chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: a dose of Shingrix was administered to a patient / the dose was not storage under correct temperature conditions /  it was outside recommended temperature range; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist reported that, a dose of Shingrix was administered to the patient and the dose was not stored under correct temperature conditions, which led to incorrect storage of drug. The health care professional did not want to provide patient's identifiers nor lot/expiration date of the vaccine. Storage conditions were not provided, just mentioned it was outside recommended temperature range for more than 72 hrs (probably 4 days). The reporter did not consent to follow-up.
Age: 6.0
Sex: F
Vaccine: HEPAB
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: received a dose of Twinrix on October 23, 2020 by mistake; received a dose of Twinrix on October 23, 2020 by mistake; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 6-year-old female patient who received HAB (Twinrix) (batch number AHABB397AB, expiry date unknown) 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.   On 23rd October 2020, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd October 2020, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Twinrix at the age of 6 years by mistake, which led to adult product administered to child and accidental overdose. The patient was waiting to receive another dose of Twinrix but healthcare professional realized that Twinrix was for adult patients. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Rash erythematous
Clinical narrative: Limited mobility of right arm; Red dots/three in number/ inner portion of the right arm.; Soreness/of the right arm; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th April 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injected limb mobility decreased, red rash and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased, red rash and pain in arm were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, red rash and pain in arm to be related to Shingrix.  Additional details was reported as follows: The patient experienced red dots, soreness and limited mobility of the right arm. The dots was three in number, circular, the size of a quarter, and located on the inner portion of the right arm. The patient could only lift his arm to a certain point due to soreness and limited mobility of right arm. The pharmacist did not have lot number or expiration date to provide. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was administrated / with 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 patient who received HBV (Engerix B) (batch number unknown, expiry date April 2021) for prophylaxis.   In May 2021, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was administrated on May 2021 with an expired dose of Engerix-B. No adverse event was reported . No patient's identifiers, vaccination date, lot number and expiration date provided. The reporter consented to follow up. Note: Due to validation error for future date, event onset date was not captured.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: Received 1st / on 07/20/2019 and is back for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 adult (1st dose received on 20th July 2019).   On an unknown date, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 1440 adult and Havrix 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 case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The pharmacist reported patient was late for Havrix Adult 1440 dosing series. It was unknown if 2nd vaccine was administered The reporter was consulting with MI to determine appropriate dosing scheduling. The reporter consented to follow up. Note : As per source document, it was unknown if 2nd vaccine was administered hence conservatively event incomplete course of vaccination was captured in the case and clarification has been raised for the same.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Insomnia, Pyrexia, Swelling face
Clinical narrative: DIFFICULTY BREATHING; SWELLING OF FACE; TROUBLE SLEEPING; COUGH; FEVER; 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 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced trouble sleeping. On 2021, the subject experienced cough. On 2021, the subject experienced fever. On 29-APR-2021, the subject experienced difficulty breathing. On 29-APR-2021, the subject experienced swelling of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble sleeping, cough, and fever on 2021, and had not recovered from difficulty breathing, and swelling of face. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Ill-defined disorder, Visual impairment
Clinical narrative: TROUBLE SEEING (COULD ONLY SEE THE WALL); LOTS OF BLOOD IN NOSE; OPEN MOUTH; This spontaneous report received from a consumer concerned a 75 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, route of admin not reported, batch number: 206A12A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced trouble seeing (could only see the wall). On 01-MAY-2021, the subject experienced lots of blood in nose. On 01-MAY-2021, the subject experienced open mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lots of blood in nose, open mouth, and trouble seeing (could only see the wall). This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient
Clinical narrative: COULD NOT SEE FOR A FEW MINUTES; This spontaneous report received via social media from a patient via a company representative concerned a male of unspecified age. The patients 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, frequency 1 total, administered on 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.  It was reported by consumer that his friend's son on unspecified date 2021, was experienced temporary blindness for few minutes after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporary blindness for few minutes. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210503255-covid-19 vaccine ad26.cov2.s-Could not see for a few minutes. 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: Asthma, Dehydration, Gait inability, Laboratory test, Meningitis
