chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Fourth dose of Hiberix at 9 months of age; Fourth dose of Hiberix at 9 months of age; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 9-month-old female patient who received Hib (Hiberix) (batch number 5P244, expiry date 21st March 2023) for prophylaxis.   Previously administered products included Hiberix (received 3 dose on an unknown date).   On 2nd February 2022, the patient received the 4th dose of Hiberix. On 2nd February 2022, unknown after receiving Hiberix, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On an unknown date, the outcome of the drug dose administration interval too short and inappropriate age at vaccine administration were unknown.  Additional information was provided as follows: The nurse reported that the 9-month-old patient inadvertently received a fourth dose of Hiberix at an interval shorter than the recommended which led to shortening of vaccination schedule and inappropriate age at vaccine administration. The reporter consented to follow up via postal mail.
Sex: U
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: splashed to nurse's eye; splashed to nurse's eye; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while administering product 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 occupational exposure while administering product and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while administering product and exposure via eye contact were unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter reported that while giving Shingrix to the patient, the shingrix solution accidentally burst out and splashed to their nurse's eye, which led to the occupational exposure while administering product and exposure via eye contact. The reporter asked that they want to know if there were any effects from this incident. No further details provided via web form.  The reporter submitted all available information. The reporter consented to follow-up.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Administration of Adult dose to pediatric patient; Patient 19 years of age received an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th February 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 6th February 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, a 19 year old patient received an adult dose of Engerix B, which led to overdose and adult product administered to child. The Healthcare professional was not at the facility to provide lot number and expiration date. The Vaccine administration facility was the same as Primary Reporter. The reporter did not consent to follow up. Note: The suspect 'Engerix-B adult' was coded as PFS as per the source document as clarification was raised regarding the formulation and no specific response was received.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Adolescent patient received an adult dose; Adolescent patient received an adult dose; This case was reported by a other health professional 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 9AX5P, expiry date 23rd November 2023) for prophylaxis.   On 29th January 2022, the patient received Engerix B adult. On 29th January 2022, 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 case was reported by the Medical assistant. The reporter stated that, an adolescent patient received an adult dose of Engerix-B, which led to overdose and adult product administered to child. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 8/21/2021, 2nd dose 9/21/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 9727R, expiry date 27th January 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 21st September 2021, the patient received the 2nd dose of Shingrix. On 21st September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The case was reported by the registered pharmacist. On 21st August 2021, the patient received 1st dose of Shingrix. The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The Healthcare professional confirmed that, the patient was immunocompetent. The reporter consented to follow up.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HAV (Havrix) (batch number e9g4e, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022021663  Additional details were provided as follows: The case was reported by the clinical supervisor. The patient was inadvertedley administrated an expired dose of Havrix, which led to expired vaccine used. No further events were reported. The reporter wanted to know if there was information on potential side effects.  The reporter was advised that, they had limited information as there was no data on use of expired vaccines. Provided Medical Information number for the Healthcare professional to contact and obtain more information. The reporter did not consent to follow up. Note: The batch number was captured as per the follow up source document.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022021663:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, no second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No demographics details were provided. The reporter did not consent to follow-up.
