chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was received on 10-May-2021 from pharmacist via Communication (reference number: SEQW21-01301) and concerned 57-year-old, female patient.  The patient's medical history included menstrual cycle disorder. The patient's concomitant medications were not listed.   On 08-Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location and route of administration: not reported) for prevention of influenza. The batch number was not reported.  On the same day, probably less than 30 minutes after receiving Flucelvax Quadrivalent, while driving home, the patient developed hives.   On unspecified date, the patient was recommended Benadryl (diphenhydramine) for treatment, but the reporter did not know if the patient actually took Benadryl.  On unspecified date in Nov-2020, the patient recovered from the event hives, reported as the symptoms lasted few days.   The reporter did not provide causality assessment.   The case was assessed as non-serious.   Company comment: The event of hives was considered as related to Flucelvax Quadrivalent.; Sender's Comments: The event of hives was considered as related to Flucelvax Quadrivalent.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Left arm muscle soreness during movement or palpation, mild vertigo when laying down that persists for as long as position is maintained. Nausea and loose bowel movements for over 24 hours starting the day after vaccination mid-day.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Left arm muscle soreness during movement or palpation, mild vertigo when laying down that persists for as long as position is maintained. Nausea and loose bowel movements for over 24 hours starting the day after vaccination mid-day.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: I had typical side effects and none requiring medical attention.  I am breastfeeding my 9 month old daughter and she is hot, irritable as well.  It?s mild and not requiring medical attention but should be noted.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eustachian tube disorder, Middle ear effusion
Clinical narrative: Fluid in the ears - creating a ?clicking? noise. Doctor described as Eustachian Tube Dysfunction.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Angina pectoris, Balance disorder, Dizziness, Headache
Clinical narrative: Shortly after taking the pfizer vaccine I suffered from blackout faint feelings off and on for more that 18  to 20 hours after taking this vaccine. server swelling of my entire body especially inside my head and  heart pains. I also,  suffered from episodes of  memory loss even now. Problems with my balance when walking....never ever suffered from anything like this in my entire life. this vaccine is extremely  dangerous and should not be given to everyone. nearly 19 hours later my face and feet  numb.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling
Clinical narrative: Shortly after taking the pfizer vaccine I suffered from blackout faint feelings off and on for more that 18  to 20 hours after taking this vaccine. server swelling of my entire body especially inside my head and  heart pains. I also,  suffered from episodes of  memory loss even now. Problems with my balance when walking....never ever suffered from anything like this in my entire life. this vaccine is extremely  dangerous and should not be given to everyone. nearly 19 hours later my face and feet  numb.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: severe (continuous) debilitating  vertigo that lasted 14 days with lingering on and off dizziness up to 30 days ; attempt to treat with meclizine but did not work. eventually resolved (after 30 days) on its own; wooziness still recur to this date - unknown if there is permanent damage - tests are being done
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: Numbness and pain to left arm from shoulder/neck to tips of fingers
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Hypoaesthesia oral, Pruritus
Clinical narrative: Patient states she received 1st dose of Pfizer vaccine oon 3/29; had an allergic reaction with whole body itching,  numbness  on mouth and lips, facial swelling (left eye).  She was given Benadryl and observed for 1.5 hours and sent home.  (at vaccine clinic 3/29/21) Patient reports she is still having some mild  itching, throat is a bit hoarse.  She is using allergy eye drops.  Patient was advised to see her PCP.  She was told that she should not get 2nd dose of the vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Immediate post-injection reaction, Nervousness, Tremor
Clinical narrative: 11:35am Patient C/O hands very shaky.  11:47am Pt reported feeling much better.  BP 159/102, 88. 11:47am Patient reported feeling much better.  Patient was advised that if symptoms return to call 911 or urgent care.  Patient verbalized understanding.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 48year old. The patients height, and weight were not reported. The patients concurrent conditions included diabetes, non smoker and non alcohol use and other pre-existing medical conditions included the patient have no known drug allergies and no illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported,1 total administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the patient had taken blood test for IgG (Immunoglobulin G) /IgM (Immunoglobulin M) and the results were negative. On 05-MAY-2021, the patient had again taken blood test for IgG (Immunoglobulin G) /IgM (Immunoglobulin M) and the results were negative (confirmed immunological vaccine failure). It was reported that the reporter came to know that the patient was not developing antibodies to the COVID-19. The patient was diabetic and the reporter wanted to know that they can use another brand of covid-19 vaccine. 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). This reported was associated with product Quality complaint: 90000178960. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed. This case is a duplicate of 20210513497.  Following receipt of additional information, it was determined that nullification was required for Manufacturer Case Number [20210513497]. The information indicated that Manufacturer Case Number [20210533028].Therefore, this case Manufacturer Case Number [20210533028] was created to correct the country of primary source. All relevant information will be submitted under Manufacturer Case Number [20210533028].; Sender's Comments: V0: 20210533028-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
