chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient called the pharmacy in the afternoon of 10/29/2021 in regards to a Moderna vaccine she had received the previous day.  Later on the night after receiving her vaccination, she reported having low grade fever of 100.1, chills, muscle pain throughout her entire body, and upset stomach.  This was followed by vomiting which occurred every time she tried to swallow water.  She reported that even after drinking water she would just vomit it up to the point where it was clear.  The patient was not delirious and was alert when speaking over the phone.  The patient was advised to consult her primary care doctor, to continue trying to intake fluids when tolerated (especially electrolyte drinks such as Pedialyte), and to take Tylenol for her pain and fever if allowed by her doctor.  Attempted to call the patient later in the day to assess her condition but not have received any response at the time of writing.
Mild tingling at site of previous shingles; Sore arm at site of injection; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 07:30 (Lot number: 32030BD) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Shingles", start date: Apr2021, stop date: May2021; "Dyspepsia" (ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for dyspepsia, start date: Oct2021 (ongoing). Vaccination history included: Bnt162b2 (dose 2 single, Batch/Lot No: ER8732, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 28Mar2021, when the patient was 57 years old, for covid 19 immunization, reaction(s): "Shingles"; Bnt162b2 (dose 1 single, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 03Mar2021, when the patient was 57 years old, for covid 19 immunization; Flu vaccine (anatomical location: arm left), administration date: 08Oct2021, when the patient was 57 years old. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Oct2021 22:00, outcome "recovered" (2021), described as "Sore arm at site of injection"; FATIGUE (non-serious) with onset 27Oct2021 22:00, outcome "recovered" (2021), described as "Fatigue"; PARAESTHESIA (non-serious) with onset 28Oct2021, outcome "recovered" (2021), described as "Mild tingling at site of previous shingles". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, paraesthesia.  Additional information included: On 08Oct2021, the patient received other Flu vaccine with in 4weeks (arm left). The patient was not diagnosed with covid prior vaccination. The patient was not tested for covid-19 post vaccination. Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? Yes. If yes above, do you consider the Pfizer product had a causal effect to the adverse event? Yes. Complete only if a 3rd dose was administered, Check one option: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications).  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a 66 year old female consumer refers to herself. In May 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose, route, indication not reported). Approximately in July 2013 (14 months later) the patient was tested for Herpes II and the test was positive for Herpes II. The patient felt that this was a "false positive" though. This was because the patient believed that ZOSTAVAX had caused her ZOSTAVAX test to be positive. The outcome of the event was unknown. Additional information is not expected.
A large raised whelp (welt) at the injection site painful itchy hard and still there 5 days post injection; A large raised whelp (welt) at the injection site painful itchy hard and still there 5 days post injection; A large raised whelp (welt) at the injection site painful itchy hard and still there 5 days post injection; A large raised whelp (welt) at the injection site painful itchy hard and still there 5 days post injection; This is a spontaneous report from a contactable other healthcare professional, patient. A 56-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Dec2020 16:00 in the right arm at single dose for COVID-19 immunization. Patient medical history included hypertension (htn), obesity, chronic pain, arthritis, and season allergies chronic. Concomitant medications were not reported. The patient previously took tramadol, tizanidine and duloxetine hcl (CYMBALTA) and experienced drug allergies. On 09Dec2020 17:00, the patient developed a large raised whelp (welt) at the injection site, painful, itchy, hard and still there 5 days post injection. The events were assessed as non-serious. Outcome of the events was not recovered.  Information on batch number has been requested.
Spinal fusion on January 12, 2021 one week after first vaccine. Second vaccine on Feb 2, 2021. Developed blood clot in right calf & pulmonary embolism in right lung the week of Feb 15th. May have been post op problem but I had no issue until after the 2nd vaccine. Surgeon felt that post op pts usually get a blood clot within 2 weeks after surgery- that's why I feel it was from the 2nd vaccine.
