chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient had not received the 2nd dose of the Shingrix vaccine; 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received  on 20th December 2018,batch number 273BZ,expiry date 15th May 2021).   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. Till the time of reporting, the patient did not received the 2nd dose of the Shingrix vaccine which led to incomplete course of vaccination. No further details were provided at the time of call. The Vaccine Administration Facility was the same as Primary Reporter. The HCP (Healthcare professional ) did not consent nor declined follow-up and wanted to answer to MI question. No further details other than ones mentioned were provided at the time of call.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: first dose of Shingrix on 2019 and has not received the second dose yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on unknown date 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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led incomplete course of vaccination. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose was on 2/7/2021 and his second dose was on 5/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received HAB (Twinrix) (batch number A955S, expiry date 22nd May 2022) 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.   Previously administered products included Twinrix (received 1st dose on 2nd February 2021, batch number A955S and expiration date 22nd May 2022).   On 13th May 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 13th May 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   The reporter considered the drug dose administration interval too long to be unrelated to Twinrix. 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 follow: The patient received his 2nd dose late by 3 months which led to drug dose administration interval too long. The reporter was looking for guidance, as patient received both vaccines have same lot number and expiration date. The reporter consented to follow up by Fax.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient received on May 19th 2021 first dose of Bexsero instead of Boostrix; 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 male patient who received Men B NVS (Bexsero) (batch number ABXA93AA, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th May 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 19th May 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 reported as follows: The patient received Bexsero instead of Boostrix, which led to wrong vaccine administered. The patient went physician's office for his regular check up. The reporter consented to follow up via email.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received 6-month Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female 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.   Previously administered products included Twinrix (received 1st dose on 12th September 2019.) and Twinrix (received 2nd dose on 19th October 2019.).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 applicable for this report. Till the time of reporting, patient did not received 3rd dose which led to incomplete course of vaccination. The reporter mentioned that, patient had not received the 6-month Twinrix dose. The reporter consented to follow up
Age: 64.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received a dose of Menveo instead of her second dose of Shingrix; Patient received a dose of Menveo / DOB: 24-MAR-1957; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 64-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA549A, expiry date 28th February 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 4th January 2021).   On 20th May 2021, the patient received Menveo. On 20th May 2021, unknown after receiving Menveo, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: MA reported that the patient received a dose of Menveo instead of second dose of Shingrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix 1st dose 2 years ago but never completed the series; This case was reported by a consumer 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 (received 1st dose on an unknown date, 2 years before the time of reporting).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. The patient never completed the series. The reporter disconnected abruptly and did not provide any additional information.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, Chest discomfort, Dyspnoea, Headache, Oropharyngeal pain
