chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received a 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not received a 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Some pts received vx after being exposed to 29 F; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Lot number and expiry date was not provided. The reporter stated that, some patients received Engerix B after being exposed to 29 degree Fahrenhiet, which led to incorrect storage of drug. The reporter provided limited information since he did not have access to patient'ss demographic information. The reporter did not consent to follow-up.
Age: 99.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: given only the adjuvant; given only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 99-year-old female patient who received Herpes zoster (Shingrix) (batch number 9e995, expiry date 16th September 2022) for prophylaxis.   On 25th October 2021, the patient received Shingrix (intramuscular). On 25th October 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 patient have been given only the adjuvant instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: 2nd dose of unk flu vaccine given at a shorter interval from first; sore arm after 2nd shot; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 7-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA PFS).   On 3rd November 2021, the patient received the 2nd dose of Influenza vaccine Quadrivalent 2021-2022 season. On 3rd November 2021, unknown after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced drug dose administration interval too short. In November 2021, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The age at vaccination was not reported but it could be 6 or 7 years. The patient was given dose 1 of fluarix on 13th October 2021 and was scheduled to receive a 2nd dose on 10th November 2021 by the facility. On 3rd November 2021, the patient was administered  another dose of flu vaccine at school, which led to shortening of vaccination schedule. The patient also had a sore arm after school shot. The patient's vaccination history was not known. The reporter consented to follow up.
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: wrong vaccine was inadvertently administered; 9 month old was given Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 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 November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate schedule of 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 as follows: The medical assistant stated that, the wrong vaccine was administered as a 9 month old male patient was inadvertently given a dose of Kinrix as part of his primary DTaP series, this was supposed to be his 6-month dose, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose 2 one month after dose 1; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 16th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 16th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter called on behalf of the patient. She stated that, the patient was not immunocompromised but was inadvertently given Shingrix dose 2 on October 16th, 2021, one month after dose 1 which was given on 18th September 2021), which led to shortening of vaccination schedule. She had questions about what to do next and was advised accordingly.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the adjuvant; administered only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2021, the patient received Shingrix. On 3rd November 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 patient administered with only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter had no demographic information of the patient and believed patient was vaccinated the day before reporting date, but was not sure. The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: dose which expired was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HAV (Havrix) (batch number be554, expiry date 1st August 2021) for prophylaxis.   On 4th November 2021, the patient received the 1st dose of Havrix. On 4th November 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, a pediatric dose of havrix which expired on 1st August 2021 was administered to the patient on 4th November 2021, which led to expired vaccine used. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received her 1st dose of Shingrix, expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Shingrix. On 14th July 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received her 1st dose of Shingrix on 14th July2021 but it expired on 28th June 2021, which led to expired vaccine used. No symptoms reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first dose of Shingrix series in 2019 and had not received second dose till the time of reporting, which led to incomplete course of vaccination. The reporter called on behalf of physician and did not have exact date of vaccination, patient information other than gender, or vaccine lot number expiration date. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: administrated only the diluent portion; administrated only the diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2021, the patient received Shingrix. On 2nd November 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 patient was administrated by error only the diluent portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional claimed they had further details on lot number, expiration date and age of the patient because at the moment of the call they were not at the work facility were it happened. Agreed to be contacted follow-up or to provide further information. No further events were reported The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: All vx from recalled lot have already been administered to patients; All vx from recalled lot have already been administered to patients; This case was reported by a other health professional via call center representative and described the occurrence of drug dispensing error in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dispensing error and recalled drug administered. On an unknown date, the outcome of the drug dispensing error and recalled drug administered were unknown.  Additional details were reported as follows: The reported had stated that the recalled lot of Shingrix vaccine (lot number 9LH3Y, expiration date 07Feb2022) was already administered to patients. The reporter was not having the number of vaccines administered, dates of administration, or patient details at the time of call. The age at the vaccination was not applicable. The reporter had consented to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 8 days before a month from 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number T030710, expiry date 15th April 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA TOXOID, HEPATITIS B VACCINE, PERTUSSIS TOXOID, POLIOMYELITIS VACCINE, TETANUS TOXOID (PEDIARIX).   On 15th October 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 15th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient received 1st dose of Pediarix on 23rd September 2021. The patient received 2nd dose of Pediarix 8 days before a month from 1st dose, at an interval shorter than the recommended, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received THIRD Shingrix vaccine in error; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2018). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 5th November 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 5th November 2021, unknown after receiving Shingrix and an unknown time 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 reporter was the patient. The patient received 2nd dose of Shingrix in October 2018. The patient received 3rd dose of Shingrix in error in unknown arm, which led to extra dose administered. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018) and Shingrix (2nd dose received in 2018).   On 5th November 2021, the patient received the 3rd dose of Shingrix. On 5th November 2021, 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 patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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. The patient administered expired dose of Bexsero, which led to expired vaccine used. The nurse declined to provide any additional details. The reporter consented to follow up with safety team.
