chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP, HEPAB
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: received by error Engerix-B vaccine.; Twinrix-6 months ago, Twinrix today; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix on an unknown date 6 months ago of reporting date).   On an unknown date, the patient received Engerix B. On 18th October 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 18th October 2021, not applicable after receiving Engerix B and unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and drug dose administration interval too long 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 pharmacist reported that the patient received Engerix B vaccine instead of Twinrix, which led to wrong vaccine administered. The patient also received 2nd dose of Twinrix after 6 month longer than the recommended interval, which led to lengthening of vaccine schedule. The patient received Twinrix vaccine in order to complete hepatitis A series, and that was the reason why there was an extra hepatitis B. The pharmacist mentioned that patient was around fifties. The reporter consented to follow up.   Follow up information was received by pharmacist on 22nd October 2021: Upon follow up it was unable to contact reporter after corresponding phone attempts. The case classification was changed to follow up no permission denied.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: mixed with MMR Varicella Diluent / did not receive Menveo diluent; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21st October 2021, the patient received Menveo. On 21st October 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.  Additional details were provided are as follows: The age at vaccination was not reported. The reporter reported that the patient received Menveo vaccine (lyophilized powder) which was incorrectly mixed with an MMR Varicella Diluent (no details on the patient or injection site), which led to wrong solution used in drug reconstitution. The patient did not received the Menveo diluent. No adverse events were reported. No lot, demographics of the patient were provided. It was not clear if the Health care professional reporting was the immunizer. The reporter did not consented to follow-up.
Age: 66.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B surface antibody, Therapeutic response decreased
Clinical narrative: Low antibodies post completed series; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 66-year-old male patient who received HBV (Engerix B) (batch number p4dj5, expiry date 15th December 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 19th July 2021, the patient received the 3rd dose of Engerix B. On an unknown date, the patient received the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, less than a month after receiving Engerix B and less than a year after receiving Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional details were provided are as follows: Nurse reported that a patient received the complete schedule of the Engerix -B vaccine and tested low antibodies after. The reporter had no further information on the subject. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tired for two days; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than 2 weeks after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient got his first dose of Shingrix about a week ago and felt tired for 2 days.  The reporter wish to know if it was safe for him to get his Covid-19 booster at the time reporting.  The patient wanted to remain anonymous and did not wish to provide any details.  The reporter did not consent to follow-up.  No health care professional information provided.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the third dose one year and 10 months later; second dose one week earlier than recommended; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 4th September 2019).   On 27th July 2019, the patient received the 3rd dose of Twinrix. On 27th July 2021, the patient started Twinrix Pre-Filled Syringe Device. On 26th September 2021, the patient received the 2nd dose of Twinrix. On 26th September 2019, the patient started Twinrix Pre-Filled Syringe Device. On 26th September 2019, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, not applicable after starting Twinrix and Twinrix Pre-Filled Syringe Device and unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On 27th July 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long 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 patient received 2nd dose of Twinrix one week earlier than recommended from 1st dose, which led to shortening of vaccination schedule. The patient was received 3rd dose of Twinrix (one year and 10 months later), later than the recommended interval, which led to lengthening of vaccination schedule. No adverse event details was provided even though it was requested. The reporter did not consent to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Nausea, Pruritus, Rash, Tremor
Clinical narrative: shaking; nausea; burning; itching; rash; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) tablet for burning sensation and pruritus and cortisone cream for burning sensation and pruritus.   On 2nd August 2021, the patient received the 1st dose of Shingrix. In October 2021, the patient started Valacyclovir at an unknown dose and frequency. In August 2021, the patient started cortisone cream at an unknown dose and frequency. On 15th August 2021, 13 days after receiving Shingrix and 7 days after starting Valacyclovir, the patient experienced rash. On 29th August 2021, the patient experienced burning sensation and pruritus. On 26th October 2021, the patient experienced tremor and nausea. The action taken with Valacyclovir was unknown. The action taken with cortisone cream was unknown. On an unknown date, the outcome of the burning sensation, pruritus, rash, tremor and nausea were not recovered/not resolved.   It was unknown if the reporter considered the burning sensation, pruritus, rash, tremor and nausea to be related to Shingrix. It was unknown if the reporter considered the rash, tremor and nausea to be related to Valacyclovir.  Additional details were provided as follows: The case was reported by patient. The patient was currently experiencing a rash, burning, itching, nausea, and shaking after receiving his first dose of SHINGRIX. The patient initially developed a rash and 2 weeks later, he experienced burning and itching. The patient went to a local pharmacy where he was recommended a cortisone steroid cream. The symptoms got worse. The patient went to his doctor who prescribed him  valacyclovir. On the day of reporting the patient was on 7th day of taking valacyclovir.  The patient saw that the rash had spread to 5 new areas and started feeling nausea and noticed his body shaking. The reporter did not consent to follow-up. The reporter did not provide any additional information. There was discrepancy in the onset date of rash, it was captured as 15 August 2021 as per structured field.
