chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vax 3/18/03, c/o swelling in arm fingers following day. On 3/21 saw MD - hand - 3 fingers numb and pain. MD said local rx causing this around nerve resulting in pain and numbness.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt has a PMH significant for CHF, hyperlipidemia, osteopenia, Diabetes. Pt was hospitalized with acute hypoxic respiratory failure 3/23 and sent home with hospice care.
Fevers, leg pain and swelling, eventually purpura in pre-tibial areas.
Shortness of breath; Fatigue; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for herself. A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6208, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 12Mar2021 (age at vaccination was 70 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date in Mar2021, the patient experienced shortness of breath and fatigue. It was reported that the event started on 17Mar2021 or 18Mar2021. The patient wanted to know how long shortness of breath and fatigue last after getting vaccinated and how long would it be. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Fever to 104; screaming for 2 days; no prescriptions given but recommended Tylenol & Benadryl;
Hives within 10 minutes post vax. Benadryl given po and hives subsided.
My left and right arms have began to tingle; left and right arms go slightly numb 3-4 times per day for about an hour in length.; first dose on 29Jan2021 at 01:15 PM and second dose on 6Feb2021 at 03:00 PM; first dose on 29Jan2021 at 01:15 PM and second dose on 6Feb2021 at 03:00 PM; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old female patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration in the left arm, on 06Feb2021 at 15:00, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included unspecified birth control and venlafaxine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) on 29Jan2021 at 13:15, in the left arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient reported that on an unspecified date, her left and right arms began to tingle and went slightly numb 3-4 times per day for about an hour in length. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events "My left and right arms have began to tingle" and "left and right arms go slightly numb 3-4 times per day for about an hour in length" was not recovered. The patient has not been tested for COVID-19 since vaccination.
Resident was vaccinated on 1/13/21.  Resident passed away on 1/16/21
Injection site pain; tiredness; headache; neck ache; muscle pain; chills; joint pain; fever; injection site redness; feeling unwell; dry eyes; swollen lymph nodes in armpits; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0169, and expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Apr2021 at 09:45 (Age at vaccination was 45 years) as dose 2, single for covid-19 immunization. The patient medical history was reported as none. The patient did not have known allergies. The patient did not have covid prior to vaccination. There were no concomitant medications. The patient did not take any other vaccine in four weeks and any other medication in two weeks. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER8732, and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 25Mar2021 at 09:45 hours (Age at vaccination was 45 years) as dose 1, single for COVID-19 immunization. On 16Apr2021 at 17:00 hours the patient experienced injection site pain, tiredness, headache, neck ache, muscle pain, chills, joint pain, fever, injection site redness, feeling unwell, dry eyes, swollen lymph nodes in armpits and tinnitus. The patient did not test covid post vaccination. Therapeutic measures were not taken for the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Gasping for air several hours post vax, chest tightness, some dizziness, swelling, redness of left arm. Exam - lump, clear, no wheezing. Heart regular rhythm and rate.
Patient had already received a flu shot on 09/13/2022. He couldn't remember if he had one already and it wasn't showing in our system. Patient has yet to have an adverse reaction. he is aware and we will be monitoring.
This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID: (176890). A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "started having health issues"; EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "have mixed emotions". Additional information: The patient reported that he was thinking what if he had any more health problems if he got the booster because he was healthy before he got the vaccine; after the vaccine he started having health problems, then he was wondering if he got the booster what he had more health problems, because to him the vaccine was unpredictable, also he was pretty healthy until he got the vaccine, then he started having health issues so he had mixed emotions with the situation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Morphine) and Drug allergy (Erythromycin). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and IBUPROFEN for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication not reported.   This case was linked to MOD-2021-133215 (Patient Link).
p/vax pt immed felt bad;pt devel a h/a & fever;pt seen by MD & fever 102.6;the reporting MD noted well developed, well nourished pt who did not feel well;neck supple;inj site was swollen & tender w/erythema;platelets 118,000 & WBC 17,7000;
Client had Moderna vaccines for Covid  2/10 and 3/10/2021.  Symptoms started 11/1/2021 : fever 101 x 4 days, nasal congestion, cough, fatigue, nausea, myalgia, sore throat.  Treated by PMD with antibiotic z-pack.
pt recv vax 1MAR96 & pt reported woke up early in morning feeling ill & could not walk d/t weakness;pt stated could not lift head as well;exp joint & muscles aches, shakiness & rapid breathing;pt arm extremely sore @ the inj site;
Day 1: uncontrollable coughing spasms for several minutes, piercing  joint pain in left shoulder capsule and right ankle, 101 degree fever lasting  6 hours  Day 2: chills, exhaustion/weakness, inability to concentrate, lack of appetite  Day 3 &4: waves of muscle aches and exhaustion
she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hurt (injection site); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration in the arm on 02Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received her first Pfizer covid vaccine dose on 02Jan2021. She gets tested regularly at work. On 04Jan2021, she tested positive for the Covid virus. She had a headache, not feeling great on Friday, after she was diagnosed with the Covid virus, but no symptoms before. No side effects from vaccine, other than her arm barely hurt (injection site) in Jan2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Metallic taste in mouth, then following with numbness, tightening, and tingling in throat and mouth. First treated with Benadryl, then decadron and Pepcid. After reaction did not stop, I was taken to the ER and given IV steroid(s). On discharge I was given epinephrine and prednisone. This occurred over a four hour period.