Four hours after receiving my injection I had diarrhea that night I had chills the next day I had 103 fever the following day I had 100 fever and aches and pains felt like I had to Covid.And severe headaches That I still have
the recent test showed low varicella titer.; This spontaneous report was received from a pharmacist and refers to a 32-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date (reported as unspecified years ago when the patient was young), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, dose description, lot #, expiry date and route of administration were not provided).  On an unknown date, the patient's recent test showed low varicella titer (vaccination failure). At the time of reporting, the outcome of the event was not reported.   The event was considered to be related to varicella virus vaccine live (oka/merck) (VARIVAX).
Myalgia, Fever, arm soreness, fatigue Narrative:  employee states: day 1=mild arm soreness day 2= significant arm soreness, tender to touch, pain with movement, fever 100.8, myalgias, fatigue day 3= mild arm soreness, fever/myalgia resolved day 4= slight tenderness to touch otherwise resolved
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with drug Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated the first night he threw up and had pain in chest and side of body. It has been two weeks since the vaccination and patient is stating he is still having pain in back and on the side of his body. Patient went to see doctor and doctor stated it shouldn't be from the shingles shot.
Rash - Information has been received from a physician concerning a 1 year old male who was vaccianted with one dose of varicella virus vaccine live.  Three hours after vaccination, the patient experienced a papular rash on the legs and arms.  Medical attention was sought.  He was administered diphanhydramine HCL (Benadryl).
Injection at 4:00 p.m. severe body shaking; vomiting (3 times in about 30 minutes) ; fever (101);  Began about 3 hours(7:00 pm)  after injection, lasted about 2 hours (9:00 p.m ) . Took Tylenol, 650 mg (2). Temp at 9:00 p.m.: 101; temp at midnight: 100; temperature next day (today) at 9:00 a,m,  98.6 (normal temp. is 97,6). Lingering body weakness. First and only allergic reaction to a vaccine in 60 years (except Yellow Fever inoculation  in 1967)
2 days after vaccine c/o "lump under (L) arm" followed by numbness/tingling down (L) arm into 4th and 6th fingers" has continued without stopping since 7/1/07. Spoke to PCP and was told to report to health dept. denies any changes in activities, bug bites, injuries, fever, illness, etc.
improperly stored temperature excursion; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 07-AUG-2020, the patient was vaccinated with vaccines which had improperly stored temperature excursion for prophylaxis. The vaccines included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #: S020160, expiration date: 30-JUN-2021, 1 dose; route and dose details were unknown) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: S038175, expiration date: 26-NOV-2021, 1 dose; route and dose details were unknown) (product storage error).   The vaccines were stored at the temperature between -6 degrees Fahrenheit to 14 degrees Fahrenheit (10 degrees Fahrenheit) for 1 hour and 15 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (44.8 degrees Fahrenheit) for 1 hour and 30 minutes; 47 degrees Fahrenheit to 77 degrees Fahrenheit (50 degrees Fahrenheit) for 2 hours and 30 minutes. There were no previous temperature excursions. The digital data logger was involved.
10/12/99:Pt. rcvd vacc.10/22/99:pt complained of a temp.,muscle aches, tiredness,& joint pain.11/7/99:pt. dvlped swelling of hands and face.11/8/99:pt. experienced atrial fib and was admitted into ICU for observation.