Clinical narrative: SUSPECTED MENINGITIS; ASTHMA; COULD BARELY WALK; DEHYDRATION; LEG PAIN; This spontaneous report received from a consumer 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, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the patient went to the hospital due to headaches, and was hospitalized. The doctors were suspecting meningitis (but reports that the patient is current in that vaccine). The patient had a Covid-19 and plaque check at the hospital. The patient was discharged from the hospital on 30-APR-2021. The patient was hospitalized for 3 days. The patient had followed up with Primary Care Provider and was having difficulty breathing, asthma, and wheezing. The patient received the nebulizer treatment and felt better. The patient could barely walk, did not think it was covid related. The Primary Care Provider thought that she could be dehydrated, however the patient kept drinking fluids and reported still not herself The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from asthma, and the outcome of leg pain, suspected meningitis, could barely walk and dehydration was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210504395-Covid-19 vaccine ad26.cov2.s-Suspected Meningitis, Asthma . These events are considered unassessable. The events 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 events.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: SUSPECTED MENINGITIS; ASTHMA; COULD BARELY WALK; DEHYDRATION; LEG PAIN; This spontaneous report received from a consumer 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, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the patient went to the hospital due to headaches, and was hospitalized. The doctors were suspecting meningitis (but reports that the patient is current in that vaccine). The patient had a Covid-19 and plaque check at the hospital. The patient was discharged from the hospital on 30-APR-2021. The patient was hospitalized for 3 days. The patient had followed up with Primary Care Provider and was having difficulty breathing, asthma, and wheezing. The patient received the nebulizer treatment and felt better. The patient could barely walk, did not think it was covid related. The Primary Care Provider thought that she could be dehydrated, however the patient kept drinking fluids and reported still not herself The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from asthma, and the outcome of leg pain, suspected meningitis, could barely walk and dehydration was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210504395-Covid-19 vaccine ad26.cov2.s-Suspected Meningitis, Asthma . These events are considered unassessable. The events 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 events.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PSORIASIS ON SCALP AND ELBOWS; 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  (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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced psoriasis on scalp and elbows. The action taken with covid-19 vaccine was not applicable. The outcome of psoriasis on scalp and elbows was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Medication error, Underdose
Clinical narrative: MEDICATION ERROR; UNDERDOSE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced medication error, and underdose. The action taken with covid-19 vaccine was not applicable. The outcome of the medication error and underdose was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight was 150 pounds, and height was 70 inches. The patient's concurrent conditions included social drinker, and non-smoker, and other pre-existing medical conditions included patient did not have any known drug allergies. patient did had any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206a21a, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced confirmed covid-19. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 20-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Limb discomfort, Migraine
Clinical narrative: ARM FELT LIKE I HAD GOTTEN BDAY  PUNCHED; MIGRAINE; DIZZINESS; STOMACH PAIN; FEVER; FATIGUE; This spontaneous report received from a patient 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: Unk) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced arm felt like i had gotten bday punched, migraine, dizziness, stomach pain, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, stomach pain, fever, and fatigue, and the outcome of dizziness and arm felt like i had gotten bday punched was not reported. This report was non-serious. This parent/child case is linked to 02159521.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ARM FELT LIKE I HAD GOTTEN BDAY  PUNCHED; MIGRAINE; DIZZINESS; STOMACH PAIN; FEVER; FATIGUE; This spontaneous report received from a patient 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: Unk) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced arm felt like i had gotten bday punched, migraine, dizziness, stomach pain, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, stomach pain, fever, and fatigue, and the outcome of dizziness and arm felt like i had gotten bday punched was not reported. This report was non-serious. This parent/child case is linked to 02159521.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pharyngeal swelling
Clinical narrative: BODY ACHES; THROAT SWELLING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hereditary angioedema, and atrial fibrillation, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, metoprolol for atrial fibrillation, and sotalol for atrial fibrillation. On 02-MAY-2021, the subject experienced throat swelling. On 03-MAY-2021, the subject experienced body aches. Treatment medications (dates unspecified) included: icatibant acetate. The action taken with covid-19 was not applicable. The patient recovered from throat swelling on 02-MAY-2021, and had not recovered from body aches. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Chest X-ray, Electrocardiogram, Head injury
Clinical narrative: PASSED OUT; SEVERE ABDOMINAL CRAMPY PAIN; CRACKED HEAD; This spontaneous report received from a patient concerned a 55 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and penicillin drug allergy.  The patient received COVID19 VACCINE AD.26.COV2.S (suspension for injection, route of admin not reported, batch number: 202a21a, expiry: UNKNOWN) dose was not reported, 1 Total administered administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, Saturday evening the patient experienced so severe pain, patient passed out, did not eat anything and did nothing out of ordinary that could have caused the severe abdominal crampy pain and hit his head (cracked head), sending patient to the ER (emergency room). It was reported that, he did not eat anything and did nothing out of ordinary that could have caused the severe abdominal and he did not know 100 percent that it comes from vaccine but nothing else was any different in his live other than vaccine. In ER they did laboratory tests included full blood test, chest X-ray, electrocardiogram and magnetic resonance imaging (MRI) of head and abdomen was normal (NR: not provided for all labs).  The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from severe abdominal pain on 02-MAY-2021, and the outcome of passed out and cracked head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210505687-JANSSEN COVID-19 VACCINE-Passed out -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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging, Magnetic resonance imaging head