Age: 62.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Administered an expired dose; Outside approved age range/ 59 year old patient received Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received Men B NVS (Bexsero) (batch number abxa81ez, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included splenectomy (had splenectomy).   On 7th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Administrative supervisor at MD office reported that the 59 years old patient received an expired dose of Bexsero, which led to expired vaccine used and inappropriate age at vaccine administration. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles breakout near site of injection; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 31st January 2022, less than 4 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 provided as follows: The reporter self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine 4 months ago and experienced shingles breakout near the site of injection (left arm). The patient stated that it was a size of a quarter. Shingles was confirmed with her doctor. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria, Pruritus
Clinical narrative: Itching; pimple-like hives; rash on her RIGHT ARM; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included biopsy (had biopsies done which had not revealed any information).   In March 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pruritus, hives and pimple-like rash. On an unknown date, the outcome of the pruritus, hives and pimple-like rash were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, hives and pimple-like rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR022529  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in her right arm and within one day she started itching and within four days she started breaking out with pimple-like hives and rash on her right arm in which it subsequently ran down to her elbow. Spoke per package insert (PI). Gave Medical Information phone number for her to provide to HCP to call on her behalf.  The patient was given medical advice disclaimer and was referred to HCP.  The reporter consented to follow-up with HCP (Pharmacy). For tolerance to the 2nd dose refer case US2022AMR022529.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR022529:Same patient, different dose
Age: 17.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix instead of Menveo; 17 year old was administered Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Herpes zoster (Shingrix) (batch number 3BD9E, expiry date 6th April 2023) for prophylaxis.   On 13th December 2021, the patient received Shingrix. On 13th December 2021, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The reporter was the clinic director. The reporter stated that the 17 years old patient was administered Shingrix instead of Menveo, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: INFANRIX instead of BOOSTRIX; 11 year old received infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 5RM39, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the patient was administered the Infanrix vaccine instead of the Boostrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter confirmed that the lot number 5RM39 was for Infanrix instead of Boostrix. The reporter stated he/she was not present during the administration. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: CHILLS; JOINT PAIN; FEELING UNWELL; ARM PAIN; HEADACHE; FATIGUE; INJECTION SITE PAIN; MUSCLE PAIN; This spontaneous report received from a patient via another manufacturer (Pfizer) concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: incontinence, neuropathy, depression, hypothyroid, high cholesterol, and sulpha allergy. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with covid-19 and since the vaccination patient had not been tested for covid-19.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series1) (suspension for injection, route of admin was not reported batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. Concomitant medications included levothyroxine, oxybutynin, paroxetine, and simvastatin.  On 21-JAN-2022, the patient experienced chills, joint pain, feeling unwell, arm pain, headache, fatigue, injection site pain, and muscle pain (all events with dose number in series1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, feeling unwell, arm pain, headache, fatigue, injection site pain, and muscle pain. The patient was received additionally non company suspect vaccine BNT162 (Pfizer Comirnaty) (dose number in series 2) (Form of administration was not reported, route of admin was not reported, batch number:unknown, expiry:unknown) doses were not reported, administered on JUN-2021 for prophylactic vaccination on left arm. It was unknown if the patient experienced any adverse event after vaccination with BNT 162 (dose number in series 2). This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain in extremity
Clinical narrative: CHILLS; JOINT PAIN; FEELING UNWELL; ARM PAIN; HEADACHE; FATIGUE; INJECTION SITE PAIN; MUSCLE PAIN; This spontaneous report received from a patient via another manufacturer (Pfizer) concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: incontinence, neuropathy, depression, hypothyroid, high cholesterol, and sulpha allergy. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with covid-19 and since the vaccination patient had not been tested for covid-19.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series1) (suspension for injection, route of admin was not reported batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. Concomitant medications included levothyroxine, oxybutynin, paroxetine, and simvastatin.  On 21-JAN-2022, the patient experienced chills, joint pain, feeling unwell, arm pain, headache, fatigue, injection site pain, and muscle pain (all events with dose number in series1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, feeling unwell, arm pain, headache, fatigue, injection site pain, and muscle pain. The patient was received additionally non company suspect vaccine BNT162 (Pfizer Comirnaty) (dose number in series 2) (Form of administration was not reported, route of admin was not reported, batch number:unknown, expiry:unknown) doses were not reported, administered on JUN-2021 for prophylactic vaccination on left arm. It was unknown if the patient experienced any adverse event after vaccination with BNT 162 (dose number in series 2). This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLAXIS/SHORTNESS OF BREATH/TIGHTNESS OF CHEST; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma since 11 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, 1 total administered on 01-FEB-2022 23:30 for prophylactic vaccination. Non-company suspect drugs included: prednisone ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported received on  01-FEB-2022 18:35, 20 mg and 03-FEB-2022 2.5mg for asthma. And patient reported she did not take Prednisone on 02-FEB-2022 really need to take every day for asthma, at least 5-10mg per day No concomitant medications were reported.  