chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Severe fatigue; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 at 11:00 (Lot number: FH8072) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Concomitant medications included: AMLODIPINE; LOSARTIN; PROZAC and TYLENOL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EF6955; Administration Location: Arm Left; Route of Administration: Unspecified), administration date: 30Mar2021, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8730; Administration Location: Arm Left; Route of Administration: Unspecified), administration date: 21Apr2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Nov2021 at 11:00, outcome "unknown", described as "Dose number: 3"; PAIN (non-serious) with onset 05Nov2021 at 16:00, outcome "recovered", described as "Body aches"; FATIGUE (non-serious) with onset 05Nov2021 at 16:00, outcome "recovered", described as "Severe fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain and fatigue.  Additional information: Therapeutic measures included treatment with TYLENOL. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Donor stated weakness about 5 pm and lightheaded.  Stated "layed down" slept the remainder of the day on 03/13/08.  Weakness lasted until 03/14/08 ending day Friday.  Saturday morning donor stated "felt fine for normal activities".
Very sore arm, can't move it, lift it, or touch it without pain. Going on 48 hours with it. Also severe migraine, again going on 48 hours. Tried taking the recommended OTC pain, but it hasn't helped
Shingles presented beginning on  4/28/2021. Confirmed by Doctor on 5/1/2021.
Pt. called clinic 7/5 and stated she began having neck pain about 2 hours after injection and later developed fever 101.
Information has been received from a physician concerning a 5 year old patient who on 03-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot# 665804/1300Y; expiration date 09-SEP-2011). Secondary suspect vaccine given on the same day included a dose of MMR II (Lot# 665426/1118Y; expiration date 13-AUG-2011). Concomitant vaccine given on the same day included a dose of KINRIX. It was reported that the patient experienced injection site swelling. On 05-MAY-2010, the parent called office stating that the child had injection site reaction. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was not reported. The office requested a lot check for lot# 665804/1300Y. A lot check has been initiated. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665804/1300Y was satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is a consolidation of two reports concerning the same patient. No further information is available.
On 11/27/2021 The patient begin to experience episodes of shortness of breath. Which progressively became worse overtime, resulting in hospital admission on 12/10/2021. When discharge from hospital she was newly diagnosed with Atrial Fibrillation and cardiomyopathy with reduced ejection fraction. She was discharged home with several medications; Digoxin, Furosemide, Lisinopril, Spironolactone, Warfarin, Carvedilol
headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on the right arm on 10Jan2021 at 09:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730 on 20Dec2020 at 09:00 AM on the right arm for COVID-19 immunization, and Benadryl. The patient took Benadryl before the second dose and throughout the day, and it somewhat helped with the constant skin irritation. On 10Jan2021, the patient experienced headache, itchy and prickly skin all over her body. No admission to hospital involved and no treatment was received. The events resolved on an unspecified date in 2021.
PASSED OUT; EXTREMELY COLD; LIGHT HEADED; SWEATING; CHANGES IN BODY TEMPERATURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced passed out, extremely cold, light headed, sweating and changes in body temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 09-APR-2021, was recovering from light headed, and had not recovered from extremely cold, sweating, and changes in body temperature. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210421673- covid-19 vaccine ad26.cov2.s-Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I had the injection in my right arm at 12:00 p.m. on Sunday, March 21, 2021.  Within 3-4 hours, I started feeling a bit achy behind my left shoulder.  By 6:00 p.m., I was very tired so I went to bed early.   I had a restless night sleeping because my entire torso ached.  I called in sick to work Monday morning, and slept all day.  With each passing hour, the achiness subsided and I started to get my energy back.  I would estimate it was a good 72 hours of general discomfort -- of which only the first 24-36 were intolerable.  I recognize that I am very sensitive to pain/discomfort, but this was an unusual feeling.  It really wiped me out.