Sex: U
Vaccine: HEPAB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Full hepB schedule; received Twinrix when supossed to receive Havrix; Full hepB schedule; received Twinrix when supossed to receive Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 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 Hepatitis B (on an unknown date, the patient received full hepatitis B schedule).   On 11th April 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 11th April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported The pharmacist reported patient with full hepatitis B schedule received Twinrix when patient was supposed to receive Havrix instead, which led to wrong vaccine administered and extra dose administered for hepatitis B. The Health Care Professional wanted to know how to proceed with schedule. The Health Care Professional provided limited information since she as not at the facility. No demographic details from patient could be collected neither lot number nor expiration date of Twinrix. The reporter did not consent to follow-up.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: never received another dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 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 (received 1st dose in July 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received another dose of Twinrix, which led to incomplete course of vaccination. The reporter was asking if they would need to restart the vaccine series. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Foetal disorder, Foetal exposure during pregnancy, Ultrasound scan
Clinical narrative: FETAL EXPOSURE DURING PREGNANCY; FETAL ABNORMALITIES; This solicited pregnancy report received from a consumer concerned a fetus of unspecified sex, race and ethnic origin. The patient was enrolled in a non-company sponsored study. The patient's height, and weight were not reported. No concurrent conditions were reported. The patient's parent's medical history: the mother of baby had no medical history, her obstetrical history included two previous pregnancies that resulted in one live newborn (outcome of the second pregnancy was not reported). She did not use drugs for recreational use, tobacco, or alcoholic beverages during pregnancy. Her last menstrual period (LMP) was calculated to be 09-NOV-2020. The estimated delivery date (EDD) was reported unknown and the type of pregnancy was singleton. On 01-Jun-2021, gestational age was 29 weeks and 1 day. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 01-JUN-2021 for prevention of covid-19. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included prenatal vitamins (ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos) for unknown indication. On an unspecified date in JUN-2021, the patient experienced fetal abnormalities. Laboratory data included: Ultrasound scan (NR: not provided) Fetal abnormalities were detected. On 01-JUN-2021, the patient had fetal exposure during pregnancy. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fetal abnormalities and fetal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and fetal abnormalities was related, and between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy was not related.  This report was serious (Congenital Anomaly/Birth Defect, and Other Medically Important Condition). This parent/child case is linked to 20210760453.; Sender's Comments: V0-20211106577- covid-19 vaccine ad26.cov2.s- Fetal exposure during pregnancy. 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   20211106577- covid-19 vaccine ad26.cov2.s  Fetal abnormalities. This event(s) is considered related. 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).
