chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Prophylaxis
Clinical narrative: administration of the Shingrix vaccine to a/ 47 year old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received Herpes zoster (Shingrix) (batch number 59lk9, expiry date 18th December 2022) for prophylaxis.   On 12th July 2021, the patient received Shingrix. On 12th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter stated that, 47 years old patient received dose of Shingrix, which led to inappropriate age at vaccine administration. No further events were reported. The health care professional agreed to be contacted for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Hyperaesthesia, Pain
Clinical narrative: received both / doses in 2019 / 7/18/2021  PA diagnosed patient with Shingles / had both doses of / vaccine about 1 or 2 years ago / HCP said I had all the symptoms of Shingles but not the rash/ suspected vaccination failure; PA diagnosed patient with Shingles / HCP said I had all the symptoms of Shingles but not the rash / it is moving and spreading around the back; experiencing pain on right side of torso / having symptoms of pain (AE: Pain) / 5 days ago on the side of the body; no raised blisters but a thin line under the skin; burning (AE: Burning) 5 days ago on the side of the body; if he gets touched on the area it hurts and burns more; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On 14th July 2021, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, blister, burning sensation and touch sensitivity increased. On an unknown date, the outcome of the vaccination failure, shingles, pain, blister, burning sensation and touch sensitivity increased were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, blister, burning sensation and touch sensitivity increased to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was unknown. The patient received both the doses of Shingrix in 2019. The reporter also stated he received both doses about 1 or 2 years ago. On 14th July 2021, 5 days before the date of reporting, the patient was experiencing pain on right side of torso and burning on the side of the body. On 18th July 2021, the patient was diagnosed with shingles. The patient reported there were no raised blisters but a thin line under the skin. The patient stated that, the healthcare professional said to him that he had all the symptoms of shingles but not the rash. The patient also stated that if he touched on the area it hurt and burnt more and was moving and spreading around the back. The patient reported that he had never had shingles before. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The patient did not have exact dates of vaccines or lot and expiration dates. The reporter did not consent to follow up with the healthcare professional.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: received both / doses in 2019 / 7/18/2021  PA diagnosed patient with Shingles / had both doses of / vaccine about 1 or 2 years ago / HCP said I had all the symptoms of Shingles but not the rash/ suspected vaccination failure; PA diagnosed patient with Shingles / HCP said I had all the symptoms of Shingles but not the rash / it is moving and spreading around the back; experiencing pain on right side of torso / having symptoms of pain (AE: Pain) / 5 days ago on the side of the body; no raised blisters but a thin line under the skin; burning (AE: Burning) 5 days ago on the side of the body; if he gets touched on the area it hurts and burns more; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On 14th July 2021, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, blister, burning sensation and touch sensitivity increased. On an unknown date, the outcome of the vaccination failure, shingles, pain, blister, burning sensation and touch sensitivity increased were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, blister, burning sensation and touch sensitivity increased to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was unknown. The patient received both the doses of Shingrix in 2019. The reporter also stated he received both doses about 1 or 2 years ago. On 14th July 2021, 5 days before the date of reporting, the patient was experiencing pain on right side of torso and burning on the side of the body. On 18th July 2021, the patient was diagnosed with shingles. The patient reported there were no raised blisters but a thin line under the skin. The patient stated that, the healthcare professional said to him that he had all the symptoms of shingles but not the rash. The patient also stated that if he touched on the area it hurt and burnt more and was moving and spreading around the back. The patient reported that he had never had shingles before. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The patient did not have exact dates of vaccines or lot and expiration dates. The reporter did not consent to follow up with the healthcare professional.
