chrisvoncsefalvay/vaers-outcomes huggingface dataset:
today she is fine; horribly in discomfort; arm is extremely sore; nausea/all those symptoms that were on the website; chills/all those symptoms that were on the website; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (today she is fine), DISCOMFORT (horribly in discomfort), MYALGIA (arm is extremely sore), NAUSEA (nausea/all those symptoms that were on the website) and CHILLS (chills/all those symptoms that were on the website) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced DISCOMFORT (horribly in discomfort), MYALGIA (arm is extremely sore), NAUSEA (nausea/all those symptoms that were on the website) and CHILLS (chills/all those symptoms that were on the website). On 13-Sep-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (today she is fine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (today she is fine), DISCOMFORT (horribly in discomfort), MYALGIA (arm is extremely sore), NAUSEA (nausea/all those symptoms that were on the website) and CHILLS (chills/all those symptoms that were on the website) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
At exactly 12 hours after the 2nd dose, I had nausea which caused me to vomit 3 times, over the course of 3 hours. I had some chills and felt like I had a fever. The next day was followed by body aches and a slight headache. The day after that I had gastrointestinal discomfort and diarrhea. Today, 3 days after my 2nd dose, I have a strange almost burning sensation in my throat and down to my lungs- as though I have inhaled a cigaret and have the urge to cough. This started late yesterday evening and continued through today.
3-4 days after vaccination, she developed a rash which started on her legs and has spread to her back, arms, and hands. Rash consist of quarter size red- purple blotchy spots which are not raised and do not itch.
Adult patient received undiluted pediatric formulation of pfizer COVID vaccine. As of 24 hrs after vaccination, pt reports mild arm soreness and headache, but no other s/sx.
Smell an odor on his skin, on his clothing in his urine, and in his mouth; Smell an odor on his skin, on his clothing in his urine, and in his mouth; an acid like taste in his mouth after second vaccine; This is a spontaneous report received from a contactable consumer (reporting on himself). A 57-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733 and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 10Apr2021 13:45 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not re-ported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine includes first dose of BNT162B2 on 20Mar2021 for COVID-19 immunization. It was reported that he was trying to find out if this was a reaction, from the vaccine. He got his first vac-cine on 20Mar2021 and his second vaccine on 10Apr2021. Patient states 3 days after his second vaccine, he noticed a smell, like a smell of medication. He can smell an odor on his skin, on his clothing in his urine, and in his mouth, described as an acid like taste in his mouth after second vaccine. Patient went to the emergency room and he had blood work done and a urinalysis and the results were normal. Patient states he has had intravenous medications before and he has never tasted or smelled those medications. He asks if anyone was reporting this specific event and how long will it last. He has taken medications for years and never had a problem and stated his medication are not relevant to report. Patient still secreting this smell, since 13Apr2021 and asking asks why is he secreting this smell. Patient asks if the vaccine was coming out of his pores. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
5/20/21: - I received my 2nd dose of Pfizer vaccine - I had severe chills and fever for two days 5/23/21: -  Chills & fever subsided, but I woke up with a severe headache that lasted all day long despite taking ibuprofen  5/24/21: - Headache continues so I called the Doctor, am told it?s a vaccine symptom that should subside in a couple days & get prescribed Naproxen for the pain 5/28/21:  - I try to ween off the medication, but the migraine is still there and now throbbing worse than ever - I call the Doctor again, this time I?m advised to get my eyes checked out and make an appt. with my primary physician  5/29/21: - Eye exam came back healthy and normal 6/1/21: - Went to appt. with PCP and she sends me for a STAT emergency MRI that day - Get MRI scans done at 8pm - Get a call personally from primary physician at 11:30pm saying one scan is inconclusive and sends me for an emergency CTB scan at the ER immediately  6/2/21: - Two CTB scans are completed at 2am - At 4am we are seen by doctor who admits me and says he wants to contact a neurologist specialist  - Neurologist comes in at 8:30am and tells me I have been diagnosed with a rare mild blood clot in my brain - Put on Eliquis blood thinner for 6 months & ButalBital Acetaminophen for migraine pain relief 6/9/21: - Met with hematologist to go over blood test results, told I am a carrier for the Factor 2 Gene Mutation
pass away/he died; couldn't breathe; kidney dialysis fail; kidney stops; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included had a stroke year before 2020 so he was weak. Concomitant medications were not provided. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as single dose for COVID-19 immunization. The patient's wife called on behalf of the patient seeking compensation due to the Pfizer-BioNTech Covid-19 Vaccine. It was stated patient 19Apr2021 they had the second vaccine together. And on Tuesday 1pm (in 2021) ambulance came in and got patient cause he couldn't breathe, and they sent him to privacy hospital cause the kidney dialysis fail. They went in the morning 8'clock they go in there and they call 8:30 patient pass away in 2021. Patient had a stroke year before 2020 so he was weak they push him, and walk him, exercise and all kind of things. They didn't warn that not supposed to have a second vaccine so patient and wife went no more a week later, 2 weeks, patient and wife had first and second shot and then patient went #. When patient died and his kidney stopped. Events reported as hospitalized in 2021. The outcome of the event pass away/he died was fatal, while of the other events was unknown. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: pass away/he died
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified doses of improperly stored PNEUMOVAX23 (lot# K019561, expiry date 20-APR-2016, strength, dose and route were unspecified). No adverse effects had been reported. This is one of several reports received from the same source. Additional information has been requested.