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Burning sensation, Electromyogram, Loss of personal independence in daily activities, Neuralgia
Clinical narrative: NERVE ISSUES SOMETHING SIMILAR TO GBS; POSSIBLE SMALL FIBER NEUROPATHY; MANY SIDE EFFECTS; LOST ABILITY TO PLAY GUITAR; BURNING IN FEET AND HANDS; NERVE PAIN COMES AND GO IN CYCLES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 nerve issues something similar to gbs, possible small fiber neuropathy, many side effects, lost ability to play guitar, burning in feet and hands, and nerve pain comes and go in cycles. Laboratory data (dates unspecified) included: EMG (NR: not provided) no nerve damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning in feet and hands, and the outcome of nerve issues something similar to gbs, possible small fiber neuropathy, many side effects, lost ability to play guitar and nerve pain comes and go in cycles was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom, Small fibre neuropathy
Clinical narrative: NERVE ISSUES SOMETHING SIMILAR TO GBS; POSSIBLE SMALL FIBER NEUROPATHY; MANY SIDE EFFECTS; LOST ABILITY TO PLAY GUITAR; BURNING IN FEET AND HANDS; NERVE PAIN COMES AND GO IN CYCLES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 nerve issues something similar to gbs, possible small fiber neuropathy, many side effects, lost ability to play guitar, burning in feet and hands, and nerve pain comes and go in cycles. Laboratory data (dates unspecified) included: EMG (NR: not provided) no nerve damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning in feet and hands, and the outcome of nerve issues something similar to gbs, possible small fiber neuropathy, many side effects, lost ability to play guitar and nerve pain comes and go in cycles was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypersomnia
Clinical narrative: FELT DIZZY; COULDN'T STAY AWAKE; FATIGUE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies. The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1855194 expiry: 09-APR-2022) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. Concomitant medications included dupilumab for allergies.  On 03-NOV-2021, the patient experienced felt dizzy. On 03-NOV-2021, the patient experienced couldn't stay awake.  On 03-NOV-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizzy, couldn't stay awake, and fatigue on 05-NOV-2021. This report was non-serious.
Sex: U
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 concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000201203.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Nervous system disorder
Clinical narrative: PERMANENT NEUROLOGICAL DAMAGE; MISERABLE LIFE OF PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia. 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 permanent neurological damage, and miserable life of pain. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the permanent neurological damage and miserable life of pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report received from a physician concerned a 62 year old male of 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: 042A21A, expiry: 19-SEP-2021) dose, 1 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, 3 to 4 weeks post vaccination, the patient experienced edema in legs and deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211118921- COVID-19 VACCINE AD26.COV2.S-  Deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT LIKE STIR FRIED CRAP; This spontaneous report received from a consumer 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, and batch number were not reported) dose was not reported, administered on 06-NOV-2021 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 07-NOV-2021, the patient experienced felt like stir fried crap. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like stir fried crap was not reported. This report was non-serious. This case, from the same reporter is linked to 20211118830.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Pain
Clinical narrative: SUPER SICK FOR LIKE THIRTY SOME HOURS, A DAY AND A HALF; BODY ACHE; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 super sick for like thirty some hours, a day and a half, body ache, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from super sick for like thirty some hours, a day and a half, and the outcome of chills, headache and body ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Sweating fever
Clinical narrative: FEVER SWEATS; FULL BODY ACHES; JOINT ACHES; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced full body aches, joint aches, headache, and fever sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body aches, joint aches, headache, and fever sweats. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Mobility decreased, Nervous system disorder
Clinical narrative: WRONG TECHNIQUE WAS USED TO ADMINISTER THE VACCINE; NERVOUS SYSTEM SYMPTOMS; LOTS OF PAIN THAT WOULD NOT GO AWAY; HARDLY LEFT HER ARM; DIZZINESS; ALMOST PASSED OUT; HEADACHE; A MEDICAL ASSISTANT ADMINISTERED THE VACCINE AND SHE IMMEDIATELY FELT EXCRUCIATING PAIN (PAIN IN HER DELTOID); This spontaneous report received from a health care professional 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: Unk) 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced wrong technique was used to administer the vaccine, nervous system symptoms, lots of pain that would not go away, hardly lift her arm, dizziness, almost passed out, headache, and a medical assistant administered the vaccine and she immediately felt excruciating pain (pain in her deltoid). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a medical assistant administered the vaccine and she immediately felt excruciating pain (pain in her deltoid), almost passed out, headache, dizziness, nervous system symptoms, wrong technique was used to administer the vaccine, lots of pain that would not go away and hardly left her arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Presyncope, Wrong technique in product usage process
Clinical narrative: WRONG TECHNIQUE WAS USED TO ADMINISTER THE VACCINE; NERVOUS SYSTEM SYMPTOMS; LOTS OF PAIN THAT WOULD NOT GO AWAY; HARDLY LEFT HER ARM; DIZZINESS; ALMOST PASSED OUT; HEADACHE; A MEDICAL ASSISTANT ADMINISTERED THE VACCINE AND SHE IMMEDIATELY FELT EXCRUCIATING PAIN (PAIN IN HER DELTOID); This spontaneous report received from a health care professional 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: Unk) 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced wrong technique was used to administer the vaccine, nervous system symptoms, lots of pain that would not go away, hardly lift her arm, dizziness, almost passed out, headache, and a medical assistant administered the vaccine and she immediately felt excruciating pain (pain in her deltoid). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a medical assistant administered the vaccine and she immediately felt excruciating pain (pain in her deltoid), almost passed out, headache, dizziness, nervous system symptoms, wrong technique was used to administer the vaccine, lots of pain that would not go away and hardly left her arm was not reported. This report was 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 a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 24-SEP-2021, 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.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: PUNCTURED VIAL ADMINISTERED; This spontaneous report received from a pharmacist concerned two 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: 213D21A, expiry: UNKNOWN) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-NOV-2021, the patient experienced punctured vial administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of punctured vial administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211121732.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINATED FROM OPEN PUNCTURED VIAL; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-NOV-2021, the patient experienced vaccinated from open punctured vial. On 09-NOV-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated from open punctured vial and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211121704.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Skin discolouration
Clinical narrative: FACE TWO TONED IN COLOR; BIG RED BUMP; LEFT SIDE OF FACE WIGGING OUT/DRY RASH/BUMPS; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: social drinker, and smoker, and other pre-existing medical conditions included: No previous history of skin problems for past 34 years. No history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-OCT-2021, the patient experienced face two toned in color. On 09-OCT-2021, the patient experienced big red bump. On 09-OCT-2021, the patient experienced left side of face wigging out/dry rash/bumps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from big red bump on NOV-2021, had not recovered from left side of face wigging out/dry rash/bumps, and the outcome of face two toned in color was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING FEELING ON RIGHT SIDE OF THE BODY; This spontaneous report received from a patient concerned a 58 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced tingling feeling on right side of the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling feeling on right side of the body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: INJECTED WITH EXPIRED JANSSEN COVID 19 VACCINE; This spontaneous report received from a health care professional concerned multiple patients. 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: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-NOV-2021, the patient experienced injected with expired janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injected with expired janssen covid 19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211122356.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE VIAL WAS PUNCTURED ON 04-NOV-21 AT 19:15, THEN ADMINISTERED ON 05-NOV-21 AT 11:28 AM; PUNCTURED VACCINE STORED IN THE REFRIGERATOR OVERNIGHT; This spontaneous report received from a pharmacist concerned a 52 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: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 05-NOV-2021 11:28 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced punctured vaccine stored in the refrigerator overnight. On 05-NOV-2021, the patient experienced vaccine vial was punctured on 04-nov-21 at 19:15, then administered on 05-nov-21 at 11:28 am. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vaccine stored in the refrigerator overnight and vaccine vial was punctured on 04-nov-21 at 19:15, then administered on 05-nov-21 at 11:28 am was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-NOV-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211121905.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: INJECTION SITE SORENESS; FELT FATIGUED; This spontaneous report received from a patient 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: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-JUL-2021, the patient experienced injection site soreness. On 14-JUL-2021, the patient experienced felt fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and felt fatigued. This report was non-serious.