chrisvoncsefalvay/vaers-outcomes huggingface dataset:
METALLIC TASTE APPEARED, WHICH PATIENT NOTICED WHEN DRINKING WATER,; FEVER; HEADACHE; FEELING OFF; BODY ACHES; CHILLS; NAUSEA; NOT BEEN ABLE TO EAT OR DRINK AS MUCH AS NORMAL; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, and marijuana, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070) dose was not reported, administered on 11-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 01-FEB-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 11-MAR-2021, the subject experienced not been able to eat or drink as much as normal. On 11-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.8 (units unspecified). On 11-MAR-2021 17:00, the subject experienced feeling off. On 11-MAR-2021 17:00, the subject experienced body aches. On 11-MAR-2021 17:00, the subject experienced chills. On 11-MAR-2021 17:00, the subject experienced fever. On 11-MAR-2021 17:00, the subject experienced headache. On 12-MAR-2021, the subject experienced metallic taste appeared, which subject noticed when drinking water. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 12-MAR-2021, had not recovered from nausea, metallic taste appeared, which patient noticed when drinking water, and headache, and the outcome of not been able to eat or drink as much as normal and feeling off was not reported. This report was non-serious.
(R) deltoid with redness, swelling & tightness, warm to touch, itching. (L) deltoid with redness, swelling, warm to touch, itching.
Sore arm; upset stomach; Aches; Very high fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (Aches), PYREXIA (Very high fever) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399105, 011M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (Aches), PYREXIA (Very high fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (Aches), PYREXIA (Very high fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-375328, MOD-2021-375313 (Patient Link).
Started having fever in the night of the day of vaccination. Fever lasted 3 days. Took tylenol and rested. At same time, upper arm in broad area around injection site turned red, was warm to the touch and arm was sore around site. Iced arm. It took an entire week for the arm to return to normal. Arm was also itchy.
Vomiting and Nausea from 0100 28 DEC til 0900 30DEC
General vaccinia, sores in mouth, swollen lymph nodes, cellulitis of site, severe headache, rash to back and face.  Given in ER, Ancef 1 gram IV, Decadron 4 mg IM, Depromedrol 80mg IM. Keflex 500 mg to go (script), Darvocet (script), Benadryl, Medrol dose pack to go.
Tingling in her throat; mild swelling in the face; This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing skin itching. Concomitant medication included loratadine (CLARITINE) taken for skin itching, start and stop date were not reported. The patient received the vaccine first dose in morning and in the afternoon reported mild swelling in the face and tingling in her throat on an unspecified date. She happened to go to the dentist that afternoon. The dentist referred patient to local ER. By time she got to the ER and had the examination the doctor did not notice any anaphylaxis reaction, no bradycardia symptoms so he sent her home and gave her Benadryl and after that was fine. Reporter's concern is with second dose of Pfizer-BioNTech COVID-19 Vaccine the doctor is concerned about possible anaphylaxis that has been reported. The patient recovered from the events on an unspecified date.   Information on the lot/batch number has been requested.; Sender's Comments: The reported pharyngeal paraesthesia and swelling face were likely causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship, and the clinical course of the events.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Received 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number XG7RF) for prophylaxis.   On 14-MAR-2023, the patient received the 3rd dose of Shingrix. On 14-MAR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Received 3rd dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 14-Mar-2023 The reporter consented to follow-up. The patient received a third dose of Shingrix, which led to extra dose administered.
