chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 2sm24, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 19th September 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra 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 patient was administered an expired dose of Flulaval Quadrivalent, which was expired on 30th June 2021, which led to expired vaccine used.  The patient would be revaccinated.  The reported did not consent to follow-up. Health care professional declined follow- up from Safety.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose of Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 74-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   On 17th September 2021, the patient received Menveo. On 17th 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: The age at vaccination was not reported but it could be 73 or 74 years. Health care professional reported the administration of an expired dose of Menveo to the patient, which led to expired vaccine used. The reporter also reported product complaint. The reporter agreed to be contacted for follow-up through email address. GSK Note: as there was no real event, product complaint was not coded.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose at 4 weeks; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number BM27F, expiry date 14th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 20th September 2021, the patient received the 2nd dose of Shingrix. On 20th September 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details provided were as follows: The patient received 2nd dose at 4 weeks and not after 8 weeks, which was earlier than the recommended schedule and led to shortening of vaccination schedule. Clarifying question was asked upon callback to health care professional to determine if patient was immunocompromised or immunosuppressed but pharmacist could not confirm or deny. This was received after hours. The pharmacist had a question about the dosing interval. Call was placed back to health care professional for additional information. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received his second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st December 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 case was reported by patient. The age at vaccination was not applicable for this report. The patient never received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know if he should restart vaccine sequence or when to get second dose.  The reporter did not provide additional information.  The reporter did not provide consent to contact health care professional.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: reconstituted with a non approved diluent; giving Menveo reconstituted with a non approved diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA467A, expiry date 30th March 2022) for prophylaxis.   On 27th August 2021, the patient received the 1st dose of Menveo. On 27th August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received  Menveo reconstituted with a non approved diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included latex allergy.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. 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 age at vaccination was not reported. The patient had anaphylactic reaction following a flu vaccine. The patient had severe latex allergy and asked if the facility was latex free. The agent further prompted to ask if it is GlaxoSmithKline vaccine and for more information but health care professional ended chat session abruptly. No other information was available.  The agent did not consent for follow up due to chat ending.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: never completed the series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 36-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose in 1999).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: Age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B and never completed the series which led to incomplete course of vaccination. No other information known as it was 22 years ago. Reporter denied to follow-up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headaches; This case was reported by a consumer via call center representative and described the occurrence of headache in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th September 2021, 6 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The case was reported for herself.   The patient stated that, she started with headaches.  The reporter spoke per Personal Information and referred her to health care professional for follow up. No health care professional information was provided. The reporter did not consent to follow up.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: liquid only of Shingrix; received the liquid only of Shingrix and then a properly reconstituted  dose; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old patient 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 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 reported. The reporter stated that, the patient received the liquid only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. On 22nd September 2021, the patient received properly reconstituted dose. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 21st September 2021, less than a day after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows:  The case was reported by patient herself. The patient received Shingrix vaccine intramuscularly in left deltoid and experienced a headache. The reporter consented to follow up.
Age: 13.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered infanrix/, Date of birth Jun 13th 2009; administered infanrix /Boostrix was the vaccine indicated; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old female patient who received DTPa (Infanrix) (batch number 49TN3, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 8th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A health care professional administered infanrix to a patient of age 13 years old, instead Boostrix was the vaccine indicated for the patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was 1 of 7 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201373:same reporter US-GLAXOSMITHKLINE-US2021201380:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter US-GLAXOSMITHKLINE-US2021201378:same reporter US-GLAXOSMITHKLINE-US2021201377:same reporter US-GLAXOSMITHKLINE-US2021201376:same reporter
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered infanrix /, Date of birth Jan 25th 2010; administered infanrix,/Boostrix was the vaccine indicated; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 49TN3, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A health care professional administered infanrix to a patient of age 11 years old, instead Boostrix was the vaccine indicated for the patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was 1 of 7 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201375:same reporter US-GLAXOSMITHKLINE-US2021201373:same reporter US-GLAXOSMITHKLINE-US2021201380:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter US-GLAXOSMITHKLINE-US2021201378:same reporter US-GLAXOSMITHKLINE-US2021201377:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 23-Oct-2019, second dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd October 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 to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose 1 in 2018 never got the 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No other detail of patient or vaccine available. The reporter consent to follow up.
