chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Chills, Ear pain, Fatigue, Headache
Clinical narrative: Menstrual period stopped, fever, chills, nightmares, injection pain, severe headache, ear pain, tiredness
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nightmare, Pyrexia
Clinical narrative: Menstrual period stopped, fever, chills, nightmares, injection pain, severe headache, ear pain, tiredness
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Decreased appetite, Pain, Pyrexia
Clinical narrative: weakness loss of appetite  continue fluids, continue soft diet, chicken soup Tylenol extra strength for aches and pains and fever
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, COVID-19, Headache, Muscle spasms, Palpitations
Clinical narrative: Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cramps; Hydroxyzine HCL; Amoxicillin; Acetaminophen.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cramps; Hydroxyzine HCL; Amoxicillin; Acetaminophen.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: She denies further adverse event; received PROQUAD that expired; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.   On 14-APR-2021, the patient was inadvertently vaccinated with one dose of expired Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status recombinant Human albumin (rHA)) (dose: 0.5 milliliter, lot number: S031882, expiration date: 07-APR-2021, strength and route were not reported) for prophylaxis. No additional adverse events reported.
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of product administration
Clinical narrative: Pt who received Pneumovax 23 IV instead of SQ; This spontaneous report as received from a physician referring to a 47-year-old patient, gender was not provided.The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.       On 21-APR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), for prophylaxis (dose, frequency, strength, lot number, and expiry date were not reported). The vaccine was administered intravenous instead of subcutaneous (incorrect route of product administration).    The outcome of incorrect route of product administration was unknown. No other issues were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: She denied further adverse event/No further adverse event. No product quality complaint. No additional adverse events reported.; a patient received expired PNEUMOVAX 23 on 30APR2021; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of pertinent medical history, current condition, concomitant therapy and drug reactions/allergies was not reported.  On 30-APR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 milliliter, lot # S018405, expiration date: 28-MAR-2021, strength, frequency and route were unknown) for prophylaxis (Expired vaccine used). The reporter denied further adverse event. The reporter was provided with the not supported expired disclaimer. No further adverse event. No product quality complaint. No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S018405; expirationdate: 28-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Loss of consciousness, Syncope, Urinary tract infection, Vomiting
Clinical narrative: patient was unconscious; patient was unconscious; UTI; Bedridden; Patient began to vomit; This case was received via FDA VAERS (Reference number: 0967119) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (patient was unconscious) and SYNCOPE (patient was unconscious) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Syncope (granddaughter states patient has episodes of syncope) and Wheelchair user.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (patient was unconscious) (seriousness criterion medically significant) and SYNCOPE (patient was unconscious) (seriousness criterion medically significant). 22-Jan-2021, the patient experienced URINARY TRACT INFECTION (UTI), BEDRIDDEN (Bedridden) and VOMITING (Patient began to vomit). At the time of the report, LOSS OF CONSCIOUSNESS (patient was unconscious) and SYNCOPE (patient was unconscious) had resolved and URINARY TRACT INFECTION (UTI), BEDRIDDEN (Bedridden) and VOMITING (Patient began to vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   After administration, the patient remained in waiting area for the recommended 15 minutes observation time. Approximately 20 minutes after vaccination, patient was unconscious and appeared not to be breathing, but pulse was palpable. Pharmacist administered 1 dose of 0.3mg epinephrine via epi-pen into patient's left thigh. The patient quickly regained consciousness, spoke to family, said she did not feel well. Emergency medical services (ems) arrived. The patient began to vomit, was placed on stretcher and left with ems. A few hours later the granddaughter reported that the patient had a urinary tract infection (UTI) and physical exam by emergency room (ER) attributed her experience to untreated infection.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Vomiting is consistent with event safety profile.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had / the 2 shringrex shots and still got the shingles, Suspected vaccination failure; Had / the 2 shringrex shots and still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingles vaccine, Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient was vaccinated with Shingles vaccine plus the 2 Shingrix shots and still got the shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and then got shingles, suspected vaccination failure; got the vaccine and then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and then got shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: can still get a mild case of shingles after getting the vaccine.Suspected Vaccination failure; mild case of shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated that, unfortunately you could still get a mild case of shingles after getting vaccine. The patient did and his/her said that, you could get them more than once. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR096305, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR096305:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: got first shot & It triggered my shingles back; No thanks for second booster; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The patient had shingles years ago and stated that he/she still have it not as bad as it was in beginning but it kicks in and out. The patient's physician told patient that he/she should have new double shingles shot. The patient got first shot of shingles and it triggered shingles back. The patient did not want to receive 2nd dose of vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Sleep disorder
Clinical narrative: second inoculation cost me a night's sleep; Shivering; Had two shingles innoculations a month apart; This case was reported by a consumer via  interactive digital media and described the occurrence of sleeplessness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced sleeplessness, shivering and drug dose administration interval too short. On an unknown date, the outcome of the sleeplessness, shivering and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the sleeplessness and shivering to be related to Shingles vaccine.  Additional details was reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received two shingles inoculations a month apart. The patient received 2nd dose of shingles vaccine, before than the recommended interval, which led to shortening of vaccination schedule. The patient stated that vaccine cost him/her a night's sleep and patient could not stop shivering. No other information was available.
