chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 on Nov 2019, Dose 2: 03/06/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 22-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 (received first dose of Twinrix in November 2019).   On 6th March 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 6th March 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 reported as follows: The age at vaccination was not reported but could be 21 or 22 years. The patient received 2nd dose, later then the recommended schedule, which led to lengthening of vaccination schedule. The pharmacist wanted to know whether to restart series for 3rd dose. No further information was reported. The reporter consented to follow up.
Age: 0.75
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 9 month old child was administered Boostrix in error; A 9 month old child was administered Boostrix in error; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 9-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient was administered Boostrix in error which led to wrong vaccine administration and inappropriate age at vaccine administration. The reporter asked for recommendations that should be followed up on. The Healthcare provider's office refused to provide any additional details or any demographic information.  The reporter claimed that the physician would call back later to report the incident. The reporter did not consent to follow-up.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: An adult dose of Engerix-B was administered to a 19 year old; An adult dose of Engerix-B was administered to a 19 year old; States that this is the first dose, but that she received a dose back in 2001; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number 2793Z, expiry date 5th December 2022) 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 (Received a dose in 2001).   On an unknown date, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the overdose, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided as follow: The patient previously received a dose of Engerix B. And now, the patient received 1 dose of Engerix B adult at 19 years of age, which led to inappropriate age at vaccine administration, overdose and inappropriate schedule of vaccine administration.  The reporter consented to follow up via email.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: PE; DVT; This spontaneous report received from a physician via a company representative concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included family history of DVT, and family history of PE. 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On unspecified date in 2021, the patient experienced PE (pulmonary embolism) and DVT (deep vein thrombosis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the PE and DVT was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210332653-Covid-19 Vaccine AD26.COV2.S-PE and DVT. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Headache, Hypertension, Rash
Clinical narrative: ELEVATED BLOOD PRESSURE; CHEST PAIN; RASH ON HER FACE THAT WAS BURNING AND SWOLLEN; RASH ON HER FACE THAT WAS BURNING AND SWOLLEN; RASH ON FACE AND RASH ON ALL OVER LEGS AND KNEES; 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination on Left Deltoid. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chest pain, elevated blood pressure, rash on her face that was burning and swollen, rash on face and rash on all over legs and knees and headache. She had went to the hospital twice but was not admitted both were the outpatient visits.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on her face that was burning and swollen, and rash on her face that was burning and swollen on 11-MAR-2021, and rash on face and rash on all over legs and knees on MAR-2021, and had not recovered from elevated blood pressure, chest pain, and headache. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210333394-COVID-19 vaccine Ad26.COV2.S-elevated blood pressure. This event is considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: ELEVATED BLOOD PRESSURE; CHEST PAIN; RASH ON HER FACE THAT WAS BURNING AND SWOLLEN; RASH ON HER FACE THAT WAS BURNING AND SWOLLEN; RASH ON FACE AND RASH ON ALL OVER LEGS AND KNEES; 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination on Left Deltoid. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chest pain, elevated blood pressure, rash on her face that was burning and swollen, rash on face and rash on all over legs and knees and headache. She had went to the hospital twice but was not admitted both were the outpatient visits.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on her face that was burning and swollen, and rash on her face that was burning and swollen on 11-MAR-2021, and rash on face and rash on all over legs and knees on MAR-2021, and had not recovered from elevated blood pressure, chest pain, and headache. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210333394-COVID-19 vaccine Ad26.COV2.S-elevated blood pressure. This event is considered unassessable. The events have 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: Dizziness, Hyperhidrosis, Hypoacusis, Nausea, Pain in extremity
Clinical narrative: LOSS OF HEARING FOR A BIT; DIZZINESS, COULD NOT HOLD HEAD UP; VISUAL DISTURBANCE; SWEAT; SORE ARM; NAUSEA; 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 was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 25-MAR-2021, the subject experienced loss of hearing for a bit. On 25-MAR-2021, the subject experienced dizziness, could not hold head up. On 25-MAR-2021, the subject experienced visual disturbance. On 25-MAR-2021, the subject experienced sweat. On 25-MAR-2021, the subject experienced sore arm. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of hearing for a bit, dizziness, could not hold head up, visual disturbance, sweat, and nausea on 25-MAR-2021, and had not recovered from sore arm. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: LOSS OF HEARING FOR A BIT; DIZZINESS, COULD NOT HOLD HEAD UP; VISUAL DISTURBANCE; SWEAT; SORE ARM; NAUSEA; 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 was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 25-MAR-2021, the subject experienced loss of hearing for a bit. On 25-MAR-2021, the subject experienced dizziness, could not hold head up. On 25-MAR-2021, the subject experienced visual disturbance. On 25-MAR-2021, the subject experienced sweat. On 25-MAR-2021, the subject experienced sore arm. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of hearing for a bit, dizziness, could not hold head up, visual disturbance, sweat, and nausea on 25-MAR-2021, and had not recovered from sore arm. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included she thought it was her allergies, as it as starting to get bad in state. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 rapid POC test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. The case was associated with a product quality complaint number: 90000174423 The suspected product quality complaint has been confirmed to be voided: does not meet PQC criteria, based on the PQC evaluation/investigation performed.; Sender's Comments: V1: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, Dyspnoea, Fatigue, Injection site pain, Insomnia
Clinical narrative: DIFFICULTY SLEEPING; SHORTNESS OF BREATH; TIREDNESS; BODY ACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight was 166 pounds, and height was 68 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient have no known drug allergies. the patient did not have any drug abuse, illicit drug use. patient did not had other medical history or medicines. patient reports fairly healthy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced shortness of breath. On 25-MAR-2021, the subject experienced difficulty sleeping. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on 15-MAR-2021, and injection site pain on 13-MAR-2021, and had not recovered from shortness of breath, and difficulty sleeping. This report was non-serious
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: DIFFICULTY SLEEPING; SHORTNESS OF BREATH; TIREDNESS; BODY ACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight was 166 pounds, and height was 68 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient have no known drug allergies. the patient did not have any drug abuse, illicit drug use. patient did not had other medical history or medicines. patient reports fairly healthy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced shortness of breath. On 25-MAR-2021, the subject experienced difficulty sleeping. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on 15-MAR-2021, and injection site pain on 13-MAR-2021, and had not recovered from shortness of breath, and difficulty sleeping. This report was non-serious
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site mass, Pain
Clinical narrative: PATIENT FELT SMALL LUMP FEW HOURS AFTERWARDS AT INJECTION SITE; FELT BODY ACHES; ALL RED (AT INJECTION SITE ONLY); FEELING A LITTLE TIRED; This spontaneous report received from a patient concerned a 62 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, vaccinated at right arm, once a total administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced subject felt small lump few hours afterwards at injection site. On MAR-2021, the subject experienced felt body aches. On MAR-2021, the subject experienced all red (at injection site only). On MAR-2021, the subject experienced feeling a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient felt small lump few hours afterwards at injection site, all red (at injection site only), felt body aches and feeling a little tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder
Clinical narrative: HIT HARD; 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: Unknown) dose, 1 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. On an unspecified date, the subject experienced hit hard (coded as ill-defined disorder). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hit hard was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: BURNING SENSATION ON THE ARM; 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 burning sensation on the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of burning sensation on the arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 68.1 kilograms, and height was not reported. The patient's pre-existing medical conditions included patient had no medical history. The patient received covid-19 vaccine  (suspension for injection, intramuscular and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on Right deltoid. No concomitant medications were reported. On 26-MAR-2021, the subject experienced suspected covid-19 infection. Laboratory data included:  rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: BAD 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, 1 total, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 24-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pyrexia
Clinical narrative: BODY ACHE; FEVER; BACK PAIN; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced back pain. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and back pain, and the outcome of body ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: SHOOK SEVERELY ALL THAT NIGHT; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients 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. 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, multiple subjects received vaccine and shook severely all that night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shook severely all that night was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Headache, Pain, Presyncope
Clinical narrative: ALMOST BLACKED OUT; ACHES; HEADACHE; FATIGUE; DEHYDRATED; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's past medical history included surgery to the ankle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced dehydrated. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. On 27-MAR-2021, the subject experienced almost blacked out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from aches, headache, and almost blacked out, and the outcome of fatigue and dehydrated was not reported. This report was non-serious.; Sender's Comments: V0 : medical assessment comment not required as per standard procedure as the case assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Fungal infection, Laboratory test, Vaginal haemorrhage
