chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of erythema in a 63-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Blood pressure medication (Unknown blood pressure "medication for an extra heartbeat/blood pressure"), Vitamin and Diuretic (Medication for fluid retention described as "medication for edema"). On 27 or 28 November 2012 during mid-morning, probably 11:30 the subject received a dose of FLULAVAL (unknown route, left arm). On 28 or 29 November 2012, 1 day after vaccination with FLULAVAL, the subject experienced erythema ("redness all over body"), itching, skin feels like it's burning, sensitivity to water, skin swelling, body rash and chicken pox like rash on feet. The subject stated that the day after she received FLULAVAL, "she experienced redness and itching all over body, burns skin when she takes a shower, and it looks like someone hit her with a stick since her sin raises up a quarter of an inch." She stated that she can "only tolerate a shower every other day now instead of every day, because her skin gets itchy and red like she has been burnt." The subject reports daily itching of the skin and a "rash redness all over her body." She noted that her "feet look like she has chicken pox." She stated that "she is itching so bad that she wants to die" and stated "that she has been in hell." The subject was treated with unknown (Cream). Then she contacted her physician who prescribed her "a large dose of" BENADRYL "which did not help". "She was then placed on a tapering dose of steroids which did not help." At the time of reporting the events were unresolved.
Fainting episode; Loss of hearing; Left collar-bone lymph node enlarged noticeable swelling to area and left lower neck near carotid artery/lymph nodes; Soreness in area; Cold sweats; Light-headedness; This is a spontaneous report from a contactable consumer, the patient.  A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Feb2021 at 07:00 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. 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.  Since the vaccination, the patient had not been tested for COVID-19.   The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no symptoms until 5 days post vaccination. On 13Feb2021 at 12:15, the patient experienced fainting episode, loss of hearing, left collar-bone lymph node enlarged (noticeable swelling to area and left lower neck near carotid artery/lymph nodes), soreness in area, cold sweats, and light-headedness. The events required a visit to the physician's office and emergency room (as reported).  The clinical outcomes of the fainting episode, loss of hearing, left collar-bone lymph node enlarged, soreness in area, cold sweats, and light-headedness were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt c/o very sore throat-lt side of face swollen from cheek to throat, low grade fever; pt seen by MD  ? dx-placed on erythromycin;
This spontaneous report was received from a Nurse Practitioner regarding a patient of unknown demographics. No concurrent condition was reported. On an unknown date in July 2011, patient was vaccinated with the first dose of GARDASIL and in November 2011, second dose was vaccinated. On 22-APR-2015, the patient was in the clinic intending to get vaccinated with the third dose of GARDASIL, (inappropriate schedule of drug administration) intramuscular. No adverse event was reported. No product quality complaint was involved. the outcome of the event was unknown. Additional information has been requested.
Nausea, vomiting, dizziness, stomach cramps, fever, weakness, passed out.  11/20/09:  PCP records received for date of service 11/5/09.  Dx:  Gastroenteritis.  Assessment:  Presents with 7 day hx. of GI sx., abd. pain, cramps, N/V, passed out and fell down stairs as she was dizzy.  Hasn't been eating, having emesis and diarrhea 2-3 times/day.  Also experiencing burning in the chest. Getting better now.
In the evening after vaccination, pt had T=100 deg. The next morning, mother noted that pt had "balance issues." She could not walk straight without holding onto something. This occurred when pt first woke up and lasted approximately 20 minutes. T=100 degrees. Gave Tylenol. No fever post 24 hrs vaccine given.
Starting this morning, the left side of my face has gone numb.  There is a charlie horse like feeling in my left cheek, which is now also present in my left jaw. The left side of my tongue is numb with slight pain, and my bottom lip is numb on the left side, and the feeling stops at the middle like there were a line drawn down my face.  My upper left cheek and the side of my left eye have a constant,  moderate burning feeling.  The shot was in my left arm.  The Dr. at urgent care said it was not a stroke, so that's good.  I have never experienced anything like this before.  It has now been over 13 hours.
Increased level of alertness; Difficulty falling asleep; Increased diastolic blood pressure(high 80's/low 90's) which is usually in 70's; feeling heart beat in chest; Minor anxious feeling; This is a spontaneous report from a contactable other HCP (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no: EK9231, expiry date: unknown), via unspecified route of administration on left arm on 05Jan2021 08:15 at a single dose (1st dose) for Covid-19 immunization.  The patient received the vaccine in a hospital. There were no other vaccine administered in the last four weeks. The patient's medical history included penicillin allergies, seasonal asthma, and increased cholesterol. Concomitant medications included Fish oil, D3, Vitamin C, Bilberry, Chromium. On 05Jan2021 20:15, patient experienced increased level of alertness, difficulty falling asleep, increased diastolic blood pressure(high 80's/low 90's) which is usually in 70's feeling heart beat in chest and minor anxious feeling. There was no treatment given for all reported adverse events. It was unknwon if patient had COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of all events was recovering.
Rash 24 hour after administration.  Rash on chest neck and face.  MD prescribed predizone 40 times one wk and antihistamine at H.S.