Clinical narrative: SHORTNESS OF BREATH; CHEST PRESSURE/PAIN IN THE CENTER OF CHEST; SORE THROAT; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included pneumonia. The patient received tylenol extra strength tablet (caplet, oral, batch number: SAA006 expiry: -OCT-2023) dose and frequency were not reported from 12-APR-2021 05:00 for headache, and fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 23-MAR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced chest pressure/pain in the center of chest. On 11-APR-2021, the subject experienced sore throat. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol extra strength tablet was not reported. The patient had not recovered from headache, sore throat, and fever, and the outcome of shortness of breath and chest pressure/pain in the center of chest was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria), based on the PQC evaluation/investigation performed.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: SHORTNESS OF BREATH; CHEST PRESSURE/PAIN IN THE CENTER OF CHEST; SORE THROAT; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included pneumonia. The patient received tylenol extra strength tablet (caplet, oral, batch number: SAA006 expiry: -OCT-2023) dose and frequency were not reported from 12-APR-2021 05:00 for headache, and fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 23-MAR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced chest pressure/pain in the center of chest. On 11-APR-2021, the subject experienced sore throat. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol extra strength tablet was not reported. The patient had not recovered from headache, sore throat, and fever, and the outcome of shortness of breath and chest pressure/pain in the center of chest was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria), based on the PQC evaluation/investigation performed.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chest pain, Computerised tomogram, Dizziness
Clinical narrative: CHEST PAINS; IRRITABLE BOWEL SYNDROME FLARE-UP; NAUSEA FLARE UP; FEVER; PAIN IN THE BACK OF THE HEAD; INFLAMED TISSUES IN THE NOSE; INFLAMED TISSUES IN THE EAR SINUSES; EAR PAIN; SINUS PRESSURE; FELT LIKE PASSING OUT; This spontaneous report received from a parent concerned a 24-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, irritable bowel syndrome, penicillin allergy, sulfas allergy, peanuts allergy, grapes allergy, and cephalosporin allergy, and other pre-existing medical conditions included no prior reactions to vaccination in the past, no vaccination in the month before Janssen covid-19 vaccination. The patient experienced drug allergy when treated with topiramate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, salbutamol for asthma, diphenhydramine hydrochloride for drug used for unknown indication, cyproheptadine for ibs, famotidine for ibs, lansoprazole for ibs, and ondansetron for ibs. On 2021, the subject experienced ear pain. On 2021, the subject experienced sinus pressure. On 2021, the subject experienced felt like passing out. On 2021, the subject experienced inflamed tissues in the nose. On 2021, the subject experienced inflamed tissues in the ear sinuses. On 2021, the subject experienced pain in the back of the head. Laboratory data included: Blood test (NR: not provided) No abnormalities, CAT scan (NR: not provided) no abnormalities, and Nasoendoscopy (NR: not provided) inflamed tissues in the nose/ear sinuses. On APR-2021, the subject experienced irritable bowel syndrome flare-up. On APR-2021, the subject experienced nausea flares up. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-MAY-2021, the subject experienced chest pains. Treatment medications (dates unspecified) included: ketorolac tromethamine, meclozine, hydrocortisone, azithromycin, prochlorperazine, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, had not recovered from pain in the back of the head, ear pain, sinus pressure, felt like passing out, chest pains, nausea flare up, and irritable bowel syndrome flare-up, and the outcome of inflamed tissues in the nose and inflamed tissues in the ear sinuses was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Headache, Inflammation, Irritable bowel syndrome, Nasal inflammation
Clinical narrative: CHEST PAINS; IRRITABLE BOWEL SYNDROME FLARE-UP; NAUSEA FLARE UP; FEVER; PAIN IN THE BACK OF THE HEAD; INFLAMED TISSUES IN THE NOSE; INFLAMED TISSUES IN THE EAR SINUSES; EAR PAIN; SINUS PRESSURE; FELT LIKE PASSING OUT; This spontaneous report received from a parent concerned a 24-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, irritable bowel syndrome, penicillin allergy, sulfas allergy, peanuts allergy, grapes allergy, and cephalosporin allergy, and other pre-existing medical conditions included no prior reactions to vaccination in the past, no vaccination in the month before Janssen covid-19 vaccination. The patient experienced drug allergy when treated with topiramate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, salbutamol for asthma, diphenhydramine hydrochloride for drug used for unknown indication, cyproheptadine for ibs, famotidine for ibs, lansoprazole for ibs, and ondansetron for ibs. On 2021, the subject experienced ear pain. On 2021, the subject experienced sinus pressure. On 2021, the subject experienced felt like passing out. On 2021, the subject experienced inflamed tissues in the nose. On 2021, the subject experienced inflamed tissues in the ear sinuses. On 2021, the subject experienced pain in the back of the head. Laboratory data included: Blood test (NR: not provided) No abnormalities, CAT scan (NR: not provided) no abnormalities, and Nasoendoscopy (NR: not provided) inflamed tissues in the nose/ear sinuses. On APR-2021, the subject experienced irritable bowel syndrome flare-up. On APR-2021, the subject experienced nausea flares up. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-MAY-2021, the subject experienced chest pains. Treatment medications (dates unspecified) included: ketorolac tromethamine, meclozine, hydrocortisone, azithromycin, prochlorperazine, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, had not recovered from pain in the back of the head, ear pain, sinus pressure, felt like passing out, chest pains, nausea flare up, and irritable bowel syndrome flare-up, and the outcome of inflamed tissues in the nose and inflamed tissues in the ear sinuses was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nasoendoscopy, Nausea, Paranasal sinus discomfort, Pyrexia
