chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to medical center on 3/29/21 with vertigo, nausea vomiting, abnormal neuro exam.  MRI 3/29/21 at 309PM showed small acute/subacute infarcts in the cerebeller vermis and right occipital lobe with additional subacute and chronic posterior circulation infarcts, no evidence of hemorrhagic transformation.   Embolism caused by a fib suspected, however, no evidence of a fib found during admission to current. No history of a fib.  Patient currently has 30 days holter monitor in place until 5/13/21. Continuing to rule out  possible causes.  Echo 3/30/21 729 AM shows Left ventricular systolic function 50-55% estimated ejection fraction. Mild aortic, mitral and tricuspid regurgitation, RVSP within normal limits and mild dilation of the ascending aorta and aortic root.
Received shot at 2:45 PM on April 2nd. Took 2 Tylenol at 10:15 PM when I went to bed in anticipation that I may wake up not feeling well (I was already starting to feel some malaise).  Woke up around 2:15 AM on April 3 with chills and took temp. It was around 101. I couldnt quote take more Tylenol yet. It continued to rise for the next hour until around 3:00 when it hit 102.7 and 103.2. Took 1 Tylenol at 3:05 and waited to take another one as soon as my 6 hrs was up. So I took the second one at 4:16. Fever went back down to 101.6 in right ear and 102.4 in left ear around 5:10 AM. Fever as of 5:55 AM is down to 101, however that is still with Tylenol in my system. Even when temp was at 103 I still had Tylenol on system. I am surprised given I have an immune deficiency that my reaction so far has been this strong. Early on with the very high fever I had uncomfortable shaking. Now at 5:57 I am chilled but also sweating. I still have a fever even with Tylenol in my system.
No additional AE information; the vaccine was going through  temperature excursions; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 15-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin)   (PROQUAD) lot # S027465, expiration date of 02-MAR-2021, 0.5 milliliter  for prophylaxis  (strength, dose, route, frequency, and anatomical location were not provided).   The vaccine was exposed to multiple temperature excursions since 01-NOV-2020 through the end of February 2021.  The call was made due to a digital data logger. No additional adverse effect reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2103USA000942: US-009507513-2103USA001024: US-009507513-2103USA000993: US-009507513-2103USA000947:
Patient got the Moderna vaccination yesterday, woke up pouring sweat about 40 minutes ago this morning and is having a headache
This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB lot # N002913 and expiration date on 23-FEB-2019, lot # L016959 and expiration date on 12-MAR-2018 and lot # N002920 with expiration date on 30-SEP-2018, (dose and route of administration were not reported) for prophylaxis. The doses of RECOMBIVAX HB were exposed to a temperature excursion of 35 degrees Fahrenheit (°F) during a time frame of 1 hour and 15 minutes, which was detected by the data logger. There was no prior temperature excursion, no adverse events were reported and no product quality complaints were present. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA013506: US-009507513-1709USA011946.
Pt received Gardasil on 5-30-07 and 8-13-07.  States both times felt nauseated, vomited, ached all over body, had bad H/A.  When asked why pt did not reveal S&S on 2nd dose, pt stated "she wanted to tough it out".  Refused 3rd shot.
Woke up with severe headache around 3am on 04/04/21.  Had headache the whole day, was not able to get up from bed. Took Tylenol every 4 hrs. for 3 times. At night the headache got slightly better but continued till 04/05/21 afternoon. On 04/04/21: Injection site left arm was red, swollen and painful. Applied cold compress as per pharmacists suggestion. Got better on 04/06/2021. On 04/05/2021: started having swelling and pain in left armpit down to left breast. After 4 days it went away. On 04/07/2021: Has black & blue bruise on  right thigh  which stayed for few days and on 04/08/21, had pain in the right leg while walking. On  04/14/21 woke up with severe headache around 3am, stayed in bed whole day, Tylenol did not help. Called the doctor in the evening, advised to go to ER. Went to ER.
Patiens has chills, is shaking, has temp 101.3. Arm is sore and slightly swollen and a little warm to touch. Is taking baby aspirin and Advil.
