chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 13Jun2022, 2nd dose on 27Jun2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 27th June 2022, the patient received the 2nd dose of Shingrix. On 27th June 2022, 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 Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comment: The patient was not immunocompromised.  At the time of reporting, the dose had not been repeated.  The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 14Oct2021, 2nd dose not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's comment: The case was self reported by the patient. The patient mentioned he forgot to get his second dose of Shingrix. The patient had nothing else to report. The reporter or patient did not want to be contacted. The reporter did not consent to follow up. The details were provided for 1st dose as 2nd dose was not administered. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 25.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 14Sep2021, 2nd on 07Sep2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 25-year-old male patient who received HAB (Twinrix) (batch number EP47E, expiry date 6th February 2023) 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 (On 14th September 2021, the patient received 1st dose of Twinrix and lot number GG355, reporter did not have expiration date).   On 7th September 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 7th September 2022, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comment: The reporter reported that, patient then forgot about coming in for next dose of Twinrix.  The second dose of Twinrix was not administered until 7th September 2022. The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Administration of third dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number PH2R2, expiry date 5th October 2023) for prophylaxis.   On 9th September 2022, the patient received the 3rd dose of Shingrix. On 9th September 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's comment: The health care professional reported that the patient received a third dose of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received a third dose of Shingrix, which led to extra dose administered.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Received second dose, Two days later diagnosed shingles; Painful rash; Painful rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 4th September 2022, 2 days after receiving Shingrix, the patient experienced shingles, rash and pain. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, rash and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter was the patient's wife. The reporter stated that 2 days after the patient received Shingrix vaccine in unknown arm, experienced painful rash then patient saw the dermatologist and he diagnosed with shingles and prescribed an unknown antiviral pill. Reporter did not have contact information for physicians. The reporter consented to follow up. Additional supportive information: This case had been linked with US2022131379 reported by same reporter.; Sender's Comments:  US-GSK-US2022131379:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, didnt get the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on 2 years prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The patient did not receive the 2nd dose. The reporter seeking medical guidance as to whether the restart the series or provide just the second dose on reporting date. VAERS details were reported for 1st dose. The vaccine administration facility was the same as primary reporter The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st doe on Nov2019, did not receive 2nd dose; 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 (1st dose received into left arm (0.5 ml) in November 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's comment: The patient self-reported this case. The patient had not yet received the second dose of Shingrix vaccine. The patient planed on getting the second Shingrix vaccine.  The patient did not want to provide any further demographics. No HCP (Health Care Professional) for follow-up. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose, two weeks after that a second dose; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In May 2022, the patient received the 2nd dose of Shingrix. In May 2022, 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 Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The nurse reported that the patient received the second dose of Shingrix two weeks after the first dose. No more information could be gathered.  Consent to follow up could not be asked from reporter. Additional Supportive Information: The patient received the second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 1.17