beta protein fractions slightly elevated; This is a spontaneous report from a contactable physician. A male patient (physician's friend) of an unspecified age received first and second both doses of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter states he was a physician, an infectious disease specialist, states a friend of his received both doses of Pfizer Covid vaccine, states his friend also routinely donates plasma, states for the last two times, the plasma center has informed him that his beta protein fraction is slightly elevated. Reporter wants to know if the mRNA vaccine causes the beta protein fractions to be slightly elevated. The patient underwent lab tests and procedures which included beta protein fractions slightly elevated. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
increased sweating after receiving first dose; spotting about two weeks after she received the first dose.; She has had increased swelling since she received the first dose; She feels like she is going through menopause.; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613, NDC number and Expiry Date are Unknown), via an unspecified route of administration, administered in Right arm on 23Mar2021 at the age of 71-years-old as dose 1, single for covid-19 immunisation. The patient's medical history including any illness at time of vaccination included Diabetes from 1976 and ongoing, it started as gestational diabetes on unspecified date. It is controlled by diet. She can only hear out of one ear from an unspecified date. Confirmed that this started prior to getting the vaccine. She hasn't seen her doctor about this. She was sweating a little prior to getting the first dose of the vaccine. AE(s) following prior vaccinations included Vaginal bleeding on an unspecified date. Family medical history relevant to AE(s) included Her mother passed away 05May2020 from Covid. She also had a heart condition and hypertension from unspecified date. Her father died of cancer on an unspecified date. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported, unspecified anti-diarrheal medications and unspecified effervescent pain reliever medication from unspecified date. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Relevant tests were none. On an unspecified date in Mar2021, the patient experienced increased sweating after receiving first dose. On an unspecified date in 2021, she started spotting about two weeks after she received the first dose. It stopped and then started again last night. It was not profuse bleeding. She never had symptoms of menopause. On an unspecified date in 2021, she has had increased swelling since she received the first dose. She felt like she was going through menopause. AE(s) did not require a visit to Emergency Room or Physician Office. Reporter seriousness for increased sweating after receiving first dose was unspecified. The outcome of events, increased sweating after receiving first dose and spotting about two weeks after she received the first dose was not recovered while other events was unknown.  No follow-up attempts are needed. No further information is expected.
bladder spams starting ~6 hours post vaccination requiring treatment with oxybutynin, Uro-MP and acetaminophen. Patient called MD post vaccine with symptoms (vaccine not administered at MD, but is established patient here). Patient discussed with MD over phone.
I lost consciousness and felt down in 9 hours after I got second shot of vaccine; fever/I also had fever for 2 days after vaccination; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 30-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0196, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 21Jun2021 at 11:00 am (age at vaccination was 30 years) as 2nd dose, single for COVID-19 immunization. The patient did not have any medical history. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0180, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 31May2021 at 12:00 pm (age at vaccination was 30 years) as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Jun2021 at 08:00 pm, the patient lost consciousness and felt down in 9 hours after she got second shot of vaccine, she also had fever for 2 days after vaccination. No treatment was received for the adverse event. The device date was reported as 22Jun2021. The case was reported as non-serious. The outcome of the events was resolved on an unspecified date in Jun2021.  No follow-up attempts are possible; No further information is expected.
emergency department at an outside hospital on November 24.  She was found to be hypoxic and to be positive for SARS-CoV-2.  She was started on nasal cannula oxygen with improvement in her hypoxia.  She was started on remdesivir and dexamethasone.  Respiratory status declined further and she required initiation of noninvasive ventilation and high-flow nasal cannula oxygen.
Covid vaccine given after the adjusted use-by date but before the official expiration date. There was no adverse event per, local health dept instructed us to file this report anyway.
I have had Covid twice, with one time being after fully vaccinated; I have had Covid twice, with one time being after fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: I have had COVID twice. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have had Covid twice, with one time being after fully vaccinated".  Additional information: The patient stated that he appreciated the message in the video although he had not gotten a booster for COVID. he was not sure he wanted to do it, as some people he knew had received it and have had negative reactions such as actual COVID symptoms that were moderate to severe. He has had COVID twice, with one time being after fully vaccinated [with the Pfizer COVID-19 vaccine].  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Still positive with a light line on 24Jul; Still positive with a light line on 24Jul; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing); "Overweight" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Still positive with a light line on 24Jul". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Unknown results; Computerised tomogram: (unspecified date) good; Electrocardiogram: (unspecified date) good; Fibrin D dimer: (unspecified date) elevated; SARS-CoV-2 test: (19Jul2022) Positive; (25Jul2022) Positive; X-ray: (unspecified date) good. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
Began having flu-like symptoms about 4 hours after injection.  Awoke in the night with severe aches and fever, like the worse case of flu I?d ever had.  Much better the second day, but still aches and pains and don?t feel like doing much of anything.  (I was fine with the first dose of Shingrix...just a little arm pain).
2 days after receiving ZOSTAVAX vaccine patient developed a 3inch diameter raised welt at the injection site. Patient denies pain or itching at present.
Pt tested positive for COVID after receiving 2 doses of Pfizer - received Regeneron monoclonal antibody
Client shaking followed and stated he felt anxious. MD advised client to wait in observation area for extended observation. Client developed  persistent dry non-productive cough. 50mg/1ml Benadryl ordered. Client symptoms improved. Client wife came to site to drive client home. Client declined transport to ER.  Client advised that if symptoms worsen to seek emergency services.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 13-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 10x1 single dose vial injection (lot #K009482, expiry date 06-MAR-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified), lasting for 24 hours, with the lowest recorded temperature of 9 degrees Fahrenheit (also reported as 9 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Mild fever.  Small red bumps on his back (Sunday, July 11) the next day  (Monday July 12) the bumps spread to his belly. Today (Tuesday July 13) the bumps have already to his face and scalp.