Sex: M
Vaccine: MMR
Symptoms: Alopecia, Appendicitis, Emotional disorder, Overweight, Pneumonia legionella
Clinical narrative: experienced a very high fever; seizures and convulsions; he was never the same; legionnaires disease; appendicitis; itching,; overweight; not much hair; "lots of body complaints," and is emotionally challenged; This spontaneous report refers to a currently 60-year-old male patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in the late 1960s, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was hospitalized due to very high fever, seizures and convulsions. The patient was put on phenobarbital as a treatment. After that, "he was never the same". On an unspecified date, the patient experienced lifelong health issues, including legionnaires disease, appendicitis, itching, overweight, not much hair, "lots of body complaints" and was emotionally challenged. On an unknown date, the patient sought medical attention. The outcome of the events was reported as not recovered.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the events of appendicitis and pneumonia legionella were considered to be medically significant.
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Seizure
Clinical narrative: experienced a very high fever; seizures and convulsions; he was never the same; legionnaires disease; appendicitis; itching,; overweight; not much hair; "lots of body complaints," and is emotionally challenged; This spontaneous report refers to a currently 60-year-old male patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in the late 1960s, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was hospitalized due to very high fever, seizures and convulsions. The patient was put on phenobarbital as a treatment. After that, "he was never the same". On an unspecified date, the patient experienced lifelong health issues, including legionnaires disease, appendicitis, itching, overweight, not much hair, "lots of body complaints" and was emotionally challenged. On an unknown date, the patient sought medical attention. The outcome of the events was reported as not recovered.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the events of appendicitis and pneumonia legionella were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Spent several days in bed sick afterwards; Arm hurt like hell for a week; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm and sickness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient receive 2nd dose of Shingrix and arm hurt really bad and spent several days in bed sick afterwards. The patient stated that it was better than getting shingles. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104374:1st dose,same reporter,same AE
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: He went and got vaccinated / its so very,very painful; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife who reported for her husband. The age at vaccination not reported. The patient got vaccinated and experienced pain and mentioned to be careful.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: died Fr the shot; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.  Additional details were provided as follows The reporter was the patient's friend. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The reporter stated that, the patient died from the shot.; Reported Cause(s) of Death: Unknown cause of death
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted by using sterile water; reconstituted by using sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number NR55Z, expiry date 22nd October 2022) for prophylaxis.   On 11th May 2021, the patient received the 2nd dose of Shingrix. On 11th May 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was a medical assistant. The reporter stated that the patient received 2nd dose of Shingrix which was reconstituted by using sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: given a 20 mcg/mL dose of Engerix-B to a 19 year old patient; given a 20 mcg/mL dose of Engerix-B to a 19 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   On 19th March 2021, the patient received the 1st dose of Engerix B adult. On 19th March 2021, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The patient had been given a 20 mcg/mL dose of Engerix B, which led to overdose and adult product administered to child. The reporter consented to follow up. For the tolerance of 2nd dose, refer case- US2021AMR103721, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Incomplete course of vaccination, Pyrexia, Tremor
