chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: injected with Rotarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 2x5l3, expiry date 15th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 31st August 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 31st August 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route 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 provided as follows: The health care professional reported that the patient was injected with Rotarix instead of oral administration, which led to inappropriate route of vaccination. No adverse event was reported. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered a dose of Menveo on 01Sept2021 and it expired on 20Aug2021.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date 20th August 2021) for prophylaxis.   On 1st September 2021, the patient received Menveo. On 1st September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Aditional details were provided as follows: The reporter stated that, the patient was administered already expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of Shingrix vaccine 5 weeks after she received the first dose; This case was reported by a other health professional and described the occurrence of drug dose administration interval too short in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix 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 age at vaccination was not reported. The healh care professional reported that a female patient, 66 years old received the 2nd dose of Shingrix vaccine 5 weeks after she received the first dose, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patients with inappropriate schedules; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that multiple patients had been coming in with inappropriate schedules of the Shingrix vaccine. At the time of the report, the reporter had no information about the patients. The reporter consented to follow up.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient was accidentally given an adult dose of Havrix; pediatric patient was accidentally given an adult dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 24-month-old patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd September 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 2nd September 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental 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 are as follows: Nurse stated that a pediatric patient was accidentally given an adult dose of Havrix about 30 minutes ago, which led to accidental overdose and adult product administered to child.  This vaccine was the patient's final dose in the Hepatitis A series. Lot number was not available at the time of call. The reporter consented to follow-up. The case was linked with case US2020198077 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198077:Same reporter
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose 26-May-2018 Second 09-Jul-2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th May 2018).   On 9th July 2020, the patient received the 2nd dose of Shingrix. On 9th July 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The pharmacist reported that a patient received 2nd dose late which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: headache; fatigue; feels achy; This case was reported by a consumer and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2021, less than a week after receiving Shingrix, the patient experienced headache, fatigue and pain. On an unknown date, the outcome of the headache, fatigue and pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received Shingrix and experienced headache, fatigue and felt achy. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: giving a patient only the Adjuvan powder portion was not used; giving a patient only the Adjuvan powder portion was not used; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number L4LH5, expiry date unknown) for prophylaxis.   On 2nd September 2021, the patient received Shingrix. On 2nd September 2021, unknown after receiving Shingrix, 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 age at vaccination was not reported. The pharmacist reported that, a nurse given a patient only the AS01B Adjuvant pf Shingrix, the powder portion was not used, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional did not have demographic data of the patient. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given a dose of adjuvant not been reconstituted with lyophillized powder portion; given a dose of adjuvant not been reconstituted with lyophillized powder portion; This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number J3PE5, expiry date 30th January 2023) for prophylaxis.   On 2nd September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 2nd September 2021, unknown after receiving Shingrix, 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 nurse reported that, the patient was given a dose of Shingrix adjuvant that had not been reconstituted with lyophillized powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received few years ago), Shingrix (1st dose received few years ago) and Shingrix (2nd dose received few years ago).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received 3rd dose of Shingrix, which led to extra dose administered. The pharmacist stated that follow-up with safety would be okay, but at the time of the call the pharmacy was very busy. The patient was not immunocompromised, to the reporter's knowledge (this might be relevant due to GSK only having data on three doses of Shingrix in immunocompromised patients in our database). The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness in the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 2nd September 2021, several hours after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not 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 patient herself. The patient received Shingrix in left arm deltoid intramuscularly and couple of hours later had soreness in her arm where she received the vaccine. The reporter did not have lot/expiry date, however, she provided NDC number: 58160-0823-11. The reporter did not give consent to follow up and with the with HCP (health care professional).
