chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed the 2nd Shingrix dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient missed the 2nd Shingrix dose till the time of reporting which led to incomplete course of vaccination, also asked do he/she need to start over. No contact details were available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash, Rash papular, Urticaria
Clinical narrative: had 4 times of breaking out in hives; acne all over the neck; bumps/rash on her neck; This case was reported by a consumer via call center representative and described the occurrence of hives in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2021, 1 week after receiving Shingrix, the patient experienced papular rash. On 24th October 2021, the patient experienced hives and acne. The patient was treated with antihistamine and clindamycin (Clindamycine). On 16th November 2021, the outcome of the hives was recovered/resolved. On an unknown date, the outcome of the acne and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the hives, acne and papular rash to be related to Shingrix.  Additional details were provided as follows: The patient had the first dose of Shingrix and within a week patient had acne all over the neck. The patient also had 4 times of breaking out in hives (total of 4 episodes of hives outbreak with no reason). The patient treated with an OTC (over the counter) antihistamine for the hives and recovered from hives within 1 hour. The patient also treated with clindamycin for neck acne and had not cleared up yet. The patient also developed bumps/rash on her neck. The patient saw the doctor and the patient was treating with a prescription cream. This had not resolved. The lot number and expiration date of the vaccine were unknown. The reporter consented to follow.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR238153:Same Patient
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: administered Flulaval that was exposed to temperatures below freezing; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unknown number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra 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 details were provided as follows: The age at vaccination was not applicable for this report. The Nurse reported that somebody in the facility administered Flulaval that was exposed to temperatures below freezing to a possible list of 165 patients.  The reporter consented to follow up.  The Lot number and expiration date was not provided since nurse did not have access to the information. The incident of the temperature excursion was previously reported by co worker. After that, it was verified that some of the vaccines were administered to patients.  The reporter did not know exactly how many patients were involved but there was a list of 165 patients who might have received Flulaval after the excursion.
Age: 66.0
Sex: M
Vaccine: VARZOS, FLUA4, VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash from scalp to feet; Itching from scalp to feet; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number C4NC5, expiry date 25th January 2020) for prophylaxis.   On 9th September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced red rash and generalized pruritus. On an unknown date, the outcome of the red rash and generalized pruritus were not recovered/not resolved.   It was unknown if the reporter considered the red rash and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine intramuscularly and soon after (unknown date), he experienced red rash and itching from his scalp to his feet. These above symptoms were still present and had not resolved. The patient provided HCP (Health Care Professional) information. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS, FLUA4, VARZOS
Symptoms: Pain, Pruritus, Rash, Urticaria
Clinical narrative: Red rash from scalp to feet; Itching from scalp to feet; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number C4NC5, expiry date 25th January 2020) for prophylaxis.   On 9th September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced red rash and generalized pruritus. On an unknown date, the outcome of the red rash and generalized pruritus were not recovered/not resolved.   It was unknown if the reporter considered the red rash and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine intramuscularly and soon after (unknown date), he experienced red rash and itching from his scalp to his feet. These above symptoms were still present and had not resolved. The patient provided HCP (Health Care Professional) information. The reporter consented to follow up.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 48 year old  pediatric dose; 48 year old  pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 48-year-old male patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 16th November 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: Registered Nurse reported that, the patient received pediatric dose of Engerix- B, which led to underdose and adult use of a child product. The reporter confirmed formulation of Engerix- B via batch number look up. The reporter consented to follow-up.