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-month-old male patient who received HAV (Havrix 720) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: The medical assistance reported the administration of an expired dose of Havrix to a patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received expired Havrix 720, which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-month-old female patient who received HAV (Havrix) (batch number YR532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's comment: Nurse reported that a patient received a 4 days expired dose of Havrix. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 10Feb2022, 2nd dose on 10May2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 26-year-old male 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 (1st dose received on 10th February 2022).   On 10th May 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 10th May 2022, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The reporter stated that at the time of reporting patient did not administer 3rd dose of vaccine. The reporter stated that the first two doses were given at a different facility so reporter did not have the lot number and expiration date information. The reporter did consent to follow up. Additional Supportive Information: The patient received 2nd dose of Twinrix vaccine later than recommended time frame, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: MNQ
Symptoms: Urinary retention
Clinical narrative: 1st dose on 2016, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo with an associated reaction of no adverse event (received 1st dose in 2016).   On an unknown date, the patient did not receive the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The pharmacist reported that the patient was late for the second dose of Menveo. The reporter reported that only the first dose of Menveo was administered. No LOT number and expiration date and no vaccination date provided. The reporter stated that the vaccine was administrated on another facility. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Menveo, which led to incomplete course of vaccination.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Administered Bexsero after exposed to 29.8 F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 459MC, expiry date 31st March 2024) 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 12th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The Medical Assistant reported that the patient received Bexsero vaccine was exposed to 29.8 F. The reporter did consent to follow up via mail. Additional supportive information: The Bexsero vaccine temperature was exposed 29.8 F, which led to incorrect storage of drug. This was one of 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022132077:Same reporter. US-GSK-US2022132076:Same reporter. US-GSK-US2022132078:Same reporter. US-GSK-US2022132075:Same reporter.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Dehydration, Dyspnoea, Eye swelling, Lip dry, Nasal congestion
Clinical narrative: MMR II VACCINE WAS ADMINISTERED ON 09/13/2022 AT 4:30PM. PT. WAS HEALTHY WITHOUT SYMPTOMS OF ILLNESS WHEN THE VACCINE WAS ADMINISTERED. ON 09/14/2022 AT 8:00AM PT. WAS AWAKEN FOR SCHOOL, WHEN I NOTICED SWELLING AROUND AND BETWEEN HER EYES, SWELLING OF THE CHEEKS AND SWELLING UNDER CHIN. SHE WAS ALSO UNABLE TO BREATHE THROUGH HER NOSE DUE TO NASAL CONGESTION AND MUCUS BUILD UP IN THE NASAL CAVITY. SHE ALSO HAD A FEVER OF 102.8 AND HER LIPS WERE DRY WITH SIGNS OF DEHYDRATION. I THEN ADMINISTERED ACETAMINOPHEN (10ML) TO COMBAT THE FEVER AND ANTIHISTAMINE (10ML) TO COMBAT ALL ALLERGY SYMPTOMS. SOON AFTER SHE WAS SEE AT URGENTCARE ABOUT 8:35 AM ON 09/14/2022. I WAS INSTRUCTED TO TAKE HER HOME AND CONTINUE HOME TRAETMENT AND WATCH HER SYMPTOMS FOR THE NEXT 5 DAYS. SHE HAD A CONTINUED FEVER AND SWELLING 9/15/2022 AND  9/16/2022. AND I CONTINUES TRAETMENTS AS REQUIRED. TODAY 9/17/2022 SHE HAS A LOWER TEMPT OF 97.0 AND THE SWELLING IN GOING DOWN.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test negative, Streptococcus test negative, Swelling
