Clinical narrative: report the issue as a PQC.; did not receive the full dose; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 49-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number AB374, expiry date 21st November 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 13th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose and pharmaceutical product complaint 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 details were provided as follows: The age at vaccination was not reported. The nurse reported that the adult patient did not receive the full dose of Boostrix due to an issue, when she was administering the dose 50 percent of the vaccine remained in the syringe, which led to accidental underdose. The reporter consented to follow up. This case has been linked to US2021172420, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021172420:Same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain
Clinical narrative: pain in her eyes; This case was reported by a consumer via call center representative and described the occurrence of eye pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 17th August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2021, less than a day after receiving Shingrix, the patient experienced eye pain. On an unknown date, the outcome of the eye pain was not recovered/not resolved.   It was unknown if the reporter considered the eye pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received 2nd dose of Shingrix vaccine and later that night experienced pain in eye. The patient was referred to follow-up with her health care professional. Batch number and expiry date was unknown. The patient did not had specific doctor at the clinic.  Note: less than a day was conservatively captured as time to onset for eye pain as per narrative until further clarification on follow up. The reporter consented to follow-up.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 2year old /received an adult /Havrix.; 2year old /received an adult /Havrix.; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-year-old male patient who received HAV (Havrix 1440 adult) (batch number 5S945, expiry date 6th April 2023) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, unknown after receiving Havrix 1440 adult, 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.  Additional details were reported as follows: This case was reported by healthcare Manager (also physical therapist). Two year old patient received an adult formulation of Havrix, which led to adult product administered to child and overdose. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: arm is still sore; disrupts his sleep; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 23rd June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 24th June 2021, 1 day after receiving Shingrix, the patient experienced pain in arm and sleep disturbance. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the pain in arm and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and sleep disturbance to be related to Shingrix.  Additional details were provided are as follows: The patient received 2nd dose of Shingrix in left arm and still had left arm sore at the top part of his arm and the pain disrupted his sleep. The patient tried Aleve for a couple off days and that helped with the pain but when he stopped the Aleve the pain came right back. The patient did not want to take Aleve everyday. Referred to health care professional. Did not gave permission to contact health care professional. Did not consent to follow-up.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: will call back to provide /account number to process credit / Credit pending; vaccine was expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number MG92G, expiry date 3rd May 2021) and (batch number 23YL4, expiry date 4th April 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th August 2021, the patient received Pediarix (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 18th August 2021, the patient started Pediarix Pre-Filled Syringe Device. On 18th August 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the expired vaccine used and pharmaceutical product complaint 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 details were provided as follows: The patient received pediarix in the left arm. The reporter stated that, she opened a box of Pedarix to give a dose, checked the expiration date on the box (lot 23YL4 exp 4/4/2022), pulled out the pediarix and administered the dose to the patient. After administration the reporter went to enter the lot and expiration date in the computer system and it did not allow her to do so because the vaccine was expired. The reporter checked the actual syringe and the expiration date said 3rd May 2021, lot MG92G instead of matching the boxes expiration date of 4th April 2022. The reporter stated that, the patient had not shown any symptoms currently from receiving the expired vaccine.  The reporter stated that, the syringes were usually stored in the original box until use and there was no evidence of tampering upon receipt. The reporter stated the last two lots ordered prior to this box were F4H92 and AZ472. Customer would be returning the box, 3 in date unused syringes left in the box, and the expired syringe. Glaxosmithkline to credit Customer for 4 doses of Pediarix to customers account. Customer would call back to provide wholesaler information and account number to process credit. Credit pending. The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 19 year old patient received an adult dose of Engerix-B; 19 year old patient received an adult dose of Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B adult) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   Previously administered products included Engerix B (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided are as follows: A 19 years old patient received an adult dose of Engerix B in her series which led to adult product administered to child and overdose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 22nd October 2019).   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 patient's spouse. The age at vaccination was not applicable for report. Till the time of reporting, the patient did not receive the second dose.   The lot number and expiration date were not available. The reporter consented to follow up. This case was linked with US2021174372, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021174372:Same reporter
