chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shingle shots / had mild cases of shingles/ Suspected Vaccination failure; had mild cases of shingles / not looking for a severe case; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received both shingle shots and had mild cases of shingles and patient not looking for a severe case. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding time to onset and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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 patient had reported for him/herself. The age at vaccination was not reported. The patient had shingles and also got the Shingles shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in an unspecified number of patient's 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 age at vaccination was not applicable. The reporter stated that, he/she had talked to many who got shingles after receiving Shingles shot. The reporter said, it might not work on everybody. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This case had been linked with case US2021AMR166251, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166251:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the shot and then I got shingles; got shingles; it hurts; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The patient received the Shingles shot and then experienced shingles and stated shingles hurts. 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.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The patient received both the two shots and still experienced shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; painful; milder rash; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles after getting vaccinated. It was very painful but a milder rash. This case considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles all over his face and body; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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 age at vaccination was not reported. The patient had received Shingles vaccine and got the shingles all over his face and body. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. The action taken with Shingrix was unknown. 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 age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 1 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter
Sex: F
Vaccine: HEP
Symptoms: Incorrect route of product administration
Clinical narrative: received an Engerix-B dose 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 female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th July 2021, the patient received Engerix B (subcutaneous) and Engerix B Pre-Filled Syringe Device. On 30th July 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received an Engerix-B dose subcutaneously, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient / received engerix-b and Havrix adult doses; pediatric patient / received engerix-b and Havrix adult doses; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 8-year-old male patient who received HAV (Havrix) (batch number G99R4, expiry date 31st May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse informed that, the pediatric patient received Havrix adult dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This case was patient linked with US2021167000, for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167000:same reporter
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient,/ received engerix-b /adult doses; pediatric patient,/ received engerix-b /adult doses; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 8-year-old male patient who received HBV (Engerix B adult) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th August 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 5th August 2021, unknown after receiving Engerix B adult and Engerix B 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 details were provided as follows: The pediatric patient received Engerix B adult dose, which led to adult product administered to child and overdose. The reporter consented to follow up. For tolerance of Havrix adult dose, refer linked case US2021166993, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021166993:same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: doses /5 weeks apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number P2J7F, expiry date 10th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 11th May 2021, the patient received the 2nd dose of Shingrix. On 11th May 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix 5 weeks after 1st  dose, earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Fever; muscle aches; rash on /abdomen and face; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th July 2021, less than a day after receiving Shingrix, the patient experienced fever, muscle pain and rash. On 18th July 2021, the outcome of the fever and muscle pain were recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the fever, muscle pain and rash to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient herself. The patient experienced fever and muscle ache which  started on the 15th July 2021 and lasted until the 18th July 2021.   She also experienced a rash on her abdomen and face starting on the 15th that had not resolved yet.  No lot number or expiration date was known. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Recieved two doses out of 3 /in 2012; 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 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 (first dose of Twinrix series received in 2012) and Twinrix (second dose of Twinrix series received in 2012).   On an unknown date, the patient received the 3rd 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: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination and his doctor was trying to give him the third dose almost 10 years later. The reporter did not consent to follow-up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for himself. The patient had arm soreness after receiving his dose of Shingrix in left deltoid. The reporter was provided medical disclaimer.  The reporter did not consent to follow-up.
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: kinrix administered to 9 month old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number 237c4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 received as follows: A 9 month old patient was administered one dose of Kinrix, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the diluent portion of the Menveo vaccine.; only the diluent portion of the Menveo vaccine; This case was reported by a nurse 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 amxa415a, expiry date 20th August 2022) for prophylaxis.   On 9th August 2021, the patient received Menveo. On 9th August 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: Nurse reported that a patient was given only the diluent portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The heath care professional had no further information on the event. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Oral herpes, Pain
Clinical narrative: pain; fatigue; episode of cold sores; This case was reported by a other health professional via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain, fatigue and cold sores. On an unknown date, the outcome of the pain and fatigue were unknown and the outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the pain, fatigue and cold sores to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself, who was the physician. The age at vaccination was not reported. The patient received Shingrix and developed pain and fatigue. The health care professional clarified that she thought she was starting an episode of cold sores and was wondering if this constituted a contraindication for dose two. The reporter had no further details regarding the symptoms experienced.  The reporter to consented to follow up.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration / with a diluent other than the GSK supplied; Administration / with a diluent other than the GSK supplied; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA440A, expiry date 31st March 2022) for prophylaxis.   On 9th August 2021, the patient received Menveo. On 9th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: Registered nurse reported that the patient was administered with a diluent other than the GlaxoSmithKline supplied diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Reporter consented to follow-up.