Sex: M
Vaccine: VARZOS
Symptoms: Gout
Clinical narrative: has a history of gout / his gout was in remission for the past 12 years / gout came back 1 week after receiving first dose; This case was reported by a consumer via call center representative and described the occurrence of gout flare in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gout. Concurrent medical conditions included kidney transplant and dialysis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 week after receiving Shingrix, the patient experienced gout flare. On an unknown date, the outcome of the gout flare was not recovered/not resolved.   It was unknown if the reporter considered the gout flare to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient had history of gout and stated that gout was in remission for the past 12 years. The patient had received first dose of Shingrix and his gout came back 1 week after vaccination. The reporter enquired if there was way to reverse Shingrix. The reporter filed adverse event with limited information and refused to provide any further information. The reporter did not consented to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Patient received only the liquid component of Menveo; Patient received only the liquid component of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva548a, expiry date 28th February 2022) for prophylaxis.   On 19th July 2021, the patient received Menveo. On 19th July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The medical assistant called to report patient received only the liquid component of Menveo, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter conented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: received her second dose of Shingrix past the 6-month period/due to COVID vaccine; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 21st September 2020).   On 16th July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 16th July 2021, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional case details were reported as follows: The case was reported by the patient.  The patient received her 2nd dose of Shingrix on left arm into the muscle past the 6-month period as she was due in March 2021 for her 2nd dose.  However, due to COVID vaccine, she was advised to not get Shingrix vaccine for some time. Therefore, she gotten second dose of Shingrix later than recommended schedule The reporter gave a consent to follow-up with health care professional (HCP).  However, the patient seen by different health care professionals on each visit, she did not had name of health care professional, fax number or email address to health care professional.  The patient provided her email address, she did not have lot number or expiration date of the Shingrix dose.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose /in September 2019/ has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2019, Batch number 77PL3, expiry date 18th April 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 case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the 2nd dose, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The case had been linked with US2020042797, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020042797:Same reporter
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Shingrix vaccine was inadvertently administered to 12 year old female; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received Herpes zoster (Shingrix) (batch number 34YF7, expiry date 23rd January 2023) for prophylaxis.   On 20th July 2021 11:30, the patient received the 1st dose of Shingrix (intramuscular). On 20th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided are as follows: The reporter was a Clinic supervisor. The reporter reported that Shingrix vaccine was inadvertently administered intramuscularly in left deltoid muscle to 12 years old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow-up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: Vaccines / exposed to negative 43 degrees Celsius / some / were administered after the temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Havrix, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Havrix, Infanrix, Infanrix Pre-Filled Syringe Device, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. The action taken with Bexsero Pre-Filled Syringe Device was unknown. The action taken with Infanrix Pre-Filled Syringe Device was unknown. The action taken with Kinrix Pre-Filled Syringe Device was unknown. The action taken with Pediarix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse calling regarding the vaccines Bexsero, Boostrix, Engerix-B, Havrix, Infanrix, Kinrix, and Pediarix exposed to negative 43 degrees C. The nurse stated some of the vaccine were administered after the temperature excursion, however at the time of call unknown which vaccines were administered which patients. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1 dose / about 4 years ago, but never received a 2nd dose; This case was reported by a consumer 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 of shingrix about 4 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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received the 2nd dose, which led to incomplete course of vaccination. The patient thought he received shingrix.  He was told that he should come back for a booster in a year after the initial dose, but he forgot about it. When he later remembered, the vaccine was not available when he asked about it. The reporter did not consent to follow-up.
Sex: F
Vaccine: MNQ
Symptoms: Product complaint, Skin laceration