Clinical narrative: CHEST PAINS; IRRITABLE BOWEL SYNDROME FLARE-UP; NAUSEA FLARE UP; FEVER; PAIN IN THE BACK OF THE HEAD; INFLAMED TISSUES IN THE NOSE; INFLAMED TISSUES IN THE EAR SINUSES; EAR PAIN; SINUS PRESSURE; FELT LIKE PASSING OUT; This spontaneous report received from a parent concerned a 24-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, irritable bowel syndrome, penicillin allergy, sulfas allergy, peanuts allergy, grapes allergy, and cephalosporin allergy, and other pre-existing medical conditions included no prior reactions to vaccination in the past, no vaccination in the month before Janssen covid-19 vaccination. The patient experienced drug allergy when treated with topiramate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, salbutamol for asthma, diphenhydramine hydrochloride for drug used for unknown indication, cyproheptadine for ibs, famotidine for ibs, lansoprazole for ibs, and ondansetron for ibs. On 2021, the subject experienced ear pain. On 2021, the subject experienced sinus pressure. On 2021, the subject experienced felt like passing out. On 2021, the subject experienced inflamed tissues in the nose. On 2021, the subject experienced inflamed tissues in the ear sinuses. On 2021, the subject experienced pain in the back of the head. Laboratory data included: Blood test (NR: not provided) No abnormalities, CAT scan (NR: not provided) no abnormalities, and Nasoendoscopy (NR: not provided) inflamed tissues in the nose/ear sinuses. On APR-2021, the subject experienced irritable bowel syndrome flare-up. On APR-2021, the subject experienced nausea flares up. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-MAY-2021, the subject experienced chest pains. Treatment medications (dates unspecified) included: ketorolac tromethamine, meclozine, hydrocortisone, azithromycin, prochlorperazine, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, had not recovered from pain in the back of the head, ear pain, sinus pressure, felt like passing out, chest pains, nausea flare up, and irritable bowel syndrome flare-up, and the outcome of inflamed tissues in the nose and inflamed tissues in the ear sinuses was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Pain, Pain in extremity
Clinical narrative: BACK PAIN; PAIN IN BOTH LEGS; BODY PAIN; ANXIOUS; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and cigarette smoker. The patient experienced drug allergy when treated with codeine. 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 14-MAY-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced anxious. On 14-MAY-2021, the subject experienced body pain. On 15-MAY-2021, the subject experienced back pain. On 15-MAY-2021, the subject experienced pain in both legs. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, pain in both legs, and back pain, and the outcome of anxious was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Gastric disorder, Hair disorder, Irritability, Loss of consciousness
Clinical narrative: PASSED OUT; SUNBURN FEELING IN VACCINE INJECTION ARM; SEVERE STOMACH ISSUES FOR A WEEK; UNSPECIFIED DISORDER OF JOINT OF SHOULDER REGION; FEELS LIKE NERVE DAMAGE; FEELING IRRITATED; FEELS LIKE THE HAIR ON ARMS HURT; ARM FROM SHOULDER TO PINKY FINGER HURTS IF SOMETHING TOUCHES IT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, patient passed out. The patient had severe stomach issues. The patient's arm that she received the vaccine in, felt like a sunburn- no redness, rash or swelling. The patient's arm didn't hurt unless something was touching it. It was not hot to the touch but felt very strange and very sensitive from her shoulder all the way to the tip of her pinky finger on the outer portion of arm. It was very sensitive even when washing the hands. The patient felt like nerves have been damaged. It felt like hair on arm hurt. It fell irritated. These events didn't last as long-maybe a couple of days and it was gone.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, sunburn feeling in vaccine injection arm, severe stomach issues for a week, unspecified disorder of joint of shoulder region, feels like nerve damage, feeling irritated, feels like the hair on arms hurt, and arm from shoulder to pinky finger hurts if something touches it on 2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210525585.; Sender's Comments: V0;20210531194 -covid-19 vaccine ad26.cov2. s passed out. 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.