Age: 41.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: given a dose that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HAV (Havrix) (batch number unknown, expiry date 26th October 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 16th November 2021, 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 details were provided as follows: The age at vaccination was not reported. The patient had been given a dose of Havrix that had expired on 26th October 2021. lot number not available to reporter.  The reporter consented to follow up by email.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Gait disturbance, Neuralgia, Pyrexia
Clinical narrative: joint and nerve pain became worse following dose; prevented her from being able to walk; Fever; Joint pain, prevented her from being able to walk; Nerve pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 years ago, prior to receiving her Shingrix dose), joint pain (prior to the vaccine) and nerve pain (prior to the vaccine).   On 7th September 2021 11:00, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 7th September 2021, 4 hrs after receiving Shingrix, the patient experienced condition aggravated and walking difficulty. On 7th September 2021 15:00, the patient experienced fever, joint pain and nerve pain. On an unknown date, the outcome of the fever, joint pain and nerve pain were recovered/resolved and the outcome of the condition aggravated and walking difficulty were unknown.   It was unknown if the reporter considered the fever, joint pain, nerve pain, condition aggravated and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine into her right arm at approximately 11am at her pharmacy and at 3pm that day she experienced fever, joint and nerve pain that prevented her from being able to walk. Her fever broke after 48 hours and was resolved till the time of reporting. Her joint and nerve pain lasted for 2 weeks. The patient had a history of having shingles 2 years ago, prior to receiving her Shingrix dose.  The patient also reported that she had a prior history of joint and nerve pain prior to the vaccine, but that the pain became worse the day of and for 2 weeks following her Shingrix dose. The reporter did not provide the lot and expiration date of the vaccine given. The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired 1st dose of engerix B; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received HBV (Engerix B) (batch number N754X, expiry date 11th November 2021) for prophylaxis.   On 15th November 2021, the patient received the 1st dose of Engerix B. On 15th November 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The medical assistant reported that a patient received an expired 1st dose of engerix B, which led to expired vaccine used. The reporter did not consent to follow up.
Age: 0.58
Sex: F
Vaccine: RV1
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: expired dose of Rotarix; second dose /administrated late for the recommended schedule; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 7-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX LYOPHILIZED FORMULATION).   On 29th October 2021, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 29th October 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administrated an expired dose of Rotarix, which led to expired vaccine used. The expired dose was meant to be a second dose which was also administrated late for the recommended schedule, which led to lengthening of vaccination schedule. The reporter did not have the exact expiration date of the vaccine because the health care professional was not at the faccility, but was informed by the colleagues that it was in fact expired. No further events were reported. The reporter consened to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant; received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number F5TT2, expiry date 4th February 2023) for prophylaxis.   On 2nd November 2021, the patient received Shingrix. On 2nd November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the adjuvant ASO1B of Shingrix without lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021237471, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021237471:same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant; received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number F5TT2, expiry date 4th February 2023) for prophylaxis.   On 2nd November 2021, the patient received Shingrix. On 2nd November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the adjuvant ASO1B of Shingrix without lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021237467, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021237467:same reporter
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of the Engerix-B vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B adult) (batch number YL2L3, expiry date 14th October 2021) for prophylaxis.   On 12th November 2021, the patient received the 2nd dose of Engerix B adult. On 12th November 2021, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered an expired dose of the Engerix-B vaccine, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: was administered the powder portion of the vial reconstituted with another diluent; was administered the powder portion of the vial reconstituted with another diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number amva391a, expiry date July 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 age at vaccination was not reported. 1 among the 5 patient was administered the powder portion of the vial reconstituted with another unknown sterile diluent , which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was 1 of 5 linked cases, reported by same reporter for different patient; Sender's Comments:  US-GLAXOSMITHKLINE-US2021237489:Same reporter US-GLAXOSMITHKLINE-US2021237485:Same reporter US-GLAXOSMITHKLINE-US2021237486:Same reporter US-GLAXOSMITHKLINE-US2021237484:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in January 2020 / 2nd dose had not yet been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th January 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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 9DM72, expiry date 28th January 2023) for prophylaxis.   On 13th September 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows:  The patient received the first dose of Shingrix and had an episode of Shingles after that.  Health care professional was looking for guidance about when should the patient receive the second dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 1 person received Shingrix Adjuvant only; 1 person received Shingrix Adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Thre age at vaccination was not reported. The reporter stated that, there was 1 patient who received the Shingrix Adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. All patients might receive 3 doses because they were unaware who received the diluent  only. The reporter consented to follow up. This case was linked with case US2021AMR238167, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR238167:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Amniocentesis, Blood test, Foetal exposure during pregnancy, Prenatal care, Trisomy 21