From telephone contact, it was reported by the patient's spouse that the patient was vaccinated with Japanese encephalitis vaccine on 15 APR 2002. The patient went to ER on 22 APR 2002 with a swollen knee and complained of neck spasms. His knee was drained and he was discharged from ER. The patient went to ER on 25 APR 2002 with weakness in both upper extremities and neck spasms. He was hospitalized for over a month for IV antibiotic therapy with Vancomycin for knee sepsis. Patient was discharged on 27 MAY 2002 on antibiotics. Discharge diagnosis was septic knee and possible Guillain-Barre Syndrome. Follow up information received on 7/30/02 that the patient was hospitalized by another doctor so they are unable to confirm diagnosis. The patient did not receive vaccine at their clinic. Following information were provided: date of birth, no known allergies, no concomitant medications and no illnesses at time of vaccination. No other information provided. It was suggested for manufacturer to contact patient for any additional information. No additional information available. Patient not seen since events.
Patient fainted for 1 to 2mins after receiving the vaccination.  This happened 5 to 6 mins after the injection. The patient was sitting down, so I approached to see if it was an allergic reaction or not. I checked for breathing and had another patient call 911.  Patient woke back up while we had the 911 operator on the phone.  He asked for some water and he felt light headed.
Injection site soreness (not as bad as first shot of this series); Extreme chills with unstoppable shivering that woke me from my sleep (midnight until about 4 AM); Headache for 24 hours; Severe fatigue that lasted for 36 hours; I presume there was a fever associated with the chills, etc., but I was too out of it to take my temperature.
pt recv vax 8FEB95 & exp a sore arm & malaise;14FEB95 pt exp intermittent nausea,vomiting & sweats;@ the time of report,sx had come gone;no further details were provided;
1.  Chest Pressure and fast heart beat; the chest pressure started 2 minutes after the vaccine and lasted non stop for 14 days.  The fast heart beats have been happening also 2 minutes after the vaccine but they have been inconsistent and also lasted for 14 days.  As of now I feel fine but I'm unsure if the reaction is fully gone.   2.  Canker Sores in the roof of my mouth, this started 1 day after the shot,  it felt like I had knifes cutting the roof of my mouth, I still have them but they are going away.  The intense pain lasted for 2 days then after that it started getting better but I was having difficulty eating for 5 days. 3.  I have been having brain fogs after the vaccine, I'm finally starting to feel myself today.
Blurred vision, weakness, dizziness, lightheaded, rapidly pounding heart - felt in chest, upper arms and shoulders. Lasted 20 min and pulse was 120 10 min after cessation. 20 min after cessation I felt perfectly normal.
Left thyroid gland is somewhatenlarged.; TSH result increased; pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation paroxysmal and cardiac ablation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) 0.375 mg and progesterone (MANUFACTURER UNKNOWN) 100 mg daily, both for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Feb2021 at 08:00 (at the age of 79-year-old) as a single dose for COVID-19 immunisation and patient experienced vaccination site pain. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient underwent routine blood test and the result was 8.22 an unspecified unit. On 27Feb2021 the patient experienced pain at the injection site. Therapeutic measures were taken for the reported events of pain at the injection site and treatment are gentle massage. On 01Apr2021 the patient experienced TSH result increased (8.22). On 14Apr2021 the patient experienced left thyroid gland enlarged. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event of pain at the injection site was recovered on 27Feb2021 at the time of one day duration. The clinical outcome of the events of TSH result increased and left thyroid gland enlarged was not recovered at the time of this report   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started complaining of some soreness at the injection site that evening. Spiked a fever of 102.4 at bedtime (7/31/15) Fever 99 Sat-Mon pt taking Acetaminophen or Ibuprofen to help with pain and fever. Does not want to move arm due to discomfort. Feet are hurting and he is walking with an odd gait.
approx 2 wks p/vax pt was hospitalized for GBS; dx made by nerologist (pos EMG & LP); pt currently has paralysis of both legs & arms; pt is on resp;
Short of breath; Heartbeat is fast; Feels like she has some swelling; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 30-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 31Dec2020 11:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the vaccine today at her place of work and at the moment she did not have any side effects. But now during the night she was feeling short of breath and her heartbeat was fast and she felt like she has some swelling and some other more severe side effects that were put on the paperwork and reporter was wondering she was not acutely ill in spite of being short of breath. But she was worried about if she could get worse. So, would it be wise for reporter to give her Benadryl if this is an allergic reaction. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Caller couldn't hear me; This is a spontaneous report from a non-contactable consumer received from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 13Mar2021 as a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. On an unknown date, the patient called and stated she feels fine, but she took an 81mg aspirin because it's her daily medicine. It was mentioned that "patient couldn't hear me" and call was dropped. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Arm started hurting; bruise at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (bruise at the injection site) and PAIN IN EXTREMITY (Arm started hurting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Blood pressure high. Concomitant products included METFORMIN for an unknown indication.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE BRUISING (bruise at the injection site). On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm started hurting). At the time of the report, INJECTION SITE BRUISING (bruise at the injection site) and PAIN IN EXTREMITY (Arm started hurting) had not resolved.            Blood pressure and asthma medications are the other concomitant medications reported by investigator. Ointment is the treatment medication reported by reporter.
pt recvd vax &  exp more severe skin & bowel react; also exp abdo pain, cramping & spasms, insomnia, noc sweats, & visual problems; APR93 lab eval revealed elevated liver functions tests; No further details were provided;
pt very irritable, screaming through noc (5hrs) fever (temp not taken), leg moderately swollen day p/vax mom states swelling has dec;
Rash on both thighs- pruritic with papular rash. Following 6 month shot no fever same rash appeared for 2 weeks after 4 month shots also per mom did not seek doctor advice on those not documented in our office.
