chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included palindromic rheumatism and sulfonamide allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number; ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. The patient experienced swelling in ankles and in feet most severe on left side on 08Apr2021 at 17:00. The patient did not receive any treatment for the events. The clinical outcome for events swelling in ankles and in feet was resolved on unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
Slight swelling, Itching, & very low grade fever. Slept little early. Next day symptoms were gone & I was back to normal.
Covid vaccine monitoring documentation. PT admission 1/14/22 ? 1/25/22. COVID-19, mRNA, LNP-S, PF, 100 mcg/ 0.5 mL dose (MODERNA) 04/17/2021 lot 038B21A. COVID-19, mRNA, LNP-S, PF, 100 mcg/ 0.5 mL dose (MODERNA) 5/15/2021 lot 002C21A.
On four days, starting on 4/30/21 and through 5/7/21, and on two additional days, one  1 week later another two weeks after that, I had the following symptoms: Nausea, diarrhea, stomach discomfort, mild headache, malaise and fatigue They were bad enough to miss work on the days that fell during the workweek.
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored multiple doses of GARDASIL 9 lot # M016193, expiration date: 24-APR-2018 (dose was not provided). There were no adverse effects reported. Administered doses of vaccines were stored in a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit for 120 hours. Digital data logger was used to capture temperature excursion. There were no previous temperature excursions. Sender's Comments: US-009507513-1709USA015134.
diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 - 99.4; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Mar2021 09:30 (lot number: EN6204) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, migraines, and thyroid disorder. The patient's concomitant medications included cyclobenzaprine, levothyroxine, telmisartan (TELMI), and topiramate (TROKENDI XR). The patient previously took erythromycin and morniflumate (FLOMAX) and experienced allergies to both. The patient experienced severe stomach cramping, diarrhea with bright red blood, extreme nausea, back cramps, temperature range 97.4 - 99.4, so sick and she had to lay on bathroom floor throughout night on 10Mar2021 20:00. There was no other vaccine in four weeks. The patient was not pregnant at the time of report. Prior to vaccination, patient has no COVID and patient was not tested for COVID post vaccination. The vaccination facility type was  Health Department. The outcome of the events were recovering.
No additional AE.; an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-SEP-2022, the patient was vaccinated with improper stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W017567, expiration date reported as 29-DEC-2021, but upon internal validation established as 29-NOV-2023, administered for prophylaxis (dose, strength, and route of administration were not provided) (product storage error). The vaccine was exposed to the temperature excursions: -11.8 Degrees Celsius for 1 hour and 45 minutes. There was no previous temperature excursion. No additional adverse event. No product quality complaint.
Myocarditis/pericarditis (chest pain, palpitation, shortness of breath)
Patient came for 1st dose COVID-19 vaccine today. Patient denied having any vaccine reaction prior to today. Patient briefly convulsed and passed out post vaccination. Reaction was immediately and woke up a few seconds shortly after his name was called a couple times by the vaccinator. Patient admitted that he was very nervous and scared of needle, but denied ever experience fainting and convulsing. Patient was instructed to sit in the pharmacy for 30 minutes for observation. He rejected our offer to call EMT/Paramedics and for someone else to pick him up instead of driving himself. Patient received 4 cups of water from pharmacy. When he left at 30 minute mark, he was stable.
Headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Apr2021 08:15 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Verbatim: High Blood Pressure. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 10Apr2021, outcome "recovered" (12Apr2021), described as "Headache"; CHILLS (non-serious) with onset 10Apr2021, outcome "recovered" (12Apr2021), described as "Chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia neuropathy from L deltoid to L elbow treated with  ice. Patient is a provider and monitoring her own treatments.
The evening of day 11 post vaccine I noticed my L upper arm was itching.  The next day there was a large warm, red and very itchy area surrounding the site of my second Covid vaccine.  I researched this and found that this had been reported but it was rare.
No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from other health care professional referring to a 4-year-old male patient. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 13-JAN-23, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W008711 has been verified to be a valid lot number, expiration date: 14-MAR-2024) (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported), and with diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (dose, route of administration, vaccination scheme frequency, anatomical location, indication, lot number, and expiration date were not reported). The administered doses of the vaccines experienced a temperature excursion at -10.5 degrees Celsius for 1 hour and 34 minutes. It was not mentioned if there was a data logger implied. There was no previous temperature excursion. No additional adverse event (AE) reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA010765:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunization; 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 immunization. The patient had no relevant medical history. Concomitant medication(s) included: BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Mar2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective and covid-19. Clinical information: It was reported that the patient had positive COVID-19 test on 22Mar2023. The patient then received PAXLOVID as treatment on 09Mar2023 until 14Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Pt seen at MC on 03Aug07 and then transferred for pericarditis diagnoses, felt to be possibly related to recent vaccination with smallpox or anthrax. Follow up following discharge from the hospital occurred on 07Aug07 at the Medical Clinic. Chest discomfort had resolved by time of visit and pt reported a decrease in SOB, but continued with lack of energy. Orders given for Ibuprofen and Prilosec at the time of his visit, he was instructed to follow up with TMC in 2 weeks or sooner if problems. 9/4/07-records received for DOS 8/3-8/6/07-atypical chest pain. Pressure sensation in throat,
Extremely sore arm--enough to wake me up multiple times every night. Swollen red puffy arm, approx. 4" x 2 1/2 inch.  Got worse on the 2nd and worse still on the 3rd night.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM5318) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown".