MESSED UP SINCE TOOK VACCINE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced messed up since took vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of messed up since took vaccine was not reported. This report was non-serious.
Local reaction with marked swelling and induration of deltoid muscle; noted erythema of overlying skin. Painful use of deltoid muscle.
pt recvd vax approx 12,11 & 6 mo ago;reported to have bilateral subcutaneous atrophy at inject site;
c/o soreness at site. Upper arm swollen. Took pain medication, applied ice.
pt had unusual rash over entire body;rash on face;pt taken to ER;pt had little red dots;dot changed to patches of rash;patches then blood red & raised in center;pt had erythema marginatum pruritic angioedema secondary to vax;
A week after receiving the vaccine, I developed a rash at the site of the injection which traveled down my right arm, rash on left arm and rash on my right breast. The next morning I woke up with a rash on my neck. I was sick in bed for the next 2 days....nauseous, chills, no appetite, no energy, slept most of the 2 days. This continued into the 3rd day (Monday), and I started to develop pain in my chest. By Wednesday, the pain had increased and I was feeling worse physically. I went back to the Dr's, did an EKG which was unremarkable. I was sent out for a chest x-ray to rule out pneumonia and for blood work. By Thursday, I was in excruciating pain throughout my entire chest cavity, it traveled to my neck and my breathing became affected...it hurt to breath. I tried my best to just sit still because any little movement activated the pain. My chest felt very full and heavy and eventually my neck became stiff. At times I had a burning sensation in my neck as well. I also had difficulty raising my arms.
Providers note: History of Present Illness: 59yo female who presents today for shoulder pain. She reports that she started with some pain after receiving the MMR vaccine in her left arm on 9/17. She received the vaccine around the triceps. 1 week later she started to get pain into her shoulder and radiated down to her left hand and fingers. Sometimes she can lift her hand and other times she cannot. When she tries to lift things, she feels discomfort. Since she is using her right hand more, she is feeling pain now in the other shoulder. She feels a burning sensation. She got her second dose on her right shoulder and has not had the pain here. She does household activities routinely (clean counters, wash dishes, cook, make beds, vacuum every week, laundry). She does not lift push or pull anything heavy. Feels like it is an ache like rolling her ankle.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. Information about patient's medical history was not provided. On 17-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, indication, route of administration and lot # were not specified) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
metalic taste in mouth ,  dry heaves - ache all over pain from arm to leg to ankle , chills , burning up
Left arm (deltoid-DTaP site IM given) red swollen, warm to touch 2 days post immunization, Keflex 250 mg PO TID x 5d
pt recvd vax; devel fever, myalgia & fatigue which resolved in 2-3 days;also devel rash which has not resolved;biopsy of rash showed hypersensitivity vasculitis;
This spontaneous report as received from a 29 year old male physician (who is also a patient) with asthma and with no drug reactions or allergies, refers to himself. On 21-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # K009105 with expiry date: 21-JAN-2016; strength, dose and route of administration unspecified). Concomitant therapies included ADVAIR and corticosteroids (unspecified). It was reported the patient subsequently had a positive anti-double-stranded DNA (anti-dsDNA) test for auto-immune disease on an unspecified date in 2014. His anti-dsDNA titer was originally 24 and then was 26 (units not provided) upon re-testing. The physician stated all other unspecified testing had been normal. The patient sought medical attention (unknown type) but no treatment was given. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
PT. REC. A VARICELLA VACC. RT ARM SUBCUT ON 4/3/08. PT HAD ITCHING ON 4/4/08. PARENT CALLED OUR OFFICE AND WAS ADVISED TO BRING PATIENT IN SO THAT WE COULD SEE HER RT ARM. I MEASURED HER RT ARM SUB CUT AND IT MEASURED 7MM X 6MM SHE HAD REDNESS WITH SWELLING AS WELL AS ITCHING. PARENT WAS ADVISED TO GIVE MOTRIN OR TYLENOL FOR PAIN AND TO USE CORTISONE CREAM AND AND GIVE BENADRYL FOR THE ITCHING. PER RN -
Papular rash buttocks, extensor surfaces arms/legs, purpuric lesions, nonblanching, pains/sores. No fever, slight irritability.