chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Paraesthesia, Pruritus, Rash
Clinical narrative: Itching in left arm, upper shoulder, right arm; painful tiny pin  prick sensations; Rash; Unable to sleep; painful tiny pin  prick sensations; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 43SG5, expiry date 13th October 2023) for prophylaxis.   On 14th October 2022, the patient received the 1st dose of Shingrix .5 ml. On 16th October 2022, 2 days after receiving Shingrix, the patient experienced pruritus, pain, rash, sleeplessness and paresthesia. On an unknown date, the outcome of the pruritus, pain, rash, sleeplessness and paresthesia were recovered/resolved.   It was unknown if the reporter considered the pruritus, pain, rash, sleeplessness and paresthesia to be related to Shingrix.     Additional Information: GSK Receipt Date: 12 DEC 2022 Reporter's comment: Pharmacist reported a patient received her first dose of  SHINGRIX vaccine on 14th October 2022.  The patient was scheduled to receive her second dose of SHINGRIX on 10th December 2022. The pharmacist held off on administering the second dose because the patient described adverse effects from the first dose.  Two days after receiving the dose of SHINGRIX, the patient experienced itching in the left arm (vaccinated arm), then it moved across the upper shoulder to the other arm.  She also experienced painful, tiny pin prick sensations, a rash, and she was unable to sleep.  The reporter stated the patient experienced these events up until 1 week prior to her scheduled 2nd vaccination date.
Age: 0.67
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Expired product administered, Inappropriate schedule of product administration, Overdose
Clinical narrative: Infanrix and Pediarix given the same day; 1st dose of Pediarix on 6th June 2022 and 2nd dose of Pediarix on 12th Dec 2022; Expired Pediarix administered; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 8-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TF425, expiry date 21st October 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 6th June 2022 ).   On 12th December 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 12th December 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose, drug dose administration interval too long and expired vaccine used. On an unknown date, the outcome of the overdose, drug dose administration interval too long and expired vaccine used 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 Information: GSK receipt date: 12-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received the 1st dose of Infanrix and 2nd dose of Pediarix on the same day, which led to overdose.  The patient received the 2nd dose of Pediarix as expired one later than the recommend interval, which led to expired vaccine used and lengthening of vaccine schedule.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Expired dose administered; 1st dose on 28Jun2022, 2nd on 13Dec2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix adult  (received 1st dose on 28th June 2022).   On 13th December 2022, the patient received the 2nd dose of Havrix adult 1 ml and Havrix Pre-Filled Syringe Device. On 13th December 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and drug dose administration interval too short. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too short 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 Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Havrix in left deltoid as expired one earlier than the recommended interval, which led to expired vaccine used and shortening of vaccine schedule.
Age: 0.33
Sex: U
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: Reconstituted with a non-GSK solution; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7, expiry date 24th February 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 9th December 2022, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 9th December 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose of Rotarix which was reconstituted with a solution that was not provided by GlaxoSmithKline, which led to wrong solution used in drug reconstitution.
Sex: U
Vaccine: UNK
Symptoms: Incorrect route of product administration
Clinical narrative: Flulaval administered IV instead of IM; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 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.   On 14th December 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intravenous) and Flulaval Tetra Pre-Filled Syringe Device. On 14th December 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date :14 DEC 2022 Reporters comment:  Pharmacist called to report that a nurse gave a Flulaval QIV intravenous instead of intramuscular by error. Pharmacist believed that the patient involved was an adult. No other details were available at the moment of this call. Did not consent to follow-up. Additional supportive information: As patient received Flulaval quadrivalent intravenously instead of intramuscular, which led to intramuscular formulation administered by other route.