On 01-FEB-2022, after receiving vaccine at 23:30 and prednisone at 18:35, the patient experienced anaphylaxis after 30 minutes and patient visited emergency care unit. On 03-FEB-2022, the patient experienced (Felt tightening in chest and shortness of breath) anaphylaxis, but not enough to use Epi-pen or go to urgent care. Treatment medications (dates unspecified) included: epinephrine for anaphylaxis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylaxis/shortness of breath/tightness of chest was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220213102-Covid-19 vaccine ad26.CoV-2.s- Anaphylaxis/Shortness of breadth/tightness of chest. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SORE SPOT; This spontaneous report received from a patient via a company representative via social media concerned a 73 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 (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on MAR-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 an unspecified date, the patient experienced sore spot (Dose number in series 1). Patient stated that, "My husband and I got the J&J last March. I was 73 and hubby insisted 80s. We barely had a sore spot. So glad we got that one. And so far no breakthrough covid. Recently had a Moderna booster. So far so good." The patient received additional non-company suspect vaccine MRNA 1273 (Dose number in series 2) (form of administration, route of administration, and batch number were not reported) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. No adverse events were observed following vaccination with MRNA 1273 (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore spot was not reported. This report was non-serious. This case, from the same reporter is linked to 20220212947.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: RIGHT LEG PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: feels sick. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-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 experienced right leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of right leg pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20220200404.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait inability, Middle insomnia, Pain in extremity, Shoulder arthroplasty
Clinical narrative: RIGHT LEG PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: feels sick. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-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 experienced right leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of right leg pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20220200404.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain
Clinical narrative: BODY ACHES; LOWER BACK PAIN; JOINT HURTS (COULD NOT ROLL OVER AT NIGHT/HURTS TO WALK); This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. Patient did not have any medical history. She stated that she was healthy in all other ways. She was walking every day and was not overweight or anything. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number was not reported) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date in JAN-2022, 10 to 14 days before booster, the patient thought patient had Covid (didn't get a test), but patient's son had Covid and he tested positive and patient had same symptoms hence, coded as suspected clinical vaccination failure and suspected covid-19 infection with first dose of covid-19 vaccine ad26. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: 27-APR-2022) dose was not reported, 1 total, administered on 04-FEB-2022 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 05-FEB-2022, in the middle of the night the patient experienced body aches. She reported that her body aches were pretty severe. Her lower back and joints hurt (she could not roll over at night/hurts to walk) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, lower back pain, and joint hurts (could not roll over at night/hurts to walk). This report was non-serious. This case, involving the same patient is linked to 20220216238 (case for dose number in series 1).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Oral herpes, Tinnitus
Clinical narrative: HAIR LOSS; COLD SORES; TINNITUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have cold sores before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: UNKNOWN) dose was not reported, administered on 15-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-DEC-2021, the patient experienced tinnitus. On 22-DEC-2021, the patient experienced cold sores. On an unspecified date, the patient experienced hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold sores, and had not recovered from tinnitus, and hair loss. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: MILDLY SICKNESS; This spontaneous report received from a consumer via a company representative concerned multiple patients 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced mildly sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mildly sickness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: LITTLE SIDE EFFECTS; This spontaneous report received from a consumer via a company representative from social media  concerned multiple patients. No past medical histories or concurrent conditions were reported. Patients previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. Patients received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that "Most of my friends n family also, had little or no side effects." (Dose number in series 1 and 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little side effects was not reported. This report was non-serious. This case, involving the same patients is linked to 20220210047 (case for dose number in series 1). This case, from the same reporter is linked to 20220216024 and 20220210428.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 65 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: 204A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JAN-2022, the patient experienced suspected covid-19 infection, and suspected clinical vaccination failure. The patient had same symptoms (unspecified) like her son who had tested positive for covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220214837. This report was associated with product quality complaint: 90000216385.; Sender's Comments: V0; 20220216238-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Ear pain, Headache, Neck pain
Clinical narrative: FEELING DIZZY; NECK PAIN; EARS PAIN; CHEST PAIN; LEFT ARM PAIN; HEADACHE; This spontaneous report received from a patient 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 was not reported, administered on 20-OCT-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 experienced feeling dizzy, neck pain, ears pain, chest pain, left arm pain, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, feeling dizzy, neck pain, ears pain, chest pain and left arm pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: FEELING DIZZY; NECK PAIN; EARS PAIN; CHEST PAIN; LEFT ARM PAIN; HEADACHE; This spontaneous report received from a patient 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 was not reported, administered on 20-OCT-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 experienced feeling dizzy, neck pain, ears pain, chest pain, left arm pain, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, feeling dizzy, neck pain, ears pain, chest pain and left arm pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident
Clinical narrative: THREE BLOOD CLOTS IN BRAIN; STROKE; This spontaneous report received from a consumer via a company representative via agency concerned a 44 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: unknown, expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced three blood clots in brain, and stroke. The reporter reported that "It's a freak thing. It's not like she's old and just a slob that doesn't take care of herself. She's only 44 and is one of those diehard people of taking care of themselves. So for her to have three blood clots in her brain and have a stroke is very suspicious of the cause. They also have her on blood thinners because there was smaller clots forming that they said they couldn't get too". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the three blood clots in brain and stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220161645.; Sender's Comments: V0: 20220216426 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Three blood clots in brain, Stroke. 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: Gait inability, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; NEVER WALKED A STEP SINCE; This spontaneous report received from a consumer via a company representative concerned a female 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 and 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 number. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, suspected covid-19 infection and never walked a step since. The reporter reported that, "my sister got the J and J vaccine got Covid went into hospital and has never walked a step since".   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, never walked a step since and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000216375.; Sender's Comments: V0 20220216471-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: FEELING WARM; HEADACHE; This spontaneous report received from a company representative concerned a male 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 was previously vaccinated with covid-19 vaccine ad26. cov2.s (manufacturer not specified) (suspension for injection, route of administration was not reported, batch number: unknown, expiry date: unknown), dose was not reported, dose number in series was 1, 01 in total, administered on an unspecified date for an prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient additionally 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, dose number in series was 2, 01 total administered on 05-FEB-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-FEB-2022, the patient experienced feeling warm, and headache (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and feeling warm was not reported (dose number in series was 2). This report was non-serious. This case, from the same reporter is linked to 20210446964, 20210436394 and 20210420604.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Neck pain
Clinical narrative: CHEST PAIN; NECK PAIN; EARS DIZZY IN MY LEFT ARM; HEADACHE; This spontaneous report received from a patient 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, and batch number were not reported) 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, the patient experienced headache, chest pain, neck pain and ears dizzy in my left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chest pain, neck pain and ears dizzy in my left arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients of unspecified ages, sex, race and ethnicity. No past medical histories or concurrent conditions were reported. Patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch numbers and expiry were not reported) dose, start therapy dates were not reported, 1 total, administered for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, patients experienced suspected covid-19 infection, and suspected clinical vaccination failure, and were hospitalized (dates unspecified). The reporter stated that, "hospital has no beds open because his doctor came out and told him the hospital is full of Covid patients who were fully vaccinated". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000216499. This case, from the same reporter is linked to 20220213367.; Sender's Comments: V0: 20220217362-covid-19 vaccine ad26.cov2.s- suspected clinical 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 20220217362-covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. 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: Pulmonary thrombosis
Clinical narrative: 03 EARTHWORM SIZE BLOOD CLOTS IN LUNGS; This spontaneous report received from a consumer via a company representative through social media concerned a female (consumer's friend) of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had never been sick her entire life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 01 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had 03 earthworm size blood clots in lungs, which was removed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 03 earthworm size blood clots in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220217407-covid-19 vaccine ad26.cov2.s-   03 earthworm size blood clots in lungs. 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: Dizziness, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; DIZZINESS; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a parent concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: epilepsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 01 total administered on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experience nausea (suspected covid-19 infection) and dizziness. On 02-FEB-2022, the patient underwent laboratory test which included: COVID-19 virus test (NR: not provided) Positive which resulted in suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and dizziness was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216410.; Sender's Comments: V0: 20220217623-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: MASSIVE STROKE; BLOOD CLOTS; This spontaneous report received from a consumer via social media via a company representative concerned a male 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 admin, and batch number and expiry date 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 reporter stated that "my husband ended up with blood clots after the J&J as well. One went to his brain and cause a massive stroke that killed him. He did have other stuff going on so no way to prove it." The patient died of massive stroke. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0. 20220217624-covid-19 vaccine ad26.cov2.s massive stroke, 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).; Reported Cause(s) of Death: MASSIVE STROKE