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient / received only the adjuvant; Patient / received only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 34SD3, expiry date 15th November 2022) for prophylaxis.   On 18th August 2021, the patient received Shingrix. On 18th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The pharmacist reported a male patient had received only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via Email.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Little swelling in / arm after / first dose; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles multiple outbreaks).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient reported that she had a little swelling in her arm after the first dose, which got resolved.  The reporter consented to follow up. For tolerance to 2nd dose, refer case US2021AMR175275.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175275:Same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered / Adjuvant portion only; Administered / Adjuvant portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number D4PA4, expiry date 10th February 2023) for prophylaxis.   On 18th August 2021, the patient received the 1st dose of Shingrix. On 18th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The practice manager reported a Medical Assistant administered the liquid AS01B Adjuvant portion only of Shingrix, without reconstituting with the lyophilized portion to 60 year old female patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021174387, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021174387:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered with liquid Adjuvant portion only; administered with liquid  Adjuvant portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number CL335, expiry date 23rd May 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The practice manager believed a patient might have been administered with liquid AS01B Adjuvant portion only of Shingrix as the practice now has an extra vial of lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient details unknown at this time, however health care professional would be researching to track down the patient. She stated the event would have happened within the past couple of weeks, but exact date was unknown. The reporter consented to follow up. This case was linked with case US2021174385, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021174385:Same reporter
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: pediatric /patient had received an adult dose; pediatric / patient had received an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 12-year-old female patient who received HAV (Havrix adult) (batch number F4EL2, expiry date 9th November 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose 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 details were reported as follows: Pharmacist reported that a pediatric patient had received an adult dose of HAVRIX which led to adult product administered to child and overdose. No further details were reported at the time of the call. The reporter consented to follow up by phone. The case had been linked with U2021174388 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-U2021174388:Same rSeporter
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient administered with the diluent part of Vaccine; Patient administered with the diluent part of Vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5708, expiry date 22nd October 2021) for prophylaxis.   On 17th August 2021, the patient received Menveo. On 17th August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that a male patient was administered with the diluent part of Menveo Vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state
Clinical narrative: Encephalitis; Meningitis; This case was reported by a consumer via call center representative and described the occurrence of encephalitis in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 9th June 2021 and also experienced swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain, refer case US2021135683) and COVID-19 VACCINE MODERNA (dose received on April 2021).   On 9th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than 2 weeks after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant) and meningitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis and meningitis were unknown.   It was unknown if the reporter considered the encephalitis and meningitis to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient reported that, she received 2nd dose and developed encephalitis and meningitis and was not hospitalized.  The patient said that, she was too confused and could not answer more questions. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021135683:Same reporter.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) 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.  In JUL-2021 (35 days prior to this report), the patient developed suspected Covid 19 infection (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 report was associated with product quality complaint: 90000190332 This case is linked to 20210834870 (same reporter).; Sender's Comments: V0: 20210835180 -COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discolouration, Pain in extremity, Paraesthesia, Rash macular
Clinical narrative: ROUND DIMED SIZED YELLOWISH (LEGAL PAD COLOR) AT THE INJECTION SITE SPOT THEN INSIDE OF SPOT A BLACK SPOT; RIGHT ARM STARTED ACHING ON TOP OF SHOULDER AND FELT LOOSE; VERY LITE YELLOW SPOT THE SIZE OF AN ERASER HEAD WITH 1 RED SPOT/2 RED SPOTS LIKE A TRIANGLE; PIN PRICK AT INJECTION SITE; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced pin prick at injection site. On 18-AUG-2021, the patient experienced very lite yellow spot the size of an eraser head with 1 red spot/2 red spots like a triangle. On an unspecified date, the patient experienced round dimed sized yellowish (legal pad color) at the injection site spot then inside of spot a black spot, and right arm started aching on top of shoulder and felt loose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pin prick at injection site on 11-APR-2021, was recovering from round dimed sized yellowish (legal pad color) at the injection site spot then inside of spot a black spot, had not recovered from very lite yellow spot the size of an eraser head with 1 red spot/2 red spots like a triangle, and the outcome of right arm started aching on top of shoulder and felt loose was not reported. This report was non-serious.