Clinical narrative: cut herself/ on the broken vial; broken vial/ crack/ on the bottom of the vial; This case was reported by a other health professional via call center representative and described the occurrence of laceration in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA398A, expiry date 31st August 2021) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. On an unknown date, immediately after receiving Menveo, the patient experienced laceration and pharmaceutical product complaint. On an unknown date, the outcome of the laceration and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not applicable. The Menveo MenCYW-135 liquid conjugate vaccine component vial was broken and the nurse cut herself on the broken vial when she was trying to draw up the MenCYW-135 liquid conjugate vaccine component.  The package or carton or blister tray was not damaged upon receipt.  There was not any evidence of leakage or product in package or carton.  There was glass pieces still in the vial. There was no product still present in the vial.  The crack or breakage was observed on the bottom of the vial. This case is linked to the case US2020210295 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020210295:Same reporter
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: patient was given Shingrix Subcutaneous instead of Intramuscular.; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 19th July 2021, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 19th July 2021, 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: Pharmacist reported that the patient was given Shingrix subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: vaccinated on 10/03/2019 / second dose is not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd October 2019, batch number PF454, expiry date 26th January 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time 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 age at vaccination was not applicable for this report. Till the time of reporting, the second dose was not administered to the patient, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The reporter consented to follow up and healthcare professional gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/10th October, 2020. And hasn't received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th October 2020, with batch number CE4DE, expiry date 25th September 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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. No further events was reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SWEAR I EXPERIENCED THIS BUT NO ONE WILL DIAGNOSE ME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced i swear i experienced this but no one will diagnose me. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of i swear i experienced this but no one will diagnose me was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: STOMACH PAIN; NUMBNESS/COULD NOT FELT LEGS OR ARMS; TINGLING; HEADACHE; This spontaneous report received from a patient concerned a 52 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: 042a21a, expiry: 21-JUN-2021) dose was not reported with frequency 1 total administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, after vaccination the patient had tingling in her legs and hands, she had headaches, sharp pain in her stomach and went to the hospital and could not felt her legs or arms when she woke up. Then she came home and she could not felt her upper part of her left leg and it was kind of numb. The patient was hospitalized for events on 24-MAY-2021 for 1 day and got discharged on 25-MAY-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness/cant feel legs or arms, tingling, stomach pain and headache was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210740945-Covid-19 vaccine ad26.cov2.s-Stomach pain, Numbness/could not feel legs or arms, Tingling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0: 20210740945-Covid-19 vaccine ad26.cov2.s-Headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: DEATH; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a company representative via Manufacturer on 16-JUL-2021 concerned multiple patients. Initial information was processed along with the additional information received on 21-JUL-2021. The patient's height, and weight were not reported.  Two patient's over 80 years old had underlying health issues, and pre-existing medical conditions of other 8 patient's were not reported.  The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 in total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, two patient's over 80 years old died from an unknown cause after being hospitalized, and eight patients also required hospitalization (hospitalization date unspecified). All patient's had contracted the virus more than two weeks after being fully vaccinated. The cases are confirmed with a positive test COVID-19 (coronavirus disease) (confirmatory test was not reported) (suspected covid 19 infection). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of suspected covid 19 infection was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint, 90000186727.; Sender's Comments: V0 20210741034-COVID-19 VACCINE AD26.COV2.S-Death  and suspected covid 19 infection. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: Unknown) dose was not reported, 1 total, administered on 09-MAR-2021 at left arm deltoid muscle for prophylactic vaccination. No concomitant medications were reported.  On 18-JUL-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive, and COVID-19 antigen (rapid) test (NR: not provided) Positive. All laboratory tests were performed at a medical clinic not at primary care physician. The patient experienced confirmed clinical vaccination failure and confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186483.; Sender's Comments: V0: 20210741174- COVID-19 VACCINE AD26.COV2.S -confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Gait disturbance, Thrombosis, Ultrasound scan, X-ray