J96.00 ACUTE RESPIRATORY FAILURE 9/10/2021 AORTIC ANEURYSM, UNSPECIFIED SITE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/2/2021 AORTIC ANEURYSM, UNSPECIFIED SITE J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 9/11/2021 AORTIC ANEURYSM, UNSPECIFIED SITE
Information has been received from doctor of pharmacy concerning  an elderly, male who on Oct 20 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). Subsequently the patient developed redness at the injection site. The patient was to be seen in the office. At the time of the report, it was unknown if the patient had any induration of hematoma. the patients outcome was not reported. Additional information has been requested.
Day after second covid dose, Pt had fever and other flu-like Sx all day.  Resolved in 2 days.  Then, about 3 1/2 weeks later, he had an ulcerative colitis flare.  He had a stool accident at school, and then he started to have blood in nearly every stool.  We are still trying to get this under control.
Admission for removal of bone plate from the mandible, local flap. Pain was controlled with oral pain medications.  Nutrition consult was sought and tube feedings were optimized.  Wound care was continued.  Antibiotics were continued. Patient was discharged from Hospital to Assisted living. Hospital admission within 6 weeks of receiving the COVID vaccine.
Three days after vaccination patient started with nasal congestion, greenish nasal secretions, body aches, headache and cough without fever. Patient was treated for Acute Sinusitis with oral decongestant plus antihistamine and PO antibiotic (AZYTHROMYCIN 250mg x 6 days). Symptoms releaved by 12/04/09.
Cellulitis at site of injection Pt seen at ER tx with KEFLEX.
blood pressure went up; blood pressure went up/Blood Pressure 180/100, her baseline is 130/80; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265),via an unspecified route of administration, administered in Arm Left on 28Jan2021 13:00 (at the age of 85-years-old) as dose 1, single for covid-19 immunization. Medical history included ongoing basedow's disease (Graves' disease: she had this for 30 years) and it was ongoing; blood pressure increased and it was ongoing; fibromyalgia (she has not had an episode in the last 10 years but had several earlier in her life, this one thing that concerns her about the second dose as she doesn't want to have any more episodes). The patient's concomitant medications were not reported. The patient previously took tetanus toxoid (she had a reaction to tetanus toxoid, it was a long time ago and given at the doctor's office, she has no manufacturer, NDC, lot, or expiry for that product). Patient did not have any adverse events prior vaccination, as reported. No family medical history. Patient did not receive other vaccine in four weeks of vaccination. On Jan2021, the patient experienced blood pressure went up. The patient had high blood pressure for years but has been under control until noticing the big jump. Doctor put her on another medication, more Hydrochlorothiazide, which is the water medication. It was clarified that the dose was increased for the Hydrochlorothiazide and that is continuing now, not a new medication that was added. She has no NDC, Lot, or Expiry for that product. The patient visited physician office for adverse event. The events was serious (medically significant). The patient underwent lab tests and procedures which included blood pressure measurement: high bp 180/100 (noted by the caller 180/100) on Jan2021 and normal bp 130/80 on Feb2021 (baseline is 130/80, as reported). Therapeutic measures were taken as a result of blood pressure went up. The Outcome of events was recovered on Feb2021.  Additional Context: Caller, reporting on the Pfizer COVID vaccine, and who explains she had the first vaccine and a day or so later her blood pressure went up until the doctor gave more medicine. Caller has questions about the vaccine. Caller was an X-ray tech. It was stated the first shot was given on 28Jan2021. She noticed on either 29Jan2021 or 30Jan2021. Caller explains that about a week after the event is when the issue resolved. It was noted by the caller 180/100, her baseline is 130/80. No other testing lab or treatment other than the increase in her dose of Hydrochlorothiazide. She is going for the second vaccine in a few days and has concerns regarding her fibromyalgia. Caller asks if we are keeping tract to the reaction after the second dose, what to expect.   Follow-up attempts completed. No further information expected.
Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot # 629874/0211J). Subsequently the patient had an adverse experience.
Client reported after she left the vaccine clinic, she was in her car. She reported after 9-10 minutes she felt pain/itch from her L shoulder to her right shoulder. She reported she immediately took Benadryl. Then she reported she had an irritated/full feeling on palate, starting from L to R on palate. Had a tingly itchy sensation in her throat. Client reported she arrived home and took her steroid. For four hours after she felt as she had a feeling of neuropathy in legs for four hours. She reported she saw her Rheumatologist for follow up. The flu shot was  administered on 10/15/21. Client called to report it to this writer on 10/22/21. She also reported she had a similar situation after her Covid vaccine, she reported she had back in march of 2021.
