chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered expired Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: The reporter reported that, they inadvertently administered expired Bexsero dose to a patient. The reporter called to inquire to know about how to proceed. The reporter did not consent to follow-up. Additional Supportive Information: The patient was inadvertently administered with expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received the Shingrix adjuvant only instead of the reconstituted vaccine; Received the Shingrix adjuvant only instead of the reconstituted vaccine; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 2nd dose of Shingrix. On 9th June 2022, 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: GSK Receipt Date: 09-Jun-2022 Reporter's Comments: The patient self-reported this case. The patient received the Shingrix adjuvant only instead of the reconstituted vaccine. The reporter had nothing else to report. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received the Shingrix adjuvant only instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: pediatric patients were inadvertently administered an adult Havrix; pediatric patients were inadvertently administered an adult Havrix; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received HAV (Havrix adult) (batch number J9587, expiry date 22nd 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 4th May 2022, the patient received Havrix adult 1 ml and Havrix Pre-Filled Syringe Device. On 4th May 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental 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: GSK Receipt Date: 10-JUN-2022  Reporter's comment: Medical Assistant called in to inquire as how to proceed and what to look for a pediatric patients who was inadvertently administered an adult Havrix (1 mL) dose. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered an adult Havrix dose, which led to overdose and inappropriate age at vaccine administration. This case is linked with US2022091775, reporter by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091775:same reporter
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: patients were inadvertently administered an adult Havrix; patients each were inadvertently administered an adult Havrix; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received HAV (Havrix adult) (batch number J9587, expiry date 22nd 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 4th May 2022, the patient received Havrix adult 1 ml and Havrix Pre-Filled Syringe Device. On 4th May 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental 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: GSK Receipt Date: 10-JUN-2022  Reporter's comment: Medical Assistant called in to inquire as how to proceed and what to look for a pediatric patients who was inadvertently administered an adult Havrix dose. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered an adult Havrix dose, which led to overdose and inappropriate age at vaccine administration. This case is linked with US2022091774, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091774:same reporter
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: was administered a dose of the havrix after a temperature excursion.; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 62-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 11th April 2022, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 10-JUN-2022  Reporter's comment: Office manager reported that a patient was administered a dose of the Havrix vaccine after a temperature excursion. The reporter consented to follow up. Additional supportive information: The patient received Havrix vaccine after a temperature excursion, which led to incorrect storage of drug.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Headaches off and on; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The patient reported case for himself. The patient had a sore arm the next day that lasted for a couple of days and getting headaches off and on that started on the third day after his vaccine and last for a few weeks. The patient did not have any further information about the vaccine. The reporter did not consent to follow-up. No HCP for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Peripheral swelling
Clinical narrative: Headache; Nausea; Tiredness; Sore arm, still very sore; Arm is very swollen; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2022, the patient received the 1st dose of Shingrix. On 8th June 2022, 1 days after receiving Shingrix, the patient experienced headache, nausea, tiredness and pain in arm. In June 2022, the patient experienced swelling arm. On an unknown date, the outcome of the headache, nausea and tiredness were unknown and the outcome of the pain in arm and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the headache, nausea, tiredness, pain in arm and swelling arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The patient reported case for herself. She stated the next day, she experienced headache, nausea, tiredness, and a sore arm. The patient stated that on the day of reporting her arm was still very sore and it was very swollen. The reporter did not consent to follow-up. The consumer declined to provide any further information.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaemia, Blood test abnormal
Clinical narrative: Blood work showed anemia after Shingrix; This case was reported by a consumer via call center representative and described the occurrence of anemia in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th May 2022, 2 days after receiving Shingrix, the patient experienced anemia. On an unknown date, the outcome of the anemia was unknown.   It was unknown if the reporter considered the anemia to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The patient reported case for himself. The patient received Shingrix vaccine and then had blood work 2 days later. The reporter stated that his blood work showed he was anemic. The reporter did not have any more information about the vaccine. The reporter consented to follow-up. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091791:Same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Blood test abnormal
Clinical narrative: blood work showed she was anemic; This case was reported by a consumer via call center representative and described the occurrence of anemia in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th May 2022, 2 days after receiving Shingrix, the patient experienced anemia. On an unknown date, the outcome of the anemia was unknown.   It was unknown if the reporter considered the anemia to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The case was reported by the patient's husband. The patient received Shingrix vaccine in left arm and then had blood work 2 days later. The reporter stated that her blood work showed she was anemic. The reporter did not have any more information about the vaccine. The reporter consented to follow-up. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091788:Same reporter