Age: 28.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first dose on May 2021 and second on Sep 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 28-year-old female patient who received HAB (Twinrix) (batch number 75c72, expiry date 13th June 2022) 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 on an unknown date in May 2021).   On 23rd September 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd September 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   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 pharmacist reported that the patient received Twinrix 2nd dose on day of reporting, later than recommended schedule which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: went back to get 2nd dose, was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd March 2018, batch number CH2X7, expiry date 25th April 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 for this report. On the day of reporting, the patient went  back to get the 2nd dose. Till the time ofreporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details were provided at the time of the call. The reporter consented to follow up. The VAERS detials were reported for 1st dose of Shingrix.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: received less than the full dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient 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 incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that Engerix-B liquid leaked during the administration of Engerix-B to a patient.  The patient received less than the full dose of the vaccine, which led to incomplete dose administered. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: SPONTANEOUS ABORTION; MATERNAL EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer concerned multiple patients. 'This case reported 49 instances of miscarriages post vaccination.' No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The patients were pregnant at the time of vaccination (maternal exposure during pregnancy). The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. The date of the patient's last menstrual period and expected delivery date were not reported.  On an unspecified date, the patients experienced miscarriage (spontaneous abortion). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous abortion and maternal exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210924179-Covid-19 Vaccine Ad26.CoV2.s-Spontaneous Abortion. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0-20210924179-Covid-19 Vaccine Ad26.CoV2.s-Maternal 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
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; INTENTIONAL PRODUCT MISUSE; OFF LABEL USE; This spontaneous report was received from literature.   This report concerned a 70 year old female of unspecified ethnicity. Initial information was processed along with additional information on 21-SEP-2021. The objective of this study was to describe the impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with ANCA vasculitis. The patient's height, and weight were not reported. The patient's concurrent conditions included: ANCA (anti-neutrophil cytoplasmic antibody) type MPO (myeloperoxidase) associated vasculitis, and microscopic polyangiitis. The patient had no previous COVID-19 infection. The patient was previously treated with rituximab for microscopic polyangiitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Patient did not required dialysis during periods of vaccination. Concomitant medications included unspecified steroids and cyclophosphamide for induction of immunosuppression. The patient was initially received 2 doses of the Pfizer vaccine (BNT162) for prophylactic vaccination and had not mount a humoral response for prophylactic vaccination.  On an unspecified date, the patient experienced suspected immunological vaccination failure, intentional product misuse and off label use. Laboratory data (dates unspecified) included: CD19 lymphocyte count abnormal (NR: not provided) less than 20 (0) cell/mL (percent), Estimated GFR (NR: not provided) 44 mL/min/{1.73_m2}, Protein urine (NR: not provided) 219 mg, and SARS-CoV-2 IgG antibody test (NR: not provided) less than 1. Immunoglobulin G antibodies to spike protein S1 subunit of on SARS-CoV-2 were measured using ELISA (Enzyme-linked immunosorbent assay) at least one month post completion of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccination failure, intentional product misuse and off label use was not reported. The author has provided data for the first demonstration of antibody development post booster dose of the COVID-19 vaccine in associated vasculitis (AAV) patients on rituximab maintenance therapy. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20210927182 and 20210935336. This report was associated with a product quality complaint: 90000194198.; Sender's Comments: V0-20210935307-covid-19 vaccine ad26.cov2.s -Suspected 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: Near death experience, Paralysis
Clinical narrative: PARALYZED; ON THE BRINK OF DEATH (CLOSE TO DEATH); This spontaneous report received from a parent's via a company representative concerned an 18 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had never took birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The reporter stated that, on an unspecified date, the patient was on the the brink of death (close to death). She was paralyzed and was in the hospital (date unspecified) for 3 months. She was still confined to a wheelchair, and could not do anything on her own. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralyzed (confined to a wheelchair, and could not do anything on her own), and the outcome of on the brink of death (close to death) was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210941226-Covid-19 vaccine ad26.cov2.s- Paralyzed, On the brink of death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Cough, Diarrhoea
Clinical narrative: FOGGY MIND; COULDN'T MOVE; HAD TO SLEEP LONG PERIODS TO HAVE ENERGY; LIGHT HEADEDNESS; SEVERE COUGH; SHORTNESS OF BREATH; WHEEZING; CHEST TIGHTNESS; DIAPHORESIS/SWEATING BUCKETS; RHINORRHEA; PRESSURE AND DISCOMFORT IN EARS; EASILY FATIGUED MUSCLES; TREMBLING MUSCLES; PALPITATIONS; NECK PAIN; MUSCLE STIFFNESS; COUGH WITH CLEAR SPUTUM PRODUCTION; SLOWER SPEECH; PRESSURE AND DISCOMFORT IN NASAL PASSAGES; CHILLS; WEAKNESS; FEVER; NAUSEA; VOMITING; SEVERE HEADACHES; SEVERE FATIGUE; ACUTE MYALGIA/ACUTE MUSCLE PAIN; DIARRHEA; BILATERAL LYMPH ADENOPATHY/CERVICAL LYMPH ADENOPATHY; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and high cholesterol. 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 foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. This report was non-serious. This case, from the same reporter is linked to 20210944355.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Ear discomfort, Fatigue, Feeling abnormal
Clinical narrative: FOGGY MIND; COULDN'T MOVE; HAD TO SLEEP LONG PERIODS TO HAVE ENERGY; LIGHT HEADEDNESS; SEVERE COUGH; SHORTNESS OF BREATH; WHEEZING; CHEST TIGHTNESS; DIAPHORESIS/SWEATING BUCKETS; RHINORRHEA; PRESSURE AND DISCOMFORT IN EARS; EASILY FATIGUED MUSCLES; TREMBLING MUSCLES; PALPITATIONS; NECK PAIN; MUSCLE STIFFNESS; COUGH WITH CLEAR SPUTUM PRODUCTION; SLOWER SPEECH; PRESSURE AND DISCOMFORT IN NASAL PASSAGES; CHILLS; WEAKNESS; FEVER; NAUSEA; VOMITING; SEVERE HEADACHES; SEVERE FATIGUE; ACUTE MYALGIA/ACUTE MUSCLE PAIN; DIARRHEA; BILATERAL LYMPH ADENOPATHY/CERVICAL LYMPH ADENOPATHY; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and high cholesterol. 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 foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. This report was non-serious. This case, from the same reporter is linked to 20210944355.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypersomnia, Hypokinesia, Lymphadenopathy
Clinical narrative: FOGGY MIND; COULDN'T MOVE; HAD TO SLEEP LONG PERIODS TO HAVE ENERGY; LIGHT HEADEDNESS; SEVERE COUGH; SHORTNESS OF BREATH; WHEEZING; CHEST TIGHTNESS; DIAPHORESIS/SWEATING BUCKETS; RHINORRHEA; PRESSURE AND DISCOMFORT IN EARS; EASILY FATIGUED MUSCLES; TREMBLING MUSCLES; PALPITATIONS; NECK PAIN; MUSCLE STIFFNESS; COUGH WITH CLEAR SPUTUM PRODUCTION; SLOWER SPEECH; PRESSURE AND DISCOMFORT IN NASAL PASSAGES; CHILLS; WEAKNESS; FEVER; NAUSEA; VOMITING; SEVERE HEADACHES; SEVERE FATIGUE; ACUTE MYALGIA/ACUTE MUSCLE PAIN; DIARRHEA; BILATERAL LYMPH ADENOPATHY/CERVICAL LYMPH ADENOPATHY; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and high cholesterol. 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 foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. This report was non-serious. This case, from the same reporter is linked to 20210944355.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Musculoskeletal stiffness, Myalgia, Nasal discomfort, Nausea