Chills, fever, severe headache started 13 hours after vaccine. Mild tinnitus started 36 hours after vaccine then continued getting worse. On day 13 after vaccine now and still have tinnitus and occasional pain/pressure in ears.
Vaccinate:  01/11/2021  Afternoon                    Onset: 01/12/2021   Morning        Site: Rt Deltoid  Adverse Event:        Upon rising from bed, arm swollen and sore.  Shortly thereafter she noticed:  Fluid filled blister (approx. 5 mm), at the injection site, and superficial epidermal erosion 2 - 3 inches from injection site.   Ice applied and f/u visit at Urgent Care. Advised to apply neosporin and monitor site.
massive headache; nausea; achy, really achy; flu achy; actually called out of work; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache, nausea, pain, influenza and activities of daily living impaired. On an unknown date, the outcome of the headache, nausea, pain, influenza and activities of daily living impaired were unknown.   It was unknown if the reporter considered the headache, nausea, pain, influenza and activities of daily living impaired to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 27-Mar-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was self reported by the patient. The second dose of Shingrix landed him/her on butt.  The patient actually called out of work due to massive headache, nausea, achy, flu achy. Additional Supportive Information: The follow up would not possible as no contact details were available.
Full blown anxiety attack; Heart started to race, it felt  like it want to come out of my chest.; Eyes start to go blurry; Sharp back pain; Shortness of breath; Blood pressure high; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0162), via an unspecified route of administration on 15Apr2021 12:00 in the right upper arm at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: ER8733) on 25Mar2021 in the right upper arm for COVID-19 immunisation. Patient experienced a full blown anxiety attack. Her heart started to race, it felt like it wanted to come out of her chest. Patient also felt that her eyes started to go blurry and she had like sharp back pain and they put her on the stretcher and that mainly she had like shortness of breath with the main thing that she asked the nurse that people tended to get anxiety since they had been given initial of dose and she said no. Because of that nurse thought that patient should call Pfizer to report because nurse said that might be something like a side effect and they put her on the stretcher right away. Patient was on the stretcher for 40 minutes. These happened on 15Apr2021 13:00, an hour after vaccination. Patient did not receive treatment for events. She was given a whole bunch of water because she had like anxiety, the heart was racing fast, patient was kept on checking the high blood pressure until it went to low. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Vasculitis, inflammation of lower leg extremities on March 18- 31 cont.  And  extreme lower back pain march 28 - cont. Level pain (1-10) = 10
pt became very tired Fri PM, Sat 11AM started w/ n/v, was sick all weekend w/diarrhea also; monday felt better, went to work but still had abdo cramping;
Chills; Fever 101.5; Headache; Nausea; joint ache; Injection Site: red; Injection Site swollen; Injection Site pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 24Feb2021 17:15 (at the age of 67-year-old) as dose 2, single for covid-19 immunisation. Medical history included High Blood Pressure, High cholesterol, obesity. Known allergies were reported as no. The concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Other medications in two weeks were reported as High Blood Pressure, High Cholesterol meds. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 03Feb2021 17:15 (at the age of 67-year-old) as dose 1, single for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient experienced chills, fever 101.5, headache, nausea, joint ache, injection site: red, injection site swollen, injection site pain on 25Feb2021 10:00. The patient underwent lab tests and procedures which included body temperature: 101.5 on 25Feb2021. Patient did not receive any treatment for adverse events. The outcome of all events was recovering.   No follow-up attempts are possible. No further information is expected.
