chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: giving an expired / dose to a patient /  Vaccination date: 12th July 2021 / Expiration date of the vaccine: July 2nd 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HBV (Engerix B) (batch number KC4OF, expiry date 2nd July 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Engerix B and Engerix B 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The reporter wanted to know how to proceed after patient was given an expired Engerix-B dose, which led to expired vaccine used. The reporter consented to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Mobility decreased
Clinical narrative: numbness in her arm to the point where she cannot function with it / numbness in left arm is intermittent / time length of numbness has gotten longer rather than shorter; numbness in her arm to the point where she cannot function with it; has experienced headache; This case was reported by a consumer via call center representative and described the occurrence of numbness of upper extremities in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 75P7G, expiry date 17th April 2022) for prophylaxis.   On 8th July 2021, the patient received the 2nd dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced numbness of upper extremities, mobility decreased and headache. On an unknown date, the outcome of the numbness of upper extremities and mobility decreased were not recovered/not resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the numbness of upper extremities, mobility decreased and headache to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for herself. The patient received the shot in her left arm and experienced numbness in her arm to the point where she could not function with it. The reporter stated that the numbness in left arm was intermittent and the time length of numbness had gotten longer rather than shorter. The patient also experienced headache and she had notified her doctor and pharmacist of her side effects. The reporter mentioned that her primary care provider was aware of the symptoms and suggested that if the symptoms did not improve in 2 days then call primary care provider office back. The patient did not have an email address nor did she give consent to contact her health care professional. No additional information was provided. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Pt. received the 1st dose of Shingrix about 3 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 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 are as follows: The age at vaccination was not applicable. Till the time of reporting, the patient did not receive 2nd dose of Shingrix yet which led to incomplete course of vaccination. No side effects were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Chills / by the next day / had resolved; Headache / by the next day / had resolved; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2021 15:30, the patient received the 1st dose of Shingrix (intramuscular). On 1st July 2021 20:30, 5 hrs after receiving Shingrix, the patient experienced chills and headache. On 2nd July 2021, the outcome of the chills and headache were recovered/resolved.   It was unknown if the reporter considered the chills and headache to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself. The patient received 1st dose of Shingrix in her left arm and began to feel chills and developed a headache. The patient reported that the next day both symptoms were resolved and she was fine. The reporter did not gave permission to contact health care professional. The reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: patient under 50 years old received the first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 47-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (had herpes zoster last year).   In April 2021, the patient received the 1st dose of Shingrix. In April 2021, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided are as follows: The age at vaccination was not reported but patient was under 50 years old. The patient received 1st dose of Shingrix 3months ago of the reporting date, which led to inappropriate age at vaccination. The pharmacist mentioned that the patient had herpes zoster last year which was the reason that the doctor gave him the shot, which led to off label use. The reporter did not have available patient demographics neither lot number and expiration date.  The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: received his first dose/on October 12, 2020 /got his second dose today/got it late due to the "craziness of COVID"; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 1232023, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th October 2020).   On 12th July 2021, the patient received the 2nd dose of Shingrix. On 12th July 2021, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided are as follows: The patient reported that he got his 2nd dose of shingrix on 12th July 2021 (inappropriate schedule of vaccine) and patient stated that he got it late due to the 'craziness of COVID'. The lot number 1232023 was provided which could not be located in our system. No additional information were provided by the patient. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old male patient who received Herpes Zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose of Shingrix received on 24th September 2019). On 7th May 2021, the patient received the 2nd dose of Shingrix. On 7th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The pharmacist reported that, the patient around 60 years old (no information about date of birth) had received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. No information about lot numbers and expirations dates from both Shingrix shots was reported. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: received Shingrix Subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23).   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient received Shingrix vaccine subcutaneously, which led to intramuscular formulation administered by other route .  The patient also received Pneumovax 23 vaccine intramuscularly on the same arm. No adverse event was reported .  No patient's identifiers were provided. No lot number and expiration date provided, no vaccination date provided, no information in which arm the vaccines was provided. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Neck pain, Pain in extremity
Clinical narrative: swelling in her eyes; soreness in her left arm that extended up into her neck.; soreness in her left arm that extended up into her neck.; This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th June 2021, 5 days after receiving Shingrix, the patient experienced eye swelling, neck pain and pain in arm. On an unknown date, the outcome of the eye swelling, neck pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the eye swelling, neck pain and pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient for herself. Consumer report that after received her 1st dose of Shingrix the patient started experiencing soreness in her left arm that extended up into her neck.  The patient also had swelling in her eyes. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: a 98 year old woman where I live got the shingles after getting the vaccine / SUSPECTED VACCINATION FAILURE; got the shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 98-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The relationship of the reporter to the patient was unclear. The age at vaccination was not reported. The reporter did not know which year or which Shingles vaccine the patient received. The reporter stated that, a 98 years old woman where he/she live got the shingles after getting the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter did not consent to follow-up. This case had been linked with US2021151558, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151558:same reporter