Clinical narrative: COULD NOT BARELY MOVE OUT OF BED; BARELY WALK; BLOOD CLOTS IN BOTH LEGS; This spontaneous report received from a patient concerned a 40-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, smoker (vapor about 10 -15 times a day), and non-alcohol user, and the patient had no known allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on left arm on 25-JUN-2021 for prophylactic vaccination. Concomitant medications included metoprolol succinate tablet for high blood pressure.  On 30-Jun-2021 (5-6 days after receiving the vaccine), the patient started feeling pain in both legs. He had no other symptoms no fever, no aches. He climbs in a machine at his job, but he knew he didn't twist it. On 16-JUL-2021, he visited his physician because the pain lasted for 3 weeks. His physician ordered X-rays and Ultrasound. On 19-JUL-2021, he was notified that he had blood clots in both legs. He stated that it was worse and he could not barely move out of bed and barely walk. Physician prescribed him Eliquis (apixaban) for blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in both legs, and the outcome of could not barely move out of bed and barely walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210743268- Covid-19 vaccine ad26.cov2.s- Blood clots in both legs. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included irregular heartbeat, occasional chest pain, non smoker and non alcoholic. The patient did not have any drug abuse/illicit drug use and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 05-AUG-2021) dose was not reported, 1 total, administered on left arm on 07-APR-2021, 14:00 for prophylactic vaccination. Concomitant medications included bisoprolol for irregular heartbeat and isosorbide mononitrate for occasional chest pain.  On 21-JUL-2021, the patient had antibody tests (SARS-CoV-2 IgG antibody test) (NR: not provided) which resulted as negative (confirmed immunological vaccine failure). Laboratory test describes that, the assay detects spike protein of SARSCOV2 including the receptor binding domain (RBI)).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210745217- covid-19 vaccine ad26.cov2.s -CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chest discomfort, Flushing, Headache
Clinical narrative: I CHEST TIGHTNESS; TENDERNESS TO LEFT ARM EFFECTING ROM/TENDER TO TOUCH LEFT UPPER ARM; FEVER OF 101F; NAUSEA; HEADACHE; PAIN AT INJECTION SITE (LEFT ARM); FACIAL FLUSHING; FEELING LIKE BLOOD PRESSURE IS HIGH/BLOOD PRESSURE ELEVATED AS HIGH AS 150/100; CANNOT MOVE LEFT ARM UP; INFLAMMATION TO THE LEFT UPPER ARM; VISION DISTURBANCES; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for premedication. On 24-MAR-2021, the subject experienced feeling like blood pressure is high/blood pressure elevated as high as 150/100. On 24-MAR-2021, the subject experienced facial flushing. On 24-MAR-2021, the subject experienced cannot move left arm up. On 24-MAR-2021, the subject experienced inflammation to the left upper arm. On 24-MAR-2021, the subject experienced vision disturbances. On 24-MAR-2021, the subject experienced tenderness to left arm effecting rom/tender to touch left upper arm. On 24-MAR-2021, the subject experienced fever of 101f. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced pain at injection site (left arm). Laboratory data included: Body temperature (NR: not provided) 101 F. On 25-MAR-2021, the subject experienced chest tightness. Laboratory data included: Blood pressure (NR: not provided) elevated as high as 150/100. Treatment medications (dates unspecified) included: metoprolol succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101f, nausea, and headache on 25-MAR-2021, was recovering from feeling like blood pressure is high/blood pressure elevated as high as 150/100, vision disturbances, and chest tightness, and had not recovered from pain at injection site (left arm), facial flushing, tenderness to left arm effecting rom/tender to touch left upper arm, cannot move left arm up, and inflammation to the left upper arm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypokinesia, Inflammation, Injection site pain, Nausea
Clinical narrative: I CHEST TIGHTNESS; TENDERNESS TO LEFT ARM EFFECTING ROM/TENDER TO TOUCH LEFT UPPER ARM; FEVER OF 101F; NAUSEA; HEADACHE; PAIN AT INJECTION SITE (LEFT ARM); FACIAL FLUSHING; FEELING LIKE BLOOD PRESSURE IS HIGH/BLOOD PRESSURE ELEVATED AS HIGH AS 150/100; CANNOT MOVE LEFT ARM UP; INFLAMMATION TO THE LEFT UPPER ARM; VISION DISTURBANCES; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for premedication. On 24-MAR-2021, the subject experienced feeling like blood pressure is high/blood pressure elevated as high as 150/100. On 24-MAR-2021, the subject experienced facial flushing. On 24-MAR-2021, the subject experienced cannot move left arm up. On 24-MAR-2021, the subject experienced inflammation to the left upper arm. On 24-MAR-2021, the subject experienced vision disturbances. On 24-MAR-2021, the subject experienced tenderness to left arm effecting rom/tender to touch left upper arm. On 24-MAR-2021, the subject experienced fever of 101f. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced pain at injection site (left arm). Laboratory data included: Body temperature (NR: not provided) 101 F. On 25-MAR-2021, the subject experienced chest tightness. Laboratory data included: Blood pressure (NR: not provided) elevated as high as 150/100. Treatment medications (dates unspecified) included: metoprolol succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101f, nausea, and headache on 25-MAR-2021, was recovering from feeling like blood pressure is high/blood pressure elevated as high as 150/100, vision disturbances, and chest tightness, and had not recovered from pain at injection site (left arm), facial flushing, tenderness to left arm effecting rom/tender to touch left upper arm, cannot move left arm up, and inflammation to the left upper arm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Visual impairment