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: given a dose of Infanrix instead of Boostrix; given a dose of Infanrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 56-year-old female patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The age at vaccination was not reported. Manager stated that a female patient was inadvertently given a dose of Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow-up via email.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA377A, expiry date 31st August 2021) for prophylaxis.   On 1st September 2021, the patient received Menveo (intramuscular) .5 ml. On 1st September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: This case was reported by a nurse. The reporter stated that a dose of MENVEO was administered to the patient on 1st September 2021 that expired on 31st August 2021,which led to expired vaccine use. She gave a consent to follow-up with her.  She provided her contact information as well as email address. The reporter consented to followup.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Dose was expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In August 2021, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, the patient started Flulaval Tetra Pre-Filled Syringe Device. In August 2021, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. The action taken with Flulaval Tetra Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not reported. The reporter stated that Flulaval Quadrivalent 2020,2021 was inadvertently administered to an unknown patient last week and the dose was expired,which led to expired vaccine used. Health care professional did not provide more information. The reporter did not consented to followup.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received their second dose of Shingrix two days after the first dose; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix 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 age at vaccination was not reported. The pharmacist reported that, the patient received their second dose of Shingrix two days after the first dose, shorter than the recommended interval, which led to shortening of the vaccine schedule. The additional information was not available.. The reporter did not consent to follow up.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: administration of Pediarix after expiration data; This case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd September 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd September 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported Health care professional reported administration of Pediarix after expiration date, which led to expired vaccine used.  Pediarix was expired by a few months. Non-symptomatic or clinical manifestations present with patient. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: received expired dose of Pediarix; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 23-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd September 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 2nd September 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported pediatric patient received expired dose of Pediarix, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 13Aug2020, has not received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 13th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.  No symptoms was reported. The health care professional did not have the lot/expiry date of the 1st dose The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroid cancer
Clinical narrative: Thyroid cancer; This spontaneous case was reported by a consumer and describes the occurrence of THYROID CANCER (Thyroid cancer) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20 and 028l20a) for COVID-19 vaccination.     The patient's past medical history included Kidney stone. Concurrent medical conditions included Sarcoidosis and Diabetes. Concomitant products included AMLODIPINE, ATORVASTATIN, FOLIC ACID, GLIPIZIDE, LOSARTAN, METHOTREXATE, METHYLPHENIDATE, OMEPRAZOLE, PREDNISONE, LEVOTHYROXINE SODIUM (SYNTHROID), BROMAZEPAM (TENSONIL), TRAZODONE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced THYROID CANCER (Thyroid cancer) (seriousness criterion medically significant). The patient was treated with ZOLEDRONIC ACID (intravenous) on 20-Aug-2021 for Thyroid cancer, at an unspecified dose and frequency. At the time of the report, THYROID CANCER (Thyroid cancer) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The patient was diagnosed with thyroid cancer in the middle of April, and on 11-May-2021, it was removed.  Company Comment: Very limited information regarding this event has been provided at this time. However, patient's past medical history/underlying medical conditions (Kidney stone, Thyroid cancer, Sarcoidosis and Diabetes) remains a confounder. Further information is not expected.   This case was linked to MOD-2021-299900 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. However, patient's past medical history/underlying medical conditions (Kidney stone, Thyroid cancer, Sarcoidosis and Diabetes) remains a confounder. Further information is not expected.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cerebrovascular accident, Inappropriate schedule of product administration
Clinical narrative: it's been 5 months, can I take the second now; 2 strokes; Atrial fibrillation; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Aug-2021 and was forwarded to Moderna on 29-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (2 strokes) and ATRIAL FIBRILLATION (Atrial fibrillation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced CEREBROVASCULAR ACCIDENT (2 strokes) (seriousness criterion medically significant) and ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it's been 5 months, can I take the second now). At the time of the report, CEREBROVASCULAR ACCIDENT (2 strokes) and ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it's been 5 months, can I take the second now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is also Inappropriate schedule of vaccine  administered in this case.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaginal haemorrhage
Clinical narrative: VAGINAL BLEEDING (PATIENT JUST FINISHED PERIOD 12 DAYS AGO); PAIN IN THE SKULL SINCE LAST NIGHT; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, non-smoker, and non-alcohol user, and other pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 30-AUG-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient experienced pain in the skull since last night. On 31-AUG-2021, the patient experienced vaginal bleeding (patient just finished period 12 days ago). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vaginal bleeding (patient just finished period 12 days ago), and the outcome of pain in the skull since last night was not reported. This report was non-serious.