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero was administered instead of the Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old patient who received Men B NVS (Bexsero) (batch number ABXA57AA, expiry date 30th September 2021) 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 16th September 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 16th September 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the a patient came in to the office for Menveo but it was not in stock at the time of the appointment. The clinician determined the patient was at high risk for MenB, so Bexsero was administered at the appointment instead of the Menveo, which led to wrong vaccine administered.  The parent did not want the Bexsero to be given so the office was completing an incident report and investigating further. The reporter consented to follow up.
Age: 0.58
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 7 month old given an adult (1mL) dose; 7 month old given an adult (1mL) dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 7-month-old female patient who received HBV (Engerix B adult) (batch number AC397, expiry date 8th August 2023) for prophylaxis.   Previously administered products included Engerix B (1st and 2nd dose received on an unknown date).   On 22nd October 2021, the patient received the 3rd dose of Engerix B adult 1 ml. On 22nd October 2021, unknown after receiving Engerix B 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 provided as follows: The nurse reported that the 7 month old patient received an adult (1mL) dose of Engerix, which led to overdose and adult product administered to child. No symptoms were reported. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Axillary pain, Musculoskeletal chest pain
Clinical narrative: sore shoulder; pain radiates to armpit and towards the ribs; pain radiates to armpit and towards the ribs; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 66-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, less than 2 weeks after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced axillary pain and rib pain. On 18th October 2021, the patient experienced shoulder soreness. On an unknown date, the outcome of the shoulder soreness, axillary pain and rib pain were not recovered/not resolved.   It was unknown if the reporter considered the shoulder soreness, axillary pain and rib pain to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. 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 self-reported this case. The patient received Fluarix Quadrivalent vaccine and experienced a sore shoulder which started the same day of vaccination. The pain was unresolved and now radiated to the armpit and towards the ribs.  This case has been linked with US2021222733, reported by same reporter The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222733:same reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10  mcg .5 ml and Engerix B Pre-Filled Syringe Device 10 mcg. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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 medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224750:Same reporter US-GLAXOSMITHKLINE-US2021AMR224751:Same reporter US-GLAXOSMITHKLINE-US2021AMR224752:same reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: received the Engerix recalled lot; received the Engerix recalled lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in an unspecified number of patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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: Age at vaccination were not applicable. A medical assistant reported that unknown amount of patients may have received the Engerix recalled product.  The vaccine was recalled on 22nd October 2021. No symptoms reported. The health care professional (HCP) received the recall letter and the lot number was showing up in their system but at the time of this report, he had not looked into how many patients might have received the vaccine.  No further details available at this time. The HCP did not have the administration dates available at the time of report. The reporter consented to follow up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix some time in 2020, has not yet had 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 90-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received of 0.5 ml in 2020 via intramuscular route).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date in 2008).   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose (booster dose) of Havrix vaccine, which led to incomplete course of vaccination. The reporter enquired if patient should receive second dose now or restart the series. The reporter did not consent to follow up. No other additional details provided.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: received Boostrix inadvertently; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 60-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The reporter was a medical assistant. The patient received a dose of the Boostrix vaccine inadvertently, which led to wrong vaccine administered. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on Jan2018 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in January 2018).   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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The health care professional had no vaccine data. The reporter did not consent to follow up.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose was administered; This case was reported by a nurse and described the occurrence of expired vaccine used in a 17-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9L39Z, expiry date 8th October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th October 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 28th October 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of a Boostrix which was already expired on 8th October 2021. Number for GlaxoSmithKline Medical Information was given as for future reference and warm transfer was provided. NDC number was provided as 5816084252. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient required vaccination, 1st dose approximately on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately in 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: The age at vaccination was not applicable for this report. The patient did not have information about exact date from 1st dose. Pharmacist reported that, the patient from another facility required Shingrix vaccination.