chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Disturbance in attention, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: he was having confusion /  he was in a fog/cloud all day  / confusion; fatigue /  went to bed early; a concerted effort to concentrate/ loss of concentration/ inability to focus/not quite tunnel vision / had to concentrate really hard / had to concentrate on everything / inability to concentrate; arm discomfort; he felt like he was in a fog; This case was reported by a nurse via call center representative and described the occurrence of confusion in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Pfizer Covid 19 shot (1st shot received on 1st December 2020). Concomitant products included COVID 19 VACCINE PFIZER.   On 1st April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2021, less than a day after receiving Shingrix, the patient experienced confusion, fatigue, concentration loss, arm discomfort and foggy feeling in head. On an unknown date, the outcome of the confusion, fatigue, concentration loss, arm discomfort and foggy feeling in head were recovered/resolved.   The reporter considered the confusion, fatigue, concentration loss, arm discomfort and foggy feeling in head to be related to Shingrix.  Additional details were reported as follows: The patient reported the case for himself.  He got the shot around 6 pm at a local pharmacy.  He did not experience any immediate problems during or shortly after the injection.  No problems that evening. He went to bed.  He woke up in the middle of the night due to left arm discomfort.  He woke up the next morning at his regular time.  He proceeded with his normal routine of drinking coffee and going to the pool to swim.  During his swimming he stated that he felt like he was in a fog.  He said that he really had to concentrate on swimming which was unusual because he swims every morning and normally did not have to think about it as he performs this routine task.  He described it as a heavy fog, a concerted effort to concentrate or loss of concentration or inability to focus or not quite tunnel vision. Then as he was driving and the whole time while he was at work he had to concentrate really hard.  He said he had to concentrate on everything like he was having confusion and this lasted through his whole work day and he could not wait to go home.  He said he was in a fog or cloud all day Friday 2nd April 2021 with confusion, inability to concentrate and fatigue.  When he came home he went to bed early.  He woke up Saturday 03rd April 2021 and felt good.  He did not have a fever or a rash or gastrointestinal symptoms.  The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder, Tunnel vision
Clinical narrative: he was having confusion /  he was in a fog/cloud all day  / confusion; fatigue /  went to bed early; a concerted effort to concentrate/ loss of concentration/ inability to focus/not quite tunnel vision / had to concentrate really hard / had to concentrate on everything / inability to concentrate; arm discomfort; he felt like he was in a fog; This case was reported by a nurse via call center representative and described the occurrence of confusion in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Pfizer Covid 19 shot (1st shot received on 1st December 2020). Concomitant products included COVID 19 VACCINE PFIZER.   On 1st April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2021, less than a day after receiving Shingrix, the patient experienced confusion, fatigue, concentration loss, arm discomfort and foggy feeling in head. On an unknown date, the outcome of the confusion, fatigue, concentration loss, arm discomfort and foggy feeling in head were recovered/resolved.   The reporter considered the confusion, fatigue, concentration loss, arm discomfort and foggy feeling in head to be related to Shingrix.  Additional details were reported as follows: The patient reported the case for himself.  He got the shot around 6 pm at a local pharmacy.  He did not experience any immediate problems during or shortly after the injection.  No problems that evening. He went to bed.  He woke up in the middle of the night due to left arm discomfort.  He woke up the next morning at his regular time.  He proceeded with his normal routine of drinking coffee and going to the pool to swim.  During his swimming he stated that he felt like he was in a fog.  He said that he really had to concentrate on swimming which was unusual because he swims every morning and normally did not have to think about it as he performs this routine task.  He described it as a heavy fog, a concerted effort to concentrate or loss of concentration or inability to focus or not quite tunnel vision. Then as he was driving and the whole time while he was at work he had to concentrate really hard.  He said he had to concentrate on everything like he was having confusion and this lasted through his whole work day and he could not wait to go home.  He said he was in a fog or cloud all day Friday 2nd April 2021 with confusion, inability to concentrate and fatigue.  When he came home he went to bed early.  He woke up Saturday 03rd April 2021 and felt good.  He did not have a fever or a rash or gastrointestinal symptoms.  The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Accidental exposure to product, Product preparation issue
Clinical narrative: received / Pediarix on April 5th 2021/ was reconstituted on April 2nd 2021 with the needle attached to it.; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st and 2nd dose on an unknown date).   On 5th April 2021, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 5th April 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 3rd dose of Pediarix which was reconstituted on 2nd April 2021 with the needle attached to it.  The vaccine was not discarded at the end of the workday and was inadvertently administered to the patient which led to wrong technique in drug usage process. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late second doses/first dose on March 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as an adult as per vaccine indication. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No information about lot number or patient details at the moment of the call. The reporter consented to follow up by email. This case has been linked with case US2021AMR077350, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077350:Same reporter, different patient
