chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The morning after shot I awoke to excruciating cramps in both calves (never experienced before) both calves very sore to touch after cramps closed, muscle pain proceeded up my legs to thighs (front and back) much like pain from excessive exercise, then to my buttocks. I now have extreme pain in my right leg with some pain in my left. I'm very active (or was) and am now having pain to use a cane due to muscle weakness, particularly in my right leg. My cardiologist retired the end of Nov. My P.C.P is not of the country. I'm in the midst of arranging for new doctors. I've been keeping pain at bay (through trial and error) with prednisone, hydrocodone, gabapentin and naproxen sodium. None of which can be good for my long range health care. Sleeping is difficult due to pain and there is a feelin of heaviness in my legs. I fear (my greatest fear) is that this condition is here to stay. I would much rather have the flu (which can be diagnosed) than go through these last few weeks. I failed to mention that the pain is exreme in my right groin area and if I do walk or try to do chores the pain is unmanageable even with the above mentioned meds. P.S. couldn't the gov. afford little more legible form?
Rash to R/L upper extremities, scratching. Diphenhydramine Hcl 12.5mg/5ml give 10ml PO Q6hrs, as needed for rash.
Six hours after receiving the vaccine shot my teeth started chattering with such intensity I could hardly speak, and my arms started to shake as if I were having a mild seizure.  I could hardly zip up my jacket, due to the intense shaking.  I immediately rushed to the local ER.  My temperature had jumped to 103 degrees.
This spontaneous report as received from 2 healthcare workers (1 medical assistant, the other not specified) refers to an unspecified number of patients. No demographic information was provided. ROTATEQ (lot number not provided) was exposed to 29-35 degrees Fahrenheit multiple times over a period of 3 months. The improperly stored ROTATEQ was administered to an unspecified number of patients on unspecified dates. Reportedly ROTATEQ was "supported by in-house stability data". No adverse symptoms were reported. This is one of several reports received from the same source (other cases IDs 1306USA008658, 1307USA008945, 1307USA008946, 1307USA008947, 1307USA008948 and 1307USA008949). Additional information has been requested.
This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis.  In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the swelling arm was recovering/resolving. It was unknown if the reporter considered the pain in arm and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient who was also working in administration. The patient received SHINGRIX shot on 25th or 26th June 2018. She had pain and soreness in her right arm for two weeks. The swelling went down after a week. The reporter agreed to be followed up from GlaxoSmithKline.
Flu-like symptoms beginning ~5 hours after vaccine, including severe muscle aches, fatigue, headache, swollen lymph nodes, sinus pressure. The bulk of the symptoms lasted 24 hours, with lingering fatigue for another 24 hours after that. Patient treated symptoms with bed rest and tylenol and did not require medical attention. Injection site was also swollen and sore for about 3 days after vaccine.
shingles eruption @ site of vax, spreading along arm & fingers, & shoulder on same side;accompanied by severe pain during & p/outbreak;outbreak occurred 20 months p/vax;no apparent case of chickenpox preceded shingles lesions;
Rt leg w/2 small papules at site surrounded by a flat non-tender patch of redness.  No infx noted.  Expected to resolve over next 1-2 wks.
Developed hives right arm to neck, chest tightness, left arm.  Hot flushed face.  To ER. Pulse 110. BP 148/90, O2 satl 100% on room air.   No c/o breathing difficulties.  IV lock with SOLUMEDROL 125 mg IV @ 11:10, ZANTAC 50 mg IV @ 11:14.  BENADRYL 10 mg IV @ 10:55.  Symptoms resolved.  D/C from ER @ 11:44, scripts for ZANTAC X 5 days &  PREDINSONE X 4 days.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 04-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
NO ADVERSE EVENT WAS NOTED.  ADMINISTERED EXPIRED VACCINE.  VACCINE EXPIRED ON 4/1/2022 AND WAS ADMINISTERED ON 04/19/2022
NONE, PT just received two flu doses- OCT 06/2020 and DEC 15/2020
One week after the shot, the area where I got the shot got red and swelled up a bit.  Was itching.  An area below the shot also got red and itchy.  This lasted a couple of days and then went away.  I also noticed on and off my face getting flushed under my eyes and across the bridge of my nose which has lasted on and off during the whole month before the second shot.