Age: 48.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently given a dose of Infanrix instead of Boostrix; inadvertently given a dose of Infanrix instead of Boostrix / 48 yo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 48-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 6th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Office administrator reported that patient was inadvertently administered a dose of Infanrix instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration. No further details provided at time of call. Consent given for safety to follow up via letter in the mail. This case was linked with the case US2021168391 and US2021168395 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168391:same reporter US-GLAXOSMITHKLINE-US2021168395:same reporter
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Nerve injury
Clinical narrative: severe pain in back; nerve damage; shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), BACK PAIN (severe pain in back) and NERVE INJURY (nerve damage) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HERPES ZOSTER (shingles). On 17-Feb-2021, the patient experienced BACK PAIN (severe pain in back) and NERVE INJURY (nerve damage). At the time of the report, HERPES ZOSTER (shingles), BACK PAIN (severe pain in back) and NERVE INJURY (nerve damage) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details for the events experienced by consumer  included valacyclovir, unspecified oinment, gabapentin   This case was linked to MOD-2021-030878 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: The event outcome update for all event as resolving.; Sender's Comments:  MOD-2021-030878:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Urticaria
Clinical narrative: CHILLS; FEVER; POST COVID HIVES; 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. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chills, fever, and post covid hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from post covid hives, and the outcome of fever and chills was not reported. This report was non-serious. The suspected Product Quality Complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210804950.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED  VACCINE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: 25-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210808029, 20210811045 and 20210807548.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Thrombosis
Clinical narrative: SWELLING IN LEG; BLOOD CLOT IN LEFT CALF; ITCHING; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included old fracture in tibula or fibula, and concurrent conditions included social alcohol drinker and non smoker. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with levofloxacin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  After receiving vaccine immediately the patient was fine but about a week later on 9-APR-2021, the patient experienced itching. The patient spoke with her doctor who said it could or could not be related to the vaccine so the patient took allergy pills, Zyrtec 10mg a day, and itching got stopped. The patient reported that she had an old fracture in her tibula or fibula that she has had for 14 years that swells occasionally. The patient recently traveled and when came back, swelling in her leg had not gone down so the patient spoke with doctor who advised her to go to the ER (emergency room) for imaging. On 28-JUL-2021, the patient was diagnosed with a blood clot in left calf. For treatment the patient was on Eliquis, 5mg twice a day, for a total of 90 days. After completion of the 90 days treatment, the patient will receive a new scan and it would be determined if she needed any further treatment. The patient also noted that she traveled before receiving the vaccine but had never experienced a blood clot before. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching, had not recovered from blood clot in left calf, and the outcome of swelling in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210815176- Covid-19 vaccine ad26.cov2.s- Blood clot in left calf. 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).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: 3 SPOTS ON LUNG IN CAT SCAN / THE LUMPS IN LUNG; BREAKING OUT INTO GOOSEBUMPS; DRIPPING SWEAT; FEELING DIZZY; FEELING HOT; FEVER; NAUSEA; 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 past medical history included: kidney with cancer, adrenal gland issue, and left kidney removal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced dripping sweat. On 09-APR-2021, the patient experienced feeling dizzy. On 09-APR-2021, the patient experienced feeling hot. On 09-APR-2021, the patient experienced fever. On 09-APR-2021, the patient experienced nausea. On JUN-2021, Laboratory data included: Computerised tomogram (NR: not provided) normal. On 09-JUL-2021, Laboratory data included: Computerised tomogram (NR: not provided) the lumps/spots in the lung. On 25-JUL-2021, the patient experienced 3 spots on lung in CAT scan / the lumps in lung. On 25-JUL-2021, the patient experienced breaking out into goosebumps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from  3 spots on lung in CAT scan / the lumps in lung, nausea, breaking out into goosebumps, dripping sweat, feeling dizzy, feeling hot, and fever. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Piloerection, Pulmonary mass, Pyrexia