Clinical narrative: I CHEST TIGHTNESS; TENDERNESS TO LEFT ARM EFFECTING ROM/TENDER TO TOUCH LEFT UPPER ARM; FEVER OF 101F; NAUSEA; HEADACHE; PAIN AT INJECTION SITE (LEFT ARM); FACIAL FLUSHING; FEELING LIKE BLOOD PRESSURE IS HIGH/BLOOD PRESSURE ELEVATED AS HIGH AS 150/100; CANNOT MOVE LEFT ARM UP; INFLAMMATION TO THE LEFT UPPER ARM; VISION DISTURBANCES; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for premedication. On 24-MAR-2021, the subject experienced feeling like blood pressure is high/blood pressure elevated as high as 150/100. On 24-MAR-2021, the subject experienced facial flushing. On 24-MAR-2021, the subject experienced cannot move left arm up. On 24-MAR-2021, the subject experienced inflammation to the left upper arm. On 24-MAR-2021, the subject experienced vision disturbances. On 24-MAR-2021, the subject experienced tenderness to left arm effecting rom/tender to touch left upper arm. On 24-MAR-2021, the subject experienced fever of 101f. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced pain at injection site (left arm). Laboratory data included: Body temperature (NR: not provided) 101 F. On 25-MAR-2021, the subject experienced chest tightness. Laboratory data included: Blood pressure (NR: not provided) elevated as high as 150/100. Treatment medications (dates unspecified) included: metoprolol succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101f, nausea, and headache on 25-MAR-2021, was recovering from feeling like blood pressure is high/blood pressure elevated as high as 150/100, vision disturbances, and chest tightness, and had not recovered from pain at injection site (left arm), facial flushing, tenderness to left arm effecting rom/tender to touch left upper arm, cannot move left arm up, and inflammation to the left upper arm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Foreign body sensation in eyes, Headache, Visual impairment
Clinical narrative: HEADACHE; COULD NOT SEE CLEARLY; FELT THERE WAS SOMETHING IN HIS EYE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, and wears readers. The patient experienced drug allergy when treated with methotrexate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-JUL-2021, the subject experienced could not see clearly. On 20-JUL-2021, the subject experienced felt there was something in his eye. On 21-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-JUL-2021, and had not recovered from could not see clearly, and felt there was something in his eye. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Injection site pain, Malaise
Clinical narrative: VOMITING; FLU; BODY ACHES; CHILLS; GENERALLY UNWELL; HEADACHE; MUSCLE ACHES; FEVER; NAUSEA; LEFT ARM PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included immunocompromised medical issue, gi upset, and digestive issues, and concurrent conditions included chronic idiopathic urticaria, cigarette smoker, non alcohol user, respiratory allergy, hives, and chemotherapy, and other pre-existing medical conditions included patient had history of drug abuse or illicit drug use of recreational drugs in her college days not recently and had not for a long time. patient has intermittent symptoms. gastrointestinal upset following episode of hives. speculate unrelated. patient had multiple drug allergies, highly sensitive immune system, had respiratory and pre-existing allergy with no known diagnosis. medical diagnosis: chemotherapy injection, 2 injections every 4 weeks. patient was sensitive to pharmaceutical products, and had multiple drug allergies opioid allergy. The patient was previously treated with omalizumab for hives, severe allergic reactions, urticaria, and cortisone for urticaria. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included epinephrine for allergy. On 09-JUL-2021, the subject experienced vomiting. On 09-JUL-2021, the subject experienced flu. On 09-JUL-2021, the subject experienced body aches. On 09-JUL-2021, the subject experienced chills. On 09-JUL-2021, the subject experienced generally unwell. On 09-JUL-2021, the subject experienced headache. On 09-JUL-2021, the subject experienced muscle aches. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced left arm pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, headache, fever, and nausea on 12-JUL-2021, flu, body aches, generally unwell, and muscle aches on 13-JUL-2021, and left arm pain at site of injection on 16-JUL-2021. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: VOMITING; FLU; BODY ACHES; CHILLS; GENERALLY UNWELL; HEADACHE; MUSCLE ACHES; FEVER; NAUSEA; LEFT ARM PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included immunocompromised medical issue, gi upset, and digestive issues, and concurrent conditions included chronic idiopathic urticaria, cigarette smoker, non alcohol user, respiratory allergy, hives, and chemotherapy, and other pre-existing medical conditions included patient had history of drug abuse or illicit drug use of recreational drugs in her college days not recently and had not for a long time. patient has intermittent symptoms. gastrointestinal upset following episode of hives. speculate unrelated. patient had multiple drug allergies, highly sensitive immune system, had respiratory and pre-existing allergy with no known diagnosis. medical diagnosis: chemotherapy injection, 2 injections every 4 weeks. patient was sensitive to pharmaceutical products, and had multiple drug allergies opioid allergy. The patient was previously treated with omalizumab for hives, severe allergic reactions, urticaria, and cortisone for urticaria. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included epinephrine for allergy. On 09-JUL-2021, the subject experienced vomiting. On 09-JUL-2021, the subject experienced flu. On 09-JUL-2021, the subject experienced body aches. On 09-JUL-2021, the subject experienced chills. On 09-JUL-2021, the subject experienced generally unwell. On 09-JUL-2021, the subject experienced headache. On 09-JUL-2021, the subject experienced muscle aches. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced left arm pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, headache, fever, and nausea on 12-JUL-2021, flu, body aches, generally unwell, and muscle aches on 13-JUL-2021, and left arm pain at site of injection on 16-JUL-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS IN RIGHT ARM FOR 5-6 WEEKS; TINGLING IN RIGHT ARM FOR 5-6 WEEKS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced numbness in right arm for 5-6 weeks, and tingling in right arm for 5-6 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in right arm for 5-6 weeks, and tingling in right arm for 5-6 weeks. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed non-serious.