Clinical narrative: MMR II VACCINE WAS ADMINISTERED ON 09/13/2022 AT 4:30PM. PT. WAS HEALTHY WITHOUT SYMPTOMS OF ILLNESS WHEN THE VACCINE WAS ADMINISTERED. ON 09/14/2022 AT 8:00AM PT. WAS AWAKEN FOR SCHOOL, WHEN I NOTICED SWELLING AROUND AND BETWEEN HER EYES, SWELLING OF THE CHEEKS AND SWELLING UNDER CHIN. SHE WAS ALSO UNABLE TO BREATHE THROUGH HER NOSE DUE TO NASAL CONGESTION AND MUCUS BUILD UP IN THE NASAL CAVITY. SHE ALSO HAD A FEVER OF 102.8 AND HER LIPS WERE DRY WITH SIGNS OF DEHYDRATION. I THEN ADMINISTERED ACETAMINOPHEN (10ML) TO COMBAT THE FEVER AND ANTIHISTAMINE (10ML) TO COMBAT ALL ALLERGY SYMPTOMS. SOON AFTER SHE WAS SEE AT URGENTCARE ABOUT 8:35 AM ON 09/14/2022. I WAS INSTRUCTED TO TAKE HER HOME AND CONTINUE HOME TRAETMENT AND WATCH HER SYMPTOMS FOR THE NEXT 5 DAYS. SHE HAD A CONTINUED FEVER AND SWELLING 9/15/2022 AND  9/16/2022. AND I CONTINUES TRAETMENTS AS REQUIRED. TODAY 9/17/2022 SHE HAS A LOWER TEMPT OF 97.0 AND THE SWELLING IN GOING DOWN.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: MMR II VACCINE WAS ADMINISTERED ON 09/13/2022 AT 4:30PM. PT. WAS HEALTHY WITHOUT SYMPTOMS OF ILLNESS WHEN THE VACCINE WAS ADMINISTERED. ON 09/14/2022 AT 8:00AM PT. WAS AWAKEN FOR SCHOOL, WHEN I NOTICED SWELLING AROUND AND BETWEEN HER EYES, SWELLING OF THE CHEEKS AND SWELLING UNDER CHIN. SHE WAS ALSO UNABLE TO BREATHE THROUGH HER NOSE DUE TO NASAL CONGESTION AND MUCUS BUILD UP IN THE NASAL CAVITY. SHE ALSO HAD A FEVER OF 102.8 AND HER LIPS WERE DRY WITH SIGNS OF DEHYDRATION. I THEN ADMINISTERED ACETAMINOPHEN (10ML) TO COMBAT THE FEVER AND ANTIHISTAMINE (10ML) TO COMBAT ALL ALLERGY SYMPTOMS. SOON AFTER SHE WAS SEE AT URGENTCARE ABOUT 8:35 AM ON 09/14/2022. I WAS INSTRUCTED TO TAKE HER HOME AND CONTINUE HOME TRAETMENT AND WATCH HER SYMPTOMS FOR THE NEXT 5 DAYS. SHE HAD A CONTINUED FEVER AND SWELLING 9/15/2022 AND  9/16/2022. AND I CONTINUES TRAETMENTS AS REQUIRED. TODAY 9/17/2022 SHE HAS A LOWER TEMPT OF 97.0 AND THE SWELLING IN GOING DOWN.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and high fever of 102.5 the next morning. Took Advil to reduce fever, placed cool washcloth on head, and he felt better.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: PATIENT COMPLAINS OF REDNESS AND INFLAMATION AT INJECTION SITE AND PROGRESSING DOWN ARM STARTING THE DAY AFTER INJECTION
Age: 71.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered
Clinical narrative: Incomplete dose given. Repeated dose on same arm.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 33.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Hypoacusis, Vision blurred
Clinical narrative: AFTER RECEIVING BOTH FLU AND BIVALENT COVID BOOSTER, PATEINT REPORTED BEING DIZZY, SWEATY, AND HOT. NO ANAPHYLAXIS PRESENT.  WE GOT PATIENT A BOTTLE OF WATER TO DRINK AND PATIENT ALSO ASKED FOR SOME CRACKERS TO EAT.  AFTER ABOUT 5 MINUTES PATIENT ADDITIONALLY REPORTED HAVING BLURRY VISION AND MUFFLED HEARING. 911  WAS CALLED AND PARAMEDICS TRANSPORTED PATIENT HOSPITAL.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: patient received Pfizer bivalent vaccine instead of monovalent vaccine for her first dose of the COVID vaccine series.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tension, Throat tightness
Clinical narrative: About two days after receiving the new Moderna Omicron booster, I began experiencing periodic mild tightening/tension of the lower throat, primarily in the subglottis region.  Ten days have elapsed since receiving the shot, and some mild tightening is still periodically noticeable when swallowing or performing aerobic exercise (light jogging or fast walking).
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: pt has had 3 doses of Covid 19 Moderna in the past. Got Pfizer Bivalent. Has right axillary lymph swelling and pain.
Sex: M
Vaccine: COVID19
Symptoms: Penis disorder
Clinical narrative: PENIS GOT BIGGER; This spontaneous report received from a patient via media (Janssen) and via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) dose, start therapy date were not reported, dose 1, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced penis got bigger (Dose number in series: 1). It was reported that "Janssen please bring a coviid booster back to market, im a healthcarehero and i had 3 jandj shots and the only side effect i had was my penis got bigger. I refuse to take a mrna vaccine. If yall dont want to lose his job please make a new omicron/flu booster. (tgj)". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of penis got bigger was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, dose 2, 1 in total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with dose 2 covid-19 vaccine ad26.cov2.s (Dose number in series: 2). This report was non-serious. This case, involving the same patient is linked to 20220912661.  Version created to amend previously reported information on 02-SEP-2022. Upon review the following information was amended: Amendment Adverse Event (Invalid field was removed and case to be reported as Valid, as case received from JOHNSON and JOHNSON managed website (Janssen).