I experienced high fever (that went the date of the vaccination and three days later with a high fever and stomach pain, I went to see my doctor and he said that it could be Transverse Diverticulitis (part of my colon was inflamed) and prescribed Amoxicillin which is making my symptoms subside.
Parents noticed rash on upper arm and redness size of 50 cent piece.  Parents gave Benadryl 1 dose.
rapid heart rate while resting; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart rate while resting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (rapid heart rate while resting). At the time of the report, HEART RATE INCREASED (rapid heart rate while resting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter. No concomitant medications were provided by the reporter.
Wheezing, tightness in chest, red watery eyes, headache, muscle soreness.
bodyaches; headache; fatigue; redness at the injection site which went down past elbow and a low grade fever, diagnosed with a "skin infection"; upset stomach; This spontaneous report was received from a 62-year-old female patient reporting on herself.   The patient's medical history included ear infections and sinus infections. The patient's concurrent condition included high blood pressure. The patient's concomitant medications included propranolol and hydrochlorothiazide, losartan potassium (HYZAAR). The patient was allergic to cefaclor (CECLOR), clarithromycin (BIAXIN), unspecified generic for azithromycin (ZITHROMAX), unspecified preservatives, thimerosal (MERSOL), and neomycin sulfate (MYCIFRADIN).  On 25-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, route, dose and frequency were unknown) (lot # R031812 and expiration date: 26-SEP-2020) for prophylaxis (also reported as " I am prone to ear infection and sinus infections and I am a teacher and my doctor thought it would help my immune system"). On same day, later at night, the patient experienced redness at the injection site which went down past her elbow, a low-grade fever, body aches, headache, upset stomach, and fatigue. As treatment the patient saw her physician on 27-JUN-2019 and was diagnosed with a "skin infection" and was prescribed with cephalexin (KEFLEX) (500mg, four times a day). Treatment also included unspecified blood work which showed "white blood cell count was up a little bit". The patient requested a lot check of the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient reported that her symptoms resolved on 30-JUN-2019. The causality assessment for all the events was not provided.
Tongue swelled up and felt tingly 50 minutes after Pfizer vaccine dose #1 administered. Admitted to ER. Tongue swelling subsided 90 minutes after vaccine administered. Tongue tingling subsided 2.5 hours after vaccine administered.
Sweating, fever, upset stomach, soreness locally at injection site: advanced to chronic muscle tenderness, lowered shoulder mobility in the injected shoulder.  Pt reports it is difficult to sleep at night on her side.
Patient called today 4/26/21 about her arms still feeling sore or throbbing sensation.
Patient was a 15 yo female. She came with her mother to get the 1st Pfizer vaccine. She was fine the vaccination room. However, after 15 minutes after the vaccine, she started to having a shortness of breath. Her face started to turn pale, she ended up passing out for 2 second which also led to 2-3 seconds of seizure. Two minutes after the event, she still look tired, mother ask to call 911. Paramedic came and check on patient as well as conducting a series of questions. After roughly 15 minutes, paramedic left and patient's mother refused to transport to the hospital. Paramedic inform patient to check with pediatric as soon as possible.  Patient looked okay and back to normal state.
Got very anxious prior because of past issues with tetanus shot (similar symptoms), then felt extremely dizzy, blurred vision, momentarily fainted and then threw up about 3 times in the parking lot
Patient has never had a pfizer vaccine and came for pfizer vaccine dose 1, instead given pfizer bivalent by provider on duty instead in error.
It gave me shingles and I got the vaccine/suspected vaccination failure; shingles next to my hip; feels like a burning like it was electricity; couldn't put on my clothes; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation and activities of daily living impaired were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine last year and had shingles next to hip and it felt like a burning like it was electricity and the patient could not put on his/her clothes. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding, primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
URI, over the counter original Mucinex, humidifier at night when sleeping. Symptoms lasted 2 weeks and fully recovered.
Developed vasculitis on her skin on her legs two weeks after covid vaccine #1 (first) Has no history of vasculitis prior to vaccine. No Hisotry of vascular problem patient saw dermatologist on 2/24/21 for treatment was treated in our office on 3/31/21
Pt recvd MMR vax & subsequently became flaccid; flaccidity progressed to paralysis of upper extremities; @ the time of report, pt had improved; Additional info had been requested;
I had severe pain in my lower side of my sternum and my ribs and progressed to my spine. My blood was very low at the time.
Nerves pain, severe chills within 48 hours after vaccination. Chest pressure and occasional heart rate raising for the following days
Instantly nauseas and exhausted, missed menstrual period. Once menstrual period arrived late, the bleeding has not stopped for 30+ days. Golf-ball sized clots are coming out of my uterus, I feel like I'm constantly going to pass out, and I'm soaking through more than 3 tampons per hour. I am struggling to take care of my kids and keep my job.