Age: 80.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Dysarthria
Clinical narrative: Slurred speech; This case was reported by a consumer via call center representative and described the occurrence of slurred speech in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 14th December 2022, the patient received Shingrix (intramuscular) and Flu vaccine (intramuscular). On 14th December 2022, less than a day after receiving Shingrix and Flu vaccine, the patient experienced slurred speech. On an unknown date, the outcome of the slurred speech was not recovered/not resolved.   It was unknown if the reporter considered the slurred speech to be related to Shingrix and Flu vaccine.     Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comment: The reporter was the patient wife.  The reporter reported that the patient received a Shingrix vaccine and a flu vaccine at the same time and both the vaccines was given intramuscularly. The reporter stated that the one vaccine is in the left deltoid and another one in the right deltoid.  The vaccines are given at the doctor's office.  The reporter did not had the brand name of the flu shot or the lot numbers for either vaccine.  The patient on the same night of vaccination and today experienced slurring of speech.  The reporter did not think her husband had a stroke because her husband was not had paralysis or face drooping. The reporter was failed to ask if this was Shingrix 1st dose or 2nd dose. The reporter did consent to follow up. Additional supportive information: The age at administration got auto populated as 81 years instead of 80 years due to system issue.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; OFF LABEL USE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned an elderly female. The patient's weight, height, and medical history were not reported. The patient received first and second dose of Pfizer (tozinameran) (dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether the adverse event reported following to first dose of vaccination (dose number in series 1). The patient received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis (revaccination with different covid-19 vaccine) (dose number in series 2). It was unknown whether the adverse event reported following to first dose of vaccination (dose number in series 2). The patient received fourth dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with off label use (dose number in series 3). No concomitant medications were reported.  On an unspecified date of OCT-2022 the patient tested positive for COVID-19. The patient was extra tired for about 3 days, and experienced confirmed covid-19 infection (dose number in series 3). But the patient was just as active as before, working in the house and working in the yard. On an unspecified date of 2022, after about 7 days the patient tested negative for COVID-19 (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on 2022, and the outcome of revaccination with different covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20221234943, 20221235149, 20221234743 and 20221234779. This report was associated with product quality complaint: 90000263487. Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: DEATH; HEART STOPPED; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date was not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient heart just stopped. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. Reporter stated that, "The vac killed my sister. Her heart just stopped" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart stopped was not reported. This report was serious (Death, and Other Medically Important Condition). This case is a duplicate of 20221239778.  It was determined that Manufacturer Case Number 20221239778 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20221237358.; Sender's Comments: V0: 20221237358- death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. 20221237358-Heart stopped. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Body temperature, Drug ineffective, Influenza like illness, Suspected COVID-19
Clinical narrative: ARRHYTHMIA; VACCINE DID ABSOLUTELY NOTHING TO PROTECT ME; FLU LIKE SYMPTOMS; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was sick with a 4 day high fever and sweats and experienced flu like symptoms. Patient also had heart palpitations (arrhythmia). Patient had to be treated by a cardiologist for arrhythmia. Patient got covid twice (suspected covid-19 infection) and also reported that vaccine did absolutely nothing to protect the patient (Lack of drug effect). Laboratory data (dates unspecified) included: Body temperature high fever. It was reported as "One and done. I was done with all vaccines. Sick with a 4 day high fever, sweats, flu like symptoms along with heart palpitations. I had to be treated by a cardiologist for arrhythmia. I got Covid twice so this vaccine did absolutely nothing to protect me. Just some bad chemicals put in your body". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, arrhythmia, suspected covid-19 infection and vaccine did absolutely nothing to protect me was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000263680.; Sender's Comments: V0: 20221238362- Arrhythmia. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221238362-Vaccine did absolutely nothing to protect me. The event 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Infection, Laryngeal cancer stage IV, Nasopharyngitis