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: polyethylene glycol allergy. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administrated, start therapy date were not reported for covid-19 prophylaxis. No adverse events reported following vaccination (dose number in series 1). The patient received of first booster dose covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administrated, start therapy date were not reported for covid-19 prophylaxis. No adverse events reported following vaccination (dose number in series 2). The patient received of second booster dose covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administrated, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Off label use. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced off label dosing frequency (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: HOSPITALIZED 3 TIMES; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. 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, 1 total start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced hospitalized 3 times, and was hospitalized (date unspecified). The of days hospitalized was not reported. It was reported that, "My family member was hospitalized 3 times from your discusting injection & now you want to hurt more? GROSS...Evil...Eff off..." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalized 3 times was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220909468-COVID-19 VACCINE AD26.COV2.S- hospitalized 3 times . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse
Clinical narrative: MASSIVE RELAPSE MULTIPLE SCLEROSIS; This spontaneous report received from a patient via social media 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 past medical history included: surgery, and alopecia, and concurrent conditions included: leiomyosarcoma, svc syndrome, and multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  Concomitant medications included ocrelizumab for multiple sclerosis relapse, botulinum toxin type a, and docetaxel.  On an unspecified date, it was reported that, "IOcrevus. In my 23 years of MS I AM thrilled 2 have Ocrevus as my treatment of choice I had a massive relapse after the first and only vaccine Actually took pics walking in College  I HAD 2 B 'd I was bedridden for months Still require a. Text 2: Scroll thru my media went thru Leiomyosarcoma SVCsyndrome surgery 2 correct both 6months of ChemoDays Taxotere has left me with Alopecia All of that didn't put me in2 amoments after the jnj vaccine i was unable 2 stand then spasticity severely contracted my muscles. Text 3: Docs said it seemed as if I had a spinal cord injury from T-2 down I had multiple botox injections 2 my legs ,which were (prev pic shows) permanently bent in2 my chest It was THE MOST INCREDIBLY PAINFUL PHYSICAL experience of my life. spasticity has declined Not enough tho". On an unspecified date, the patient experienced massive relapse multiple sclerosis (bedridden, unable to stand, muscle spasticity, and most incredibly painful physical experience). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of massive relapse multiple sclerosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220909503-covid-19 vaccine ad26.cov2.s-Massive relapse multiple sclerosis. 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis.  It was unknown if patient experienced any adverse event after covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed (dose number in series 2). It was reported that "we will not know how many have died...the vaccines are making way too much money. My niece died shortly after taking her second shot. There is know proof it will never be released if there was proof. Too much money being made." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220909775-COVID-19 VACCINE AD26.COV2.S- Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast swelling, Fatigue, Gastrointestinal disorder, Illness
Clinical narrative: IMMUNE SYSTEM NOT RIGHT; BREAST SWELLING; GOT SICK; SWOLLEN ARM AT INJECTION SITE FOR MONTHS; GI (GASTROINTESTINAL) ISSUES; UNBEARABLE JOINT PAIN AS LONG AS 18 MONTHS AFTER SHOT; SWOLLEN LYMPH NODE IN ARMPIT; FATIGUE; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced immune system not right, breast swelling, got sick, swollen arm at injection site for months, gi (gastrointestinal) issues, unbearable joint pain as long as 18 months after shot, swollen lymph node in armpit, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen arm at injection site for months, had not recovered from immune system not right, and the outcome of got sick, unbearable joint pain as long as 18 months after shot, swollen lymph node in armpit, breast swelling, fatigue and gi (gastrointestinal) issues was not reported. This report was non-serious. This case is a duplicate of 20220911625.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Lymphadenopathy, Peripheral swelling
Clinical narrative: IMMUNE SYSTEM NOT RIGHT; BREAST SWELLING; GOT SICK; SWOLLEN ARM AT INJECTION SITE FOR MONTHS; GI (GASTROINTESTINAL) ISSUES; UNBEARABLE JOINT PAIN AS LONG AS 18 MONTHS AFTER SHOT; SWOLLEN LYMPH NODE IN ARMPIT; FATIGUE; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced immune system not right, breast swelling, got sick, swollen arm at injection site for months, gi (gastrointestinal) issues, unbearable joint pain as long as 18 months after shot, swollen lymph node in armpit, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen arm at injection site for months, had not recovered from immune system not right, and the outcome of got sick, unbearable joint pain as long as 18 months after shot, swollen lymph node in armpit, breast swelling, fatigue and gi (gastrointestinal) issues was not reported. This report was non-serious. This case is a duplicate of 20220911625.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VACCINE INJURY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injury was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Headache, Neurosis, Pain, Pyrexia
