chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo only diluent administration; Menveo only diluent administration; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, only diluent of Menveo administrated to the patient. The reporter stated that a mispaired extra dose of Menveo lyophilized powder was found. The reporter stated that, the patient might have received a dose of diluent only but it might have been that a diluent vial broke and it was not reported by staff, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The healthcare professional did not collect information about patients or vaccines that may be administered incorrectly. The reporter consent to follow up was not gathered. This case has been linked to US2021250237, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021250237:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (SHINGRIX) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received only the diluent part of SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No other details were reporter at the time of reporting. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis. On 6th December 2021, the patient received Shingrix. On 6th December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The patient received expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter asked should they repeat the dose. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Muscular weakness, Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; Weakness in arms, legs and shoulders; Weakness in arms, legs and shoulders; Weakness in shoulders; This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2021, 1 week after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), weakness of arms, lower extremities weakness of and weakness. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the polymyalgia rheumatica, weakness of arms, lower extremities weakness of and weakness were not recovered/not resolved.   It was unknown if the reporter considered the polymyalgia rheumatica, weakness of arms, lower extremities weakness of and weakness to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received his 2nd Shingrix vaccine, about 1 week later, he began to experience weakness in his arms, legs and shoulders.  The patient was seen by his healthcare professional. About 6 weeks later, he was diagnosed with polymyalgia rheumatica.  This had not resolved and he was being treated with steroids at present.  The case had been linked with US2021AMR251541 and US2021AMR251540 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR251541:same reporter US-GLAXOSMITHKLINE-US2021AMR251540:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (received 1st dose in 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not received the second Shingrix shot yet, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 3rd December 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter reported that, misread the portion of the label that stated Kinrix should be administered to four to six year old children, resulting in Kinrix being accidentally administered to a 4 month old child, which led to inappropriate age at vaccine administration. The reporter reported no side effects had been observed. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose received in 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 details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported late dose of Shingrix. The patient did not receive the 2nd dose till the time of reporting, which led to incomplete course of vaccination. No further information reported. The reporter consented to follow-up. This case has been linked with case US2021251174, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021251174:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019, wants to get 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 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 reported as follows: The age at vaccination was not applicable for this report. Registered pharmacist reported that a patient wanted to get 2nd dose of Shingrix and did not receive 2nd dose till time of reporting which led to incomplete course of vaccination.  The reporter asked what would be the best practices, how to proceed with schedule. The reporter provided limited information regarding patient. Lot number and expiration date were not available. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 4 to 5 years ago). 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 are as follows: The age at vaccination was not applicable for this report. Nurse practitioner reported that till time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter remained anonymous and no other adverse event information was provided. The reporter did not gave consent for safety team to follow-up.
Age: 12.0
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: administered  bexsero instead of menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old patient who received Men B NVS (Bexsero) 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 7th December 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th December 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: Nurse reported that a 12 years old patient was administered Bexsero instead of Menveo, which led to wrong vaccine administered. No other detail available. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 63-year-old male patient who received Herpes zoster (SHINGRIX) (batch number unknown, expiry date April 2023) for prophylaxis. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX). On 7th December 2021, the patient received the 2nd dose of SHINGRIX. On 7th December 2021, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided are as follows: Registered nurse reported that a patient received 2nd dose of SHINGRIX was given before recommended minimum interval, which led to shortening of vaccination schedule. The reporter consented to follow-up.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS IN BOTH LUNGS; This solicited report received from a health care professional via PPSPHN002323: concerned a 69-year-old female. The patient's weight was 86.4 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient was treated with macitentan (tablet, oral, batch number: ZE025A0101 expiry: 31-AUG-2025) 10 mg, 1 time every 1 day, therapy dates were not reported; and selexipag (tablet, oral, batch number: 117381701 expiry: 28-FEB-2023) 200 ug, 2 times every 1 day, therapy dates were not reported for primary pulmonary hypertension. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Janssen series 1, suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 07-OCT-2021, the patient experienced blood clots in both lungs, and was hospitalized for four days from 07-OCT-2021 to 11-OCT-2021. The doctor placed selexipag on hold for now. The patient has an appointment on 09-NOV-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; treatment with selexipag was withdrawn; and dose of macitentan was not changed. The outcome of blood clots in both lungs was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots in both lungs was not related; between selexipag, and blood clots in both lungs was not related; and between macitentan, and blood clots in both lungs was not related.  This report was serious (Hospitalization Caused / Prolonged).  This case, involving the same patient is linked to 20210346375 and 20210335753.  Additional information was received from other health professional on 29-NOV-2021. The following information was updated and incorporated into the case narrative: new reporter and Janssen covid-19 vaccine added and ranked as primary suspect.; Sender's Comments: V1: Follow up information updates about addition of new reporter and Janssen covid-19 vaccine as primary suspect. 20211047780-covid-19 vaccine ad26.cov2.s-blood clots in both lungs. This event(s) is considered not related. 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: UNDERLYING DISEASE 20211047780 -selexipag and macitentan-blood clots in both lungs. 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: UNDERLYING DISEASE
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; A BIT OF HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus.  On an unspecified date, the patient received vaccination with covid-19 vaccine ad26.cov2.s unspecified manufacturer (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 01 total, administered for prophylactic vaccination. (Dose number in series 1) No adverse events associated with previous covid-19 vaccine ad26.cov2.s vaccination were reported.  On 19-NOV-2021, the patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number and expiry were not reported) dose was not reported, 01 total, administered for prophylactic vaccination.(Dose number in series 2) The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.   On 19-NOV-2021, the patient experienced sore arm and a bit of headache.(Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from sore arm, and a bit of headache.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (series 1) for prophylactic vaccination (manufacturer unspecified).  The patient received company booster covid-19 vaccine ad26.cov2.s  (series 2) (suspension for injection, route of admin not reported, batch number and expiry: 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 numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s the patient experienced slight headache and felt great by the evening. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache. This report was non-serious. This case, from the same reporter is linked to 20211150219.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Tinnitus
Clinical narrative: FATIGUE; HEADACHE; MUSCLE ACHES; RINGING IN THE EARS; SLIGHT FEVER; This spontaneous report received from a health care professional concerned a 6 decade white and non Hispanic or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (dose Number in series: 2) 1 total administered on 18-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After receiving booster dose, On NOV-2021 the patient experienced fatigue, headache, muscle aches, ringing in the ears, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the experiencing fatigue, headache, muscle aches, ringing in the ears and slight fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: INJECT LIQUID, IT LEAKED OUT; INCOMPLETE DOSE ADMINISTERED; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number series 1) for prophylactic vaccination of unspecified manufacturer. No adverse event was reported after receiving dose series 1.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: unknown) dose, 01 total was administered on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-NOV-2021 at 12:10 PM, the booster shot the patient received had a potentially defective syringe (batch number: 1054572) (B-D Integra Syringe 3ml 25gx1 REF 305270). Further it was reported that, the joint between the needle and the cylinder was loosen, and when the health care professional (HCP) pushed the piston to inject liquid, it leaked out from that joint which might have resulted in incomplete dose administration (both events dose number in series 2). The HCP found another shot and it worked. The suspected defective product was discarded. The action taken with covid-19 vaccine ad26.cov2.s (dose number in series 2) was not applicable. The outcome of inject liquid, it leaked out and incomplete dose administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: HURTING IN LEGS; MUSCLE ACHE; FATIGUE; BODY ACHES/BODY FELT SORE; JOINT PAIN/HURTING IN JOINTS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included: spinal fracture. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. 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, (dose number in series: 2),1 total, administered on 19-NOV-2021 09:15 to left arm for prophylactic vaccination.  Concomitant medications included paracetamol occasionally and ice packs for spinal fracture.  On 19-NOV-2021, the patient experienced body aches/body felt sore, joint pain/hurting in joints, muscle ache and fatigue. The hurting in joints and legs felt like beaten up (all events dose number in series: 2).  On 20-NOV-2021, the patient experienced hurting in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches/body felt sore, joint pain/hurting in joints, muscle ache, and fatigue on 20-NOV-2021, and the outcome of hurting in legs was not reported. This report was non-serious. This case, involving the same patient is linked to 20210421085.