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Pain in extremity, Skin burning sensation
Clinical narrative: PASSED OUT; SUNBURN FEELING IN VACCINE INJECTION ARM; SEVERE STOMACH ISSUES FOR A WEEK; UNSPECIFIED DISORDER OF JOINT OF SHOULDER REGION; FEELS LIKE NERVE DAMAGE; FEELING IRRITATED; FEELS LIKE THE HAIR ON ARMS HURT; ARM FROM SHOULDER TO PINKY FINGER HURTS IF SOMETHING TOUCHES IT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, patient passed out. The patient had severe stomach issues. The patient's arm that she received the vaccine in, felt like a sunburn- no redness, rash or swelling. The patient's arm didn't hurt unless something was touching it. It was not hot to the touch but felt very strange and very sensitive from her shoulder all the way to the tip of her pinky finger on the outer portion of arm. It was very sensitive even when washing the hands. The patient felt like nerves have been damaged. It felt like hair on arm hurt. It fell irritated. These events didn't last as long-maybe a couple of days and it was gone.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, sunburn feeling in vaccine injection arm, severe stomach issues for a week, unspecified disorder of joint of shoulder region, feels like nerve damage, feeling irritated, feels like the hair on arms hurt, and arm from shoulder to pinky finger hurts if something touches it on 2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210525585.; Sender's Comments: V0;20210531194 -covid-19 vaccine ad26.cov2. s passed out. 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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lethargy, Limb mass, Pyrexia
Clinical narrative: PAINFUL LUMP IN THE RIGHT ARM; LETHARGIC; LOW GRADE FEVER; TIRED; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the patient experienced painful lump in the right arm. On 15-MAY-2021, the patient experienced lethargic. On 15-MAY-2021, the patient experienced low grade fever. On 15-MAY-2021, the patient experienced tired. Laboratory data included: Body temperature (NR: not provided) Low grade. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever on MAY-2021, was recovering from lethargic, and tired, and had not recovered from painful lump in the right arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: METAL AFTER TASTE WITHIN AN HOUR; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced metal after taste within an hour after it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metal after taste within an hour after it. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight was 225 pounds, and height was 67 inches. The patient's pre-existing medical conditions included patient does not consumed alcohol and non-smoke  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the patient underwent to laboratory test for antibody detection which was negative (confirmed immunological vaccine failure). The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210532314-COVID-19 VACCINE AD26.COV2.S-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Feeling hot, Lacrimation increased, Nasal congestion, Pain in extremity
Clinical narrative: POSITIVE COVID TEST AFTER VACCINE; SORE ARM; DRY THROAT; WARMTH WENT UP NECK; VERY THIRSTY; WATERY EYES; FEELING A LITTLE NASALLY; This spontaneous report received from a consumer concerned a 50 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling a little nasally. On APR-2021, the subject experienced watery eyes. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced dry throat. On 09-APR-2021, the subject experienced warmth went up neck. On 09-APR-2021, the subject experienced very thirsty. On 18-APR-2021, the subject experienced positive covid test after vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 25-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from positive covid test after vaccine on 25-APR-2021, and the outcome of sore arm, feeling a little nasally, dry throat, warmth went up neck, very thirsty and watery eyes was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be pqv management approval - confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Thirst
Clinical narrative: POSITIVE COVID TEST AFTER VACCINE; SORE ARM; DRY THROAT; WARMTH WENT UP NECK; VERY THIRSTY; WATERY EYES; FEELING A LITTLE NASALLY; This spontaneous report received from a consumer concerned a 50 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling a little nasally. On APR-2021, the subject experienced watery eyes. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced dry throat. On 09-APR-2021, the subject experienced warmth went up neck. On 09-APR-2021, the subject experienced very thirsty. On 18-APR-2021, the subject experienced positive covid test after vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 25-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from positive covid test after vaccine on 25-APR-2021, and the outcome of sore arm, feeling a little nasally, dry throat, warmth went up neck, very thirsty and watery eyes was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be pqv management approval - confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Chromaturia, Constipation, Decreased appetite
Clinical narrative: CONSTIPATION; LETHARGY; COLD; SWEATING; MUSCLE WEAKNESS; CHILLS; MUSCLE ACHES/MYALGIA; FEVER; DARKLY COLOURED URINE; TREMOR; TINNITUS; LOSS OF APPETITE; STUFFINESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and he consumed alcohol no more than 2-3 drinks at any one time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included celecoxib for knee pain, and minerals nos/vitamins nos. On 19-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 24-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On 30-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On MAY-2021, the subject experienced stuffiness. Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 F. Treatment medications included: paracetamol. On 06-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 09-MAY-2021, the subject experienced darkly coloured urine. On 09-MAY-2021, the subject experienced tremor. On 09-MAY-2021, the subject experienced tinnitus. On 09-MAY-2021, the subject experienced loss of appetite. On 09-MAY-2021, the subject experienced constipation. On 09-MAY-2021, the subject experienced lethargy. On 09-MAY-2021, the subject experienced cold. On 09-MAY-2021, the subject experienced sweating. On 09-MAY-2021, the subject experienced muscle weakness. On 09-MAY-2021, the subject experienced chills. On 09-MAY-2021, the subject experienced muscle aches/myalgia. On 09-MAY-2021, the subject experienced fever. On 12-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 13-MAY-2021, treatment medications included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from darkly coloured urine on 15-MAY-2021, tremor, tinnitus, loss of appetite, constipation, lethargy, cold, sweating, muscle weakness, chills, muscle aches/myalgia, and fever on 17-MAY-2021, and stuffiness on MAY-2021. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Muscular weakness, Myalgia, Nasal congestion