Clinical narrative: NEUROTIC (IN TERMS OF HYSTERIA AROUND THE JANSSEN VACCINE); TINY ACHY; LITTLE HEADACHE; TINY FEVER; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 60 year old, female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, sulfite allergy, non alcohol user, non smoker, b-thalassemia, osteoporosis, and meningioma, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient had lot of genetic mutations and she gets tested for every medication. The patient previously received experienced pfizer covid-19 vaccine (tozinameran)(dose number in series 1) (form of admin, route of admin not reported, batch number were not reported, expiry: unknwon) dose was not reported, administered on 09-FEB-2021 for covid-19 prophylaxis.  On 09-FEB-2021, immediately after the vaccination, the patient experienced anaphylactic reaction and had to go to the hospital (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 18-FEB-2022) dose was not reported, administered on right arm 08-AUG-2021 for covid-19 prophylaxis. Age at time of vaccination 60 years old. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). On an unspecified date, the patient experienced neurotic (in terms of hysteria around the janssen vaccine), tiny achy, little headache, and tiny fever (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neurotic (in terms of hysteria around the janssen vaccine), tiny achy, little headache, and tiny fever, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20220925588.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, stomach problem, penicillin allergy, drug allergy (Aspirin), allergic to alcohol, no alcohol use, and no smoking, and other pre-existing medical conditions included: There was no drug abuse or illicit drug usage. 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 09-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 68 years old. No concomitant medications were reported. On an unspecified date, the patient experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme tiredness was not reported. This report was non-serious. This case, involving the same patient is linked to 20220913752. This case, from the same reporter is linked to 20220911986.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, stomach problem, penicillin allergy, aspirin allergy, allergies to alcohol, no alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on upper left arm, on 09-APR-2021 for covid-19 prophylaxis. for covid-19 prophylaxis. On an unspecified date following vaccination with covid-19 vaccine ad26. cov2.s, the patient experienced extreme tiredness (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 total, administered on upper left arm, on 05-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 68 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced extreme tiredness (dose number in series 2), and related that to may be being diabetic. The consumer first described the side effect as a little bit tired but then describe it as extreme tiredness. No fever, no pain just tired the patient was very pleased that she can handle that and was still functioning. The patient added that she and her mother who was around 90 years old took the vaccine and her mother did not have any side effect or pain. The patient also reported that, her husband, kids, and grandkids all got the Janssen vaccine and had no side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme tiredness was not reported. This report was non-serious. This case, involving the same patient is linked to 20220913642. This case, from the same reporter is linked to 20220911986.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Impaired work ability, Joint lock, Limb discomfort, Muscular weakness
Clinical narrative: CAN'T WORK ANYMORE; JOINTS GET LOCKED INCLUDING THE ANKLE, KNEE, ARM, 2 FINGERS, ELBOW, SHOULDER; CAN'T LIFT HER ARM ABOVE HER HEAD; ARM WAS VERY HEAVY; ARM WAS VERY PAINFUL; NO STRENGTH IN THE ARM ANYMORE; LEFT ENTIRE ARM GOT SWOLLEN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for covid-19 prophylaxis. Age at time of vaccination 55 years old. No concomitant medications were reported. On NOV-2021, the patient experienced left entire arm got swollen, joints get locked including the ankle, knee, arm, 2 fingers, elbow, shoulder, can't lift her arm above her head, arm was very heavy, arm was very painful, and no strength in the arm anymore. On an unspecified date, the patient experienced can't work anymore. Laboratory data (dates unspecified) included: Diagnostic ultrasound not reported (helped with diagnosis) ; and X-ray Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left entire arm got swollen, can't lift her arm above her head, arm was very heavy, arm was very painful, no strength in the arm anymore, joints get locked including the ankle, knee, arm, 2 fingers, elbow, shoulder and can't work anymore was not reported. This report was non-serious. This case, from the same reporter is linked to 20220915954.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound scan, X-ray
Clinical narrative: CAN'T WORK ANYMORE; JOINTS GET LOCKED INCLUDING THE ANKLE, KNEE, ARM, 2 FINGERS, ELBOW, SHOULDER; CAN'T LIFT HER ARM ABOVE HER HEAD; ARM WAS VERY HEAVY; ARM WAS VERY PAINFUL; NO STRENGTH IN THE ARM ANYMORE; LEFT ENTIRE ARM GOT SWOLLEN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for covid-19 prophylaxis. Age at time of vaccination 55 years old. No concomitant medications were reported. On NOV-2021, the patient experienced left entire arm got swollen, joints get locked including the ankle, knee, arm, 2 fingers, elbow, shoulder, can't lift her arm above her head, arm was very heavy, arm was very painful, and no strength in the arm anymore. On an unspecified date, the patient experienced can't work anymore. Laboratory data (dates unspecified) included: Diagnostic ultrasound not reported (helped with diagnosis) ; and X-ray Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left entire arm got swollen, can't lift her arm above her head, arm was very heavy, arm was very painful, no strength in the arm anymore, joints get locked including the ankle, knee, arm, 2 fingers, elbow, shoulder and can't work anymore was not reported. This report was non-serious. This case, from the same reporter is linked to 20220915954.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SAME SITUATION; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced same situation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of same situation was not reported. This report was non-serious. This case, from the same reporter is linked to 20220914708.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Tendonitis, Tinnitus
Clinical narrative: PSORIASIS ISSUES ON BOTTOM OF BOTH FEET AND ITCHING ON HANDS/BURNING AT THE BOTTOM OF FEET; TENDONITIS IN EAR; RINGING IN EAR; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced psoriasis issues on bottom of both feet and itching on hands/burning at the bottom of feet, tendonitis in ear, and ringing in ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient had not recovered from psoriasis issues on bottom of both feet and itching on hands/burning at the bottom of feet, and tendonitis in ear, and the outcome of ringing in ear was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.