Age: 11.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old patient who received HBV (Engerix B) (batch number 3JD32, expiry date 6th April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On 3rd May 2021, 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 reporter stated that, the patient was administered already expired vaccine, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Twinrix on 12Dec2020 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old female 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 (1st dose received on 12th December 2020 with batch number 75C72 and expirydate- 13th June 2022).   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 did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up. VAERS details reported for 1st dose of Twinrix.
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult dose of Engerix-B to a female 4 month patient; adult dose of Engerix-B to a female 4 month patient; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-month-old female patient who received HBV (Engerix B adult) (batch number 2224M, expiry date 1st March 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th April 2021, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 8th April 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that 4 months old child received an adult dose of Engerix-B, which led to overdose and adult product administered to child. No further events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 4/17/2021 and the second dose today, 5/3/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) (batch number F93YS, expiry date 8th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd May 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd May 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 case was reported by patient for herself. The age at vaccination was not reported. The patient received her 1st dose on 17th April 2021. The patient received 2nd dose of Shingrix shorter than recommended interval  which led shortening of vaccination schedule. The pharmacist did not have the patient's date of birth of birth (DOB). The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received dose two / late / First dose 12.28.20 - Second dose 4/23/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old female patient who received HAB (Twinrix) (batch number 3Y7NL, expiry date 24th May 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 28th December 2020).   On 23rd April 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd April 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 age at vaccination was not reported. The pharmacist reported the patient received dose two of Twinrix longer than recommended interval, which led to lengthening of vaccination schedule. Lot number and expiration date for dose 1 of Twinrix were not provided. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of Menveo conjugate only; Administration of Menveo conjugate only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date 31st August 2022) for prophylaxis.   On 3rd May 2021, the patient received Menveo. On 3rd May 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 3rd May 2021, the outcome of the inappropriate preparation of medication was unknown. On an unknown date, the outcome of the inappropriate dose of vaccine administered was unknown.  Additional details were provided as follows: The reporter stated that, the patient received Menveo conjugate only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The batch number of Menveo was updated from AMXA419A to AMVA419A as per sales data sheet.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the third dose/ the third 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 85-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (2nd dose of Engerix B administered on 24th September 2020, batch number L5C49, expiry date 17th May 2022).   On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B 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. The patient received 2nd dose of Engerix B at primary reporter's facility. Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 2.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: Overdose; Administration of two diluents of the Menveo vaccine/on the same day; Administration of two diluents of the Menveo vaccine/on the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 2-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 3rd May 2021, the patient received Menveo (intramuscular). On 3rd May 2021, unknown after receiving Menveo, the patient experienced overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received two diluents of the Menveo vaccine in the left deltoid, which led to inappropriate preparation of medication, overdose of MenCWY-135 component and inappropriate dose of vaccine administered as did not received MenA component. No further events were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: POSSIBLE CLOT IN THE LEFT ARM; PAIN IN THE LEFT ARM/SIDE; This spontaneous report received from a patient via a company representative concerned a 6 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced possible clot in the left arm, and pain in the left arm/side, and was hospitalized (date unspecified). it was reported that the patient had reaction to the JnJ vaccine. She was  being watched closely and taken care of. Pain on the left arm/side. They think it as clot in the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the left arm/side and possible clot in the left arm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: v0;20210456346-Covid vaccine ad26.cov2.s-Possible clot in the left arm. Follow-up received regarding Clinical Details. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  v0;20210456346-Covid vaccine ad26.cov2.s-Pain in left arm. Follow-up received regarding Clinical Details. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: SLIGHT CHILL; TIRED; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced slight chill, and tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight chill, and tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: CHILLS; LITTLE TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and the outcome of little tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Taste disorder
Clinical narrative: LEFT HAND FEELING LIKE HAMMER HIT IT; NASTY TASTE IN MOUTH; THROAT PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  On 30-APR-2021, the subject experienced left hand feeling like hammer hit it, nasty taste in mouth and throat pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left hand feeling like hammer hit it, nasty taste in mouth and throat pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Dyspepsia, Eructation, Headache
Clinical narrative: FEELS LIKE A KNOT DEEP INSIDE THE LEG; SEVERE STOMACH PAIN; LEG ACHY; STOMACH BURNING; UNUSUAL BURPING; STOMACH DISCOMFORT; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-APR-2021, the subject experienced headache. On 16-APR-2021, the subject experienced stomach burning. On 16-APR-2021, the subject experienced burping. On 16-APR-2021, the subject experienced stomach discomfort. On an unspecified date, the subject experienced feels like a knot deep inside the leg, severe stomach pain, and leg achy. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, feels like a knot deep inside the leg, severe stomach pain, stomach burning, burping, leg achy, and stomach discomfort. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity
Clinical narrative: FEELS LIKE A KNOT DEEP INSIDE THE LEG; SEVERE STOMACH PAIN; LEG ACHY; STOMACH BURNING; UNUSUAL BURPING; STOMACH DISCOMFORT; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-APR-2021, the subject experienced headache. On 16-APR-2021, the subject experienced stomach burning. On 16-APR-2021, the subject experienced burping. On 16-APR-2021, the subject experienced stomach discomfort. On an unspecified date, the subject experienced feels like a knot deep inside the leg, severe stomach pain, and leg achy. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, feels like a knot deep inside the leg, severe stomach pain, stomach burning, burping, leg achy, and stomach discomfort. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Body temperature, Chills, Condition aggravated
Clinical narrative: THROWING UP; SWEATING PERFUSELY; ABDOMINAL PAIN; COULDN'T EAT; LOST 10 POUNDS; COULDN'T SLEEP; SHAKING WITH CHILLS; LACK OF ENERGY; FEVER; NAUSEA; MUSCLE ACHES GOT WORST/FELT HORRIBLE; ITCHY; LETHARGIC; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced itchy, lethargic, muscle aches, headache. On 07-APR-2021, the subject experienced throwing up, sweating profusely, abdominal pain, couldn't eat, lost 10 pounds,  couldn't sleep,  shaking with chills, lack of energy, fever, nausea,  muscle aches got worst/felt horrible.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headache, and lack of energy, and the outcome of itchy, lethargic, throwing up, fever, shaking with chills, sweating perfusely, abdominal pain, couldn't eat, lost 10 pounds, couldn't sleep and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Eating disorder, Headache, Hyperhidrosis, Insomnia, Lethargy
Clinical narrative: THROWING UP; SWEATING PERFUSELY; ABDOMINAL PAIN; COULDN'T EAT; LOST 10 POUNDS; COULDN'T SLEEP; SHAKING WITH CHILLS; LACK OF ENERGY; FEVER; NAUSEA; MUSCLE ACHES GOT WORST/FELT HORRIBLE; ITCHY; LETHARGIC; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced itchy, lethargic, muscle aches, headache. On 07-APR-2021, the subject experienced throwing up, sweating profusely, abdominal pain, couldn't eat, lost 10 pounds,  couldn't sleep,  shaking with chills, lack of energy, fever, nausea,  muscle aches got worst/felt horrible.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headache, and lack of energy, and the outcome of itchy, lethargic, throwing up, fever, shaking with chills, sweating perfusely, abdominal pain, couldn't eat, lost 10 pounds, couldn't sleep and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pruritus, Pyrexia, Vomiting