Woke up on 02/02/2021 with what I believe was left hip and left back pain but was able to manage the pain throughout the day. On 2/3 pain was to the point of almost being unable to get out of bed. I have a history of left hip labral repair and subsequent dislocation for which I thought the pain was coming from. 2/3 I woke up with severe back pain and I did a tele health visit at 6am at 2/3 via Medical Center and was told to see my orthopedist that day and if they couldn't get me in then I should proceed to the ER. Ortho called me and offered me an appointment on 2/4. So I proceeded to the ER on 2/3. At the ER lab work and urine was normal. CT of the abdomen showed epiploic appendigitis I was admitted to observation for pain.  I was discharged to home on 2/4 but unable to manage the pain. I went back to the ER on 2/5. Labs and urine still normal. Second CT of abdomen stilled showed epiploic appendigitis. Readmitted to observation.  Surgery was consulted. For surgery pain was too diffuse for EA and given history of endometriosis was thought to be abdominal deposits of endometriosis. The surgeon thought that the endometriosis could have been exacerbated by the covid vaccine.
suspected vaccination failure; 15 people / experienced shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and experienced Shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476:
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Adhd" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; CYMBALTA; VYVANSE; OMEPRAZOLE; ALLEGRA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was received other medication in 2 weeks. Patient did not  had any Known allergies. Treatment start date- 01May2022, Treatment stop date- 06May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy cannot be ruled out.
N/A. NO ADVERSE EVENT TO VACCINE. VACCINE OUTSIDE OF STORAGE REQUIREMENTS. REVACCINATION RECOMMENDED
On 3/5/2022, I received my Moderna booster. On 3/7/2022, I felt so fatigued that I only got out of bed long enough to use the toilet and take my temperature. I have a pre-existing condition, myalgia encephalomyelitis, and the booster exacerbated the symptoms. I was so fatigued that day that I slept almost the entire time and was up for no longer than 15 minutes. The fatigue was so severe that I had to stop in the middle of the message I was trying to type to my doctor in the medical portal, because I didn't have the energy to continue. I also had a headache, which I treated with ibuprofen and aspirin. I also had orthostatic intolerance, so I had difficulty walking properly to and from my bedroom. My temperature was 93.2, and I felt cold. I didn't even eat that day. The fatigue lasted until the evening of 3/8/2022.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 27-FEB-2018, the patient was vaccinated with an expired dose of VARIVAX (route, dose, frequency, and anatomical location were unknown) with lot # M009769 and expiration date 25-FEB-2018 for prophylaxis, reconstituted with sterile diluent (MERCK) with lot # M024786 and expiration date 19-FEB-2019. No adverse effects were reported.
Redness, warmth, swelling at the injection site on Left thigh. Limping when walking d/t pain.
Had consented for a Moderna vaccine on the registration. Was given Pfizer vaccine.  Patient was made aware of the mistake, Made aware of the VARES report. Visibly upset re: the mix up.
This non-serious initial spontaneous case was received from Other-Non-Health Professional on 23-Oct-2017, concerning a female patient of unspecified age. On an unspecified date, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture: not reported). On an unspecified date, the patient was also administered with non-company suspect drug COSENTYX (dose, route of administration, anatomical location: not reported) for unknown indication. On an unspecified date, the patient took flu shot while she was on COSENTYX medication (explicitly coded as contraindicated product administered). The outcome of the event was not reported.