His left and right side neck musclefrom up to collarbone up to the back of ears and into jaw line; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 immunization. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "not recovered", described as "His left and right side neck musclefrom up to collarbone up to the back of ears and into jaw line". Therapeutic measures were taken as a result of musculoskeletal discomfort.  Additional information: Caller was a consumer and he already got the booster shot for the Pfizer covid-19 vaccine. He mentioned that he called us several months ago about the side effects of the booster shot. He said that he's been through physical therapy, doctor and chiropractor and still has the same issue with his neck. His left and right side neck muscle from up to collarbone up to the back of ears and into jaw line.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer reported for a male patient. A 48-year-old male patient received bnt162b2 (Formulation: solution for injection, Lot Number: Unknown), dose 1 via an intramuscular route of administration on an unspecified date in Apr2021 as dose 1, single and dose 2 via an intramuscular route of administration on an unspecified date in May2021 (Lot Number: Unknown) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jul2021, the patient experienced COVID-19 and Vaccination failure. On an unspecified date in Jul2021, the patient was tested positive for COVID after being fully vaccinated. The patient did not receive treatment to treat the events. The outcome of the event was resolved on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
soreness with movement of the arm from wrist to shoulder in arm vaccines were administered in.  Pain began one week after administration.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 27 year-old male patient. On 08-Oct-2016, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
I was sick with both shots for the first two weeks including shortness of breath, nausea, fever, body aches all over, huge migraine.  After my second does I then came down with pneumonia June 6 and was in the Urgent care twice in 4 days and almost had to be hospitalized.  Two doses of antibiotics, nebulizer and rest.  I continue to have trouble breathing and have to take off work frequently because I am so sick still.  I missed three weeks of work and am a single mom.  I am exhausted and constantly feel pressure in my chest.  This week I have started having swelling in my hands and have started having heart palpitations off and on with a feeling of not being able to catch my breath when. that happens.
she has an inflammatory/rheumatologic disease and she had a flare just this week/relapsing polychondritis flare; sore right arm; Arm discomfort; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EM9809) via an unspecified route of administration into arm right on 13Feb2021 08:30 (age at vaccination 58 Years) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was Relapsing polychondritis, (she was diagnosed with about 7 years ago. she has an inflammatory/rheumatologic disease). Concomitant medications:None. The patient was reported that she was diagnosed with polychondritis about 7 years ago and clarified about 1 in 1,000,000 people are diagnosed with the disease . It was reported that patient did not take any vaccine within 4 weeks prior to vaccination. On Feb2021the patient had experienced she had a sore right arm for several days after receiving her first dose of the COVID-19 Vaccine, arm discomfort and an inflammatory/rheumatologic disease and she had a flare just this week/relapsing polychondritis flare because of that, she decided that she is no longer going to get the 2nd dose this weekend(06Mar2021). She wants to know the efficacy rate of the vaccine with just 1 dose. Therapeutic measures were taken for the AE inflammatory/rheumatologic disease and she had a flare just this week/relapsing polychondritis flare and treatment was given with Colchicine 0.6mg 1 to 2 times daily and was taking Ibuprofen 400mg daily.She said her doctor was considering putting her on other medication because the Colchicine 0.6mg doesn't work as good as it used to. The clinical outcome of the events inflammatory/rheumatologic disease and she had a flare just this week/relapsing polychondritis flare was not recovered and sore right arm, arm discomfort was recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker/certified medical assistant and refers to 4 patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L050908, expiry date: 14-JUN-2017, route of vaccination was not reported). Concomitant therapy was not reported. Reported temperature excursion was -11 degree of Celsius for 15 hours. Data logger was involved. There was no previous temperature excursion. No adverse symptom was reported. Additional information has been requested.
sx of rash on chest, back, cheeks, buttocks progressed w/in 10min;ears bright red;mom stated eyes look funny;;epi given approx 12min post inj & transported to ER via amb 22 min post inj;
Vaccinated in 9-10-2008. Developed bruise and redness at sight of injection. Few days later developed about 10 dots all over body (mild case of chicken pox) ? I called Merck directly- as well.
Patient received vaccine and approximately 2 weeks later had a miscarriage - because gestational age of fetus, doctor said vaccine may have caused miscarriage.