Sex: M
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 male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported,1 total, administered on MAY-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 tested positive for covid and have developed symptoms(suspected covid-19 infection, suspected clinical vaccination failure) and fortunately the patient was not hospitalized at that point but had been very ill.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210839400.; Sender's Comments: 20210839107 -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.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: HAND STILL HURTS/ARM STILL PAINFUL; SEVERE HEADACHE; HAND SHAKING FOR A COUPLE OF DAYS; DECREASED BLOOD PRESSURE; SWOLLEN HAND/ARM STILL SWOLLEN; This spontaneous report received from a patient concerned an 89 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced hand shaking for a couple of days. On 12-MAR-2021, the patient experienced decreased blood pressure. On 12-MAR-2021, the patient experienced swollen hand/arm still swollen. On 12-MAR-2021, the patient experienced severe headache. Laboratory data included: Blood pressure (NR: not provided) Blood pressure dropped. On an unspecified date, the patient experienced hand still hurts/arm still painful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand shaking for a couple of days, decreased blood pressure on 15-MAR-2021, and severe headache on 14-MAR-2021, and had not recovered from swollen hand/arm still swollen, and hand still hurts/arm still painful. This report was non-serious. This case, from the same reporter is linked to 20210840400.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: HAND STILL HURTS/ARM STILL PAINFUL; SEVERE HEADACHE; HAND SHAKING FOR A COUPLE OF DAYS; DECREASED BLOOD PRESSURE; SWOLLEN HAND/ARM STILL SWOLLEN; This spontaneous report received from a patient concerned an 89 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced hand shaking for a couple of days. On 12-MAR-2021, the patient experienced decreased blood pressure. On 12-MAR-2021, the patient experienced swollen hand/arm still swollen. On 12-MAR-2021, the patient experienced severe headache. Laboratory data included: Blood pressure (NR: not provided) Blood pressure dropped. On an unspecified date, the patient experienced hand still hurts/arm still painful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand shaking for a couple of days, decreased blood pressure on 15-MAR-2021, and severe headache on 14-MAR-2021, and had not recovered from swollen hand/arm still swollen, and hand still hurts/arm still painful. This report was non-serious. This case, from the same reporter is linked to 20210840400.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Cardiac disorder, Chest pain, Fatigue, Hyperthyroidism
Clinical narrative: SUB-CLINICAL HYPERTHYROIDISM; GRAVE'S DISEASE; BLURRY VISION; FELT ILL; FELT TIRED AND EXHAUSTED; HEART COMPLICATIONS; CHEST PAIN; FLU-LIKE SYMPTOMS; BODY ACHE; This spontaneous report received from a patient concerned a 49 year old white, not Hispanic or Latino female. The patient's weight was 65.3 kilograms, and height was 67.5 inches. The patient's past medical history included: Smoker. concurrent conditions included: HIV infection, alcoholic, anxiety. Other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the patient experienced heart complications that her heart felt weird and fluttering, however, this symptom decreased. Heart symptoms began four to five hours after receiving the vaccine. She could not work all day after she received the vaccine. She experienced chest pain, flu-like symptoms, body ache, felt ill, felt tired and exhausted. On 05-APR-2021, she experienced blurry vision. In MAY-2021, Patient was diagnosed with sub-clinical hyperthyroidism, grave's disease at her annual check-up. She was tested again in JUN-2021 to confirm initial findings. She received sodium iodide as a part of thyroid test in AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, flu-like symptoms, body ache, and felt ill on 06-APR-2021, and felt tired and exhausted, had not recovered from sub-clinical hyperthyroidism, and the outcome of grave's disease, heart complications and blurry vision was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210840811-Covid-19 vaccine ad26.cov2.s-Sub-clinical hyperthyroidism, Grave's disease . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Pain, Thyroid function test, Vision blurred