Sex: U
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 66 year old white not Hispanic or Latino of unspecified 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, and batch number: 206A21A expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On unspecified date at the end of JUL-2021, the patient had an IgG spike semi quantitative antibody test done by physician which came negative (confirmed immunological vaccine failure).  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). This report was associated with product quality complaint: 90000192052.; Sender's Comments: V0:20210905583-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
Sex: F
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: RECEIVED PFIZER VACCINE AFTER BEING FULLY VACCINATED WITH JANSSEN COVID 19 VACCINE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 203 pounds, and height was not reported. The patient's concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: Patient has no known drug allergies, healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 23-AUG-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included BNT 162 for prophylactic vaccination.  On 16-AUG-2021, the patient experienced received Pfizer vaccine after being fully vaccinated with Janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received Pfizer vaccine after being fully vaccinated with Janssen covid 19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210909424 and 20210909555.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: LITTLE PAIN IN THE ARM; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned an 80 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: 1805022, and expiry: Unknown) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination into right arm. No concomitant medications were reported. On an unspecified date, the patient experienced little pain in the arm and that was it. On 17-AUG-2021, the patient's health care professional (HCP) ordered a blood test, an antibodies test (Severe acute respiratory syndrome coronavirus 2 Antibody Immunoglobulin G, Spike, Semi-Quantitative, reported as "SARS COV2 AB IGG SPIKE SEMI QN") which came negative (confirmed immunological vaccine failure). Reporter was concerned that patient was protected against Covid-19 infection or not. The HCP provider recommended taking another dose of COVID-19 vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure and pain in the arm was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000192053. This case, from the same reporter is linked to 20210905692.; Sender's Comments: V0.20210905663-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
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; PAIN IN THE ARM; This spontaneous report received from a patient concerned a 76 year old white and hispanic or latino 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: 1805022, expiry: UNKNOWN) dose was not reported,1 total, administered to left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date patient experienced pain in the arm after vaccination. On 17-AUG-2021, the patient was performed with SARS cov2 AB IGG spike semi QN test which was found to be negative (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the arm and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210905663. This report was associated with product quality complaint number 90000192051.; Sender's Comments: V0: 20210905692-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
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Haematoma
Clinical narrative: LARGE BLUE/PURPLE BRUISE AFTER VACCINATION; LARGE HEMATOMA; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced large blue/purple bruise after vaccination, and large hematoma. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the large blue/purple bruise after vaccination and large hematoma was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Feeling abnormal, Headache, SARS-CoV-2 test
Clinical narrative: STOMACH STARTING TO HURT; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SLEEP DISRUPTION; FEEL HORRIBLE; COUGH; HORRIBLE HEADACHE; This spontaneous report received from a parent concerned a 28 year old white and Not Hispanic or Latino male. The patient's height, and weight were not reported. Patient's concurrent conditions included: alcohol user (social consumption) and non-smoker. Patient had no known allergies and he did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced cough, horrible headache, sleep disruption and feel horrible (symptoms only lasted one day). Patient was really sick (described as, 8.5 out of 10). On 01-SEP-2021, the patient had terrible cough, fever, no appetite and had rapid test done for COVID-19 which came positive (suspected clinical vaccination failure and suspected covid-19 infection). On 02-SEP-2021, the patient's stomach started to hurt, patient was ill and was supposed to be in quarantine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep disruption, feel horrible, cough, and horrible headache on 11-MAR-2021, had not recovered from suspected covid-19 infection, and stomach starting to hurt, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210906282-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Suspected COVID-19, Vaccination failure
Clinical narrative: STOMACH STARTING TO HURT; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SLEEP DISRUPTION; FEEL HORRIBLE; COUGH; HORRIBLE HEADACHE; This spontaneous report received from a parent concerned a 28 year old white and Not Hispanic or Latino male. The patient's height, and weight were not reported. Patient's concurrent conditions included: alcohol user (social consumption) and non-smoker. Patient had no known allergies and he did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced cough, horrible headache, sleep disruption and feel horrible (symptoms only lasted one day). Patient was really sick (described as, 8.5 out of 10). On 01-SEP-2021, the patient had terrible cough, fever, no appetite and had rapid test done for COVID-19 which came positive (suspected clinical vaccination failure and suspected covid-19 infection). On 02-SEP-2021, the patient's stomach started to hurt, patient was ill and was supposed to be in quarantine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep disruption, feel horrible, cough, and horrible headache on 11-MAR-2021, had not recovered from suspected covid-19 infection, and stomach starting to hurt, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210906282-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Feeling cold, Muscle spasms