Clinical narrative: STAGE 4 LARYNX CANCER; COMPROMISED IMMUNE SYSTEM; TERRIBLE INCURABLE COLDS; INFECTION; This spontaneous report received from a consumer via social media via company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s.(Dose number in series 1) The patient additionally received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced stage 4 larynx cancer, compromised immune system, terrible incurable colds and infection. (Dose number in series 2) Reporter stated that, "My mother had all the recommended COVID vaccines and boosters per requirements of her job, which in turn compromised her immune system, dealt with terrible incurable colds and infection and is currently battling stage 4 larynx cancer. I never had any vaccines and I have been fine, had COVID with very mild symptoms. I'd love to learn more about your research" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stage 4 larynx cancer, and the outcome of compromised immune system, terrible incurable colds and infection was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20221240499 and 20221240550. This case, involving the same patient is linked to 20221240593 (Dose number in series 1)  It was determined that manufacturer Case Number 20221240499 and 20221240550 were duplicate of this case. All relevant information regarding this case will be submitted under manufacturer Case Number 20221239600.; Sender's Comments: V0-20221239600- Stage 4 larynx cancer- The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: SUPPOSED HEART ATTACK; This spontaneous report received from a consumer via social media (J and J Corporate) via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, approximately 4 or 5 months post vaccination the patient died from a supposed heart attack. Reporter stated that, "my grandchildren's others grandma took the J&J shot after my daughter-in-law begged her mother not to. She died approximately 4 or 5 months later from a supposed heart attack. They had a closed casket funeral because of something they didn't want others to see after finding her dead several hours later. I don't trust any of these experimental gene altering injections". It was unknown 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: 20221240762- Supposed heart attack. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: HEART ATTACK
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: THEY KILLED MY DAD WITH THE VAX; This spontaneous report received from a consumer via social media (J and J Corporate/Johnson and Johnson Global) via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed. Reporter stated that, "put your report on VAERS. I had two shots and had to report on VAERS due to the severe reaction. NEVER AGAIN. They killed my Dad with the vax. Nobody can convince me otherwise". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221237165 and 20221237171.; Sender's Comments: V0: 20221240843 - They killed my dad with the vax.  Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media via a company representative concerned (5) multiple patients of an unspecified age, sex, race and ethnicity. The patients' weight, height, and medical history were not reported. The patients' all received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose and start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients' experienced death from an unknown cause of death. It was unknown whether an autopsy was performed or not. It was reported that, "I personally know 5 people that died from the vaccination". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221241416.; Sender's Comments: V0: 20221241346 -death.  Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: MORE SICK THAN BEFORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced more sick than before. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of more sick than before was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID MULTIPLE TIMES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid multiple times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid multiple times was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000263873.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness was not reported. This report was non-serious. This case, involving the same patient is linked to 20221243764.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to chemicals, Autoantibody positive, Autoantibody test, Food intolerance, Inflammation
Clinical narrative: CHEMICAL INTOLERANCE; SUDDEN HIGH LEVELS OF AUTOANTIBODIES; SEVERE PAIN; SEVERE INFLAMMATION; FOOD INTOLERANCE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chemical intolerance, sudden high levels of autoantibodies, severe pain, severe inflammation, and food intolerance (Dose number in series 2). Laboratory data (dates unspecified) included: Autoantibody test High levels. It was reported as "So you are now going to study the very condition that your Covid vaccines have caused me and many others?! Seriously? I filed a VAERS report, which has been filed with the CDC and FDA, but these reported adverse events go nowhere!!! There is currently no help or studies being done for/on those of us who are having sudden high levels of autoantibodies triggering severe pain and inflammation, food intolerance, chemical intolerance, since being vaccinated and boosted with your Covid Vaccine. Apparently, you discovered your Covid vaccine triggers autoantibodies, then quit the mass manufacturing of it, and now you are going to finds the answer/treatment for the condition you have caused in so many from your vaccine? I sure hope an investigation occurs into J and J Covid Vaccine Adverse Events!" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chemical intolerance, sudden high levels of autoantibodies, severe pain, severe inflammation and food intolerance was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: CHEMICAL INTOLERANCE; SUDDEN HIGH LEVELS OF AUTOANTIBODIES; SEVERE PAIN; SEVERE INFLAMMATION; FOOD INTOLERANCE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chemical intolerance, sudden high levels of autoantibodies, severe pain, severe inflammation, and food intolerance (Dose number in series 2). Laboratory data (dates unspecified) included: Autoantibody test High levels. It was reported as "So you are now going to study the very condition that your Covid vaccines have caused me and many others?! Seriously? I filed a VAERS report, which has been filed with the CDC and FDA, but these reported adverse events go nowhere!!! There is currently no help or studies being done for/on those of us who are having sudden high levels of autoantibodies triggering severe pain and inflammation, food intolerance, chemical intolerance, since being vaccinated and boosted with your Covid Vaccine. Apparently, you discovered your Covid vaccine triggers autoantibodies, then quit the mass manufacturing of it, and now you are going to finds the answer/treatment for the condition you have caused in so many from your vaccine? I sure hope an investigation occurs into J and J Covid Vaccine Adverse Events!" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chemical intolerance, sudden high levels of autoantibodies, severe pain, severe inflammation and food intolerance was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: CONVULSIONS FOR 2 HOURS; This spontaneous report received from a patient via company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total (first shot) administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On the same day night of vaccination with covid-19 vaccine ad26.cov2.s (unspecified date), the patient experienced convulsions for 2 hours. It was reported that "After that first Covid shot, that night went into convulsions for 2 hours. Called the Pharmacy and asked about it and said it was normal. Is this correct". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from convulsions for 2 hours. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221241972-convulsions for 2 hours.. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Off label use
Clinical narrative: MAJOR STROKE; 4 BLOOD CLOTS IN BRAIN; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient also received second dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 2). The patient received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis which was off label dosing frequency (Dose number in series 3). The drug was associated with off label use. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced major stroke which was ended up with 4 blood clots in brain (Dose number in series 3). It was reported as "I have taken 3 Covid shots and had a major stroke in November end up with 4. Blood Clots in my brain so did not take no more". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the major stroke, 4 blood clots in brain and off label dosing frequency was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221242030-major stroke, 4 blood clots in brain. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: BREAST CANCER; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate) concerned multiple patients (5 women). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced breast cancer 3 months after covid jab. It was reported that "Natural remedies only. Those covid jabs hurt a lot of people. I know 5 women 3 months after covid jabs got breast cancer". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breast cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221242169-breast cancer. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: LOST HALF HAIR AND ITS NOT GROWING BACK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced lost half hair and its not growing back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lost half hair and its not growing back. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 (dose number in series 2). Reporter stated that, "The shots we were told to prevent covid. They lied. I still got it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000263899.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE REACTIONS; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: HANDS SO PAINFUL SAT THERE RUBBING THEM NEARLY CRYING; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced hands so painful sat there rubbing them nearly crying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hands so painful sat there rubbing them nearly crying was not reported. This report was non-serious. This case, from the same reporter is linked to 20221243356, 20221243606, 20221243261, 20221245881, 20221245816 and 20221245969.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: SEVERE TINNITUS; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe tinnitus was not reported. This report was non-serious. This case, from the same reporter is linked to 20221243340, 20221243261, 20221243606, 20221245881, 20221245816 and 20221245969.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a consumer via social media via a company representative concerned a 75 year old of unspecified sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The patient was sick on the same night with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s  (Dose number series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 8 decade old. No concomitant medications were reported.  On an unspecified date, the patient experienced sick (Dose number series 2). As per reporter " I had the J&J and was sick on night that I got shot Then got booster shot. Was sick again. But I'm not getting any more booster's I'm 75. I don't think they even offer another booster for J&J ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20221241808.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; FEELING UNDER THE WEATHER; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-OCT-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Age at time of vaccination 62 years old. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid, and feeling under the weather. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from tested positive for covid, and the outcome of feeling under the weather was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: DID NOT FEEL FABULOUS; This spontaneous report received from a patient via a social media via company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, and expiry: Unknown) dose was not reported, 1 total, dose 1 was administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin and batch number were not reported, and expiry: Unknown) dose was not reported, 1 total, dose 2 (booster) was administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient did not feel fabulous (Adverse event NOS) (dose number in series 2). It was reported as, "I didn't feel fabulous after my Omicron booster, but it's a small price to pay to stay safe. I wear a mask at the grocery store. My son died from the after effects of Covid. It's a long story". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of did not feel fabulous was not reported. This report was non-serious. This case, from the same reporter is linked to 20221244119.