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal cord insertion, Exposure during pregnancy, Fatigue, Headache, Maternal exposure before pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; MARGINAL CORD INSERTION; HEADACHE; FATIGUE; SORE ARM; VACCINE EXPOSURE BEFORE PREGNANCY; This solicited pregnancy report received from a consumer concerned a 26-year-old female of unspecified ethnic origin. The patient was enrolled in a non-company sponsored study. The patient's weight was 83.45 kilograms, and height was not reported. The patient was gravida 2 and para 1. The patient's concurrent conditions included: multigravida (She had a previous pregnancy that resulted in a live baby), anxiety, polycystic ovary syndrome, no alcohol use, and no tobacco use. The patient had taken the prenatal vitamins. She had no recreational drug use. The pregnancy was still ongoing. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: JUN-2021) dose was not reported, 1 total, administered on 03-APR-2021 for prophylactic vaccination. Concomitant medications included metformin, and sertraline hydrochloride for unknown indications. On APR-2021, the patient experienced vaccine exposure before pregnancy and on an unspecified date, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period was 05-APR-2021 and expected delivery date was 10-JAN-2022. On 03-APR-2021, she had sore arm. On 04-APR-2021, she had headache and fatigue. On 07-SEP-2021, she underwent prenatal ultrasound (Ultrasound scan) which showed marginal cord insertion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 05-APR-2021, was recovering from headache, and fatigue, and the outcome of marginal cord insertion, vaccine exposure before pregnancy and vaccine exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and marginal cord insertion, vaccine exposure before pregnancy, and vaccine exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, headache, and fatigue was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211056779-covid-19 vaccine ad26.cov2.s-Marginal cord insertion. 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: MEDICAL HISTORY  20211056779-covid-19 vaccine ad26.cov2.s- Vaccine exposure after pregnancy, Vaccine exposure before pregnancy. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; MARGINAL CORD INSERTION; HEADACHE; FATIGUE; SORE ARM; VACCINE EXPOSURE BEFORE PREGNANCY; This solicited pregnancy report received from a consumer concerned a 26-year-old female of unspecified ethnic origin. The patient was enrolled in a non-company sponsored study. The patient's weight was 83.45 kilograms, and height was not reported. The patient was gravida 2 and para 1. The patient's concurrent conditions included: multigravida (She had a previous pregnancy that resulted in a live baby), anxiety, polycystic ovary syndrome, no alcohol use, and no tobacco use. The patient had taken the prenatal vitamins. She had no recreational drug use. The pregnancy was still ongoing. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: JUN-2021) dose was not reported, 1 total, administered on 03-APR-2021 for prophylactic vaccination. Concomitant medications included metformin, and sertraline hydrochloride for unknown indications. On APR-2021, the patient experienced vaccine exposure before pregnancy and on an unspecified date, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period was 05-APR-2021 and expected delivery date was 10-JAN-2022. On 03-APR-2021, she had sore arm. On 04-APR-2021, she had headache and fatigue. On 07-SEP-2021, she underwent prenatal ultrasound (Ultrasound scan) which showed marginal cord insertion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 05-APR-2021, was recovering from headache, and fatigue, and the outcome of marginal cord insertion, vaccine exposure before pregnancy and vaccine exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and marginal cord insertion, vaccine exposure before pregnancy, and vaccine exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, headache, and fatigue was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211056779-covid-19 vaccine ad26.cov2.s-Marginal cord insertion. 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: MEDICAL HISTORY  20211056779-covid-19 vaccine ad26.cov2.s- Vaccine exposure after pregnancy, Vaccine exposure before pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer (heard from pharmacist) concerned multiple adult female patients (28) of age in between 18-48 of an unspecified race and ethnic origin. No past medical history or concurrent conditions were reported. The patients 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 frequency 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date the consumer heard from pharmacist that , "28 women got blood clots and that is why the vaccine was paused for a while. Her words: Comment about side effects when it was paused, pharmacist said, 15 million shots, out of those only 28 people, all women, had blood clots, and those women, age range 18-48, all women having periods, not  menopausal." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211058383.; Sender's Comments: V0: 20211059158-COVID-19 VACCINE AD26.COV2.S-blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response decreased
Clinical narrative: STEEP DECLINE IN EFFICACY, FROM 88% (MARCH 2021) TO 3% (AUGUST 2021); This spontaneous report received from a health care professional concerned multiple patients. 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 steep decline in efficacy, from 88% (march 2021) to 3% (august 2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of steep decline in efficacy, from 88% (march 2021) to 3% (august 2021) was not reported. This report was non-serious. This report is associated with product quality complaint: 90000199748.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Incorrect dose administered, Lymphadenopathy
Clinical narrative: INAPPROPRIATE DOSE ADMINISTERED; EXPIRED VACCINE ADMINISTERED; SWOLLEN LYMPH NODES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) 1 ml, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced inappropriate dose administered, expired vaccine administered, and swollen lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen lymph nodes, inappropriate dose administered and expired vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue
Clinical narrative: BACK PAIN; FATIGUE; This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known allergies and no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced back pain, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and had not recovered from back pain. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache
Clinical narrative: BACK ACHE; HEADACHE (RE-STARTED AND THEY WERE SO BAD HE COULDN'T SPEAK); This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 167 pounds, and height was 69 inches. The patient's concurrent conditions included: asthma, human immunodeficiency viruse (hiv), blind in right eye, smoker, alcohol user, contrast media allergy, and drug abuse (used to smoke crack cocaine). The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol, and lisinopril for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: Unknown) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, the patient experienced back ache. On OCT-2021, the patient experienced headache (re-started and they were so bad he couldn't speak). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache (re-started and they were so bad he couldn't speak), and the outcome of back ache was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation, Illness, Vomiting
Clinical narrative: SICK AS A DOG; BAD CRAMPS IN STOMACH; CONSTIPATION; THROWING UP; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No pre-existing health conditions. 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 30-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-OCT-2021, the patient experienced sick as a dog. On 28-OCT-2021, the patient experienced bad cramps in stomach. On 28-OCT-2021, the patient experienced constipation. On 28-OCT-2021, the patient experienced throwing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick as a dog, bad cramps in stomach, constipation, and throwing up on 29-OCT-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; 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: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211061581.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE GIVEN 4 HOURS AFTER FIRST VIAL PUNCTURE AT ROOM TEMPERATURE FOR THE 4 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist 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 was not reported, administered on 30-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-OCT-2021, the patient experienced vaccine given 4 hours after first vial puncture at room temperature for the 4 hours. On 30-OCT-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given 4 hours after first vial puncture at room temperature for the 4 hours and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PUNCTURED VIAL OF THE JNJ COVID-19 VACCINE LEFT AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist 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, and expiry: UNKNOWN) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-OCT-2021, the patient experienced punctured vial of the JNJ covid-19 vaccine left at room temperature for more than 2 hours, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial of the JNJ covid-19 vaccine left at room temperature for more than 2 hours and out of specification product use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: DOSE ADMINISTERED FROM THE VIAL LEFT OUT FOR 4 HOURS AT ROOM TEMPERATURE; VIAL LEFT OUT FOR 4 HOURS AT ROOM TEMPERATURE; This spontaneous report received from a pharmacist 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 dose administered from the vial left out for 4 hours at room temperature, and vial left out for 4 hours at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose administered from the vial left out for 4 hours at room temperature and vial left out for 4 hours at room temperature was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Medication error, Pyrexia
Clinical narrative: MUSCLE TREMORS; MEDICATION ERROR; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and did not have any drug abuse or illicit drug use. 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, administered on 29-OCT-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination.  On 29-OCT-2021, the patient experienced muscle tremors. On 29-OCT-2021, the patient experienced medication error. On 29-OCT-2021, the patient experienced headache. On 29-OCT-2021, the patient experienced fever. On 29-OCT-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and fatigue, had not recovered from headache, and muscle tremors, and the outcome of medication error was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: MUSCLE TREMORS; MEDICATION ERROR; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and did not have any drug abuse or illicit drug use. 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, administered on 29-OCT-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination.  On 29-OCT-2021, the patient experienced muscle tremors. On 29-OCT-2021, the patient experienced medication error. On 29-OCT-2021, the patient experienced headache. On 29-OCT-2021, the patient experienced fever. On 29-OCT-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and fatigue, had not recovered from headache, and muscle tremors, and the outcome of medication error was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: FAST HEARTBEAT; This spontaneous report received from a patient concerned a 52 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included: depression, hyperlipidemia, insomnia and cigarette 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included sertraline for depression and simvastatin for hyperlipidemia.  On 29-AUG-2021, the patient experienced fast heartbeat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fast heartbeat. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: 23-AUG-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient experienced chills. On 12-MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 15-MAR-2021. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: BODY ACHES; SWEATING; PAIN IN RIGHT SIDE OF LOWER ABDOMEN THAT STARTED AROUND 11PM LAST NIGHT; CHILLS; HEADACHES; VOMITING; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker, and other pre-existing medical conditions included: Patient was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 30-OCT-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 30-OCT-2021, the patient experienced body aches. On 30-OCT-2021, the patient experienced sweating. On 30-OCT-2021, the patient experienced pain in right side of lower abdomen that started around 11pm last night. On 30-OCT-2021, the patient experienced chills. On 30-OCT-2021, the patient experienced headaches. On 30-OCT-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headaches, vomiting, body aches, sweating, and pain in right side of lower abdomen that started around 11pm last night. This report was non-serious. This case, from the same reporter is linked to 20211100672.