Bladder pain went to er(meds given) Superficial blood clot on right thigh(meds given) Calf pain right leg ***Er with bilateral pulmonary embolism ( hospital 3 nights) ***Dvt right leg(on warfarin)
Mom reports that for 48 hours patient had a fever that reached 102 and the injection sight was red and hot with the entire arm very sore. Mom knew/knows that these can be symptoms but she had to give Tylenol for 48 hours to keep her fever down and her arm less sore to where she would use it.
Sick a little bit; Like a flu for the first 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick a little bit) and INFLUENZA (Like a flu for the first 2 days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced ILLNESS (Sick a little bit) and INFLUENZA (Like a flu for the first 2 days). On 27-Jul-2021, ILLNESS (Sick a little bit) and INFLUENZA (Like a flu for the first 2 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.  Treatment include Migraine medication.  Patient reported that she received second dose on 22 Aug 2021 on her left arm (lot 053E21A).   This case was linked to MOD-2021-306705.
Flu shot given on 11/13/00. Glands were swollen, 8 hours later, with swelling in front of ears. Dizzy. Had red rash on legs and arms, sick to stomach; lasted 2 days but felt weak for days. Put me to bed for 2 full days. Had temperature. Had rash for 10 days.
Vertigo; Fatigued; Arm started getting sore; Felt dizzy; This is spontaneous report from a contactable consumer, the patient.  A 29-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via unspecified route of administration in the left arm on 08Mar2021 at 09:30, (at the age of 29-years-old) as a single dose for COVID-19 immunization. Medical history included immune suppression, obese, allergy to latex and past drug history included allergy to oxycodone. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. Concomitant medications included terbinafine (MANUFACTURER UNKNOWN) and ciprofloxacin (MANUFACTURER UNKNOWN)  for unknown indication from unknown date. Past medication included oxycodone (MANUFACTURER UNKNOWN). Patient had experienced sore arm about 6 hours after receiving the vaccine  and also experienced fatigue and dizziness on 08Mar2021 at 15:45. Patient's arm was even more sore after 24 hours on 09Mar2021 and also experienced vertigo. The patient did not receive any treatment for the reported events. The clinical outcome of events sore arm, fatigue, dizziness and vertigo were recovered .No follow-up attempts are needed. No further information is expected.
Patient told Pharmacist this was first dose. Pharmacist went through all processes like first covid-19 moderna vaccine, schedule second dose appointment, and administered vaccine. After vaccine was administered patient admitted that she had lied and thiswas her third "BOOSTER" dose. She told pharmacist she got 2 Pfizer doses at the stadium. She reported a date in March, 2021 for second dose.
very tired; soreness in the arm; body aches; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly on 18Jan2021 13:00, at right arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via a unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient experienced soreness in the arm, body aches, very tired on 19Jan2021 12:00AM. Therapeutic measures were taken as a result of all events includes Tylenol Every 6 Hours. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, thirst, shaking, feeling of crawling out of body.  Lasted 3 1/2 days.  Last 2 days shaking and crawling out of body feeling was not present.  Diarrhea only day 1. Nausea lasted 1 1/2 days.  Day 4 no adverse effects remained.  Not certain if the above was related to vaccine but timing seemed to match.
Pain in right arm after pneumon shot low grade fever. Some swelling.   I call the office they said it is normal for the shot to hurt a few days.  I went back to to office the next Tues.  Dr. pers. prednisone, Tramadol and Keflex.  I slowly was better but still could not lift my arm to the side or above my head. The pain worsened on 2-26.  I went back in to the office.  Perscribed Prednisone - Percocet.
I had sore joints and slight fever and I started feeling better about 8 days following the symptoms.  I had to adjust my heart medicine so that I wouldn't have a hear attack.
chills, body aches, headache, sweating started 8 hours after vaccine injection and lasted approximately 9 hours before starting to subside.