Presented to the ER 1 day after receiving the second dose of Moderna vaccine with truncal ataxia, vertigo, and dizziness. Patient later became aphasic in the ER.  Patient also noted to be febrile, hypotensive, with elevated lactic acid. Patient discharged on day 3 of admission per neurology clearance.
runny nose; tiredness; congestion; chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via medical information team.  A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date (3 weeks ago), as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced runny nose, tiredness, congestion and chills. Reporter asked whether she could take the Johnson and Johnson, Covid-19 for her second vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained
Boostrix - Expired dose administration.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4M2EZ, expiry date 03-JUN-2023) for prophylaxis.   On 19-JUN-2023, the patient received Boostrix. On 19-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix - Expired dose administration.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter asked for the efficacy of the expired vaccine. The reporter consented to follow up via email. The patient received an expired Boostrix, which led to expired vaccine used.
Getting like a hives or rash all over my legs and my arms; It was like the bumps like the color of my skin; Getting like a hives or rash all over my legs and my arms; This is a spontaneous report from a contactable consumer. This 37-year-old female consumer (patient) that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199; Expiration Date: 30Jun2021; NDC number, UPC number: unknown), via an unspecified route of administration on 08Mar2021 (at the age of 37 years) as dose number unknow, single for covid-19 immunisation. Medical history included anxiety and panic attack. Concomitant medication(s) included escitalopram oxalate (LEXAPRO), once a day taken for anxiety, panic attack. No investigation assessment done. Consumer stated that she was not sure of her weight at the time of report but she thought she was 150, 155 pounds. She hadn't weigh in a while. She got her vaccine on 08th, Monday the 8th of this month. Two days ago, she started noticing that she got like a hives or rash all over her legs and her arms. It was like an over a week but it might be like 2-3 days ago, she started noticing that she got like a hives or rash all over her legs and rash like bumps, on her arms. It was kind of hives or rash on her arms or legs and they just felt like, they were getting worse at the time of report. She didn't notice it because when she first noticed it wasn't itchy at all. It was like the bumps like the color of her skin. They were not like inflamed or anything like that, not like red or anything. She just started feeling like bumps on her skin. She started noticing them like she wanted to say like Thursday or Friday. At the time of report, she still experiencing the events and it actually got more itchy. She was scratching her leg a minute ago and she realized they were coming out more. She took Benadryl (Batch/Lot number, NDC number, UPC number, Expiry date: Unknown) the other day like a day before but took the Benadryl on the day of report but it did not seem to be very helping. She did only took one. She took Benadryl but she thought it was supposed to take 2 but she only took one. The outcome of reaction/event at the time of last observation was not recovered/not resolved.  No follow-up attempts are possible. No further information is expected.   She did not know if it was just from the vaccine or what but she only know where else she had got them from. So she was calling for some advice.   The patient experienced getting like a hives or rash all over my legs and my arms (rash) (non-serious) on an unspecified date with outcome of not recovered , it was like the bumps like the color of my skin (skin disorder) (non-serious) on an unspecified date with outcome of unknown , getting like a hives or rash all over my legs and my arms (urticaria) (non-serious) on an unspecified date with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of getting like a hives or rash all over my legs and my arms (rash).
Sever pain in wrist bones, fingers swollen, legs swelling, ankles hurt. both shoulders and elbows hurt. On 9-30-13 Client's daughter report that Dr. told client on 9-27-13 that her condition was just her arthritis flaring up. Daughter states that the swelling seems to decreasing.
NO ADVERSE EVENT OR REACTION.  SHOT GIVEN OUTSIDE OF APPROVED PROTOCOL DUE TO FATHER LYING ON ADMINISTRATION FORM AND TO ADMINISTERING PHARMACIST REGARDING HIS DAUGHTERS BIRTHDAY.  HE CLAIMED SHE WAS 12 WHEN IN REALITY SHE IS 10.
Broke out 7/4/08 with rash-started on stomach and back -were large red and many small red raised. Did not stop for next couple days- Went to ambucare 4/6/08- Had fever in 100's, lethargic- Became blisters-all little bumps also today has only red raised rash and no fever.
Rash (diffuse, urticarial-type, pruritus) treated w/BENADRYL and prednisolone.
I had COVID; I had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had COVID". The patient underwent the following laboratory tests and procedures: Angiogram: Unknown Results; Computerised tomogram: Unknown Results, notes: I told I went to ER and they said it was be going to take X-rays, CTs, Bladder or uterus,; X-ray: Unknown Results, notes: I told I went to ER and they said it was be going to take X-rays, CTs, Bladder or uterus,.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.