Clinical narrative: first Shingrix vaccine "over a year ago" / not had the second dose; rigors/uncontrollable shaking; fever; rigors / uncontrollable shaking / chills; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml and the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tremor, fever, chills and incomplete course of vaccination. On an unknown date, the outcome of the tremor, fever and chills were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the tremor, fever and chills to be related to Shingrix.  Additional details were provided as follow: This case was reported by patient herself. The age at vaccination was not reported. Over a year ago, the patient received 1st dose of Shingrix in unknown deltoid and after 12 hours the patient developed rigors/uncontrollable shaking, fever and chills, which lasted for 24 hours. The patient was not sure if she should take 2nd dose and till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient was referred to her healthcare professional and spoke from PI (package insert) on adverse events, offered copy. The reporter declined to provide healthcare professional information. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix "in september" / dose two (late second dose); This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care provider contacted medical information for instructions on how to proceed with dose two (late second dose). No more information was available. The reporter did not consent to follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both Shingrix Vaccinations in 2018 / after / 2nd Covid vaccinations / developed Shingles / in April of 2021/ suspected Vaccination failure; developed Shingles on / left side of forehead and neck / in April of 2021; This case was reported by a consumer via call center representative and described the occurrence of Suspected vaccination failure in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE for prophylaxis.   Concomitant products included COVID-19 VACCINE.   In July 2018, the patient received the 2nd dose of Shingrix. On 1st February 2018, the patient received the 1st dose of Shingrix. On 25th March 2021, the patient received the 2nd dose of COVID-19 VACCINE. On 10th April 2021, more than 2 years after receiving Shingrix and 1164 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was vaccinated with 2 doses of Shingrix in 2018 and developed Shingles on his left side of forehead and neck. The 2nd dose of Shingrix was received 5 months after 1st one. 16 days after his 2nd Covid vaccinations, the patient developed Shingles on his left side of forehead and neck. The patient was placed on medication within 12 hours of diagnosis. The reporter did not had exact dates of vaccination so dates were a guesstimate. The reporter was was unsure of the Lot Number and Expiration Dates of vaccines. This case was considered as suspected vaccination failure as details regarding  laboratory confirmation was unknown at the time of reporting. It was unknown if the reporter considered the vaccination failure and shingles to be related to COVID-19 VACCINE.  Note-VAERs deatils were reported only for Shingrix vaccine however it got aucaptured for covid 19 vaccine as well, after deleting from covid vaccine tab it was get also deleted for Shingrix.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Nausea, Pain in extremity
Clinical narrative: redness at the injection site; Fever; chills; nauseous; sore arm; very tired; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th May 2021, 1 days after receiving Shingrix, the patient experienced injection site erythema, fever, chills, nausea, pain in arm and tiredness. On an unknown date, the outcome of the injection site erythema, fever, chills, nausea, pain in arm and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, fever, chills, nausea, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient reported this case for herself. The patient received 1st dose of Shingrix (50 mcg) in the left deltoid at the pharmacy and on the very next day, experienced side effects fever/chills, then a sore arm, redness at the site of injection, nauseous, and very tired and on next day this side effects gotten pretty hard and intense. Till the time of reporting, the symptoms had not been resolved. The patient stated that she was a very active person, and to be very tired was unusual for her. The reporter did not have the lot number or expiration date of the Shingrix vaccine, however she had NDC (national drug code) number on the receipt (NDC no.: 58160-0819-12) The reporter did not give a consent to follow-up with Health care practitioner. The reporter did not consent to follow up.; Sender's Comments: 0.5 mL
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: redness at the injection site; Fever; chills; nauseous; sore arm; very tired; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th May 2021, 1 days after receiving Shingrix, the patient experienced injection site erythema, fever, chills, nausea, pain in arm and tiredness. On an unknown date, the outcome of the injection site erythema, fever, chills, nausea, pain in arm and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, fever, chills, nausea, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient reported this case for herself. The patient received 1st dose of Shingrix (50 mcg) in the left deltoid at the pharmacy and on the very next day, experienced side effects fever/chills, then a sore arm, redness at the site of injection, nauseous, and very tired and on next day this side effects gotten pretty hard and intense. Till the time of reporting, the symptoms had not been resolved. The patient stated that she was a very active person, and to be very tired was unusual for her. The reporter did not have the lot number or expiration date of the Shingrix vaccine, however she had NDC (national drug code) number on the receipt (NDC no.: 58160-0819-12) The reporter did not give a consent to follow-up with Health care practitioner. The reporter did not consent to follow up.; Sender's Comments: 0.5 mL
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received a dose of Menveo only with the diluent portion (without the powder component) /  nurse did not reconstitute the liquid with the powder portion; patient received a dose of Menveo only with the diluent portion (without the powder component); This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Menveo only with the diluent portion (without the powder component) the nurse did not reconstitute the liquid with the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care practitioner did not have available patient's information. The reporter consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Panic attack