pt brought to ED by EMS unresponsive; intubated for acute hypoxic respiratory failure and airway protection; positive for COVID; pt in DKA; given insulin, tocilizimab, and steroids; pt became bradycardic and hypoxic; pt went into cardiac arrest and she died in the ED
NO EVENTS REPORTED.  WANTED TO REPORT MEDICAL ERROR.  PT 8 MONTHS PREGNANT RECIEVED H1N1 MIST
Itching face, toes, hands, bumps on throat with mild itching, upper body heavy, fingers tingling, headache, fever 100.6, sore throat, headache and roving joint pain, fatigue
ALLERGY TO VACCINE; JOINT SWELLING IN ANKLES AND KNEES; This spontaneous report received from a patient via other company concerned a 52 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient received non-company suspect drugs Humira (adalimumab), (form of admin unknown, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On JUL-2022, the patient experienced joint swelling in ankles and knees (Dose number in series 1). On an unspecified date, the patient experienced allergy to vaccine (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and allergy to vaccine as not related. On an unspecified date, the patient also received booster dose of Moderna covid-19 vaccine, (Dose number in series 2), (Intramuscular, form of admin, batch number and expiry date were not reported) dose was not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The outcome of the joint swelling in ankles and knees and allergy to vaccine was not reported. This report was non-serious.
Monday afternoon started with the shakes and freezing,  By early  evening had a temp of 103.4.  Lympnodes under ears very temder.  No energy.  Took Tylenol and drank lots of liquid.  Tuesday am got up and not cold anymore and no temp but very wore out
head to toe pain/Head severe pain; head to toe pain; Cognitive problems; Brain fog; elevated blood sugar/High blood sugar; Joint pain; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right, administration date 22Feb2021 10:00 (Lot number: EN6202) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes", start date: 2000 (ongoing); "Blood pressure" (ongoing); "Hypothyroidism" (ongoing); "Cholesterol" (ongoing); "Insomnia" (unspecified if ongoing); "Fibromyalgia", start date: 2009 (ongoing). Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); SYNTHROID taken for hypothyroidism (ongoing); ROSUVASTATIN taken for blood cholesterol (ongoing); TRAZODONE taken for insomnia (ongoing); DULOXETINE taken for fibromyalgia (ongoing). Vaccination history included: Bnt162b2 (DOSE: 1, Time: 11:00 AM, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch/Lot number: Lot# EL9262), administration date: 24Jan2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "Joint pain", "Head severe pain", "Nausea", "High blood sugar", "Brain fog", "Head to toe pain", "Cognitive problems", "bloody nose", "mild flu like symptoms", "severe pain in her stomach", "tongue was throbbing and hurt", "throat was hoarse", "cough/producing a lot of phlegm", "dyspnea", "slept for several days", "vaginal mucous", "eyes also feels like a film is over them", "gums began to hurt", "weakness", "body felt heavy", "fatigue, total exhaustion". The following information was reported: HEADACHE (disability) with onset 2021, outcome "recovering", described as "head to toe pain/Head severe pain"; PAIN IN EXTREMITY (disability) with onset 2021, outcome "recovering", described as "head to toe pain"; COGNITIVE DISORDER (disability) with onset 2021, outcome "recovering", described as "Cognitive problems"; FEELING ABNORMAL (disability) with onset 2021, outcome "recovering", described as "Brain fog"; BLOOD GLUCOSE INCREASED (medically significant) with onset 2021, outcome "recovered" (2021), described as "elevated blood sugar/High blood sugar"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (Apr2021), described as "Joint pain"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (Mar2021), described as "Nausea". The patient underwent the following laboratory tests and procedures: blood glucose increased: (2021) elevated, notes: elevated blood sugar/High blood sugar; covid-19: (2021) negative; magnetic resonance imaging: (Oct2021) unknown results. Therapeutic measures were not taken as a result of headache, pain in extremity. Therapeutic measures were taken as a result of blood glucose increased.
no adverse event; HBP calling to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient on 08/31/2023.  No symptoms or further details reported.  No other AE and no PQC; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-AUG-2023, the patient was vaccinated with the expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot #U032086, expiration date: 29-AUG-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
Left arm very red, painful and hot to touch. Headache, muscle pain, vomiting, stomach pain, fever 100.4 F, chills. Fatigue.
Dizziness, Rash, Palpitations, Tachycardia, PAINFUL INJECTION SITE, SITE REDNESS(SYMPTOMS FROM INITIAL REACTION HAD REPEATED ON DAY 9, HIVES ON BOTH SHOULDERS AND CHEST, SHORTNESS OF BREATH, LIGHTHEADED, TONGUE TINGLING Narrative:  THESE SYMPTOMS OCCURRED ON DAY 1 AND REPEATED ON DAY 9
Immediately after vaccines administered, infant cryed, then, cry sounded weaker became pale in color, sweaty, awake, but not very alert, vs, heart rate 100, resp. 24, no wheeze heard. Layed infant flat on bed loosened clothes infant awake. Follows red gain, blinks, quiet. Infant taken to ER for evaluation I watch infant approx 30 minutes.
ipol being administered intradermally instead of tubersol with no reported adverse event; Initial information received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2023SA043796 and 2023SA043813.  This case involves a 38 years old female patient and it was reported that poliomyelitis vaccine (inactivated) [IPOL] being administered intradermally instead of tubersol with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 31-Jan-2023, the patient received 0.1 ml (milliliter) of suspect poliomyelitis vaccine (inactivated), suspension for injection (lot W1A191M, expiry date: 16-Feb-2025)  (with unknown strength) via intradermal route in the left forearm for Tuberculin test.  On 31-Jan-2023 the reporter reported that ipol being administered intradermally instead of tubersol with no reported adverse event (wrong product administered) (latency: same day).  No lab data were reported  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.  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 the guidelines. 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.
Child was given immunization 11/29/17. 11/30/17 Mom reports after lunch he reported feeling "ill" C/O tummy ache. Fine by evening. Mom noted redness/warmth and swelling to (R) arm. 12/1/17 AM area was larger in redness and slightly painful to touch. Red area measures approx. 3.25 length 2.75 width.
Mom noticed a few spots on cheek when awakened for feeding.  When she put her back to bed at 12:30 am, she had a couple more spots.  When she awoke at 4:00am, the side of her face was covered in rash and was swollen.  Continued with increasing rash.  Was instructed to give dose of Benadryl by Dr on Call.  Pt was seen in Urgent Care on 2/25/2012 @ 4:45pm with increasing urticarial rash.
herpes zoster/shingles- treated with valtrex 1 gm po tid x 7 days and medrol dose pak 4/1/21
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 2/26/2023  &  2/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Given vaccine, returned within one hour tachycardia 150 AP. Observation 1.5 hour pulse decreased 106.
This spontaneous report as received from an medical assistant refers to a female patient of unknown age. On 04-MAR-2013 the patient was vaccinated with (Merck) VARIVAX (strength, dose, frequency not provided) injection, in error, instead of (Merck) ZOSTAVAX. No adverse event reported. No product confusion discovered, just medication error. Additional information has been requested.
After about 5 minutes, patient returns to me saying she is 'not feeling well' and as she says this, I see her slowly collapse. I caught her and had her lay down for 5 minutes. Afterwards, she felt better to sit down, and then we checked her BP. Her BP reading was 75/46 mmHg. She stated she was feeling waves of faintness. We called ambulance about 10 minutes after her BP reading. Patient was still laying with her head resting at her side. After taking another BP reading, it came out to be about 98/70 mmHg. Patient stated she was feeling slightly better. Ambulance arrived about 10 minutes later and advised her to go with them to confirm she was doing okay.
No adverse effects were reported; Patient was inadvertently administered one dose of expired VAQTA; This spontaneous report was received from a Registered Nurse concerning to a patient of an unknown age, race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 14-JUN-2019, the patient was vaccinated with one dose of expired Hepatitis A Vaccine, inactivated (VAQTA) (expired product administered) 25/0.5 (units not reported) lot number R013858 with expiration date on 12-JUN-2019 (route of administration and frequency were not reported) for prophylaxis. The outcome of expired vaccine used was unknown.   No adverse effects were reported.
I immediately felt numbness in one arm, which I understood was normal.  A day later I started having numbness in both hands and fingers which still continues now.  I also have had irregular and very heavy periods since, bleeding for over 10 days for the few months after the shot.
So the COVID-19 I was up every hour with coughing, a little fever and sweats, I would up and took a COVID-19 test and it was positive. I called my doctor and asked if she wanted me to take antiviral and she said yes. I took the antivirals for the next five days. I was fluish and fatigue. I was nausea on the first day but not the rest of the time. I was still fluish and fatigued that following week. I was still fatigued for two to three weeks afterwards. I had a bit of the rebound.  The second health event, January 26th I was traveling, and I had a terrible wet cough. I was very warm I didn't get better rater three days. My doctor instructed me to go to urgent to ensure it was not pneumonia. They tested me and it was not pneumonia, but they thought it viral Bronchitis. I didn't take any medicine since there medication, so I had to wait for it to pass.