Clinical narrative: FOGGY MIND; COULDN'T MOVE; HAD TO SLEEP LONG PERIODS TO HAVE ENERGY; LIGHT HEADEDNESS; SEVERE COUGH; SHORTNESS OF BREATH; WHEEZING; CHEST TIGHTNESS; DIAPHORESIS/SWEATING BUCKETS; RHINORRHEA; PRESSURE AND DISCOMFORT IN EARS; EASILY FATIGUED MUSCLES; TREMBLING MUSCLES; PALPITATIONS; NECK PAIN; MUSCLE STIFFNESS; COUGH WITH CLEAR SPUTUM PRODUCTION; SLOWER SPEECH; PRESSURE AND DISCOMFORT IN NASAL PASSAGES; CHILLS; WEAKNESS; FEVER; NAUSEA; VOMITING; SEVERE HEADACHES; SEVERE FATIGUE; ACUTE MYALGIA/ACUTE MUSCLE PAIN; DIARRHEA; BILATERAL LYMPH ADENOPATHY/CERVICAL LYMPH ADENOPATHY; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and high cholesterol. 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 foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. This report was non-serious. This case, from the same reporter is linked to 20210944355.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Palpitations, Productive cough, Pyrexia, Rhinorrhoea
Clinical narrative: FOGGY MIND; COULDN'T MOVE; HAD TO SLEEP LONG PERIODS TO HAVE ENERGY; LIGHT HEADEDNESS; SEVERE COUGH; SHORTNESS OF BREATH; WHEEZING; CHEST TIGHTNESS; DIAPHORESIS/SWEATING BUCKETS; RHINORRHEA; PRESSURE AND DISCOMFORT IN EARS; EASILY FATIGUED MUSCLES; TREMBLING MUSCLES; PALPITATIONS; NECK PAIN; MUSCLE STIFFNESS; COUGH WITH CLEAR SPUTUM PRODUCTION; SLOWER SPEECH; PRESSURE AND DISCOMFORT IN NASAL PASSAGES; CHILLS; WEAKNESS; FEVER; NAUSEA; VOMITING; SEVERE HEADACHES; SEVERE FATIGUE; ACUTE MYALGIA/ACUTE MUSCLE PAIN; DIARRHEA; BILATERAL LYMPH ADENOPATHY/CERVICAL LYMPH ADENOPATHY; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and high cholesterol. 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 foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. This report was non-serious. This case, from the same reporter is linked to 20210944355.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Slow speech, Tremor, Vomiting, Wheezing
Clinical narrative: FOGGY MIND; COULDN'T MOVE; HAD TO SLEEP LONG PERIODS TO HAVE ENERGY; LIGHT HEADEDNESS; SEVERE COUGH; SHORTNESS OF BREATH; WHEEZING; CHEST TIGHTNESS; DIAPHORESIS/SWEATING BUCKETS; RHINORRHEA; PRESSURE AND DISCOMFORT IN EARS; EASILY FATIGUED MUSCLES; TREMBLING MUSCLES; PALPITATIONS; NECK PAIN; MUSCLE STIFFNESS; COUGH WITH CLEAR SPUTUM PRODUCTION; SLOWER SPEECH; PRESSURE AND DISCOMFORT IN NASAL PASSAGES; CHILLS; WEAKNESS; FEVER; NAUSEA; VOMITING; SEVERE HEADACHES; SEVERE FATIGUE; ACUTE MYALGIA/ACUTE MUSCLE PAIN; DIARRHEA; BILATERAL LYMPH ADENOPATHY/CERVICAL LYMPH ADENOPATHY; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and high cholesterol. 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 foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. This report was non-serious. This case, from the same reporter is linked to 20210944355.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Fatigue, Flushing, Syncope
Clinical narrative: INCAPACITATED; FATIGUE; VOMITED; FAINTED; FLUSHING FROM ARMS UP TO THE NECK AND THEN INTO THE FACE; BED RIDDEN; This spontaneous report received from a patient concerned a 69 year old white and not 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 (suspension for injection, route of admin not reported, batch number: 1802070 expiry: 23-AUG-2021) dose was not reported,1 total, administered on 10-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient within twenty minutes of receiving the shot experienced flushing from arms, up to the neck and then into the face, fainted, after being revived patient vomited. On 11-MAR-2021, the patient experienced fatigue and incapacitated. On an unspecified date in MAR-2021, the patient experienced bed ridden for three days and no change in patient lifestyle. The action taken with covid-19 vaccine was not applicable. The patient recovered from fainted, flushing from arms up to the neck and then into the face, and vomited on 11-MAR-2021, incapacitated, and fatigue on 18-MAR-2021, and bed ridden. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210944286 -JANSSEN COVID-19 VACCINE fainted -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).