Clinical narrative: VAGINAL SPOTTING; VACCINE EXPOSURE DURING PREGNANCY; YEAST INFECTION; FATIGUE; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included alcoholic, and concurrent conditions included diabetes (gestational), and nonsmoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug use. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced yeast infection. On MAR-2021, the subject experienced fatigue. Laboratory data included: Laboratory test (NR: not provided) NEGATIVE. On 09-MAR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. On 14-MAR-2021, the subject experienced vaginal spotting.  The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaginal spotting on 22-MAR-2021, had not recovered from vaccine exposure during pregnancy, and the outcome of fatigue and yeast infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia
Clinical narrative: DID NOT SLEEP WELL; LITTLE TIRED; FELT HEAVY CHILLS/ FREEZING; BAD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19.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 18-MAR-2021 09:45 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021 around 20:00, the subject experienced felt heavy chills/ freezing. On 18-MAR-2021 20:00, the subject experienced bad headache. On 19-MAR-2021, treatment medications included: paracetamol. On an unspecified date, the subject experienced did not sleep well, and little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt heavy chills/ freezing, bad headache, and little tired, and the outcome of did not sleep well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: FEVER; 5 HOURS AFTER SHE GOT THE SHOT, SHE WAS SHIVERING UNCONTROLLABLY; 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 11:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the subject experienced 5 hours after she got the shot, she was shivering uncontrollably. Laboratory data included: Body temperature (NR: not provided) 102 F, 103 F. On 27-MAR-2021 17:00, the subject experienced fever. On 28-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 5 hours after she got the shot, she was shivering uncontrollably, and fever on 28-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Nausea
Clinical narrative: BODY ACHES; DIZZINESS; CHILLS; HEADACHE; FEVER; NAUSEA; 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: 1805031,expiry: UNKNOWN) dose was not reported, once a total administered on 27-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 (units unspecified). On 27-MAR-2021 18:00, the subject experienced body aches. On 27-MAR-2021 18:00, the subject experienced dizziness. On 27-MAR-2021 18:00, the subject experienced chills. On 27-MAR-2021 18:00, the subject experienced headache. On 27-MAR-2021 18:00, the subject experienced fever. On 27-MAR-2021 18:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, dizziness, chills, fever, and nausea on MAR-2021, and had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; DIZZINESS; CHILLS; HEADACHE; FEVER; NAUSEA; 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: 1805031,expiry: UNKNOWN) dose was not reported, once a total administered on 27-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 (units unspecified). On 27-MAR-2021 18:00, the subject experienced body aches. On 27-MAR-2021 18:00, the subject experienced dizziness. On 27-MAR-2021 18:00, the subject experienced chills. On 27-MAR-2021 18:00, the subject experienced headache. On 27-MAR-2021 18:00, the subject experienced fever. On 27-MAR-2021 18:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, dizziness, chills, fever, and nausea on MAR-2021, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Nausea, Pain
Clinical narrative: BODYACHE; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned 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: 1802072,  expiry: UNKNOWN) 1 total administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced bodyache, chills, fever, nausea, and headache. Laboratory data (dates unspecified) included: Body temperature increased (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, chills, bodyache and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODYACHE; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned 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: 1802072,  expiry: UNKNOWN) 1 total administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced bodyache, chills, fever, nausea, and headache. Laboratory data (dates unspecified) included: Body temperature increased (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, chills, bodyache and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Feeling hot, Injection site pain
Clinical narrative: BODY PAIN SPECIFICALLY AT HIPS, NECK, HEAD; FEELING WARM INSIDE; CHILLS, FELT LIKE BLOCKS OF ICE; ARM PAIN AT INJECTION SITE; FEELING LOOPY AND HYPER; SLIGHTLY DIZZY; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, and concurrent conditions included hiv positive, emphysema, chronic obstructive pulmonary disease, sulfa allergy, alcohol user consumes half a cup liquor per week, and cigarette smoker pack a day, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry : UNKNOWN) dose was not reported, administered on 26-MAR-2021 at around14:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced feeling loopy and hyper. On 26-MAR-2021, the subject experienced slightly dizzy. On 27-MAR-2021, the subject experienced body pain specifically at hips, neck, head. On 27-MAR-2021, the subject experienced feeling warm inside. On 27-MAR-2021, the subject experienced chills, felt like blocks of ice. On 27-MAR-2021, the subject experienced arm pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling loopy and hyper, and slightly dizzy on 26-MAR-2021, and was recovering from chills, felt like blocks of ice, body pain specifically at hips, neck, head, feeling warm inside, and arm pain at injection site. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY PAIN SPECIFICALLY AT HIPS, NECK, HEAD; FEELING WARM INSIDE; CHILLS, FELT LIKE BLOCKS OF ICE; ARM PAIN AT INJECTION SITE; FEELING LOOPY AND HYPER; SLIGHTLY DIZZY; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, and concurrent conditions included hiv positive, emphysema, chronic obstructive pulmonary disease, sulfa allergy, alcohol user consumes half a cup liquor per week, and cigarette smoker pack a day, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry : UNKNOWN) dose was not reported, administered on 26-MAR-2021 at around14:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced feeling loopy and hyper. On 26-MAR-2021, the subject experienced slightly dizzy. On 27-MAR-2021, the subject experienced body pain specifically at hips, neck, head. On 27-MAR-2021, the subject experienced feeling warm inside. On 27-MAR-2021, the subject experienced chills, felt like blocks of ice. On 27-MAR-2021, the subject experienced arm pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling loopy and hyper, and slightly dizzy on 26-MAR-2021, and was recovering from chills, felt like blocks of ice, body pain specifically at hips, neck, head, feeling warm inside, and arm pain at injection site. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain
Clinical narrative: CHILLS AFTER TAKING THEIR LANTUS  MEDICATION; INJECTION SITE PAIN IN THEIR LEFT ARM; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-smoker, non-alcoholic and other pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included insulin glargine. On 26-MAR-2021, the subject experienced chills after taking their lantus medication. On 26-MAR-2021, the subject experienced injection site pain in their left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain in their left arm, and chills after taking their lantus medication. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, Rash
Clinical narrative: RASH ON LEGS AND ARMS; SORENESS; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 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: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced soreness. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced rash on legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 22-MAR-2021, and fever on MAR-2021, and had not recovered from soreness, tiredness, and rash on legs and arms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Pain, Rash, Rash pruritic
Clinical narrative: FAST HEART BEAT; BODY ACHE; ITCHY RASH (PUFFY); RASH (THEY SEEM LIKE WARTS); HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included penicillin allergy, inflammatory bowel disease, nonsmoker, and abstains from alcohol, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced itchy rash (puffy). On 26-MAR-2021, the subject experienced rash (they seem like warts). On 27-MAR-2021, the subject experienced fast heart beat. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache, and had not recovered from rash (they seem like warts), headache, fast heart beat, and itchy rash (puffy). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nasopharyngitis
Clinical narrative: COLD; CHILLS; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced muscle ache. On MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache, headache, cold and chills was not reported. This report was non-serious.  Additional information was received from patient on 26-MAR-2021 following information was updated and incorporated into case narrative: Cold and chills event added
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspepsia, Nasopharyngitis, SARS-CoV-2 test positive, Tinnitus
Clinical narrative: RINGING IN EAR; HEAD COLD; DIGESTIVE ISSUE; COVID POSITIVE; SHAKES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered to the left arm, on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced covid positive. On 20-MAR-2021, the subject experienced shakes. On 21-MAR-2021, the subject experienced digestive issue. On 22-MAR-2021, the subject experienced ringing in ear. On 22-MAR-2021, the subject experienced head cold. On 25-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes on 21-MAR-2021, and digestive issue on 23-MAR-2021, and had not recovered from head cold, covid positive, and ringing in ear. 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: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: RINGING IN EAR; HEAD COLD; DIGESTIVE ISSUE; COVID POSITIVE; SHAKES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered to the left arm, on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced covid positive. On 20-MAR-2021, the subject experienced shakes. On 21-MAR-2021, the subject experienced digestive issue. On 22-MAR-2021, the subject experienced ringing in ear. On 22-MAR-2021, the subject experienced head cold. On 25-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes on 21-MAR-2021, and digestive issue on 23-MAR-2021, and had not recovered from head cold, covid positive, and ringing in ear. 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: Injection site pain, Injection site swelling
Clinical narrative: LEFT FOREARM STARTED SWELLING; INJECTION SITE PAIN; This spontaneous report received from a patient 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) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left forearm started swelling. On 27-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left forearm started swelling, and injection site pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Headache, Peripheral swelling, Pyrexia
Clinical narrative: ARM FELT SWOLLEN; REDNESS ALL OVER; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, vaccinated on left deltoid, once a total administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced arm felt swollen. On 26-MAR-2021, the subject experienced redness all over. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm felt swollen on MAR-2021, and had not recovered from headache, fever, and redness all over. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: RASH ON HER LEGS; HIVES; ITCHING; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced itching. On 25-MAR-2021, the subject experienced hives. On an unspecified date, the subject experienced rash on her legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives, and itching, and the outcome of rash on her legs was not reported. This report was non-serious.