5 hrs crying spell p/DTP; inconsolable during period 30JUN92;
Hospitalization for COVID-19 Nausea/vomiting on dates 10/26/22 - 10/31/22. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Higher blood sugar levels noted within one week of Vaccine indicated Type II diabetes levels when I had not previously had diabetes-level blood sugar. Constant high pitched ringing in ears X 6 weeks a; Higher blood sugar levels noted within one week of Vaccine indicated Type II diabetes levels when I had not previously had diabetes-level blood sugar. Constant high pitched ringing in ears X 6 weeks a; headache X 3 days after 1st and 2nd vaccines; Higher blood sugar levels noted within one week of Vaccine indicated Type II diabetes levels when I had not previously had diabetes-level blood sugar. Constant high pitched ringing in ears X 6 weeks a; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female non- pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left at the age of 59-year-old on 01Apr2021 16:00 (Lot Number: EN6202) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included perennial allergies. Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC); fluticasone propionate (FLONASE ALLERGY RELIEF); amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3), multi- vitamin, all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration administered in arm left at the age of 59-year-old on 04Mar2021 16:00 for covid-19 immunisation and experienced ringing in ears and headache; seldane and experienced drug hypersensitivity, horseradish and experienced drug hypersensitivity.  The patient experienced higher blood sugar levels noted within one week of vaccine indicated type ii diabetes levels when the patient had not previously had diabetes-level blood sugar (on an unknown date); constant high pitched ringing in ears for 6 weeks and headache for 3 days after 1st and 2nd vaccines, both occurred on 01Apr2021 16:00. Events all resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 10May2021. Therapeutic measures were taken as a result of all events. It is reported as high blood sugar noted routine check, 3 months recheck. The outcome of the events was unknown.
102 fever and chills lasting about 10 hours starting 30 hours after injection extreme fatigue after 48 hours of injection
post vaccination pt had no problems. mother called in at 1308 stating  approx 30 min after began 'shaking really bad' per father, had nausea, stomach cramps and headache. temp 99.6.    at this time recommended close monitoring and follow up call within 1 hour.   mother called in at 1358 stating headache was better, but rest of symptoms continued.   temp - 101.4,  BP 95/62,  HR 113.   skin now sensitive to touch (generalized)   Recommended ER at this time.  1428 - pt arrived in ER 1546 - received acetaminophen 1000 mg, 0.9% NaCl 1000mL, ondanestron HCl/PF 4 mg  discharged at 1818 to home Symptoms fully resolved at time of completing this form.
Extreme fatigue, followed by approx. 5-6 hours of Tachycardia (heart rate was continuously around 113/116), extreme chills with shaking ( 4 blankets on me), followed by extreme sweating for 1 hr. After that I was fine as had no other symptoms.
Redness, edema, left deltoid pain, area felt hot. Los of appetite, lethargic, some sweats, no chills symptoms  developed within 2 days of receiving vaccine. Elevate arm, return if symptoms worsen or if unable to move  the arm or a joint.
Approximately 6-8 months after taking the Lymerix vaccine the pt developed shoulder problems. First in the left shoulder now in the right. The range of motion is very limited without severe pain. Have seen three different doctors and have had physical therapy to no avial. The doctors only have "ideas" of what it could be but nothing solid. He has talked to other with Lyme disease and he suffers the same joint symptoms as them. He also states that the test came out negative for Lymes. Neither he nor the doctors can not definitively say the Lymerix show did it but he thinks that he should report it anyway.
On her vaginal area one blister popped up and it subsided and then lots of small blisters came and couple grow big and flake and since yesterday it is spreading to the her inner thigh.
c/o h/a, generalized aches, rt arm hot to touch;notified Md & instructed to use a warm compress to the inj site on 6NOV98;
Patient received first dose of covid vaccine on 03/23/23 at 0932 AM. Patient was monitored after administration and was sent home. Step mom states patient went to school afterwards, felt fine but later that afternoon "had difficulty breathing and an elephant on the chest."  She was rushed to the ER (arrival of 22:20). on arrival, she continued to complain of difficulty breathing, was tachycardic, tachypneic, O2 sat dropped to 80%, and had cyanotic extremities. A rapid response team was called and patient received Epinephrine along with steroid and Benadryl with improvement afterwards.  She later had a significant work-up including salicylate, acetaminophen, ethanol level, pregnancy test, CK, lipase, magnesium. Labs significant with AST 185, ALT 265.  US gallbladder demonstrating hepatomegaly.
Pt recvd vax 10NOV92 & immed p/vax exp burning & felt the vax going in; 17NOV92 pt exp pain the arm which radiated into the shoulder; No further details were provided;
Strep throat onset with sore throat, headache, fever. White patches on left tonsil, chills, and fatigue after onset. Treated with 7 day course of antibiotics.