Clinical narrative: PASSED OUT; SEVERE ABDOMINAL CRAMPY PAIN; CRACKED HEAD; This spontaneous report received from a patient concerned a 55 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and penicillin drug allergy.  The patient received COVID19 VACCINE AD.26.COV2.S (suspension for injection, route of admin not reported, batch number: 202a21a, expiry: UNKNOWN) dose was not reported, 1 Total administered administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, Saturday evening the patient experienced so severe pain, patient passed out, did not eat anything and did nothing out of ordinary that could have caused the severe abdominal crampy pain and hit his head (cracked head), sending patient to the ER (emergency room). It was reported that, he did not eat anything and did nothing out of ordinary that could have caused the severe abdominal and he did not know 100 percent that it comes from vaccine but nothing else was any different in his live other than vaccine. In ER they did laboratory tests included full blood test, chest X-ray, electrocardiogram and magnetic resonance imaging (MRI) of head and abdomen was normal (NR: not provided for all labs).  The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from severe abdominal pain on 02-MAY-2021, and the outcome of passed out and cracked head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210505687-JANSSEN COVID-19 VACCINE-Passed out -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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Influenza, Pain
Clinical narrative: PAIN IN SPINE; BODY SORENESS; JOINT PAIN; FLU; VOMITING; CHILLS; SHAKING; HEADACHE; HEART RACING; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and compazine - napazine codeine allergy, and other pre-existing medical conditions included the patient was non alcoholic and non smoker. the patient did not have any drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced heart racing. On 02-MAY-2021, the subject experienced body soreness. On 02-MAY-2021, the subject experienced joint pain. On 02-MAY-2021, the subject experienced flu. On 02-MAY-2021, the subject experienced vomiting. On 02-MAY-2021, the subject experienced chills. On 02-MAY-2021, the subject experienced shaking. On 02-MAY-2021, the subject experienced headache. On 04-MAY-2021, the subject experienced pain in spine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, vomiting, and chills on 04-MAY-2021, and shaking, and had not recovered from body soreness, joint pain, headache, pain in spine, and flu. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Spinal pain, Tremor, Vomiting
Clinical narrative: PAIN IN SPINE; BODY SORENESS; JOINT PAIN; FLU; VOMITING; CHILLS; SHAKING; HEADACHE; HEART RACING; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and compazine - napazine codeine allergy, and other pre-existing medical conditions included the patient was non alcoholic and non smoker. the patient did not have any drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced heart racing. On 02-MAY-2021, the subject experienced body soreness. On 02-MAY-2021, the subject experienced joint pain. On 02-MAY-2021, the subject experienced flu. On 02-MAY-2021, the subject experienced vomiting. On 02-MAY-2021, the subject experienced chills. On 02-MAY-2021, the subject experienced shaking. On 02-MAY-2021, the subject experienced headache. On 04-MAY-2021, the subject experienced pain in spine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, vomiting, and chills on 04-MAY-2021, and shaking, and had not recovered from body soreness, joint pain, headache, pain in spine, and flu. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SOME UNSPECIFIED PROBLEMS; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some unspecified problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some unspecified problems. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: PAIN IN ARM/ SORENESS ON ARM; This spontaneous report received from a patient concerned a 45 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: unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis- psoriatic arthritis, and psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced pain in arm/ soreness on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of pain in arm/ soreness on arm was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity
Clinical narrative: ALLERGIC REACTION; TIRED; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tired. Treatment medications included: hydroxyzine. On 26-MAR-2021, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergic reaction, and tired. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Heart rate increased, Migraine
Clinical narrative: HEART RATE WAS 130/ RAPID HEART RATE; FEEL DIZZY/ FEEL VERY LIGHTHEADED; WHOLE BODY FEVER/ BURNING UP REAL BAD; NAUSEA; FELT WEAK WHEN WALK; HEADACHE / MIGRAINE; This spontaneous report received from a patient concerned an 18 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, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced headache / migraine. On MAY-2021, the subject experienced felt weak when walk. On 04-MAY-2021, the subject experienced heart rate was 130/ rapid heart rate. On 04-MAY-2021, the subject experienced feel dizzy/ feel very lightheaded. On 04-MAY-2021, the subject experienced whole body fever/ burning up real bad. On 04-MAY-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 130. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel dizzy/ feel very lightheaded, nausea, whole body fever/ burning up real bad, and heart rate was 130/ rapid heart rate, and the outcome of headache / migraine and felt weak when walk was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: HEART RATE WAS 130/ RAPID HEART RATE; FEEL DIZZY/ FEEL VERY LIGHTHEADED; WHOLE BODY FEVER/ BURNING UP REAL BAD; NAUSEA; FELT WEAK WHEN WALK; HEADACHE / MIGRAINE; This spontaneous report received from a patient concerned an 18 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, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced headache / migraine. On MAY-2021, the subject experienced felt weak when walk. On 04-MAY-2021, the subject experienced heart rate was 130/ rapid heart rate. On 04-MAY-2021, the subject experienced feel dizzy/ feel very lightheaded. On 04-MAY-2021, the subject experienced whole body fever/ burning up real bad. On 04-MAY-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 130. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel dizzy/ feel very lightheaded, nausea, whole body fever/ burning up real bad, and heart rate was 130/ rapid heart rate, and the outcome of headache / migraine and felt weak when walk was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous report received from a consumer concerned an adult 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, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Muscle tightness, Myalgia, Poor quality sleep