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Throat irritation
Clinical narrative: THROAT BURNING; CITRUS TASTE; This spontaneous report received from a patient concerned a 72 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: spinal stenosis.  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 (dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.   On an unspecified date, the patient experienced throat burning, and citrus taste.(dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the throat burning and citrus taste was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211143069 (Dose number in series 2).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pruritus
Clinical narrative: SEVERE ITCHINESS; NUMB ON RIGHT HAND PINKY; This spontaneous report received from a patient concerned a 68 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: acid reflux, and inflammation in right knee, and other pre-existing medical conditions included: No pregnancy. The patient reported she does not take any medications because of her kidneys. 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 on APR-2021 for prophylactic vaccination (dose series 1). The batch number was not reported. The company is unable to perform follow up to request batch/lot number. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced severe itchiness (dose series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe itchiness was recovered (date not specified) (dose series 1). On 22-NOV-2021 afternoon, the patient received additional non-company suspect vaccine included: mrna 1273 (batch number: OL19E21A expiry: UNKNOWN, form of admin, and route of admin, were not reported) dose was not reported, administered on right arm for prophylactic vaccination (dose series 2).   On an unspecified date in NOV-2021, following vaccination with mrna 1273, the patient experienced recurrent itchiness and numb on her right hand pinky with no other symptoms (dose series 2). She reported numb on her right hand pinky had never happened before. She saw a nurse on an unspecified date and received no treatment for side effects. The action taken with mrna 1273, was not applicable.  The outcome of recurrent itchiness and numb on right hand pinky was not reported.   This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: FEELING HOT; FLU LIKE SYMPTOMS; FEELING SICK; ARM SORENESS; NO ENERGY; This spontaneous report received from a patient concerned a 56-year-old female.  The patient's weight, height, and medical history were not reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 201A21A and expiry: Unknown) dose was not reported, frequency 1 total administered on left arm on 07-Apr-2021 for prophylactic vaccination (Dose number in series 1).  On evening of 07-Apr-2021, the patient experienced felt tired, Slight headache. On 08-Apr-2021, the patient experienced very tired, not achy but was just lethargic and did not wanted to do anything. On 08-Apr-2021, later in the day the patient started to feel better. (Dose number in series 1)  The patient recovered from felt tired, Slight headache, lethargic on 08-Apr-2021.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: 11-APR-2022) dose was not reported, frequency 1 total administered at left arm on 17-NOV-2021 for prophylactic vaccination.( Dose number in series 2). No concomitant medications were reported.   On 18-Nov-2021, early morning the patient experienced no energy. The patient had no headaches this time around, her arm was more sore, compared to the first dose. During evening, the patient felt better ( Dose number in series 2). On 24-Nov-2021, one week after booster dose, the patient stated that she was hit hard with feeling sick. That evening, the patient was hot, with fever, slight headache, no energy, freezing with cold chills, and achy. She felt like she had the flu. ( Dose number in series 2)  The patient was planning to get tested for COVID. The patient felt better the following day (25-Nov-2021) with no cold chills, but slight headache and no energy. At the time of reporting the patient felt the same with no energy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from arm soreness on 18-NOV-2021, was recovering from feeling hot, flu like symptoms, and feeling sick, and had not recovered from no energy.  This report was non-serious.  This case, involving the same patient is linked to 20211161728.(Dose number in series 1 case)
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hypersomnia, Pain
Clinical narrative: BIT ACHEY; CHILLS; KNOCKED ME OUT FOR A DAY AND SLEPT 15 HOURS/SLEPT UNTIL NOON; .This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race and ethnicity The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (dose number in series: 1) for prophylactic vaccination. No events reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (dose number in series: 2) start therapy date were not reported, 1 total administered, for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced knocked me out for a day and slept 15 hours/slept until noon, chills, and bit achey (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the knocked me out for a day and slept 15 hours/slept until noon, chills and bit achey was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Malaise, Nausea