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Pain in extremity, Psoriasis
Clinical narrative: PSORIASIS FLARE UP/ BREAK OUT ON LEFT BUTTOCKS; SORE ARM; This spontaneous report received from a patient via other manufacturer concerned 6 decade old adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, and moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced psoriasis flare up/ break out on left buttocks and sore arm (dose number in series 1). The patient received non-company suspect vaccine included Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin unknown, intramuscular, batch number: unknown and expiry: unknown) dose not reported, (1 in once) administered on an unspecified date for prophylactic vaccination. No concomitant medications were reported. The patient received non-company suspect drug Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number: unknown and expiry: unknown) dose and frequency were not reported from 27-OCT-2017 for psoriatic arthritis and moderate to severe chronic plaque psoriasis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with tozinameran was not reported; and dose of adalimumab was not changed. The patient had not recovered from psoriasis flare up/ break out on left buttocks, and the outcome of sore arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20220625171.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; METALLIC TASTE IN MOUTH; This spontaneous report received from a patient concerned a patient of an unspecified age, sex, race and ethnic origin. Initial information was processed along with the additional information received on 10-JUN-2022. The patient's height, and weight were not reported. The patient's concomitant medical history included: Drug allergy. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, 01 total administered on 11-MAR-2021 for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient had Covid-19 (coded as suspected covid-19 and suspected clinical vaccination failure) (Dose number in series 1) and received treatment. The patient was taking other medications/products within 2 weeks of initiation of COVID-19 treatment (Dose number in series 1). The patient additionally received non-company suspect vaccine elasomeran (Moderna Covid-19 vaccine) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 033F21A expiry: UNKNOWN) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. Concomitant medications included ethinylestradiol/norgestimate for birth control, and dextromethorphan hydrobromide/ethanol/guaifenesin for cough suppressant. The patient received non-company suspect drug Plaxovid (form of admin, route of admin, batch number were not reported), dose was not reported administered on 25-MAY-2022 for Covid-19 treatment.  On 25-MAY-2022, the patient experienced metallic taste in mouth (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable, and for Plaxovid not reported. The outcome of the metallic taste in mouth, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This case is associated with product quality complaint number: 90000235217. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220609401-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: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cellulitis, Injection site mass, Injection site pain
Clinical narrative: CELLULITIS; LUMP AT INJECTION SITE; BURNING HAS SPREAD TO LYMPH NODES; SWELLING TO LYMPH NODES; BURNING AT INJECTION SITE; COVID-19; This spontaneous report received from a patient concerned a male of an unspecified age, race and ethnicity. Initial information was processed along with additional information received on 06-JUN-2022. 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: 1855194 expiry: UNKNOWN) dose was not reported, 1 in total administered to the back of the left arm on 16-APR-2022 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2022, 3 weeks after vaccination the patient experienced covid-19 and had symptoms of fever of 102.4 F and headache.  On 04-JUN-2022, the patient woke up with reaction to injection site. The patient experienced lump in injection site with burning, and the burning was spreading to lymph nodes under and there was swelling (swelling to lymph nodes).  On an unspecified date, the patient went to urgent care and patient was diagnosed with cellulitis. Treatment medications (dates unspecified) included: cefalexin, 500 mg four times a day for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at injection site, burning at injection site, burning has spread to lymph nodes, and swelling to lymph nodes, and the outcome of covid-19 and cellulitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220609638-COVID-19 VACCINE AD26.COV2.S-CELLULITIS. 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: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: CELLULITIS; LUMP AT INJECTION SITE; BURNING HAS SPREAD TO LYMPH NODES; SWELLING TO LYMPH NODES; BURNING AT INJECTION SITE; COVID-19; This spontaneous report received from a patient concerned a male of an unspecified age, race and ethnicity. Initial information was processed along with additional information received on 06-JUN-2022. 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: 1855194 expiry: UNKNOWN) dose was not reported, 1 in total administered to the back of the left arm on 16-APR-2022 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2022, 3 weeks after vaccination the patient experienced covid-19 and had symptoms of fever of 102.4 F and headache.  On 04-JUN-2022, the patient woke up with reaction to injection site. The patient experienced lump in injection site with burning, and the burning was spreading to lymph nodes under and there was swelling (swelling to lymph nodes).  On an unspecified date, the patient went to urgent care and patient was diagnosed with cellulitis. Treatment medications (dates unspecified) included: cefalexin, 500 mg four times a day for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at injection site, burning at injection site, burning has spread to lymph nodes, and swelling to lymph nodes, and the outcome of covid-19 and cellulitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220609638-COVID-19 VACCINE AD26.COV2.S-CELLULITIS. 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: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Infection, Surgery