Clinical narrative: RESTLESS NIGHT; MUSCLES FELT SLIGHTLY TIGHT; ALL NIGHT HAD A FEVER; MUSCLES FELT SLIGHTLY SORE; 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, 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 restless night, muscles felt slightly tight, all night had a fever, muscles felt slightly sore, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 units unspecified, 100 units not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from all night had a fever, and the outcome of muscles felt slightly sore, headache, restless night and muscles felt slightly tight was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: RESTLESS NIGHT; MUSCLES FELT SLIGHTLY TIGHT; ALL NIGHT HAD A FEVER; MUSCLES FELT SLIGHTLY SORE; 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, 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 restless night, muscles felt slightly tight, all night had a fever, muscles felt slightly sore, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 units unspecified, 100 units not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from all night had a fever, and the outcome of muscles felt slightly sore, headache, restless night and muscles felt slightly tight was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED AFTER 2 HOUR ROOM TEMPERATURE STORAGE RANGE; This spontaneous report received from a pharmacist 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: Not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered after 2 hour room temperature storage range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after 2 hour room temperature storage range was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: LUNGS ARE CLEAR AND MUCH BETTER; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 200A2/A OR 206A2/A, and batch number: 200A2/A OR 206A2/A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vacccination. No concomitant medications were reported. On an unspecified date, the subject experienced lungs are clear and much better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lungs are clear and much better. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Headache, Pain, Paraesthesia
Clinical narrative: VOMITING; PRESSURE; TINGLES THAT COMES AND GOES; SHOOTING PAIN; CHILLS; HEADACHE; FEVER; 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: Not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, pressure, tingles that comes and goes, shooting pain, chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, headache, fever, pressure, tingles that comes and goes, shooting pain and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: VOMITING; PRESSURE; TINGLES THAT COMES AND GOES; SHOOTING PAIN; CHILLS; HEADACHE; FEVER; 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: Not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, pressure, tingles that comes and goes, shooting pain, chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, headache, fever, pressure, tingles that comes and goes, shooting pain and chills was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA TEST INCREASED 0.3; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included transurethral resection of the prostate cancer, and prostate cancer, and other pre-existing medical conditions included in 2010, the patient had radiation treatment, and in 2015 chemo pills treatments, and then remission until now. They also did targeted radiation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180-5031) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the subject experienced prostatic specific antigen increased (PSA) test increased 0.3. Laboratory data included: Elevated prostate specific antigen [PSA] (NR: not provided) 0.3 (Unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of PSA test increased 0.3 was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostatic specific antigen
Clinical narrative: PSA TEST INCREASED 0.3; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included transurethral resection of the prostate cancer, and prostate cancer, and other pre-existing medical conditions included in 2010, the patient had radiation treatment, and in 2015 chemo pills treatments, and then remission until now. They also did targeted radiation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180-5031) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the subject experienced prostatic specific antigen increased (PSA) test increased 0.3. Laboratory data included: Elevated prostate specific antigen [PSA] (NR: not provided) 0.3 (Unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of PSA test increased 0.3 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: ONLY FELT SLIGHT EFFECTS THE  SECOND DAY AT NIGHT; This spontaneous report received from a patient via a company representative 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: 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 subject experienced only felt slight effects the second day at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of only felt slight effects the second day at night was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: VACCINE GIVEN WITH INSULIN SYRINGE NOT SURE IF GOT THROUGH THE MUSCLE; This spontaneous report received from a patient 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, 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 subject experienced vaccine given with insulin syringe not sure if got through the muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given with insulin syringe not sure if got through the muscle was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 test, Underdose
Clinical narrative: PARTIAL DOSE ADMINISTERED; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) NEGATIVE. On 14-APR-2021, Laboratory data included: Antibody test (NR: not provided) 21 (POSITIVE). On an unspecified date, the subject experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: INJECTION SITE SWELLING; INJECTION SITE PAIN; 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, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site swelling. On APR-2021, the subject experienced injection site pain. 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 injection site swelling, and injection site pain. This report was non-serious.