Clinical narrative: MAGNETIC INJECTION SITE; PANIC; This spontaneous report received from a pharmacist 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: Unk) .5 ml, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced panic. On an unspecified date, the subject experienced magnetic injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the panic and magnetic injection site was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be no pqc was identified within the reported complaint reported. complaint is approved for void. void:y based on the PQC evaluation/investigation performed.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain assessment, Pyrexia
Clinical narrative: FATIGUE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breastfeeding, and psoriasis. The patient experienced drug allergy when treated with doxycycline, and tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0242A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.8 F, and Pain scale (NR: not provided) 06/10 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 08-APR-2021, headache on 13-APR-2021, and fever on 07-APR-2021. This report was non-serious. This parent/child case is linked to 20210531484.; Sender's Comments: V0-Medical Assessment Comment not required as per standard operating procedures, as case was assessed as non-serious.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Haematochezia, Haemorrhage urinary tract, Penile haemorrhage
Clinical narrative: BLOOD CLOTS IN URINE; VISUAL BLOOD CLOTS IN PENILE DISCHARGE; DISCOLOURATION OF URINE; BLOOD DISCHARGE AND CLOTS IN STOOL (CLOTS WOULD FALL OUT WHEN WENT FROM SITTING TO STANDING); This spontaneous report received from a consumer concerned an 86 year old white, not Hispanic or Latino male. 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 administration not reported, batch number: 206A21A, expiry: 23-JUN-2021) frequency one total, dose was not reported, administered on 10-MAY-2021 at 10:00 a.m. in left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-MAY-2021, the patient experienced clots in stool which would fall out when patient went from sitting to standing. They are about 3 inches in diameter. He also experienced blood discharge. On 12-MAY-2021, he experienced discoloration of urine with unknown origin. From the night of 13-MAY-2021 to the morning to 14-MAY-2021, he experienced clots in urine and visual of blood clots in penile discharge. The patient was hospitalized on 14-MAY-2021 and the duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from discoloration of urine, blood discharge and clots in stool (clots would fall out when went from sitting to standing), blood clots in urine, and visual blood clots in penile discharge. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210529768 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood in stool, Discoloration of urine, Blood clots in urine and Penile bleeding. This event(s) is considered unassessable. The event(s) 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(s).
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer concerned 3 women with unknown race and ethnicity . 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 and expiry was unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date,3 women died from blood clots after getting (Janssen) covid 19 vaccine. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 : 20210530454-COVID-19 VACCINE AD26.COV2.S-Blood clots . This event is considered unassessable. The event 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.; Reported Cause(s) of Death: BLOOD CLOT
Sex: F
Vaccine: COVID19
Symptoms: Hemiplegia, Seizure
Clinical narrative: SEIZURES; PARALYSIS ON ONE SIDE OF BODY; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age (teenager), race and ethnicity. 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) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced seizures, and paralysis on one side of body, and on an unspecified date, she was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures and paralysis on one side of body was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210530732-covid-19 vaccine ad26.cov2.s-seizures and paralysis on one side of body. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient 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 1 total ,start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced blood clots, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots leading to hospitalization was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: v0-20210530971-covid-19 vaccine ad26.cov2.s-Blood Clots. This event(s) is considered Un assessable. The event(s) 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(s).
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient concerned a patient of unspecified ethnicity, 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 not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 06-APR-2021 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 2021, the patient developed a 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: V0:20210531990-COVID-19 VACCINE AD26.COV2.S-Blood clot. This event(s) is considered unassessable. The event(s) 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(s).
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT (NOT HAD AN EPISODE OF DIZZINESS  SINCE); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included positional vertigo. 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 05-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 unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: DOSE ADMINISTERED OUTSIDE OF APPROPRIATE STORAGE CONDITIONS; This spontaneous report received from a pharmacist concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced dose administered outside of appropriate storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose administered outside of appropriate storage conditions was not reported. This report was non-serious. This case, from the same reporter is linked to 20210532970.