Clinical narrative: This spontaneous report received from a patient via other manufacturer concerned a 50-year-old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry date: UNKNOWN) 1 total, 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. The patient received non-company suspect drugs included adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: unknown and expiry date: unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced infection and had surgery in MAR-2022 and had been in and out of hospital due to infections. Number of days of hospitalization was not reported. It was unknown if patient was discharged. On an unspecified date, the patient felt like she went downhill post receiving Covid vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable and action taken with adalimumab was not reported. The outcome of the infection, felt like went downhill and surgery was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0:20220612987-COVID-19 VACCINE AD26.COV2.S- surgery, infection - The event(s) has a 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Amoxicillin), fish allergy, shell fish allergy, and asthma. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 24-MAR-2021 for prophylactic vaccination. Age at time of vaccination 26 years old. Concomitant medications included beclometasone dipropionate, and venlafaxine. The patient additionally received booster dose with non-company suspect vaccine Spikevax (elasomeran) (Dose number in series 2) (form of admin and route of admin not reported, batch number: 023C21A expiry: Unknown) dose was not reported, administered in left arm on 14-DEC-2021 for prophylactic vaccination. Age at time of vaccination 27 years old. On 30-MAY-2022, the patient experienced confirmed clinical vaccination failure (Dose number in series 1) and confirmed covid-19 infection (Dose number in series 2). The patient reported that, she tested negative on 27-MAY-2022 and was feeling better. On the same day at night, the patient started having runny nose and on 31-MAY-2022, she tested positive again. On 27-MAY-2022, Laboratory data included: COVID-19 virus test Negative. On 31-MAY-2022, Laboratory data included: COVID-19 virus test Positive. The patient took Paxlovid from 21-MAY-2022 to 26-MAY-2022 for Covid-19 treatment. The patient thought it was the Paxlovid rebound. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and confirmed clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000235165.; Sender's Comments: V0. 20220617357-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Death, Foetal exposure during pregnancy, Heart disease congenital
Clinical narrative: This spontaneous pregnancy report received from a consumer via a company representative concerned a neonate 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's parent received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose and start therapy date were not reported, 1 in total was 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 was exposed to vaccine in utero via transplacental (fetal exposure during pregnancy). It was reported that the pregnancy was discovered one month after vaccination. On an unspecified date, the patient was born with a heart defect (heart disease congenital) and passed away from unknown cause of death at 4 weeks of birth. It was unknown if an autopsy was performed. The reporter suspected it to be an adverse event related to the vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause of death, and the outcome of congenital heart defect and fetal exposure during pregnancy was not reported. This report was serious (Death, Congenital Anomaly/Birth Defect, and Other Medically Important Condition). This parent/child case is linked to 20220617426. Sender's Comments: V0: 20220617386 -COVID-19 VACCINE AD26.COV2.S- Death, Congenital heart defect. The event(s) has a 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. 20220617386 -COVID-19 VACCINE AD26.COV2.S-Fetal exposure during pregnancy. 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. Therefore, this event is considered not related. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy unspecified, and other pre-existing medical conditions included: None. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A expiry: Unknown) dose was not reported, 1 total administered to left arm on 02-APR-2021 for prophylactic vaccination. Age at time of vaccination 4 decade old.  The patient received additional non-company suspect vaccine included: Moderna Covid-19 Vaccine (elasomeran) (form of admin, route of admin were not reported, batch number: 088D21A expiry: Unknown) dose was not reported, administered to left arm on 13-AUG-2021 for prophylactic vaccination. Age at time of vaccination 4 decade old.  The patient received non-company suspect Paxlovid (Nirmatrelvir; ritonavir) (form of admin, route of admin, batch number and expiry were not reported) therapy started on 23-MAY-2022, Therapy ended on 27-MAY-2022 administered for covid-19 treatment. No concomitant medications were reported. On an unspecified date in MAY-2022, the patient had covid-19 infection (dose number in series 2) (suspected covid-19 infection) which led to suspected clinical vaccination failure (dose number in series 1). On 23-MAY-2022 patient started treatment with Paxlovid. On 31-MAY-2022 at 21:00 (4 days after stopping treatment), the patient had rebound of covid-19. It started with intense congestion and then the rest of the symptoms followed (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with paxlovid was not reported. The patient was recovering 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: 90000235216.; Sender's Comments: V0:20220618811-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient via other company manufacturer (Pfizer) concerned a 35 year old male and unspecified ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, Route and batch number was not reported, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate.  On 24-May-2022, the patient started non-company treatment drug Paxlovid for treatment of COVID-19. Paxlovid was discontinued on 29-May-2022. On 02-JUN-2022 at 09:00 hours, the patient experienced covid-19 and had rebound (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via a company representative via social media concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (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.  On an unspecified date, the patient experienced stroke (at the time of reporting the patient can not use his right hand or speak).  The reporter reported that "Bf - 38 year old heathy male stroke after J and J vaccine. Now can't use his right hand still or speak a year later and has gone form $200 thousand income to no job." and "Bf had a stroke from the JNJ vaccine.. healthy 38 year old male. He can not speak now or use his right hand. Lost his job. Has no income but yet doesn't "qualify" for disability." and "JNJ you reached out to me regarding my contact information about my boyfriends stroke from the #vaccine but you haven't even replied. Seems like a show you me. Lives ruined by vaccine injuries." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220623834-covid-19 vaccine ad26.cov2.s -stroke. 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