I've had facial droop on the corner of the right side of my mouth/I'm still dealing with nerve damage in my face. And It's gotten worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 33-year-old patient received BNT162b2 (BNT162B2), as dose 1, 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: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "I've had facial droop on the corner of the right side of my mouth/I'm still dealing with nerve damage in my face. And It's gotten worse".  Clinical course: Reporter stated, I have had facial droop on the corner of the right side of my mouth since I was vaccinated with your first dose. I got vaccinated to work and educate myself in this city, and 9 months later I'm still dealing with nerve damage in my face. And It's gotten worse. I'm seeing a neurologist today, who I will try to get to file a report stating this is a side effect from pfizer's covid vaccine. I seek reparations for my lost quality of life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient developed  myocarditis, cardiomyopathy after MOderna  booster  shot  in November, transient , now  resolved, EF  was 20-25%  , now back to 60-65%
Rash/hives on inner thighs, insideknee/upper calf, outside upper arms.Both arms and both legs.; hives on inner thighs, insideknee/upper calf, outside upper arms.Both arms and both legs.Red, itchy,slightly swollen; Rash/hives on inner thighs, insideknee/upper calf, outside upper arms.Both arms and both legs. Red; itchy; slightly swollen; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 at 11:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and obesity. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 20Mar2021 at 13:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), cannabidiol (MANUFACTURER UNKNOWN), loratadine (CLARITIN) and oral contraceptive nos (MANUFACTURER UNKNOWN); all were from unknown date and for unspecified indication. On 17Apr2021 at 06:00 the patient experienced rash/hives on inner thighs, inside knee/upper calf, outside upper arms. Both arms and both legs. Red, itchy, slightly swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as the result of adverse events and included treatment with Benadryl.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash/hives on inner thighs, inside knee/upper calf, outside upper arms. Both arms and both legs. Red, itchy, slightly swollen were resolving at the time report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning her daughter a 15 year old female who on 29-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). On approximately 29-JUL-2008 the patient experienced a little bit of swelling at the injection site after getting the shot. The patient's a little bit of swelling at the injection site persisted. The patient did not seek medical attention. No further information is available.
This spontaneous report as received from a nurse refers to a 4 year old patient. On 04-AUG-2014 the patient ws vaccinated with M-M-R II (0.5 ml, subcutaneous, lot # was not reported, exp 03-AUG-2014). The vaccine was expired. No adverse effect reported. Additional information has been requested.
Left deltoid, 2 circular vesicles 1 cm apart with central ulceration yellowish discharge, 11- 12 cm erythema.  Positve ancillary lymph nodes.
Diverticulitis; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male (as reported; pending clarification) patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. They wanted to know if the patient can still get the second dose of COVID-19 vaccine next Monday (05Apr2021) if the patient started antibiotics for diverticulitis on an unspecified date. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Information has been received from a nurse practitioner through the Merck pregnancy registry concerning a female who was vaccinated with Varivax. Subsequently the patient experienced an unspecified "pregnancy adverse event." Unspecified medical attention was sought. It was reported that the nurse practitioner would call with additional information. At the time of this report, no additional details were available. There was no product quality complaint involved. Additional information has been requested.
Pt felt dizziness & pale 5 - 10 min after shot given, we had pt sitting few minutes, pt felt better.
No adverse effect; dose of Proquad that had been improperly stored was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 05-NOV-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA (recombinant human albumin) albumin status) injection, lot # S008574, expiration date 16-SEP-2020 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15.4 degrees Fahrenheit for 1 hour. There was no previous temperature excursions. Data logger was involved.
This case was reported by a nurse and described an adult female patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). The reporter is the patient. On an unspecified date in 1994, the patient received the third dose of Engerix B. At an unspecified time later, before 3/29/2005, a hepatitis B surface titer was negative. On an unspecified date, the patient received the fourth dose of Engerix B. Approximately 30 days after the fourth dose, on an unspecified date before 3/29/2005, a hepatitis B surface antibody titer was negative. On an unspecified date, the patient received the fifth dose of Engerix B vaccine. Approximately 30 days after the fifth dose, on an unspecified date before Mar 29 2005, a hepatitis b surface antibody titer was negative.
11/11: Small red area around injection site of chicken pox vaccine. 11/12: Area continued to grow until it was about the size of a quarter. 11/13: Small bumps appeared. 11/14: Bumps turned into vesicles which took approximately 7-10 days to heal.1 continued . ZYRTEC and applied BENADYL cream to area.
Patient was given Fluzone Hd instead of Flublok. Patient did not experience any adverse symptoms.
70-YEAR-OLD ELDERLY FEMALE CONSUMER WHO TOOK VAXCHORA; RECEIVED VAXCHORA WITHOUT BUFFER; A spontaneous case report was received from a caregiver on 28-May-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201905-000427 (PVX2019-1356; wife) and PVX201905-000428 (PVX2019-1355, husband) were created and cross-linked in the database.  This case describes a "70-year-old elderly female consumer who took Vaxchora" and she "received Vaxchora without buffer". The consumer was receiving oral Vaxchora (lot no: 7000014 and expiry date: Sep 2019) for cholera prophylaxis.  Case report: A 70-year-old female took a dose of Vaxchora on 24-May-2019 and she took it without adding buffer. She mixed the active component of Vaxchora with 100 mL of water. She did not experience any side effects after that.  Action taken with Vaxchora was not applicable.  The clinical outcome of the events was unknown.; Sender's Comments: Company's Comment: The causality of the event "70-year-old elderly female consumer who took Vaxchora" and she "received Vaxchora without buffer"was considered as not applicable.
Received both a pneumonia booster and a flu vaccination; one in each arm. The flu vaccine caused internal bleeding in my arm. By that evening the bicep and triceps muscles were swollen and very painful. By Thursday, the bruising was starting to show. By Sunday, the bruising was no longer visible. The arm was warm to the touch and noticeably swollen for three days. I also felt extremely fatigued for three days and had to take frequent naps. I've had flu shots for many years. I've never had this kind of reaction before; I've never had any reaction. My husband had his vaccination at the same time. He had a more severe bruising reaction. (He'll file a separate report.)
REDNESS OF ARM FROM SHOULDER TO ABOUT 2/3 DOWN TO ELBOW ON LEFT ARM.
Immediately felt dizzy and lightheaded. Lethargic, fever since vaccine has been between 99 and 103 even with OTC fever reducer, swollen throat - difficulty swallowing but no pain.  Currently going on fours days of symptoms with no relief.
Caller states they experienced a sore arm for a few days; slight pressure headache; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine of BNT162B2 as dose 1, single for covid-19 immunisation was taken. The patient experienced a sore arm for a few days and slight pressure headache on an unspecified date. Outcome of the events was unknown.    Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Initial report was received from a health care professional on 18 October 2010. A 74 year-old female patient with a uTI and yeast infection at the time of vaccination and a past medical history of hyperthyroidism, diabetes, hyperlipidemia and angina pectoris, had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number U3609AA between 11:45am and 12:30pm on 14 October 2010. The evening of 14 October 2010 the patient experienced shortness of breath and itchy eyes. The patient was hospitalized (dates unspecified) and treatments for the adverse events were not provided. The patient was on concomitant medications of CIPRO, Nystatin, MIRAPEX, COZAAR, LOVENOX, LASIX, metformin HCL, LIPITOR, ferrous gluconate, naproxen sodium, NEXIUM, QVAR, KAPIDEX, LIBRIUM, SPIRIVA, IMDUR, nitro, MIRALAX, COLACE, DULCOLAX, oxygen and albuterol. It was noted the CIPRO was used to treat the patient's UTI. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Developed nausea, fever, redness, warmth. Went to E.R. and said it was cellulitis at injection site.
Pt started feeling lightheaded/dizzy after vaccine (second dose), and was escorted to treatment area where history and vitals were obained. Pt stated this is a common reaction for him following any injection. He was given water and monitored. Initial VS: P=72, BP=112/66  P. Ox=97%   After several minutes and pt stating he was feeling fine, he sat up. VS: P=88  BP=126/64  P. Ox=98%   After a few more minutes, he stood up, felt fine. VS: P=94  BP=122/80  P. Ox=98%   Pt discharged home without further incident. Advised to get next shot laying on cot.
Patient stated that her arm became red, swollen, and tender for an area a couple of inches wide around the vaccine site.
Mild body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Mild body aches". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
became pale, limp, blank stare 3 hrs p/vax; pt remained pale & listless but became more responsive;
Very Dizzy unable to function; This is a spontaneous report from a contactable other healthcare professional, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the right arm on 11Mar2021 at 14:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, diabetes, endometrial cancer, allergy to tree nuts (walnut) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and triamterene/hydrochlorothiazide (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown dates and unknown if ongoing. On 14Mar2021 at 00:30, the patient experienced very dizzy and was unable to function. The events did not result in doctor or other health care professional office or clinic visit and emergency room or department or urgent care. It was unknown whether therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Low grade fever for one day Chills for one day Fatigue for one day  (All after dose 2)
H1N1 injection given R deltoid, 10 minutes after injection developed involuntary shaking, tachycardia, dizziness, nausea. BENADRYL 25 mg po given with slow resolution - 1 1/2 hours.
Pt developed papulovesicular lesions on face, trunk, arms and legs consistent with varicella 2 wks after receiving varicella vaccine.
I had absolutely NO adverse reaction to my two Pfizer shots.  However, when I saw my endocrinologist for my routine visit he pointed out that I had an "irregular irregular" heartbeat.  I had never been told that before.  I had no knowledge of it and there is no way to know how soon after my second dose the AFib began. I made an appointment with a cardiologist and, after having an EKG I was started on Eliquis, twice daily.  I had a second visit and had an Echocardiogram and wore a Holter monitor for 24 hours. It appears that I am in "persistent AFib" at this time. I also now take Amiodarone.
Cellulitis of right lower extremity - Placed on Zosyn.  Erythema resolved.  CRP was declining.  Check was oftentimes lethargic but would wake up and sit up in the chair.  Was seen by physical therapy and ambulated in the hall.  Family felt his level of alertness was baseline as it varies through the day and night.  Foot was looking better.  Can follow-up with podiatry as an outpatient for the scabs on his toes.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.