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: in adverted administration of a 4th dose of Engerix-B; was supposed to be receiving the last dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 61-year-old female patient who received HBV (Engerix B) (batch number n4ga4, expiry date 2nd January 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received first 3 doses of Engerix B on an unknown date).   On 12th July 2021, the patient received the 4th dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered 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 age at the vaccination was not reported. The nurse reported that, the patient was supposed to be receiving the last dose of Havrix but received in adverted administration of 4th dose of Engerix-B, which led to extra dose administered and wrong vaccine administered.  No further events were reported. The health care professional agreed on follow-up.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 6 year-old male child received Havrix adult first dose by error; 6 year-old male child received Havrix adult first dose by error; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 6-year-old male patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 13th July 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose 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 case details were reported as follows: Nurse reported that a patient received Havrix adult dose by error which led to adult product administered to child and overdose. No data about expiration date. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: late for the second dose/ first dose/ on April 2021/ the second dose was not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in April 2021 with batch number dk23d and expiry date 8th February 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Age at vaccination was not applicable for this report. Pharmacist reported that a patient was late for the 2nd dose of Twinrix and the 2nd dose was not given till the time of reporting which led to incomplete course of vaccination.  No adverse event was reported . The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got first dose of Shingrix 9/11/2020 and has not gotten the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of 0.5 ml received in an unknown arm by intramuscular route on 11th September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by patient. Age at vaccination was not applicable for this report. The patient had not gotten the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Shingrix 12 days before reaching the recommended two months; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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 reported as follows: Age at vaccination was not reported. Pharmacist Intern reported that a patient received the second dose of Shingrix 12 days before reaching the recommended two months which led to shortening of vaccination schedule. Health care professional (HCP) did not have available patient demographic neither vaccination date and lot number of the vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: experience tingling on top of her foot.  This symptom has not resolved; This case was reported by a consumer via sales rep and described the occurrence of tingling of extremity in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2021, the patient received the 1st dose of Shingrix .5 ml. On 15th June 2021, 1 days after receiving Shingrix, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received her vaccine from the health department. On the next day of vaccination, the patient began to experience tingling on top of her foot. Till the time of reporting, the symptom had not resolved. No lot no or expiration date was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got first dose on 10/1/2020 and just not trying to get 2nd dose /  had been 9 months since patient got first vaccine / wanted to know if patient had to start over or if she could give 2 vaccine; This case was reported by a pharmacist 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 in 1st October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix (injection). 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. The patient was just not trying to get 2nd dose and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter stated that it had been 9 months since patient got first vaccine. The reporter wanted to know if patient had to start over or if she could give 2 vaccine. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Didn´t received second dose / and 1st dose was given during 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with US2021151596, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151596:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / almost a year ago and has not received the second dose yet; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose almost a year ago of batch number MT7C9 and expiry date was 15th April 2022).   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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. VAERS details of 1st dose was reported. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received the first dose / in 2018 and has not received dose two; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / on 10/21/2018 and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st October 2018, batch number-9de73, expiry date- 6th December 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. No further events were reported. The health care professional agreed to be contacted for follow up. The reporter consented to follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a patient concerned a 31 year old female. The patient was enrolled in a study. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 27-FEB-2021 for covid-19 immunisation. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. No concomitant medications were reported.  On 27-FEB-2021, the patient experienced maternal exposure during pregnancy. The date of the patient's last menstrual period was 18-OCT-2020. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related.  This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Limb discomfort, Pain, Pain in extremity
Clinical narrative: ANXIETY; GENERALIZED PAIN; FINGER PAIN; FOOT ACHE; ARTHRITIC PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included eye surgery, lazy eye, and ovarian cyst removal, and concurrent conditions included penicillin allergy, and sulfur allergy, and other pre-existing medical conditions included the patient was on breath bio.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced arthritic pain. On 30-JUN-2021, the subject experienced foot ache. On 01-JUL-2021, the subject experienced finger pain. On an unspecified date, the subject experienced anxiety, and generalized pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety, arthritic pain, finger pain, foot ache and generalized pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: PAIN FROM THE JAB WAS HORRIBLE; SO SICK COULDN'T DRIVE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 subject experienced pain from the jab was horrible, and so sick couldn't drive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the so sick couldn't drive and pain from the jab was horrible was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fall, Thrombosis