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient who received only the diluent component of Menveo; patient who received only the diluent component of Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA436A, expiry date 30th September 2022) for prophylaxis.   On 5th April 2021, the patient received Menveo. On 5th April 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The patient received only the diluent component of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. The reported batch number AMXA436A for Menveo did not exist and was updated to AMVA436A as per the sales database.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Chills, Pain, Pyrexia, Rash
Clinical narrative: aching; temp of 101.9 / fever; rash; blisters on his forehead; shivering; This case was reported by a consumer via call center representative and described the occurrence of pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bladder disorder. Concomitant products included COVID 19 VACCINE.   In March 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than a day after receiving Shingrix, the patient experienced pain, fever, rash, blister and shivering. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain, fever, rash, blister and shivering were recovered/resolved.   It was unknown if the reporter considered the pain, fever, rash, blister and shivering to be related to Shingrix.  Additional details were provided as follows: The patient had pre-existing conditions of bladder disorder. The concomitant medication included CBC drug for bladder disorder, COVID-19 vaccine for COVID-19 prophylaxis. The patient reported that he was vaccinated with Shingrix approximately two weeks ago. On the same day the patient experienced shivering, aching, rash and fever blisters on his forehead. The temperature was recorded on the same and found to be 101.9 degree F.  The patient took Tylenol for temperature as treatment medication. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: received / first dose / roughly a year ago! When COVID hit/ missed their second dose; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of shingrix received roughly a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination was not applicable to this report. The age group was not reported but captured as an adult as per vaccine indication. The pharmacist reported that the patient had not received the second dose of Shingrix due to Covid-19. HCP declined to provide date of birth and did not have any additional vaccine information as she was not at work. The reporter consented to follow up. The case is linked with US2021075986, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075986:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: Patient was given less or half the dose due to a needle malfunction; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   On 4th April 2021, the patient received the 2nd dose of Shingrix (unknown). On 4th April 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were received as follows: The age at vaccination was not reported but could be 75 or 76 years. The reporter stated that the patient was given less or half the dose due to a needle malfunction during the administration of the second dose, which led to accidental underdose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / September 22th 2020 / second dose has not been received yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The VAERS details were reported for the 1st dose. Till the time of reporting patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: WRIST SWELLING; 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: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced wrist swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wrist swelling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pyrexia, Vomiting
Clinical narrative: VOMITING; CHILLS; FEVER; DON'T FEEL WELL; 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 type 1 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 0451A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 16:00 PM for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced don't feel well. On 01-APR-2021 03:00 AM, the subject experienced vomiting. On 01-APR-2021 03:00 AM, the subject experienced chills. On 01-APR-2021 03:00 AM, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and vomiting, and the outcome of don't feel well was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: COUGH; CHILLS; FEVER; This spontaneous report received from a patient concerned a 47 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient was healthy. patient do not have any known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination at left arm.The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced cough. On 10-MAR-2021, the subject experienced chills. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) unknown, and COVID-19 rapid POC test (NR: not provided) unknown. Treatment medications (dates unspecified) included: paracetamol, benzonatate, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and cough was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Muscle twitching, Musculoskeletal stiffness, Neck pain, Vertigo
Clinical narrative: FELL; ROOM SPINNING; DIZZY SPELL WHEN HE LOOKS DOWN MORE THAN 5 SECONDS/ DIZZINESS UPON GETTING UP FROM LYING DOWN/LIGHTHEADEDNESS; HAVE NOT BEEN ABLE TO SLEEP; UNCONTROLLABLE STIFFNESS IN THE LEFT SIDE OF NECK; UNCONTROLLABLE PAIN IN LEFT SIDE OF NECK; UNCONTROLLABLE PAIN IN THE LEFT SHOULDER JOINT; UNCONTROLLABLE MUSCLE TWITCHING IN THE LEFT ARM; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included right shoulder surgery. 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 16-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced uncontrollable muscle twitching in the left arm. On 17-MAR-2021, the subject experienced uncontrollable stiffness in the left side of neck. On 17-MAR-2021, the subject experienced uncontrollable pain in left side of neck. On 17-MAR-2021, the subject experienced uncontrollable pain in the left shoulder joint. On 19-MAR-2021, the subject experienced have not been able to sleep. On 29-MAR-2021, the subject experienced dizzy spell when he looks down more than 5 seconds/ dizziness upon getting up from lying down/lightheadedness. On 29-MAR-2021, the subject experienced room spinning. On 01-APR-2021, the subject experienced fell. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrollable pain in the left shoulder joint, uncontrollable stiffness in the left side of neck, uncontrollable pain in left side of neck, have not been able to sleep, dizzy spell when he looks down more than 5 seconds/ dizziness upon getting up from lying down/lightheadedness, uncontrollable muscle twitching in the left arm, and room spinning, and the outcome of fell was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: FEVER; HEADACHE; PAIN AT THE SITE; MUSCLE ACHES; STIFFNESS RIGHT AWAY, LEFT SIDE OF THE NECK AND BACK DOWN TO THE ELBOW; This spontaneous report received from a patient concerned a 55 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 in left arm (Deltoid) for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced stiffness right away, left side of the neck and back down to the elbow. On 31-MAR-2021, the subject experienced muscle aches. On 31-MAR-2021, the subject experienced pain at the site. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle aches, and headache, and the outcome of pain at the site and stiffness right away, left side of the neck and back down to the elbow was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEEL ICKY; 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, in arm 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 feel icky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feel icky was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Headache, Nausea
Clinical narrative: BRUISING; FREEZING; PERSISTENT SORENESS; NAUSEOUS; HEADACHE; DIZZINESS; LIGHTHEADEDNESS; THROBBING; DIDNOT SLEEP LAST NIGHT; 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 past medical history included hysterectomy, migraines, blood transfusion-anemia, and FE infusion, and concurrent conditions included abstains from alcohol, cigarette smoker, penicillin allergy, and epilepsy keppra cause plaque psoriasis, and other pre-existing medical conditions included patient did not 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 14:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced throbbing. On 31-MAR-2021, the subject experienced lightheadedness. On 31-MAR-2021, the subject experienced did not sleep last night. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced nauseous. On 31-MAR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced persistent soreness. On 01-APR-2021, the subject experienced freezing. On an unspecified date, the subject experienced bruising. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide, diazepam, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness, dizziness, and headache on 01-APR-2021, was recovering from nauseous, had not recovered from persistent soreness, throbbing, and freezing, and the outcome of didnot sleep last night and bruising was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Injection site haemorrhage, Injection site pain
Clinical narrative: METALLIC TASTE; TASTE BITTER; Injection site bleeding; Injection site stinging; 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 j and j national consumer product (form of admin and route of admin were not reported, batch number: Unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. 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 MAR-2021, the subject experienced metallic taste. On MAR-2021, the subject experienced taste bitter. On MAR-2021, the subject experienced injection site bleeding. On MAR-2021, the subject experienced injection site stinging. The action taken with covid-19 vaccine ad26.cov2.s, and j and j national consumer product was not applicable. The outcome of the injection site stinging, metallic taste, taste bitter and injection site bleeding was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 and expiry date: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion, Rhinorrhoea
Clinical narrative: RUNNY NOSE; CONGESTION; COUGH; HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included lovenox allergy, and concurrent conditions included immunocompromised, penicillin allergy, latex allergy, tape allergy, and berries allergy/blueberries allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, 1 total administered on 30-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced runny nose. On 01-APR-2021, the subject experienced congestion. On 01-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 01-APR-2021, and had not recovered from runny nose, congestion, and cough. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: GOT EVERY SINGLE SYMPTOM; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced got every single symptom. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got every single symptom was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS (NO FEVER BUT BODY PAIN); FEELING MISERABLE; 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 tylenol unspecified (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 31-MAR-2021 for flu like symptoms, and feeling miserable. 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 30-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 31-MAR-2021, the subject experienced flu like symptoms (no fever but body pain). On 31-MAR-2021, the subject experienced feeling miserable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol unspecified was not reported. The outcome of the flu like symptoms (no fever but body pain) and feeling miserable was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Chest pain, Chills, Discomfort
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site pain, Insomnia
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Pyrexia, Skin discolouration, Tinnitus
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Toothache
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Bone pain, Burning sensation
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Coordination abnormal, Cyanosis, Diarrhoea
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Dizziness, Dyspnoea, Dysstasia, Ear discomfort
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die 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.