chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EC9266), in left arm, on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 26Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of vsd" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "history of breast cancer, stage 1" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codine, reaction(s): "known allergies: Codine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 4 days after negative test; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID from 06Mar2023 to 11Mar2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, lower back pain, panic attack. VS 140/100, 80, 100% recheck 125/88, 130/90
Arm pain: started about 4 hours after shot, got worse despite early ice and movement Insomnia: went to sleep around 9:30pm, woke up at 11:30pm and an hour and a half later, still unable to go back to sleep, despite meditation, reading, music, etc. Wide awake.
1030-37hr maculopapular rash on trunk;diffuse hot, itchy;
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
patient had a Gardasil injection on 8/30/07 at 10:30 am, at 6:00 pm developed sinus headache. No other symptoms. 8/31/07 Headache resolved without medication-9/6/07 headache took Tylenol with no relief went to sleep. Awoke on 9/7/07 with headache. No complaint of headache or any other symptoms 9/7/07. Pt has hx of headaches at intervals before Gardasil vaccine.
Initial misuse report received from a healthcare professional on 19 August 2013. A patient (no other information was provided regarding patient) had received the dose of PENTACEL gave it reconstituted with sterile water i.e. wrong solution used in drug reconstitution. No adverse event was reported. List of documents held by sender: none.
PATIENT GIVEN 5 VACCINES AS LISTED BELOW.  ADVISED TO WAIT IN CLINIC 15 MINUTES BEFORE LEAVING.  TEN MINUTES AFTER SHOTS CHILD PRESENTED WITH RAISED HIVES ABOVE LEFT ARM AND BACK OF SHOULDER PROXIMAL TO SITE OF DTAP IMMUNIZATION.  NO RESP DISTRESS NOTED, CHILD WEIGHED, V/S TAKEN BP 90/50, P 88 TEMP 97.7 (AXILLARY) DR CALLED ORDERS TO GIVE 1 1/2 TSP BENADRYL AND 4-6 HOURS AS NEEDED.  CHILD WEIGHS 42 POUNDS.  INSTRUCTED TO CALL 911 IF CHILD HAS ANY RESP DISTRESS.  BENADRYL 1 1/2 TSP GIVEN AT 11:45 AM, 12:20PM HIVES ARE GONE. KEPT UNTIL 12:45PM FOR OBSERVATION.  NO S/S RESP DISTRESS OBSERVED.  CHILD HAS HEADACHE BUT MOTHER STATES HE HAS NOT HAD ANYTHING TO EAT TODAY.
This case was reported by a nurse via call center representative and described the occurrence of seizure in a 20-year-old female patient who received HAVRIX (batch number TB995, expiry date 25th October 2020). This case was associated with a product complaint. In March 2018, the patient received the 1st dose of HAVRIX .5 ml. In March 2018, immediately after receiving HAVRIX, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was recovered/resolved. The reporter considered the seizure to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The registered nurse reported that she administered the HAVRIX vaccine in the afternoon to the patient (in right deltoid). No additional details were available. Follow up information was received from nurse via call center representative on 24th April 2018: This case was associated with product complaint. The health care professional called back later relating previously reported adverse event to two new adverse event with a quality complaint. In addition, the nurse reported that she previously reported seizure but she used the term convulsion when she called back. The dosage of the vaccine administered was corrected to 1 ml.
My family has a strong history of arthritis. Mine has never been active, I?ve never been tested for it, I have never been diagnosed. But my grandma, mom, aunt and twin sister all have it.  I woke up on Wednesday the 28th with a slightly swollen and stiff knee, not triggered by any activity or environmental factor. There has been no injury or stress on the joint. But it has swollen and appears to be experiencing an RA flare up.
Diagnosed 5 years ago with severe allergy to flu vaccine (anyphylaxis & intubated x 4 hours)has avoided since. 11/11/08 22 Co-workers received Fluzone vaccine in small, not well ventillated room, syringes were prepped in another area so minimal aerosolization occured. 20 minutes later she walked into this room and developed top lip numbness and stuffy nose, went for quick walk out of area, returned to same room & developed chest tightness and wheeze.  50mg Benadry po without relief, brought to ED.  Treated with steroids po and IV, Resp. treatments O2 sats 84%.  Improved for a while then decompensated, tach 180's.  Gastric Bypass 2 months ago with PICC line, did Chest CT with contrast to r/o PE, which was negative. Hospitalized x 48 hours, sent home on po steroids, Benadryl, Zyrtec, Albuterol inhaler.  Has epi-pen and has been educated to avoid handling of flu vaccinations, IM and nasal. 12/15/08-records received 11/118/08-presented to ED with indirect exposure to influezna vaccince which caused intense allergic reaction and after steroids became tachycardic and short of breath. Admitted for observation.
Patient complained of having fever, achy joints, an upset stomach, a sore arm, and nausea. I recommended TYLENOL for aches/fever. I also told her to contact her physician if she did not feel better.