Arm numb; Vomiting; Fever; This is a spontaneous report from a contactable consumer. An adult non pregnant female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 31Jan2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. It was unknown that the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was unknown. On 31Jan2021, the patient experienced arm numb, vomiting, fever. Treatment was received for the adverse event was unknown. The outcome of events were recovered.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sudden drop of platelets with diffuse hemorrhagic rash & palpable purpura 1 week after flu shot.
This case was reported by a nurse and described the occurrence of accidental overdose in a 4-year-old male patient who received PEDIARIX (batch number 232P5, expiry date 30th August 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. It was unknown if the reporter considered the accidental overdose to be related to PEDIARIX. Additional information: The nurse reported that the patient was accidentally administered both PEDIARIX and INFANRIX during the same day office visit which led to maladministration "accidental overdose". The intended product to be administered was INFANRIX only.
Two most recent crowns (One crown was about a year ago, the other was 5 months ago.) on two teeth on left side became very painful. Very similar to the same pain I experienced right after the crown was applied, with the exception that the pain would come and go. I would have no pain at all, then 5 minutes later the pain would increase to about a level 5. After about a half hour to an hour, the pain would subside.  This would repeat many times a day.   One week from the shot, I visited my dentist, but they didn't find any problems with the crowns. They gave me Amoxicillin thinking it may be an infection. I don't think it was because it was both of the teeth, one on top, one on the bottom at the exact same time. In the course of the next week the pain gradually subsided. Today it is almost completely gone and only on the most recent crown.
Itchy pink/red rash around site of vaccination beginning approximately 1 week after vaccination and continuing through today, 2/1/2021. Warm at touch.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the improperly stored (in the temperature of above 14F but less than 46F, for 50 hours) dose of ROTATEQ (orally, lot # M019708, expiration date 25-OCT-2017; dose was not reported) for prophylaxis. No adverse effect and no previous excursion were reported. Additional information has been requested.
Got Covid 19 with the vaccine; Got Covid 19 with the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER2613) and on 28Apr2021 as dose 2, single (Lot number: EW016) at the age of 21 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jul2021, outcome "recovered" and all described as "Got Covid 19 with the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2021) Positive, notes: Nasal Swab. Clinical Information: Facility type vaccine was Health Clinic. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
In one week fell and was in Icu.  now in rehabilitation.  can't walk.  very weak, even voice sounded different.   All test were negative.  Don't really know what happened.
Pt initially started feeling lethargic with muscle aches. The next day, a red rash developed from the site of injection. Per pt, the rash was similar to a "sunburn but it's about 7in long down the arm, and 4in wide." Pt was concerned because she didn't have a reaction at all the first time she had it. Pt states she has no issues with ROM and does not have any severe pain or swelling. The rash itself is warm and tender to touch.
WHEN SCREENING PATIENT WE ASKED IF PATIENT HAD ANY OTHER VACCINATIONS FOR COVID AND THE PATIENT ANSWERED NO AFTER ADMINISTERING THE VACCINE AND UPON BILLING THE VACCINE WE SEARCHED THE LOCAL DATABASE AND THE PATIENT HAS HAD PREVIOUS COVID VACCINATIONS (PFIZER X2, MODERNA X 4, JANSSEN X1) WE CALLED THE PATIENT TO GET AN EXPLANATION AND EXPLAIN THAT WE WILL NOT ADMINISTER A 2ND NOVAVAX DOSE
Pt reported a swollen vaccine shot and described the site as "swollen to the size of softball yesterday (11/17/2021) and today (11/18/2021) it's down to the size of a tennis ball. Pt. also reported itching and the vaccine site as "hot when I touch it." Advised patient to continue taking Benadryl and Ibuprofen. If symptoms worsen, patient was advised to contact her primary healthcare provider.
a minor attack of vertigo; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the second of three reports. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on an unspecified date, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient had a minor attack of vertigo (hospitalization) on an unspecified date with outcome of unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021400449 same drug, different patient, similar AE;US-PFIZER INC-2021402493 same drug, different patient, similar AE
MODERNA  Received dose at 4:59pm 5:01pm- patient c/o dizzy and fell onto wall then parents caught her before hitting the ground; EMS called. Patient immediately became alert and placed on ground to rest until ambulance arrived. BP, P, O2 remained stable. A/Ox3. EMS assessed and offered to take to hospital- patient refused.