Clinical narrative: DOWN SYNDROME; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a foetus of unknown gender and age. The patient's mother was a 35 year old female enrolled in a non-company sponsored study. The patient's height, and weight were not reported. Maternal obstetrical history included 8 previous pregnancies: two ending in live babies, three in miscarriage and three in elective termination. Maternal first day of the last menstrual period (LMP) was reported to be 02-Jun-2021. The estimated delivery date (EDD) was calculated to be 09-Mar-2022.Type of pregnancy was reported as singleton. mother had history of tobacco, recreational use, alcohol, and e-cigarette, and concurrent conditions included: anxiety, bipolar disorder, depression, and migraine.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 20-MAY-2021 for covid-19 immunisation. Concomitant medications included minerals nos/vitamins nos, and paracetamol.  On 20-MAY-2021, the patient had foetal exposure during pregnancy. On 20-OCT-2021, the mother of the foetus underwent blood tests, such as cell-free DNA screening, alfa fetoprotein or the quad screen. The test detected Down syndrome. It was reported that, on an unspecified date in 2021, the mother of the foetus underwent amniocentesis and prenatal ultrasound. None of the tests showed any problem or concern. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the down syndrome and foetal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and down syndrome as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy, down syndrome was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211135269- covid-19 vaccine ad26.cov2.s- Fetal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS   20211135269- covid-19 vaccine ad26.cov2.s Down's syndrome. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY (Advanced maternal age)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: FEELING LOTS OF ENERGY AFTER RECEIVING THE BOOSTER SHOT; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sinus infection and positive lupus test 10-15 years ago. Concurrent conditions included: high blood pressure, high cholesterol, seasonal allergies, and occasional alcohol use (only socially). The patient was a non smoker. The patient previously received covid-19 vaccine on 06-MAR-2021 as a primary vaccination and felt tired post-vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) on 23-OCT-2021 as a booster for prophylactic vaccination. No concomitant medications were reported.  On 24-OCT-2021, the patient was "feeling lots of energy after receiving the booster shot." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The event of "feeling lots of energy after receiving the booster shot" had not resolved.  This report was non-serious. This case, involving the same patient is linked to 20211120226.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Gastrointestinal pain, Pain, Paraesthesia
Clinical narrative: BODY ACHES; GASTROINTESTINAL PAIN; MILD JOINT ACHES; SKIN TINGLING; DIARRHEA; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with Janssen covid-19 vaccine on an unspecified date. The patient subsequently received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1822811, expiry: UNKNOWN) dose was not reported, administered on 25-OCT-2021 as a booster for for prophylactic vaccination. No concomitant medications were reported.  On 26-OCT-2021, the morning after the vaccine booster, the patient woke up with with mild joint aches and a sensation of tingling in the skin throughout the body. Some mild gastrointestinal pain (also reported as GI distress) developed during the afternoon. No fever or headaches. Symptoms were generally mild and "expected" and did not limit activity or functions.  The patient also developed diarrhea and body aches..  The patient's symptoms seemed to be tapering during the day.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from the events.   This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age with an unspecified race and ethnic origin. The patient's height, and weight were not reported. Concurrent conditions included: multiple sclerosis (MS) which was treated with unspecified immunosuppressants for 14 months.  The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, expiry: unknown), single dose, on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  On an unspecified date in JUL-2021, 4 months post-vaccination, a COVID-19 antibody test and showed no spike antibodies (b-cells) which met criteria for confirmed immunological vaccine failure. Her doctor instructed her to stay home due to her history of MS and immunosuppressants and recommended she received 2 dosed of Pfizer's mRNA vaccine. On an unspecified date in SEP-2021, 7 months post vaccination, a repeat COVID-19 antibody test was positive for antibodies. The patient recovered from confirmed immunological vaccine failure in SEP-2021. The patient underwent corneal surgery on an unspecified date and on 08-NOV-2021, 1.5 months post surgery, the patient received a booster dose of Pfizer's mRNA vaccine The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211118872-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FELT TIRED; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sinus infection and positive lupus test 10-15 years ago. Concurrent conditions included: high blood pressure, high cholesterol, seasonal allergies, and occasional alcohol use. The patient was a non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the patient felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired on 09-MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20211051924.