Received the vaccine at 1600 on 13 Jan 2021. At approximately 0700 on 14 Jan 2021, I noticed redness and swelling directly below injection site. It was tender to the touch but painless otherwise. At approximately 1400, the swelling began to burn without touching, causing discomfort and pain. Moving my arm causes pain at swollen area.
Client received varicella vaccine in 2003. Developed S/S chicken pox 12/10/07.
Backache; Aches and Pains all over her body/Sore all over; Chills; Little fever; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), MYALGIA (Aches and Pains all over her body/Sore all over), CHILLS (Chills) and PYREXIA (Little fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008BZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021 at 2:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced BACK PAIN (Backache), MYALGIA (Aches and Pains all over her body/Sore all over), CHILLS (Chills) and PYREXIA (Little fever). At the time of the report, BACK PAIN (Backache), MYALGIA (Aches and Pains all over her body/Sore all over), CHILLS (Chills) and PYREXIA (Little fever) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-059900 (Patient Link).
Moderna vaccine (NDC 8077-0273-98) lot # 039D21A + GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted Manufacturer Moderna = no need to repeat the dose.
Severe migraine and nausea lasting 4 days, Vomiting lasting 2 days, pains at the injection site, Heart rate increase to 138 bbm. cold sweats, minor tremors. Prescribed anti nausea medication and OTC Tylenol.
Fever 102, chills, nausea , severe left arm pain.  Unable to move arm above chest after 1 week. Other symptoms subsided after 24 hrs.  Fever, chills etc.  arm pAin continued.
SWEATING; LEG WARM TO TOUCH; MUSCLE BULGING DUE TO THE CONTRACTIONS; FREEZING; ON AND OFF HEADACHE; FEVER; SEVERE LEFT LEG CRAMP; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: leg cramps. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced severe left leg cramp. On 14-AUG-2021, the patient experienced sweating. On 14-AUG-2021, the patient experienced freezing. On 14-AUG-2021, the patient experienced leg warm to touch. On 14-AUG-2021, the patient experienced muscle bulging due to the contractions. On 14-AUG-2021, the patient experienced on and off headache. On 14-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, severe left leg cramp, sweating, freezing, leg warm to touch, on and off headache, and muscle bulging due to the contractions. This report was non-serious.
Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs. Finally back to bed to continue with violent shakes. fever, aches and head aches lasting until late Thursday afternoon. Exhausted feeling still remaining through Saturday. Felt myself on Sunday 1/24
daughter had a blood after the vaccine was administered; daughter had a blood after the vaccine was administered; daughter had a blood after the vaccine was administered; This is a spontaneous report from contactable consumer (patient father) from a Pfizer sponsored program .  A 14-year-old female patient received first dose of bnt162b2 (PFIZER COVID 19 VACCINE, Solution for Injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date at a 1st dose, single dose; patient received second dose of bnt162b2 (PFIZER COVID 19 VACCINE, Solution for Injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date at a 2nd dose, single dose, both doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced daughter had a blood after the vaccine was administered on an unspecified date. Reporter called for his 14 year old daughter who got the second dose of the vaccine (Unspecified Medication) yesterday, now he said that when it was administered, the one who administered the vaccine said that he hit a blood vessel and his daughter had a blood after the vaccine was administered (on an unspecified date). The reporter had a question whether they need to watch out for others signs or side effects that might arise since a blood vessel that was hit when the vaccine was administered and if there was something that they need to concerned with. Reporter stated patient was not really having any major side effects right now. Reporter just had a question whether they should be concerned for having hit the blood vessel. Outcome of the events was unknown.  Information about Lot Batch number has been requested.
17 year-old was administered Flublok/No AE; Initial information was received on 11-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 17 year old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment, vaccination and family history were not provided.   On 31-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1951, expiry date-30-06-2020 via unknown route in the left deltoid.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
immediately after - sharp pain in left side of neck and head 2 hours later - left side of body numb and tingling - left side of face, left shoulder, left arm, left hand 4 and 5 digit, left hip, left knee, left ankle 1st and 2nd toes all numb and tingling face red and slightly
Sleepy; dizziness; Nausea; trembling; not feeling very well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), NAUSEA (Nausea), TREMOR (trembling), MALAISE (not feeling very well) and SOMNOLENCE (Sleepy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant product use was not reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (Nausea), TREMOR (trembling) and MALAISE (not feeling very well). On 16-Apr-2021, the patient experienced SOMNOLENCE (Sleepy). At the time of the report, DIZZINESS (dizziness), NAUSEA (Nausea), TREMOR (trembling), MALAISE (not feeling very well) and SOMNOLENCE (Sleepy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-079302, US-MODERNATX, INC.-MOD-2021-079291, US-MODERNATX, INC.-MOD-2021-079429, US-MODERNATX, INC.-MOD-2021-079429, US-MODERNATX, INC.-MOD-2021-079441 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079302: US-MODERNATX, INC.-MOD-2021-079291: US-MODERNATX, INC.-MOD-2021-079441: