chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his lips swelled and his tongue swelled, so edema of the facial area around his mouth; his lips swelled and his tongue swelled, so edema of the facial area around his mouth; his lips swelled and his tongue swelled, so edema of the facial area around his mouth; This is a spontaneous report from a contactable consumer.  A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: ENS318; Expiration Date: May2021), dose 1 via an unspecified route of administration on 04Jan2021 at 11:30 (at the age of 65-years-old) as 1st dose, single for COVID-19 immunization. Patient medical history included ongoing multiple sclerosis had for 30 years. Patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had no adverse event prior to vaccination. Patient had no relevant family history. Patient did not perform any relevant test. Patient concomitant medication history was not reported. The patient experienced lips and tongue started swelling started on 04Jan2021 at 16:00. The patient was given Benadryl, Tylenol and Aleve. It was completely gone at 04:00 in the morning on 05Jan2021. It was reported that, never had a reaction to a vaccine previously but he did have a reaction to a medication, that was 15 years ago. It was the same type of reaction which was why she knew what to do. She only has the name of the medication, it was modafinil.. Patient did not visit to emergency room/physician office. The doctor advised that patient to not get the 2nd shot due to this reaction. The outcome of the events were recovered on 05Jan2021 at 04:00.    Follow-up attempts are completed. No further information is expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 79 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included: non-smoker, non-alcoholic and other pre-existing medical conditions included: Patient did not had known drug allergies and drug abuse or illicit drug use. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin was not reported. batch number: 202A21A  and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 on left arm for prophylactic vaccination. It was unknown if the patient had any adverse events with covid-19 vaccine ad26. cov2. s (dose number series1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin was not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered, 17-Nov-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experience body aches, chills, fever, cough, heavy congestion, sore throat and headache(dose number in series 2) .On 25-JAN-2022 , the patient diagnosed with suspected covid-19 infection which lead to suspected clinical vaccination failure. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.6.(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20220153760-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients of unknown ages and genders. Pertinent Medical History and Drug Reactions/Allergies were not reported. On unknown dates, the patients were vaccinated with unspecified dates of improperly stored (Oka/Merck) VARIVAX (batch; lot# K0088253, expiration date 19-JUNJ-2016) (route not reported). Concomitant therapies were reported. No adverse effect was reported. No further information was provided. This is one of four reports from the same spruce. Additional information has been requested (correspondence containing a request for additional information is scheduled).
Large erythematous, warm patch surrounding injection site, measured 6cm x 4cm on exam, but parents report initially was much larger.
BITTERNESS IN MOUTH; MUSCLE ACHES; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced muscle aches. On 06-MAR-2021, the patient experienced headache. On 06-MAR-2021, the patient experienced chills. On 09-MAR-2021, the patient experienced bitterness in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, headache, and chills on 08-MAR-2021, and had not recovered from bitterness in mouth. This report was non-serious.
swelling of eyelids, burning sensation of face (feeling like sunburn), flushed skin on face, and swelling, warmth, and redness below the injection site-about 2.5 inches in diameter
Shot administered 8/8/03 (MMR), pt in 8/91/03 (per mom symptoms started 8/18/03) with diffuse mac-pap rash c/w measles.
Child reported feeling nauseated and had episode of vomiting on 8/25/16 in the AM (the morning following vaccination). Reported redness, warmth and pain at injection site. Symptoms self resolved and child presented to clinic on 8/29/16 for follow up and evaluation. Did not contact clinic prior to this date for evaluation of vaccine side effect/reaction.
Patient stated that her hands have been hurting since she got the flu vaccination. She stated that she couldn't move her arms for 2 weeks after receiving flu vaccination.
Patient left office, alert and oriented, after receiving TDAP vaccination. No complaints noted. Patient reported to wife in elevator outside office after leaving that he was not feeling well. Patient then fell to floor of elevator, noted to hit back of head on elevator floor. No loss of consciousness noted. Patient assisted to a sitting position by staff and after sitting for a couple of minutes began to regain color to skin, alert and oriented to person, place, and time. Denied pain.  Per staff members, patient was assisted to wheelchair and escorted to Emergency Department. Patient refused treatment at Emergency Department but stated that he was feeling much better after about 15 -20 minutes and consuming sprite and crackers.  Spoke with patient again around 4:00 PM, patient states that he is feeling much better, denies pain, nausea/vomiting/ dizziness. States, " I am home and I am fine."
bad headache that lasted for a few hours the day after; I took aspirin for the pain.   I also experienced being very tired a couple hours after receiving the shot and later that evening.  I feel more tired than usual the next day. Left arm is quite sore, maybe swollen.  Slightly more light-headedness than usual.
VZV vaccine #1 given 5-16-07. Developed varicella disease on 5-27-07.
SkinRash, Tachypnea, Rash, Employee reported HR of 112  Narrative:
Heart and Lung inflammation; Heart and Lung inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: MYOCARDITIS (death, medically significant), PNEUMONITIS (death) all with onset May2020, outcome "fatal" and all described as "Heart and Lung inflammation". Therapeutic measures were not taken as a result of myocarditis, pneumonitis. The patient date of death was May2021. The reported cause of death was myocarditis, pneumonitis. It was not reported if an autopsy was performed.Clinical comment: The patient was not tested positive for COVID-19 post vaccination. It was unknown if the patient took any other vaccine in four weeks and other medications in two weeks. It was unknown if the patient had COVID-19 prior to vaccination. Known allergies and other medical history were unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart and Lung inflammation; Heart and Lung inflammation
Fever arm pain 24 hours after second shot 3 days after second shot: numbness, tingling in toes, some numbness, weak knees.  Tight muscles These symptoms have continued now in 6th week.   Now burning in toes at night waking him up.
Red/pinkish around injection site, swelling of the area around the injection site, hard/firm area with margins around injection site, listless, lethargic, no interest in anything, minimal verbal noises.
Patient was fine 10 minutes post vaccine. Walked out to lobby and mother reported he looked a little pale so she told him to sit. He missed the chair and collapsed onto the floor. Patient alert and oriented when nurse arrived, No bodily injuries noted. Patient reported feeling dizzy, noted sweating and clamminess. Nurse gave patient juice box and granola bar and kept under observation for the next 10 minutes. Patient regained color, no longer sweating, or dizzy.
Information has been received from a line listing obtained on request by the Company from the FDA under the Freedom of Information: Refers to an 81 year old male with sciatica, constipation and edema at the time of vaccination. The pre-existing conditions included Lasix allergy, tramadol, cardiovascular disease, malignant neoplasm of prostate, spondylosis and sciatica. On 17-SEP-2007 at 14:10, the patient was vaccinated with the first dose of ZOSTAVAX (lot # 0886U; exp. date: unknown) subcutaneously in the right arm. Concomitant therapies included AMBIEN, FLOMAX (MORNIFLUMATE), LORAZEPAM, NEURONTIN, PROTONIX and ZOSTRIX. On 18-SEP-2007 at 09:15, the patient developed shingles outbreak on chest/abdomen. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.
Last year several days after vaccine had a seizure was sent to ER and evaluated and released. No further seizures in the last year. Received flu vaccine and 1 days post vaccine had another seizure. To ER for evaluation and treatment released and was to follow up at PCP office 12/10/12.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion/ Lethargy-Medium
NUMBNESS LIPS; FELT COLD AIR IN THE NECK; WEAKNESS IN THE LEFT ARM; INJECTION ARM HURT; MIGRAINE (DIZZY, HEADACHE, NAUSEA, FELT LIKE SOMETHING WAS RATTLING IN HER HEAD, FELT LIKE THERE WAS A HOLE ON HER HEAD); This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021around 10:30 in right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, around 5 pm, the patient was dizzy, and had a headache and her injection arm hurt. On 07-APR-2021, the patient experienced numbness lips, and reported that "felt like something was rattling in her head, felt like there was a hole on her head, felt cold air in the neck", weakness in the left arm, nausea for which she was put on IV. On an unspecified date, the patient experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness lips, injection arm hurt, felt cold air in the neck, and weakness in the left arm 08-APR-2021, and was recovering from migraine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210419870-covid-19 vaccine ad26.cov2.s-Migraine, numbness lips, felt cold air in the neck and weakness in the left arm. 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). 20210419870-covid-19 vaccine ad26.cov2.s-injection arm hurt. This event(s) is labeled per RSI and is therefore considered potentially related.
10PM day of vaccines had chills, fever; took ALKA SELTZER for fever and 1/4 of a "sleeping pill". Symptoms recurred at 3AM. By 11AM next day, still feels "bad"  but better (PT. concerned about receiving both vaccines at the same time).
Had the single dose Jansen in the left arm in muscle. A couple of weeks later  hair top of head fell out. Now balding
HIVES....APPROXIMATELY 4 - 5 DAYS AFTER COVID VACCINE, BEEN TWO WEEKS AND STILL GETTING HIVES
Patient stated she developed around 8pm that evening she started to sweating, chills, nausea, her arm swelled/redness, and severe vertigo/dizziness and diarrhea for 3 days. She stated on 08-30-18 that her arm was feeling better, less tender and the other symptoms subsided. I contacted Md office and they have been informed as well.
Pain at injection site for several days Severe headaches for several days Fever and Chills Generalized joint and muscle pain Weakness Fatigue Still having recurrent waves of symptoms months after the vaccines?.symptoms were much more severe after the second shot?have not completely returned to normal even 5 months later
Sore arm at injection site. Fever, chills, dizziness, body aches, headache. Lasting about 24 hours
About 12 hours after my vaccine I started having chills, body aches , low grade fever and headache.  The symptoms lasted about 24 hours.  Very fatigued as well.
same night pt began to vomit , body aches and chills, localized redness at injection site, nausea
For approximately 8 hours pt had - fever, chills, aches, headache and fatigue. No treatment was requested.
Feeling Nauseous; Have bouts of diarrhea; Dizziness/lightheadedness; Tired; Aches; Headache; Frustrated and hesitant to get the 2nd dose.; This is a spontaneous report from a non-contactable consumer, patient. A 51-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the arm left on 22Mar2021 11:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not had allergies to any medications, food or other products. The patient did not receive other medications within 2 weeks of vaccination. 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 had not been tested for COVID-19. On 22Mar2021 at 14:30, the patient experienced nauseous, diarrhea, dizziness/light headedness, tired, aches and headache. The patient was frustrated and hesitant to get the 2nd dose. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcomes of the events nauseous, diarrhea, headache, ache, dizziness, frustration and tired were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I got Pfizer BioNTech COVID-19 Vaccine first shot. On the next day I got allergic rash on my ass area, on my face and my belly button turned red (belly button never been this way). I started taking antihistamines, face got better though I got couple of red marks on my body. On the third day after vaccination belly button's skin started coming off as flakes. On the 6th day after vaccination I got muscle spasms (never before in my life).  I came to the ER room to report but doctor said "please stop taking antihistamines and other meds because we don't knot how vaccine works and maybe some medication will affect the effectiveness of the vaccine shot. Please go home and maybe at some point you'd get better"
Nausea; dizziness; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), via an unspecified route of administration in the left arm on 08Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included migraine and seasonal allergies. The patient was not pregnant at the time of vaccination. The patient have no known allergies to medications, food, or other products. Concomitant medications included melatonin and levocetirizine dihydrochloride (XYZAL). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), intramuscular in the left arm on 18Dec2020 at the age of 41-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 08Jan2021 09:30, the patient experienced nausea, dizziness, fever. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
arm pain; pain at the site of the injection; This is a spontaneous report from a contactable consumer (patient's mother).  A 21-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date in Sep2019 at single dose for immunization/ meningitis prevention.  The patient's medical history concomitant medications were not reported.  it was reported that for the first injection the patient just had arm pain, or pain at the site of the injection. The outcome of the events was unknown.
Patient with case of regional ileitis starting the day after his 3rd booster.; DOSE 3 (BOOSTER), SINGLE; DOSE 3 (BOOSTER), SINGLE; This is a spontaneous report from a contactable physician. A 53-years-old male patient received BNT162B2 dose 3 via an unspecified route of administration on 27Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single, at the age of 53-years-old, for COVID-19 immunisation. Medical history included hypertension (HTN). No Known allergy. The patient previously received the first dose of BNT162B2 on 23Dec2020 and second dose of BNT162B2 on 13Jan2021, both at the age of 53-years-old, for COVID-19 immunization. Concomitant medication included lisinopril. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination. The patient had not had covid tested post vaccination. The patient with case of regional ileitis starting the day after his 3rd booster. Event (regional ileitis) onset date reported as 28Sep2021. Treatment received for the event (regional ileitis) that included antibiotics. Event (regional ileitis) resulted in physician office visit. The event (regional ileitis) was resolved in 2021. The patient underwent lab tests and procedures which included CT scan: ileitis on 28Sep2021.    The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Crohn's disease and the suspect drug BNT162B2 cannot be excluded.    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.
"PIMPLE LOOKING" ROUND AREAS ON FACE, TRUNK AREA WITH ITCHING.
Vaccines given on 5/9/16. He developed fever afternoon/eve and was given TYLENOL. Awoke with fever 103.5 and nausea and vomiting. Taken to ER where fever was recorded. Given ibuprofen and ZOFRAN.
my sense of taste became altered with everything tasting bland or bitter; administration date=12Jan2021, dose number=2/administration date=26Dec2020, dose number=1; This is a spontaneous report from a contactable nurse for himself. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EL 1284) via intramuscular route of administration in the right arm on 12Jan2021 18:30 at SINGLE DOSE for COVID-19 Immunization in the workplace clinic. The patient had no medical history. The patient's concomitant medications were not reported. The patient had allergies to doxycycline, ciprofloxacin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EK 9231) via intramuscular route of administration in the right arm on 26Dec2020 07:45 at SINGLE DOSE for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking second dose on 14Jan2021 08:00 the patient's sense of taste became altered with everything tasting bland or bitter. He has been told by workplace this was symptom and not a known side effect and to get COVID- 19 virus test, which was negative. The event assessed as non-serious by the reporter. The patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent saliva test for COVID-19 on 15Jan2021 which was negative. Symptoms resolved on its own on 16Jan2021. The patient did not receive treatment. The outcome of the event was recovered on 16Jan2021 and outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
have a fever/104/Now keeps 107 F; whole body is aching and warm; pain in her arm/My arm is still hurting where I got the shot; headache; Backache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Aug2021 (Lot Number: EW0180) as 0.3 mL single for COVID-19 immunization. Medical history included positive for COVID-19 from Mar2021 to an unknown date. The patient's concomitant medications were not reported. On 03Aug2021, the patient has a fever. The first time she came to know it was 104, but now keeps 107 degree Fahrenheit. On 03Aug2021, she experienced headache, whole body is aching and warm, arm is still hurting where she got the shot. Took the vaccine at 9 or 10 and an hour after that she had a pain in her arm, headache and back ache around 10:15 or 11 yesterday. No treatment received for fever and body aches. Events did not require a visit to Emergency Room or Physician Office. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.