Clinical narrative: CHILLS; FEVER; NOT FEELING GOOD; NAUSEA; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 62 year old male white Not Hispanic/Latino ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: 5 stents in the heart and drug allergy (bactrim).  The patient was previously received with covid-19 vaccine ad26. cov2. s (manufacturer not specified) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on unspecified day for prophylactic vaccination (Dose number in series 1). No adverse events were reported for dose series 1.  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, 1 total administered on 29-NOV-2021 on right arm for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported.  On 29-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced nausea and severe headache (dose series 2). The reporter stated that in the early morning, the patient was complaining of a major headache (also reported as  severe headache) with a  pain level of 10/10. The patient took 2 Tylenol (paracetamol) tablets without any relief. Laboratory data included: Pain scale (NR: not provided) 10/10. On 30-NOV-2021, the patient experienced not feeling good, fever, chills, nausea and severe headache (dose series 2). The reporter stated the patient's temperature reached as high as 102.2 and stated he felt freezing and required additional clothing. Laboratory data included: Body temperature (NR: not provided) 102.2 F measured via ear. Treatment medications (dates unspecified) included: paracetamol for headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. At the time of this report, the  patient had not recovered chills, severe headache, fever, nausea, and not feeling good.  This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Pyrexia
Clinical narrative: CHILLS; FEVER; NOT FEELING GOOD; NAUSEA; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 62 year old male white Not Hispanic/Latino ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: 5 stents in the heart and drug allergy (bactrim).  The patient was previously received with covid-19 vaccine ad26. cov2. s (manufacturer not specified) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on unspecified day for prophylactic vaccination (Dose number in series 1). No adverse events were reported for dose series 1.  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, 1 total administered on 29-NOV-2021 on right arm for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported.  On 29-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced nausea and severe headache (dose series 2). The reporter stated that in the early morning, the patient was complaining of a major headache (also reported as  severe headache) with a  pain level of 10/10. The patient took 2 Tylenol (paracetamol) tablets without any relief. Laboratory data included: Pain scale (NR: not provided) 10/10. On 30-NOV-2021, the patient experienced not feeling good, fever, chills, nausea and severe headache (dose series 2). The reporter stated the patient's temperature reached as high as 102.2 and stated he felt freezing and required additional clothing. Laboratory data included: Body temperature (NR: not provided) 102.2 F measured via ear. Treatment medications (dates unspecified) included: paracetamol for headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. At the time of this report, the  patient had not recovered chills, severe headache, fever, nausea, and not feeling good.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Feeling cold, Feeling hot, Fibromyalgia
Clinical narrative: FIBROMYALGIA ATTACK; HANDS SHAKING; COULD NOT STAND; COLD FEELING; FINGERS HURT; BOTH LEGS VERY WEAK; CHILLS; FEVER FEELING; HOT FEELING; TOOTH ACHE; FELT  A WAVE OF PAIN OVER THE ENTIRE BODY; This spontaneous report received from a patient concerned a 74-year-old white not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included: polymyalgia rheumatica, and concurrent conditions included: fibromyalgia  The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, 1 total administered on 30-Apr-2021 for prophylactic vaccination (dose number series 1).  On 17-May-2021 to 19-May-2021, the patient stated that she had a fibromyalgia attack but did not correlate this to the administration of the Janssen vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, 1 total, administered on left arm on 16-NOV-2021 at 13:30 for prophylactic vaccination (dose number series  2).  No concomitant medications were reported.  On 16-NOV-2021  at 23:00, the patient experienced hot, fever feeling which lasted about 15 minutes. She did not take her temperature. The patient then experienced a very cold feeling, hands shaking, and after 15 minutes it was resolved. Then the patient felt a wave of pain throughout her entire body that was very weird, unusual, not a muscle ache/pain. She tried to stand but both legs were very weak, and she could not stand. She then laid back down. The patient stated that the pain lasted 10 hours solid and would rate it as a 10 on the pain scale. She did not take any medications because she could not get up. Patient stated that every tooth in her mouth had a tooth ache, the fingertips hurt, and entire body hurt (dose series 2). After 10 hours it disappeared, and patient went into her normal attack of Fibromyalgia. For about 2-3 days she took it easy. Patient reported she was now experiencing her normal fibromyalgia pain and has not experienced anything else.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot feeling, hands shaking, cold feeling, chills, and fever feeling on 16-NOV-2021, and tooth ache, felt a wave of pain over the entire body, could not stand, fingers hurt, and both legs very weak on 17-NOV-2021, and the outcome of fibromyalgia attack was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Pain assessment, Pain in extremity, Pyrexia
Clinical narrative: FIBROMYALGIA ATTACK; HANDS SHAKING; COULD NOT STAND; COLD FEELING; FINGERS HURT; BOTH LEGS VERY WEAK; CHILLS; FEVER FEELING; HOT FEELING; TOOTH ACHE; FELT  A WAVE OF PAIN OVER THE ENTIRE BODY; This spontaneous report received from a patient concerned a 74-year-old white not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included: polymyalgia rheumatica, and concurrent conditions included: fibromyalgia  The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, 1 total administered on 30-Apr-2021 for prophylactic vaccination (dose number series 1).  On 17-May-2021 to 19-May-2021, the patient stated that she had a fibromyalgia attack but did not correlate this to the administration of the Janssen vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, 1 total, administered on left arm on 16-NOV-2021 at 13:30 for prophylactic vaccination (dose number series  2).  No concomitant medications were reported.  