Clinical narrative: VERY ITCHY; RASH ALL OVER BODY (RAISED AT SOME POINTS); FOUR QUARTER-SIZE RAISED MARKING ON HER ARMS (TWO ON EACH SIDE) WHERE SHE HAD THE BUG BITES; SORENESS IN LEGS, HIPS AND SHOULDERS; TIRED; SHARP PAIN IN HER ANKLE AND WRISTS/JOINT PAIN IN KNEES WHEN SHE WALKS; CONVULSING (SPASMING) STARTED FROM TOE AND SPREAD TO HER HEAD (TOE TO HEAD) THAT WOULD BE OFF AND ON; FREEZING; FEVER BETWEEN 100 TO 102 DEGREES F; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included: mosquito bite, and concurrent conditions included: seasonal allergies, seasonal bronchitis, alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced stomach issues (stomach ache) when treated with ciprofloxacin, and azithromycin. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 13-AUG-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 14-AUG-2021, the patient experienced sharp pain in her ankle and wrists/joint pain in knees when she walks. On 14-AUG-2021, the patient experienced convulsing (spasming) started from toe and spread to her head (toe to head) that would be off and on. On 14-AUG-2021, the patient experienced freezing. On 14-AUG-2021, the patient experienced fever between 100 to 102 degrees f. Laboratory data included: Body temperature (NR: not provided) 100 to 102 degrees F. On 16-AUG-2021, the patient experienced soreness in legs, hips and shoulders. On 16-AUG-2021, the patient experienced tired. On 25-AUG-2021, the patient experienced four quarter-size raised marking on her arms (two on each side) where she had the bug bites. On 02-SEP-2021, the patient experienced rash all over body (raised at some points). On 02-SEP-2021, the patient experienced very itchy. The action taken with covid-19  was not applicable. The patient recovered from convulsing (spasming) started from toe and spread to her head (toe to head) that would be off and on, freezing, and fever between 100 to 102 degrees f on 17-AUG-2021, was recovering from soreness in legs, hips and shoulders, and tired, and had not recovered from sharp pain in her ankle and wrists/joint pain in knees when she walks, rash all over body (raised at some points), very itchy, and four quarter-size raised marking on her arms (two on each side) where she had the bug bites. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia, Rash, Skin discolouration
Clinical narrative: VERY ITCHY; RASH ALL OVER BODY (RAISED AT SOME POINTS); FOUR QUARTER-SIZE RAISED MARKING ON HER ARMS (TWO ON EACH SIDE) WHERE SHE HAD THE BUG BITES; SORENESS IN LEGS, HIPS AND SHOULDERS; TIRED; SHARP PAIN IN HER ANKLE AND WRISTS/JOINT PAIN IN KNEES WHEN SHE WALKS; CONVULSING (SPASMING) STARTED FROM TOE AND SPREAD TO HER HEAD (TOE TO HEAD) THAT WOULD BE OFF AND ON; FREEZING; FEVER BETWEEN 100 TO 102 DEGREES F; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included: mosquito bite, and concurrent conditions included: seasonal allergies, seasonal bronchitis, alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced stomach issues (stomach ache) when treated with ciprofloxacin, and azithromycin. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 13-AUG-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 14-AUG-2021, the patient experienced sharp pain in her ankle and wrists/joint pain in knees when she walks. On 14-AUG-2021, the patient experienced convulsing (spasming) started from toe and spread to her head (toe to head) that would be off and on. On 14-AUG-2021, the patient experienced freezing. On 14-AUG-2021, the patient experienced fever between 100 to 102 degrees f. Laboratory data included: Body temperature (NR: not provided) 100 to 102 degrees F. On 16-AUG-2021, the patient experienced soreness in legs, hips and shoulders. On 16-AUG-2021, the patient experienced tired. On 25-AUG-2021, the patient experienced four quarter-size raised marking on her arms (two on each side) where she had the bug bites. On 02-SEP-2021, the patient experienced rash all over body (raised at some points). On 02-SEP-2021, the patient experienced very itchy. The action taken with covid-19  was not applicable. The patient recovered from convulsing (spasming) started from toe and spread to her head (toe to head) that would be off and on, freezing, and fever between 100 to 102 degrees f on 17-AUG-2021, was recovering from soreness in legs, hips and shoulders, and tired, and had not recovered from sharp pain in her ankle and wrists/joint pain in knees when she walks, rash all over body (raised at some points), very itchy, and four quarter-size raised marking on her arms (two on each side) where she had the bug bites. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: THE VACCINE WAS STORED IN THE FRIDGE AFTER PUNCTURE FOR ABOUT 20 HOURS; THE VIAL WAS PUNCTURED THE PREVIOUS DAY, THE PUNCTURED VIAL WAS USED AT LEAST 20 HOURS AFTER IT WAS FIRST PUNCTURED; This spontaneous report received from a health care professional 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 (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-SEP-2021, the patient experienced the vial was punctured the previous day, the punctured vial was used at least 20 hours after it was first punctured. On an unspecified date, the patient experienced the vaccine was stored in the fridge after puncture for about 20 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the the vial was punctured the previous day, the punctured vial was used at least 20 hours after it was first punctured and the vaccine was stored in the fridge after puncture for about 20 hours was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Injection site pain, Nasal congestion
Clinical narrative: ZERO APPETITE; NASAL CONGESTION; SLEEPING ALL DAY; EXTREME FATIGUE, TIREDNESS; PAIN ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid, and two liver transplants, and concurrent conditions included: diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808986 and expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-SEP-2021, the patient experienced pain on the injection site. On 03-SEP-2021, the patient experienced zero appetite. On 03-SEP-2021, the patient experienced nasal congestion. On 03-SEP-2021, the patient experienced sleeping all day. On 03-SEP-2021, the patient experienced extreme fatigue, tiredness. On SEP-2021, treatment medications included: paracetamol.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme fatigue, tiredness, nasal congestion, sleeping all day, and pain on the injection site, and had not recovered from zero appetite. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO 9 PATIENTS; 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: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced expired vaccine administered to 9 patients. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to 9 patients was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: NEUROLOGICAL PROBLEMS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced neurological problems. The action taken with covid-19 vaccine was not applicable. The outcome of neurological problems was not reported. This report was non-serious.