left side started to feel numb dragging of her leg/Left side is toatally intereupted; Injected limb mobility decreased; sore, injection arm; She can't hold things like she wants to; This is a spontaneous report from a contactable female consumer reported for herself. A 67-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 22Feb2021 15:45 as dose 1, single at the age of 67-years-old for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, ongoing HIV positive. Concomitant medications were not reported. It was provided for the other conditions that onset date as let's just say over 20 years but reported condition is well controlled, and her being very healthy. It is a flare up thing, not all the time. She uses an inhaler every now and then for asthma but is doing well. 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) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect: Vaccines If applicable, all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. On 14Mar2021 11:30, patient experienced left side is totally interrupted. She can't hold things like she wants to, and her left foot is dragging a little bit. Affecting her left side including shoulder, arm, leg and foot. Outcome is a little worse. She cannot work like this, unable to work today and wants to work the other day. Hypoaesthesia, Injected limb mobility Injected limb mobility decreased sore, injection arm injection site pain, left side started to feel numb, dragging of her leg, minimal use of left arm. The adverse event did not result in emergency room/physician office visit. Patient was not hospitalized. It was mentioned later in the call that she was local yesterday at time of onset of event. She has not travelled out of the area in the last 3 weeks. Dose change: she was supposed to go back on 26Mar2021 for second dose but has no plan to get second dose due to this event. The patient underwent lab tests and procedures which included sars-cov-2 test negative resulted as negative on an unknown date 2021, she can't hold things like she wants to resulted as decreased on an unknown date 2021. The clinical outcome of the event left side started to feel numb dragging of her leg/Left side is totally interrupted was not resolved and rest of the events was unknown.  No follow up attempts are needed. Information about lot/ batch number cannot be obtained.
was in contact with someone that had Covid-19; sore throat; allergies; This is a spontaneous report from a Pfizer-sponsored program via a medical information team. A contactable consumer reported that a male patient of unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. It was reported receiving both doses of the vaccine and was in contact with someone that had Covid-19. He was going to get tested for the virus since he was in contact with vulnerable individuals and asked if the vaccine will affect the results of the test. Stated he has a little bit of a sore throat and allergies but nothing out of the ordinary on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained
This spontaneous report as received from a nurse practitioner refers to a male patient in his 60's (years of age, exact age were unknown). The patient's medical history, concurrent conditions, drug reactions and allergies were unknown. On an unspecified date, approximately in April 2013 (reported as "approximately 18 months ago"), the patient received ZOSTAVAX dose, frequency, therapy route, lot # and expiration date were not reported. Concomitant medications were not reported. On an unspecified date, in October 2014 (reported as "last week"), the patient developed unspecified shingles symptoms. The patient sought medical attention and he was treated with acyclovir and prednisone. At the time of the report the patient did not recover from adverse event. The relatedness between vaccination with ZOSTAVAX and the event was not reported. Additional information has been requested.
reddened area @ site of vax;itching @ site, swelling, sore x 3 days;pt SOB w/rxn;pt given anti-inflammatory med @ MD office;pt unable to recall med;
Information has been received from a physician's assistant concerning a 58 year old female patient with hypertension who on 12/17/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvent (lot number 641027/1051L). On 12/18/01, the patient developed pruritus and urticaria (site not reported). The patient took diphenhydramine (BENADRYL) for symptoms. The patient was to be seen in the office on 12/19/01. Unspecified medical attention was sought. Additional information has been requested.
Patient wanted only a Covid shot, but received a flu shot. Patient was then given Covid shot - patient said they are feeling okay today, only minor headache.
p/vax pt started c/stuffy nose; next day had heavy nose bleed; then deep cough & continues to have cough & runny nose
Very painful, large redness spreading from injection site, doctor prescribed Doxycycline; redness spread further that night; redness seemed to lessen starting on 02/15/2015; patient developed respiratory infection 02/15/2015 but is unknown whether it is related to vaccine.
This spontaneous report was received from a consumer (patient wife) refers to a 80 year old male patient. The patient pertinent medical history included mild congestive heart and diabetes. On an unknown date in 2010 (also reported as about four years ago) the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported) subcutaneous. Concomitant medication included diabetes medications (manufacturing unknown). On 26-APR-2014, the patient experienced ear infection and pain. The patient sought medical attention and visited the physician office on an unspecified date. The patient was treated with ANTIPYRINE BENZOCAINE (unspecified dose/frequency and manufacturer), AMOXICILLIN (500 mg for ten days, unspecified manufacturer) and NEOMYCIN POLYMYXIN B SULFATES (unspecified dose/frequency and manufacturer), and HYDROCORTISONE (unspecified dose/frequency and manufacturer). On 30-APR-2014, the patient visited the physician office again and was diagnosed with shingles. On an unknown date, the patient had an MRI and result was unknown. On an unknown date, the patient discontinued all the treatment medications to treat the ear infection and pain and started using VALACYCLOVIR (1 g/ three times daily, unspecified manufacturer). The outcome of the event shingles was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
20 min post vax, pt developed redness and irritation in arm.  Seen in MD office on 10/15/99 was grossly swollen, r/arm with erythema from deltoid region down to forearm.  Given course of Cipro if symptoms continue.  Pt didn't need to take.