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: ARM FELT IRRITATED, LIKE SUNBURN; This spontaneous report received from a parent 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 was not reported, and batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced arm felt irritated, like sunburn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm felt irritated, like sunburn on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210530441.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethinicity. 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, 1 total, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-APR-2021, the patient underwent Antibody test and result was 3 with the highest possible being greater than 2500. On 11-MAY-2021, the patient again underwent Antibody test which was found to be 30 and identified as confirmed immunological vaccine failure.  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).; Sender's Comments: V0:20210532357-COVID-19 VACCINE AD26.COV2.S-Confirmed immunlogical vaccine failure. This event(s) is considered unassessable. The event(s) 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(s).
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Feeling hot, Gait disturbance, Pain in extremity
Clinical narrative: CROOKED WALK; FEET SWOLLEN AND CRAMPED; FEET ARE  HOT; LOSS OF APPETITE/CANT EAT  ANYTHING; SEVERE DIARRHEA; HIVES ALL OVER BODY AND ALL OVER FACE; FEET HURT; This spontaneous report received from a patient concerned a female of unspecified age of unknown race and ethnicity. 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, Expiry: Unknown) dose was not reported, 1 total administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had crooked walk and the patient's feet ware hot, swollen, and hurt. Patient had loss of  appetite and cant eat anything. Patient broke out in hives all over body and all over face. Patient experienced severe diarrhea. The patient had been hospitalized three times and given only Maalox and opioids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the crooked walk, severe diarrhea, loss of appetite/cant eat anything, feet swollen and cramped, hives all over body and all over face, feet hurt and feet are hot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210532364-COVID-19 VACCINE AD26.COV2.S-crooked walk, feet swollen and cramped, feet are hot, loss of appetite/cant eat anything, severe diarrhea. This event(s) is considered unassessable. The event(s) 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(s). 20210532364-COVID-19 VACCINE AD26.COV2.S-hives all over body and all over face, feet hurt. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: CROOKED WALK; FEET SWOLLEN AND CRAMPED; FEET ARE  HOT; LOSS OF APPETITE/CANT EAT  ANYTHING; SEVERE DIARRHEA; HIVES ALL OVER BODY AND ALL OVER FACE; FEET HURT; This spontaneous report received from a patient concerned a female of unspecified age of unknown race and ethnicity. 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, Expiry: Unknown) dose was not reported, 1 total administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had crooked walk and the patient's feet ware hot, swollen, and hurt. Patient had loss of  appetite and cant eat anything. Patient broke out in hives all over body and all over face. Patient experienced severe diarrhea. The patient had been hospitalized three times and given only Maalox and opioids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the crooked walk, severe diarrhea, loss of appetite/cant eat anything, feet swollen and cramped, hives all over body and all over face, feet hurt and feet are hot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210532364-COVID-19 VACCINE AD26.COV2.S-crooked walk, feet swollen and cramped, feet are hot, loss of appetite/cant eat anything, severe diarrhea. This event(s) is considered unassessable. The event(s) 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(s). 20210532364-COVID-19 VACCINE AD26.COV2.S-hives all over body and all over face, feet hurt. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON LEFT FOREARM; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced rash on left forearm. Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on left forearm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Application site induration, Application site rash, Fatigue, Headache, Pain in extremity
Clinical narrative: BUMP IN THE LEFT ARM; HARD BUMP IN LEFT ARM; SORE ARM; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history and no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 15-MAY-2021, the subject experienced sore arm. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced tiredness. On 17-MAY-2021, the subject experienced bump in the left arm. On 17-MAY-2021, the subject experienced hard bump in left arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from headache, and tiredness, and had not recovered from bump in the left arm, sore arm, and hard bump in left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: BUMP IN THE LEFT ARM; HARD BUMP IN LEFT ARM; SORE ARM; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history and no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 15-MAY-2021, the subject experienced sore arm. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced tiredness. On 17-MAY-2021, the subject experienced bump in the left arm. On 17-MAY-2021, the subject experienced hard bump in left arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from headache, and tiredness, and had not recovered from bump in the left arm, sore arm, and hard bump in left arm. This report was non-serious.