I received my vaccine at a drug store on a Thursday.  Vaccine was unexpectedly very painful.  After that, I had a bad headache , beginning the next day, for about 36 hours.  I felt fine after that for a day or 2, and then I began feeling considerable pain on my right side, vertically going toward my hip from my arm pit.  This continued and spread, wrapping around my back toward my spine and toward my mid-section in the front of my body.  Then, I noticed red spots in the front which were very painful.  By this point, the pain was constant, and when I looked up the red blotches, I realized that I had shingles.  I have now had this for about 10 days, and they seem no better.  I will try to go to a doctor, although I have no regular "doctor".
severe lethargy 24hr p/vax;severe vomiting & mod dehydration 36hr p/vax;
loss of taste and smell; loss of taste and smell; fever; congestion (including runny nose); congestion (including runny nose); This is a spontaneous report from a contactable consumer (patient's wife) via medical information team. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number and expiration date: was not reported), via an unspecified route of administration, on an unspecified date as single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced loss of taste and smell; fever; and congestion (including runny nose). The reporter stated that she was calling on behalf of her husband who had the Pfizer Covid vaccine on Monday and reported loss of taste and smell, fever, and congestion (including runny nose); her husband (the patient) was asking as if this was normal. The outcome of all events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : 2021523850 Original Case : 2021513846 (Different patient with same reporter and drug)
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 fever for 4 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No medical history was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (102 fever for 4 days). At the time of the report, PYREXIA (102 fever for 4 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication was reported , No treatment medication was reported .
awoke this morning and began with  throwing up, not violent, but it would come back again and again.  Since she got the covid shot yesterday, we assumed that wae the cause of it.
Bilateral pulmonary embolisms  Hospital 4 days  Symptoms 10 minutes after Covid and flu vaccine
On 12/03/2022 I went to an urgent care. It hit me really fast and hard. It started early in the morning, unable to sleep, body aches, fatigue and congestion. The first two days were very bad. The third day I lost my smell and taste. They did not swab me correctly on 12/03/2022 so I tested negative. I then tested positive on 12/06/22.
At approximately 1600 on 9-16-17 patient reported experiencing a headache. On 9-16-17 at night time patient reported experiencing fever/chills/sweats. On 9-17-17 sweats continued. On 9-18-17 patient reported that when arrived to work her right arm was swollen and painful. On 9-18-17 patient left work at went to ER around 1200 where the MD diagnosed her with erysipelas/cellulitis and was given ibuprofen 800 mg and cephalexin 500 mg to be taken orally for 10 days. Outcome TBD.
This spontaneous report was received from a 81 year old female patient, who was referring to herself. The patient's current conditions included high blood pressure and an unspecified thyroid disorder. The patient was allergic to sulfonamides. The patient's historical medication included a pill for eye pressure vision. On an unknown date in approximately 2012 (reported as 4 to 5 years ago), the patient was vaccinated with ZOSTAVAX in the left arm to prevent shingles (dose, route of administration, lot # and expiration date were not reported). Concomitant medications included high blood pressure medication and thyroid medication. On an unknown date in approximately 2014 (reported as about 2 to 3 years after the vaccination), the patient got shingles two times. On an unknown date, the patient started experiencing nerve ending twinges in her back, intermittently, that lasted for 2 to 5 minutes at a time, but the last one lasted longer than most. The patient did not receive treatment for the adverse events. The outcome of the adverse events and the relatedness between the adverse events and ZOSTAVAX were not reported.
A nurse reported that a 13 month old male received a dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 09/15/03.  Concomitant therapy included a 3rd dose of Act-Hib (Haemophilus b conjugate vaccine).  Relevant medical history was not provided.  Indication for Prevnar was immunization.  Product was administered on 09/15/03.  Dose regimen was 0.5mL (IM).  Concomitant therapy included Act-Hib (Haemophilus b conjugate vaccine).  On 09/17/03, 2 days post-immunization, the pt developed redness and warmth at the injection site (right thigh), as well as irritation.  No additional information was available at the time of this report.