Clinical narrative: THROWING UP; SWEATING PERFUSELY; ABDOMINAL PAIN; COULDN'T EAT; LOST 10 POUNDS; COULDN'T SLEEP; SHAKING WITH CHILLS; LACK OF ENERGY; FEVER; NAUSEA; MUSCLE ACHES GOT WORST/FELT HORRIBLE; ITCHY; LETHARGIC; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced itchy, lethargic, muscle aches, headache. On 07-APR-2021, the subject experienced throwing up, sweating profusely, abdominal pain, couldn't eat, lost 10 pounds,  couldn't sleep,  shaking with chills, lack of energy, fever, nausea,  muscle aches got worst/felt horrible.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headache, and lack of energy, and the outcome of itchy, lethargic, throwing up, fever, shaking with chills, sweating perfusely, abdominal pain, couldn't eat, lost 10 pounds, couldn't sleep and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: THROWING UP; SWEATING PERFUSELY; ABDOMINAL PAIN; COULDN'T EAT; LOST 10 POUNDS; COULDN'T SLEEP; SHAKING WITH CHILLS; LACK OF ENERGY; FEVER; NAUSEA; MUSCLE ACHES GOT WORST/FELT HORRIBLE; ITCHY; LETHARGIC; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced itchy, lethargic, muscle aches, headache. On 07-APR-2021, the subject experienced throwing up, sweating profusely, abdominal pain, couldn't eat, lost 10 pounds,  couldn't sleep,  shaking with chills, lack of energy, fever, nausea,  muscle aches got worst/felt horrible.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headache, and lack of energy, and the outcome of itchy, lethargic, throwing up, fever, shaking with chills, sweating perfusely, abdominal pain, couldn't eat, lost 10 pounds, couldn't sleep and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via social media through a company representative and concerned a patient of unspecified age and sex The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot three weeks later without any underlying conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210504574.; Sender's Comments: V0:20210503763-Covid-19 vaccine ad26.cov2.s-Blood clot. 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: U
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Asthenia, Blood test, Chills
Clinical narrative: BLURRED VISION; VOMITING; WEAKNESS; CHILLS; HEADACHE; FEVER; FATIGUE; STOMACH PAINS; POOR SLEEP; ABDOMINAL BLOATING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced stomach pains. On APR-2021, the subject experienced poor sleep. On APR-2021, the subject experienced abdominal bloating. On APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced blurred vision. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) No major abnormalities in blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, vomiting, weakness, chills, and fever on 13-APR-2021, and had not recovered from headache, fatigue, poor sleep, stomach pains, and abdominal bloating. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Poor quality sleep, Pyrexia, Vision blurred
Clinical narrative: BLURRED VISION; VOMITING; WEAKNESS; CHILLS; HEADACHE; FEVER; FATIGUE; STOMACH PAINS; POOR SLEEP; ABDOMINAL BLOATING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced stomach pains. On APR-2021, the subject experienced poor sleep. On APR-2021, the subject experienced abdominal bloating. On APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced blurred vision. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) No major abnormalities in blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, vomiting, weakness, chills, and fever on 13-APR-2021, and had not recovered from headache, fatigue, poor sleep, stomach pains, and abdominal bloating. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: BLURRED VISION; VOMITING; WEAKNESS; CHILLS; HEADACHE; FEVER; FATIGUE; STOMACH PAINS; POOR SLEEP; ABDOMINAL BLOATING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced stomach pains. On APR-2021, the subject experienced poor sleep. On APR-2021, the subject experienced abdominal bloating. On APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced blurred vision. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) No major abnormalities in blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, vomiting, weakness, chills, and fever on 13-APR-2021, and had not recovered from headache, fatigue, poor sleep, stomach pains, and abdominal bloating. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Magnetic resonance imaging
Clinical narrative: HEADACHE; This spontaneous report received from a patient via social media  a concerned a female of unspecified age. The patient's weight, height and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced side affect and head ache. On 2021, Laboratory data included: Blood test (NR: not provided) normal and MRI (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head ache and side affect was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a social media via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency one total ,start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. no concomitant medications were reported. The consumer reported that, patient experienced stroke 4 weeks ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504221-covid-19 vaccine ad26.cov2.s-stroke. 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site haemorrhage, Pain in extremity
Clinical narrative: BRUISE AT THE INJECTION SITE; SORE ARM; INJECTION SITE BLEEDING; This spontaneous report received from a pharmacist concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and  expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2021, the subject experienced injection site bleeding. On an unspecified date, the subject experienced bruise at the injection site, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bleeding, and the outcome of sore arm and bruise at the injection site was not reported. This report was non-serious.