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: IMMUNOCOMPROMISED; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis (since 2002). 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, frequency time 1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Simponi (golimumab) for drug used for unknown indication. On an unspecified date, the patient was self isolated herself as she was immunocompromised and she did not get out of the house often. She didn't specify if she became immunocompromised after getting the vaccine or before.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immunocompromised was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211122405-COVID-19 VACCINE AD26.COV2.S- immunocompromised. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date was 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 an unspecified date, "Consumer mentioned he heard of a 60 year old woman dying". The patient died from unknown cause of death. It was unspecified if an 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: 20211136879-covid-19 vaccine ad26.cov2.s-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a female patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 01 total administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in NOV-2021, the patient underwent laboratory test SARS-CoV-2 antibody test which showed no antibodies. Reportedly on the same day, her doctor said that she had no antibodies (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). This report was associated with product quality complaint: 90000202717.; Sender's Comments: V0: 20211139112-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder, Thrombosis
Clinical narrative: SUFFERING BLOOD CLOTS; NERVE PROBLEM; This spontaneous report received from a patient via a company representative via Social media which concerned a patient of unspecified age and sex The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total, administered , 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 an unspecified date, the patient experienced suffering blood clots and nerve problem. Patient stated J and J should pay for my side effects suffering blood clots, nerve problem and Johnson and Johnson vaccine mess me up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suffering blood clots and nerve problem was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211139414 -covid-19 vaccine ad26.cov2.s- suffering blood clots. 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: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, 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 an unspecified date, the patient tested positive for Covid-19 twice (confirmed covid-19 infection, confirmed clinical vaccination failure) and only symptom he had was a running nose. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000202803.; Sender's Comments: V0 20211139699-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (FAR THE MOST AFFECTED); This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) 1 total, dose, 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 an unspecified date, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (far the most affected). As per the reporter, "My vaccinated uncle was with my family when we all got covid. He was by far the most affected. Poison dealers." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection (far the most affected) and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product Quality Complaint. This case, from the same reporter is linked to 20211140382.; Sender's Comments: V0: 20211139879-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: POSSIBLE VACCINE ADMINISTRATION TO 16 YEAR OLD MALE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-OCT-2021, the patient experienced possible vaccine administration to 16 year old male. On 27-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible vaccine administration to 16 year old male and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Nonspecific reaction
Clinical narrative: ADVERSE REACTIONS BY THE VACCINE; MOM OR SISTER HAD A BAD REACTION TO THIS  VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reactions by the vaccine, and mom or sister had a bad reaction to this vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the adverse reactions by the vaccine and mom or sister had a bad reaction to this vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211138887 and 20211139987.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Nausea
Clinical narrative: NAUSEOUS; ARM SORE AT INJECTION SITE; BRUISING OF ARM/BLUE AND BLACK AROUND INJECTION SITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced bruising of arm/blue and black around injection site. On 16-NOV-2021, the patient experienced arm sore at injection site. On 17-NOV-2021, the patient experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nauseous, arm sore at injection site, and bruising of arm/blue and black around injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 an unspecified date, the patient experienced covid positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid positive was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000203024.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; LITTLE WEAKNESS FOR A DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 an unspecified date, the patient experienced chills, fever, and little weakness for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and little weakness for a day. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; FREEZING; 99F TEMPERATURE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 18-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced freezing. On 18-MAR-2021, the patient experienced 99f temperature. Laboratory data included: Body temperature (NR: not provided) 99 F. On 19-MAR-2021, the patient experienced sore arm. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on MAR-2021, and freezing, and 99f temperature on 19-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: GOT COVID POSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got covid positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000202909.