Clinical narrative: 3 SPOTS ON LUNG IN CAT SCAN / THE LUMPS IN LUNG; BREAKING OUT INTO GOOSEBUMPS; DRIPPING SWEAT; FEELING DIZZY; FEELING HOT; FEVER; NAUSEA; 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 past medical history included: kidney with cancer, adrenal gland issue, and left kidney removal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced dripping sweat. On 09-APR-2021, the patient experienced feeling dizzy. On 09-APR-2021, the patient experienced feeling hot. On 09-APR-2021, the patient experienced fever. On 09-APR-2021, the patient experienced nausea. On JUN-2021, Laboratory data included: Computerised tomogram (NR: not provided) normal. On 09-JUL-2021, Laboratory data included: Computerised tomogram (NR: not provided) the lumps/spots in the lung. On 25-JUL-2021, the patient experienced 3 spots on lung in CAT scan / the lumps in lung. On 25-JUL-2021, the patient experienced breaking out into goosebumps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from  3 spots on lung in CAT scan / the lumps in lung, nausea, breaking out into goosebumps, dripping sweat, feeling dizzy, feeling hot, and fever. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: BACK OF RIGHT LEG IS REALLY HOT (IT COMES AND GOES); This spontaneous report received from a patient concerned a 23 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: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-AUG-2021, the patient experienced back of right leg is really hot (it comes and goes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back of right leg is really hot (it comes and goes). This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's medical history included: history of being immunocompromised. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and expiry: unknown) dose was not reported,  frequency time was 1 total administered on 08-MAR-2021 to left deltoid as prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient had confirmed immunological vaccine failure (did not developed antibodies) and laboratory data included (NR: not provided): antibody test showed no antibodies toward Covid-19. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210815255-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: MEDICAL HISTORY, SPECIAL SITUATIONS
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Feeling cold, Gait disturbance
Clinical narrative: CAN BARELY WALK; SEVERE BACK PAIN; HEADACHES; CHILLS; FELT LIKE FREEZING; FEVER; 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: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced chills. On 05-AUG-2021, the patient experienced felt like freezing. On 05-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) Not reported. On 06-AUG-2021, the patient experienced can barely walk. On 06-AUG-2021, the patient experienced severe back pain. On 06-AUG-2021, the patient experienced headaches. Laboratory data included: Pain scale (NR: not provided) On a scale of 1 to 10, pain is at 9 or 10/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe back pain, can barely walk, and headaches, and the outcome of fever, chills and felt like freezing was not reported. 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: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain assessment, Pyrexia
Clinical narrative: CAN BARELY WALK; SEVERE BACK PAIN; HEADACHES; CHILLS; FELT LIKE FREEZING; FEVER; 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: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced chills. On 05-AUG-2021, the patient experienced felt like freezing. On 05-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) Not reported. On 06-AUG-2021, the patient experienced can barely walk. On 06-AUG-2021, the patient experienced severe back pain. On 06-AUG-2021, the patient experienced headaches. Laboratory data included: Pain scale (NR: not provided) On a scale of 1 to 10, pain is at 9 or 10/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe back pain, can barely walk, and headaches, and the outcome of fever, chills and felt like freezing was not reported. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer (parent) via a company representative concerned a 26-year-old female unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection (suspected clinical vaccine failure and suspected covid-19 infection) with symptoms of fever of 100 degrees (unit unspecified), deep wet cough and loss of smell. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 degree (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210815284-Covid-19 vaccine ad26.cov2. s- suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Influenza like illness, Insomnia, Sinusitis
Clinical narrative: SLEEPING ALL DAY; DIDN'T SLEEP; SINUSITIS STARTED IN THE NIGHT AND IN MORNING, HE WOKE UP WITH MILD TO MODERATE HEADACHE FROM SINUS PRESSURE; FELT TIRED ON THE DAY OF VACCINATION, STARTED TO FEEL FLU-LIKE SYMPTOMS SUCH AS FEVERISH (DID NOT MEASURE TEMPERATURE), CHILLS, BODY ACHES AND DIFFICULTY BREATHING THROUGH NOSE; This spontaneous report received from a consumer concerned a 39 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced felt tired, started to feel flu-like symptoms such as feverish (did not measure temperature), chills, body aches and difficulty breathing through nose. On 06-AUG-2021, the patient experienced sinusitis started in the night and in morning, he woke up with mild to moderate headache from sinus pressure. On 06-AUG-2021, the patient experienced didn't sleep. On 07-AUG-2021, the patient experienced sleeping all day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt tired on the day of vaccination, started to feel flu-like symptoms such as feverish (did not measure temperature), chills, body aches and difficulty breathing through nose, and had not recovered from sinusitis started in the night and in morning, he woke up with mild to moderate headache from sinus pressure, sleeping all day, and didn't sleep. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, 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 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, expiry: unknown) dose was not reported, 1 total administered on unspecified date in early 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021 (1-2 days prior reporting), the patient had Covid-19 test and found to be positive and had suspected clinical vaccination failure.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210815333-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1805022 expiry: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000188783.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.