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered, 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 stroke. It was reported that ""I got vaccinated and still lost my job due to the stroke the vaccine caused me to have. Would have much rather lost it from not getting vaccinated." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220624066-Covid-19 vaccine ad26.cov2.s-Stroke. 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: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: MILD ILLNESS; This spontaneous report received from a parent via social media via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total 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 mild illness (dose number in series 1). The reporter posted as  "My son and I both had the J and J vaccine and have recently gotten the booster as well. We only had mild illness after the vaccine and no symptoms after the booster". The patient received additional covid-19 vaccine (unspecified manufacturer, dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination.  The patient had no symptoms after booster dose (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild illness was not reported. This report was non-serious. This case, from the same reporter is linked to 20220624885.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: KILLED; This spontaneous report received from a parent via a social media, via a company representative concerned a 32 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 32 years old. No concomitant medications were reported.  On an unspecified date, the patient was killed. The patient died from unknown cause of death. It was unknown if an autopsy was performed. It was reported that, "killed my 32 year old stepson in 5 hours". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220624757 -Covid-19 vaccine ad26.cov2.s-Killed. 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
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: PAINFUL LEG LIKE A BEE STING; LEFT LEG SWOLLEN (SWELLING STARTS RIGHT BELOW THE KNEE AT THE CALF AND GOES ALL THE WAY TO THE ANKLE); This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies and no medical issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Age at time of vaccination 62 years old. No concomitant medications were reported.  On AUG-2021, the patient experienced left leg swollen (swelling starts right below the knee at the calf and goes all the way to the ankle). On an unspecified date, the patient experienced painful leg like a bee sting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg swollen (swelling starts right below the knee at the calf and goes all the way to the ankle), and the outcome of painful leg like a bee sting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: MILD ILLNESS; 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, 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 mild illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild illness was not reported. This report was non-serious. This case, from the same reporter is linked to 20220624624.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious. This case, involving the same patient is linked to 20220625319.
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via other manufacturer concerned 6 decade old adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, and moderate to severe chronic plaque psoriasis. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient experienced psoriasis flare up/break out on left buttock and sore arm when treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) The patient was previously treated with Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown and expiry: unknown) dose not reported (1 in once), administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with Pfizer Biontech Covid-19 Vaccine (tozinameran) (dose number in series 2) The patient received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 09-NOV-2021 for prophylactic vaccination which was off label dosing frequency. Age at time of vaccination 53 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient had Non-company suspect drug included: Humira (adalimumab) (solution for infusion in pre-filled syringe, subcutaneous, batch number: unknown and expiry: unknown) dose and frequency were not reported from 20-OCT-2017 for psoriatic arthritis and moderate to severe chronic plaque psoriasis. On 09-NOV-2021, the patient had off label dosing frequency (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220607090.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Migraine, Nausea, Sinusitis
Clinical narrative: SINUS INFECTION; NAUSEA; SUFFERS FROM MIGRAINES EVERY TWO WEEKS (HEADACHES ON THE FRONT, BACK AND SIDE OF HIS HEAD); This spontaneous report received from a patient 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: 213D21A expiry: UNKNOWN) dose was not reported, administered on 07-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-DEC-2021, the patient experienced suffers from migraines every two weeks (headaches on the front, back and side of his head), and nausea. On an unspecified date, the patient experienced sinus infection. Laboratory data (dates unspecified) included: Magnetic resonance imaging sinus infection. Treatment medications (dates unspecified) included: levofloxacin, and acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, suffers from migraines every two weeks (headaches on the front, back and side of his head), and sinus infection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MILD FEVER; This spontaneous report received from a consumer 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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown, and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. On an unspecified date, the patient experienced fever (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, batch number: unknown, and expiry: unknown) dose, 1 total, 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 mild fever (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild fever was not reported. This report was non-serious. This case, involving the same patient is linked to 20220624917.