Clinical narrative: SUB-CLINICAL HYPERTHYROIDISM; GRAVE'S DISEASE; BLURRY VISION; FELT ILL; FELT TIRED AND EXHAUSTED; HEART COMPLICATIONS; CHEST PAIN; FLU-LIKE SYMPTOMS; BODY ACHE; This spontaneous report received from a patient concerned a 49 year old white, not Hispanic or Latino female. The patient's weight was 65.3 kilograms, and height was 67.5 inches. The patient's past medical history included: Smoker. concurrent conditions included: HIV infection, alcoholic, anxiety. Other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the patient experienced heart complications that her heart felt weird and fluttering, however, this symptom decreased. Heart symptoms began four to five hours after receiving the vaccine. She could not work all day after she received the vaccine. She experienced chest pain, flu-like symptoms, body ache, felt ill, felt tired and exhausted. On 05-APR-2021, she experienced blurry vision. In MAY-2021, Patient was diagnosed with sub-clinical hyperthyroidism, grave's disease at her annual check-up. She was tested again in JUN-2021 to confirm initial findings. She received sodium iodide as a part of thyroid test in AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, flu-like symptoms, body ache, and felt ill on 06-APR-2021, and felt tired and exhausted, had not recovered from sub-clinical hyperthyroidism, and the outcome of grave's disease, heart complications and blurry vision was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210840811-Covid-19 vaccine ad26.cov2.s-Sub-clinical hyperthyroidism, Grave's disease . 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: Malaise, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ILL; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number unknown) dose was not reported, 1 total, administered on MAY-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 suspected clinical vaccination failure and suspected covid-19 infection. She had developed symptoms. Fortunately, she had not been hospitalized at that point but she had been very ill. Laboratory data (dates unspecified) included COVID-19 virus test (NR not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and ill was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190272. This case, from the same reporter is linked to 20210839107.; Sender's Comments: V0: 20210841062- 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: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210843021, 20210843411 and 20210842933.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Rash pruritic
Clinical narrative: SEVERE HEADACHE; LITTLE DIZZY; NECK WAS ITCHING AND BREAKING OUT/ RASH AND A BUMP ON HIS NECK; SORE ARM; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced little dizzy. On 16-AUG-2021, the patient experienced neck was itching and breaking out/ rash and a bump on his neck. On 16-AUG-2021, the patient experienced sore arm. On 17-AUG-2021, the patient experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, little dizzy, and neck was itching and breaking out/ rash and a bump on his neck, and the outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: WEAKNESS; FELT TIRED; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced weakness, felt tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, felt tired and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210842894.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Pain
Clinical narrative: PAIN ON ENTIRE RIGHT-SIDE (FROM RIGHT SHOULDER TO RIGHT ARM, RIGHT HIP AND ALL THE WAY DOWN TO RIGHT FOOT); BONES HURTING; MUSCLES HURTING; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-AUG-2021, the patient experienced pain on entire right-side (from right shoulder to right arm, right hip and all the way down to right foot). On 20-AUG-2021, the patient experienced bones hurting. On 20-AUG-2021, the patient experienced muscles hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on entire right-side (from right shoulder to right arm, right hip and all the way down to right foot), muscles hurting, and bones hurting. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT ICKY; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 felt icky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt icky was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced headache. Laboratory data (dates unspecified) included: CT (Computerised tomogram) scan (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: LOSS OF TASTE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, allergy to bactrim, alcohol use, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste on 17-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: INCORRECT ROUTE OF ADMINISTRATION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number was not reported) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-AUG-2021, the patient experienced incorrect route of administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of incorrect route of administration was not reported. This report was non-serious.