High fever, aches, pains, headache, lethargy, hypersomnia, fatigue, malaise - lasting 6 days before becoming functional again, but with lessened symptoms.   Chronic inflammation of underlying autoimmune disorders lasting in renewed and continuing musculoskeletal pain, brain fog, extreme fatigue, muscle spasms to date with no signs of ending to date. Could be permanent disability if it does not improve.
Expired Vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038321A) for COVID-19 vaccination.     The patient's past medical history included Cough, Vitamin D deficiency, Vitamin B12 deficiency, Lumbar radiculopathy (L5.), Musculoskeletal pain (Lowback pain.), Atrophy (Mild on MRI), Hyperlipidemia, Cognitive impairment (Mild), Word finding difficulty, Fatigue, Cerebral small vessel ischemic disease and Lumbar disc disease. Concomitant products included FINASTERIDE, ROSUVASTATIN CALCIUM (CRESTOR), L-METHYLFOLATE, ACETYLSALICYLIC ACID (ASPIRIN LOW), VITAMIN B12 [VITAMIN B12 NOS], VITAMIN D3, UBIDECARENONE (COQ-10) and INFLUENZA VACCINE (INFLUENZA) from 30-Nov-2021 to an unknown date for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had screening for CAD, skin cancer, colon cancer, lung cancer and prostrate cancer.
Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old male patient who received 0.5 ml dose of suspect PENTACEL (lot number, route and site of administration were not reported) on 22-Aug-2018 too early. The patient also received a dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number, route and site of administration were not reported) on 26-Apr-2018. Concomitant medications included PROQUAD for Immunisation; and PREVNAR 13 for Immunisation. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was reported that the patient was not due for his fourth dose until 16-May-2021. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of the documents held by sender: none.
Pt began feelin g light headed and then went unconscious and had a seizure involving  her arms, bilaterally as well as her legs, bilaterally.
Initial reaction occurred approximately ten hours after the vaccine, chills and injection site soreness, exhaustion next day hot flashes and body pain, following day (day3) just tired thought it was getting better then day 4 extreme dizziness, nausea, exhaustion, increased body pain especially behind left shoulder day 5 and today same
1FEB extreme lethargy; 3FEB corners of mouth cold sores started to develop?; neck & upper back sore
Pt received flu vaccine at approximately 11:30 am on 9/12/2017. At 2:00 pm on 9/12/17, pt reports itching all over with no rash, shortness of breath, or difficulty swallowing. Pt sent to Emergency Dept. Pt given prescription for Prednisone 20 mg and recommended to take Benadryl, Claritin, or Zyrtec as needed for itching. Pt reports red blotches on face, continued itching, and feeling hot all over that evening. Pt took Allegra (without D) and Prednisone on 9/13/2017. Pt was seen 9/14/2017 at Occupational Health Services to report lessening itching and blotches are clearing. Physician's Assistant told pt to continue Prednisone and Allegra.
Site: Swelling at Injection Site-Mild, Systemic: pt just hs sharp pain across lower back for few minutes-Mild
The stuff on my ankle after the second dose was very itchy like deer fly bite. It was really red and about four inches up my ankle 6-8 inches around the ankle it was like this on both ankles. It was a mixture of bumps and blistery. It itched so bad that they busted and seeped a clear liquid from itching. It was about 3 weeks before I saw a doctor. The doctor prescribed a topical cream. Will call back with the dates of the dose 2 and dates.
Returned to clinic 2 days post vaccination with L arm tenderness and swelling, shoulder to elbow. Area warm to touch. Benadryl and cool compresses ordered.