Clinical narrative: STROKE; BLOOD CLOT; FELL  DOWN; This spontaneous report received from a health care professional( Nurse) concerned an 86 year old male, The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes mellitus type 2. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 28-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Post vaccination 2 week patient experienced symptoms. On(unspecified date) JUN-2021, the patient fell down and was and brought to the hospital via ambulance. On 12-JUN-2021 patient  was diagnosed with Stroke and was hospitalized 3 to 4 days. On (unspecified date) JUN-2021 patient for profound left sided weakness was in the nursing home. On (unspecified date) JUN-2021 patient had blood clot and it was reported stroke might had due to Blood clot but it was unsure was that due to Janssen Covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, blood clot, felt down and profound left sided weakness was not reported. This report was serious (Hospitalization Caused / Prolonged) .; Sender's Comments: V0-20210705027-COVID-19 VACCINE AD26.COV2.S-Stroke, blood clot, fell down. These events are considered not related. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: WOUND ON THE LEG; This spontaneous report received from a patient concerned an 87 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 UNKNOWN) dose was not reported, one total administered on 28-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after receiving vaccine, the patient experienced wound on the leg, and was hospitalized (date unspecified) for 2-3 days. It was not diagnosed as a Cellulitis 4-5 weeks later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wound on the leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210708265- COVID-19 VACCINE AD26.COV2.S-WOUND ON THE LEG. This event is considered unassessable. 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.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Malaise
Clinical narrative: SHORTNESS OF BREATH; TIGHTNESS IN HER CHEST AS IF SHE HAD HEARTBURN, BUT IT IS NOT HEART BURN; FEELING UNDER THE WEATHER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hives possibly due to preservatives in food, and allergy to possibly preservatives in food.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. The batch lot number was not reported and has been requested. No concomitant medications were reported. On 04-JUL-2021, the subject experienced shortness of breath. On 04-JUL-2021, the subject experienced tightness in her chest as if she had heartburn, but it is not heart burn. On 04-JUL-2021, the subject experienced feeling under the weather. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and tightness in her chest as if she had heartburn, but it is not heart burn, and the outcome of feeling under the weather was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedures, as case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vomiting
Clinical narrative: PUKED WHOLE NIGHT; HIGH FEVER OVER 40 CELCIUS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced puked whole night, and high fever over 40 celcius. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) High fever over 40 celcius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the puked whole night and high fever over 40 celcius was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210708514-Covid-19 vaccine ad26.cov2.s Stroke. This event(s) is considered unassessable. The event(s) has unknown 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: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified date in Mar-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) frequency 1 total, dose was not reported, 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 in Jun-2021, the patient experienced suspected covid-19 infection. The patient stated that she still had symptoms four weeks after getting COVID while working (suspected covid-19 infection). On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210708714- covid-19 vaccine ad26.cov2.s -Suspected vaccine failure, suspected covid-19 infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Headache, Heart rate, Heart rate abnormal
Clinical narrative: PULSE RATE; HEADACHE(COMING AND GOING); NAUSEA; FEVER; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207821A, expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced pulse rate. On 03-JUL-2021, the subject experienced headache (coming and going). On 03-JUL-2021, the subject experienced nausea. On 03-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, Body temperature decrease (NR: not provided) 97.1 F, and Pulse rate (NR: not provided) not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-JUL-2021, had not recovered from headache(coming and going), and the outcome of nausea and pulse rate was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: PULSE RATE; HEADACHE(COMING AND GOING); NAUSEA; FEVER; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207821A, expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced pulse rate. On 03-JUL-2021, the subject experienced headache (coming and going). On 03-JUL-2021, the subject experienced nausea. On 03-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, Body temperature decrease (NR: not provided) 97.1 F, and Pulse rate (NR: not provided) not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-JUL-2021, had not recovered from headache(coming and going), and the outcome of nausea and pulse rate was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: SEVERE RASH; This spontaneous report received from a consumer 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 08-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 subject experienced severe rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe rash was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation, Decreased appetite, Gastrointestinal pain, Headache
Clinical narrative: LOSS OF APPETITE; MILD/SHARP PAIN IN STOMACH; CONSTIPATION; GASTROINTESTINAL PAIN; HEAD PAIN; A LITTLE SORE AT INJECTION SITE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced loss of appetite, sharp/mild pain in stomach, constipation, gastrointestinal pain, head pain, and a little sore at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, sharp/mild pain in stomach, constipation, gastrointestinal pain, head pain, and a little sore at injection site. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: LOSS OF APPETITE; MILD/SHARP PAIN IN STOMACH; CONSTIPATION; GASTROINTESTINAL PAIN; HEAD PAIN; A LITTLE SORE AT INJECTION SITE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced loss of appetite, sharp/mild pain in stomach, constipation, gastrointestinal pain, head pain, and a little sore at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, sharp/mild pain in stomach, constipation, gastrointestinal pain, head pain, and a little sore at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Liver function test increased
Clinical narrative: ELEVATED LIVER LEVELS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the subject experienced elevated liver levels. Laboratory data included: Blood test (NR: not provided) Elevated liver levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of elevated liver levels was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise
Clinical narrative: NOT FEELING WELL; FEEL WEAK; HORRIBLE HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 subject experienced not feeling well, feel weak, and horrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not feeling well, feel weak, and horrible headache. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Lethargy, Pain in extremity
Clinical narrative: LETHARGIC; FELT PAIN IN HIS ARM INSTANTLY; HEADACHE; PAIN BEHIND EYES WHEN LOOKING  LEFT AND RIGHT/STRAIGHT; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced pain behind eyes when looking left and right/straight. On 02-JUL-2021, the subject experienced felt pain in his arm instantly. On 02-JUL-2021, the subject experienced headache. On 03-JUL-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, and felt pain in his arm instantly on JUL-2021, and headache on 04-JUL-2021, and had not recovered from pain behind eyes when looking left and right/straight. This report was non-serious. This case, from the same reporter is linked.