On 16-NOV-2021  at 23:00, the patient experienced hot, fever feeling which lasted about 15 minutes. She did not take her temperature. The patient then experienced a very cold feeling, hands shaking, and after 15 minutes it was resolved. Then the patient felt a wave of pain throughout her entire body that was very weird, unusual, not a muscle ache/pain. She tried to stand but both legs were very weak, and she could not stand. She then laid back down. The patient stated that the pain lasted 10 hours solid and would rate it as a 10 on the pain scale. She did not take any medications because she could not get up. Patient stated that every tooth in her mouth had a tooth ache, the fingertips hurt, and entire body hurt (dose series 2). After 10 hours it disappeared, and patient went into her normal attack of Fibromyalgia. For about 2-3 days she took it easy. Patient reported she was now experiencing her normal fibromyalgia pain and has not experienced anything else.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot feeling, hands shaking, cold feeling, chills, and fever feeling on 16-NOV-2021, and tooth ache, felt a wave of pain over the entire body, could not stand, fingers hurt, and both legs very weak on 17-NOV-2021, and the outcome of fibromyalgia attack was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Toothache, Tremor
Clinical narrative: FIBROMYALGIA ATTACK; HANDS SHAKING; COULD NOT STAND; COLD FEELING; FINGERS HURT; BOTH LEGS VERY WEAK; CHILLS; FEVER FEELING; HOT FEELING; TOOTH ACHE; FELT  A WAVE OF PAIN OVER THE ENTIRE BODY; This spontaneous report received from a patient concerned a 74-year-old white not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included: polymyalgia rheumatica, and concurrent conditions included: fibromyalgia  The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, 1 total administered on 30-Apr-2021 for prophylactic vaccination (dose number series 1).  On 17-May-2021 to 19-May-2021, the patient stated that she had a fibromyalgia attack but did not correlate this to the administration of the Janssen vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, 1 total, administered on left arm on 16-NOV-2021 at 13:30 for prophylactic vaccination (dose number series  2).  No concomitant medications were reported.  On 16-NOV-2021  at 23:00, the patient experienced hot, fever feeling which lasted about 15 minutes. She did not take her temperature. The patient then experienced a very cold feeling, hands shaking, and after 15 minutes it was resolved. Then the patient felt a wave of pain throughout her entire body that was very weird, unusual, not a muscle ache/pain. She tried to stand but both legs were very weak, and she could not stand. She then laid back down. The patient stated that the pain lasted 10 hours solid and would rate it as a 10 on the pain scale. She did not take any medications because she could not get up. Patient stated that every tooth in her mouth had a tooth ache, the fingertips hurt, and entire body hurt (dose series 2). After 10 hours it disappeared, and patient went into her normal attack of Fibromyalgia. For about 2-3 days she took it easy. Patient reported she was now experiencing her normal fibromyalgia pain and has not experienced anything else.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot feeling, hands shaking, cold feeling, chills, and fever feeling on 16-NOV-2021, and tooth ache, felt a wave of pain over the entire body, could not stand, fingers hurt, and both legs very weak on 17-NOV-2021, and the outcome of fibromyalgia attack was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5 ML (APPROXIMATELY AROUND 0.3 ML) OF THE INITIAL DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced received less than 0.5 ml (approximately around 0.3 ml) of the initial dose. On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5 ml (approximately around 0.3 ml) of the initial dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211209976, 20211209843, 20211210058, 20211210549, 20211210112, 20211210409, 20211210610, 20211210555, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211209775, 20211212088, 20211212082, 20211209679, 20211209740, 20211210588, 20211210670, 20211210824, 20211209912, 20211210067, 20211210160, 20211210350, 20211210141, 20211210585, 20211210107, 20211209921, 20211210180 and 20211210385.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURE; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: seizure, and virus. The patient received covid-19 vaccine ad26.cov2.s (vaccination dose series was 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that " grandson had a virus over 1 year ago so immune system and incepilitious caused the seizure was in hospital for 2 months on meds and got the vaccine this year and had the seizure" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211213078-COVID-19 VACCINE AD26.COV2.S-Seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Lethargy, Nausea
Clinical narrative: TIREDNESS; FEELING LETHARGIC; FEVER; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: Unknown) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-DEC-2021, the patient experienced feeling lethargic. On 03-DEC-2021, the patient experienced fever. On 03-DEC-2021, the patient experienced headaches. On 03-DEC-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.9 F. On 06-DEC-2021, the patient experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling lethargic, headaches, and nausea on 06-DEC-2021, and had not recovered from fever, and tiredness. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: TIREDNESS; FEELING LETHARGIC; FEVER; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: Unknown) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-DEC-2021, the patient experienced feeling lethargic. On 03-DEC-2021, the patient experienced fever. On 03-DEC-2021, the patient experienced headaches. On 03-DEC-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.9 F. On 06-DEC-2021, the patient experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling lethargic, headaches, and nausea on 06-DEC-2021, and had not recovered from fever, and tiredness. This report was non-serious.