Clinical narrative: CONSTIPATION; LETHARGY; COLD; SWEATING; MUSCLE WEAKNESS; CHILLS; MUSCLE ACHES/MYALGIA; FEVER; DARKLY COLOURED URINE; TREMOR; TINNITUS; LOSS OF APPETITE; STUFFINESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and he consumed alcohol no more than 2-3 drinks at any one time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included celecoxib for knee pain, and minerals nos/vitamins nos. On 19-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 24-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On 30-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On MAY-2021, the subject experienced stuffiness. Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 F. Treatment medications included: paracetamol. On 06-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 09-MAY-2021, the subject experienced darkly coloured urine. On 09-MAY-2021, the subject experienced tremor. On 09-MAY-2021, the subject experienced tinnitus. On 09-MAY-2021, the subject experienced loss of appetite. On 09-MAY-2021, the subject experienced constipation. On 09-MAY-2021, the subject experienced lethargy. On 09-MAY-2021, the subject experienced cold. On 09-MAY-2021, the subject experienced sweating. On 09-MAY-2021, the subject experienced muscle weakness. On 09-MAY-2021, the subject experienced chills. On 09-MAY-2021, the subject experienced muscle aches/myalgia. On 09-MAY-2021, the subject experienced fever. On 12-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 13-MAY-2021, treatment medications included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from darkly coloured urine on 15-MAY-2021, tremor, tinnitus, loss of appetite, constipation, lethargy, cold, sweating, muscle weakness, chills, muscle aches/myalgia, and fever on 17-MAY-2021, and stuffiness on MAY-2021. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia, SARS-CoV-2 test, Tinnitus, Tremor
Clinical narrative: CONSTIPATION; LETHARGY; COLD; SWEATING; MUSCLE WEAKNESS; CHILLS; MUSCLE ACHES/MYALGIA; FEVER; DARKLY COLOURED URINE; TREMOR; TINNITUS; LOSS OF APPETITE; STUFFINESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and he consumed alcohol no more than 2-3 drinks at any one time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included celecoxib for knee pain, and minerals nos/vitamins nos. On 19-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 24-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On 30-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On MAY-2021, the subject experienced stuffiness. Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 F. Treatment medications included: paracetamol. On 06-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 09-MAY-2021, the subject experienced darkly coloured urine. On 09-MAY-2021, the subject experienced tremor. On 09-MAY-2021, the subject experienced tinnitus. On 09-MAY-2021, the subject experienced loss of appetite. On 09-MAY-2021, the subject experienced constipation. On 09-MAY-2021, the subject experienced lethargy. On 09-MAY-2021, the subject experienced cold. On 09-MAY-2021, the subject experienced sweating. On 09-MAY-2021, the subject experienced muscle weakness. On 09-MAY-2021, the subject experienced chills. On 09-MAY-2021, the subject experienced muscle aches/myalgia. On 09-MAY-2021, the subject experienced fever. On 12-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 13-MAY-2021, treatment medications included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from darkly coloured urine on 15-MAY-2021, tremor, tinnitus, loss of appetite, constipation, lethargy, cold, sweating, muscle weakness, chills, muscle aches/myalgia, and fever on 17-MAY-2021, and stuffiness on MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: Unknown) dose was not reported, total 1 dose administered, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient underwent an antibody laboratory test for spike protein antibody test which returned negative (confirmed immunological vaccine failure) about a month after receiving the Janssen covid-19 vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000179849 The suspected product quality complaint has been confirmed to be Void: No based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210533168 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; WOKE UP THE NEXT MORNING WITH EXTREME HEADACHE; This spontaneous report received from a patient via a company representative concerned multiple patients. The patient's weight, height, and medical history were not 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced body aches. On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced woke up the next morning with extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and woke up the next morning with extreme headache on 2021. This report was non-serious. This case, from the same reporter is linked to 20210541124.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 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 in 2021, the subject experienced suspected clinical vaccination failure, the patient reports to be tested positive for Covid-19 multiple time within 90 days after vaccination. On 01-FEB-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 16-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210534882-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not 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, 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 got blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210534929-covid-19 vaccine ad26.cov2.s-blood clot. 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).