48hr p/vax localized swelling, pain, erythema 4.1x7.8cm induration lt arm lower area of deltoid;sx lasted >2wk urticaria;
(L) arm swollen, red, hot, itchy, sore. Temp 100.2. Chills and body aches swelling and redness has continued for a week and its still red.
I noticed after wringing a wash rag out, my arm was really sore for a good 2-3 months. I was unable to sleep on my left side. At night it bothered me more than during the day. It was pretty painful. I had an MRI which showed a torn muscle. The pain is not as bad as it was initially. There is like an indentation in the muscle. There are certain positions I can move my arm where the indentation is visible. Back when it was hurting badly, I was unable to wash my hair. I saw my neurologist who ordered the MRI but did not prescribe me anything. She wanted to recommend me to an orthopedic surgeon, but I refused. Now that it doesn?t hurt as much, I decided I will wait before doing anything with it.
inflammation and swelling at the injection site; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2019SA157325.  This case involves a female patient of unknown age who experienced inflammation and swelling at the injection site, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-May-2019, the patient received 1st dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5609AA and expiry date: 04-Apr-2021 via intramuscular route in the right deltoid.   On an unknown date, following the vaccination the patient experienced injection site inflammation.  (Other relevant tests included no lab data.)  Final diagnosis was Injection site inflammation.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as unknown at the time of reporting.  List of documents held by sender: none.
Immediately, post vax, child's head dropped, eyes rolled back as though she had fainted. Then she started posturing with jaw clenched and neck hyperextended, lasting 1 minute. Child regained consciousness fully. No treatment necessary.
Heart rate of 210 for over 30 minutes Then rate rate dropped to fluctuate between 130 and 160 At time of going to bed, 9 pm heart rate was still 110-125 As of 7 am on 5/22 rate rate is down to 90
Patient came to office on 4/8/08 - vaccines given 4/4/08. Patient with 1cm x 2cm hardened nodule with 3in x 3in bruising around sq injection site on right arm - left arm with 0.7cm x 0.7cm bruising with 1cm x 1cm urticaria. Mom reported much worse 1-2 days after injection. No fever, no other symptoms or complaints at this time.
This spontaneous report was received from a consumer refers to her son of unknown age who on 18-JUN-2012, was vaccinated intramuscularly with the first dose of GARDASIL (dose and lot number not reported). The consumer reported that the dose had been stored at room temperature for a three week period. The consumer and her son would be speaking with the physician's office to determine if the series would have to be re-started at this point. Additional information has been requested.
Have fever now 100.7; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included MODERNA VACCINE (already had moderna shots and booster on an unknown date).   On 7th December 2021, the patient received Shingles vaccine. On 7th December 2021, less than a day after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient already had moderna shots and booster. The patient received a dose of Shingles vaccine a day before reporting and had fever 100.7 degree in afternoon. The reporter consented to follow-up.
This spontaneous report as received from a pharmacist refers to a approximate 67 year old female patient. On 25-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H018798, expiration date 15-JAN-2014 (reported as 10/2013), 0.65 ml, subcutaneous). Concomitant medications were not reported. On an unspecified date in March 2014 the patient developed shingles after receiving ZOSTAVAX. At time of the report, outcome of the event was reported as not improved. The patient sought medical attention by contacting pharmacist. This is one of several reports received from the same reporter. Additional information has been requested.
11/25/21 presents to ED for "dyspnea". PMHx of "ILD, IDDM, HTN, HLD"
3JAN91 pt exhibited fever of 103 orally; 1 wk p/MMR immun; Also given @ this time TB skin test; fever above 101 x 3 days; pt seen by MD placed on ATB;
COVID; COVID; floaters in my eyes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly male patient received BNT162b2 (COMIRNATY), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID"; VITREOUS FLOATERS (non-serious), outcome "unknown", described as "floaters in my eyes".  Clinical course: Reporter was considered event as caused by suspect product(s). Well I was fine until I took the vaccine; then I got COVID. Mild and now a have floaters in my eyes  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was almost like I had no control of my body; I was like walking forward I couldn't stop myself; it's almost like I have been pushed like into the window braced myself it scared me; my arm of course they gave me the shot I couldn't even brush my teeth/my arm didn't hurt till I woke up in the middle of the night; I couldn't even brush my teeth this morning; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration, administered in arm on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the vaccine at 3 O'clock and had no reaction, didn't feel anything had no reaction so the patient went to bed around 8:30 or 9 and watched TV for some time and sleep around 10:30, woke up at 2:30 because of the bathroom and weirdest thing the patient stood up and didn't feel dizzy but went to turn the TV off and it was almost like the patient had no control of the body was like walking forward and couldn't stop, it's almost like the patient has been pushed like into the window braced self, and it scared the patient. The patient sat on the table and was going to the bathroom and stood up and same thing happened, could see the opening of the bathroom of course but the body did the same thing it was like the patient has not control and kind of falling towards the lift. The patient went into the kitchen to get the information from the hospital where the vaccine was administered, to see if the patient got the number to call and it happened again it hasn't happened since but didn't know all the number, tried to call and didn't know how serious that was. The patient tried to call the hospital back but it kind of worried the patient because this is kind of (incomplete sentence) and then patient's arm of course they gave the shot, the patient couldn't even brush my teeth this morning but that's kind of expected when you get this type of a shot sometimes so that was not concerning me, the only thing that said on the paper was dizziness and this may be a form of dizziness but the patient wasn't feeling dizzy though my head wasn't spinning. The patient didn't know how serious this may or may not be and how long it lasts. That's okay, that's nobody's fault, the patient just didn't know what to do how serious, that a reaction the patient was assuming. The patient further stated that like motor skills are (incomplete sentence), honestly it was like the patient was a little drunk like, was staggering and couldn't control the body, was awake for 8 hours after the shot and nothing was going on and the arm wasn't hurting either, arm didn't hurt till waking up in the middle of the night. The patient was asking if this was a serious side effect and that the patient should not get the second shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Upper (L) arm deltoid muscle red & swollen and warm (baseball size -> softball size in redness) slight tenderness to touch. No drainage. Treatment: 50 mg BENADRYL q 6 hours x 24 hours then as needed, cold compresses. If no better will start BACTRIM.
Pt received flu injection on 11/25/13 and ever since has had pain at the site, decreased range of motion. Pt reports decrease use of deltoid. Pt has tried NSAIDs - ice - heat - massage little relief.
I started a severe fever like I have never had before. I was also already taking Tyenol at the I took the vacaine. It would always get worse at night, I would experience shaking chills like I have never experienced before this went on for 3 days. I could not eat, only drink liquids. I became pale, and very weak, dizziness did occur and a fast heart beat at times. I also threw up on 10/21/2010.  I did get it to stop by taking over the counter fever reducers. I had to take every four hours. Finally recovered on 10/25/2010.
MENSTRUAL PERIOD; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced menstrual period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menstrual period was not reported. This report was non-serious.
Information has been received from a nurse via a field representative referring to a female patient of unknown age. The patient's medical history included dizziness. The patient's concurrent condition was anxious with her choir group. No information regarding the patient's concomitant medications, drug reactions or allergies was provided. On an unspecified date, the patient received dose of GARDASIL 9 (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. It was unknown if this was the patient's second or third dose of GARDASIL 9. The GARDASIL 9 was the only vaccine the patient received that day. After receiving dose of GARDASIL 9, the patient experienced syncope. The patient was monitored in the office for more than 15 minutes and had recovered by the time she left the office. The causality assessment was not provided. Upon internal review, syncope was determined to be medically significant.
Dizzy; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 03Mar2021 at 14:30 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disorder (COPD), arthritis and known allergies to bees. It was unknown if the patient had any other medications within two weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021, the patient reported that he was still dizzy about 45 minutes after vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy was resolved on 03Mar2021 at 15:15.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
On 4/10/2023, my left ear and my throat were hurting, so I took a home antigen test and got a positive result. I also eventually developed a cough. I called the doctor's office and got a prescription for Paxlovid, which I began taking that day. I became nauseous and vomited at one point. I suspected that the symptoms were caused by the Paxlovid, so I contacted the doctor to see if I could stop taking it, but he encouraged me not to and explained that we didn't know if the symptoms were caused by the medication or by the virus. I finished out the Paxlovid. I was prescribed Zofran for the nausea, but it didn't help much. My sore throat persisted, and I asked the doctor's office if I could possibly have a bacterial infection, so I was prescribed Z-Pak on 4/13/2023 to treat it. I took the Z-Pak, and the sore throat finally went away. My symptoms abated, and I was okay between 4/19/2023 and 4/22/2023. On 4/23/2023, I had a runny nose, sneezing, and a bit of a cough. I felt like I had a cold, but it wasn't as bad as it was when the symptoms began during the earlier part of the month. I took another home antigen test on 4/23/2023 and got another positive result. When I tested myself again on 4/27/2023, I got a negative result. I currently feel pretty good, though I still have a cough. I plan to test myself again tomorrow. If I test negative again, I plan to quit wearing the mask.
Four hours after vaccination pt reported she experienced severe joint pain (fingers, wrists, knees) and swelling.  Resolved after 3 days.  Did not report symptoms until today 07/02/2010 when she presented for second MMR required to register for classes.
Terrible migraine, Severe gripping pain on both sides of my head, Nausea, Vomiting.
Chills, shivering, alternating with hot flashes, rapid heart rate preventing sleep, headache, nausea, panic symptoms.  Symptoms lasted 24 hours with a subsequent 24 hours feeling weak and dizzy.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. The healthcare worker reported that since 11-DEC-2015, the patients had been vaccinated with unspecified doses of PEDVAXHIB (lot # L014429, Exp date 15-MAR-2018 (Strength and route were not provided), which were exposed to temperatures outside of the commended range. Concomitant medication was not reported. No adverse experience had been reported. This is one of several reports from the same reporter. Additional information has been requested.