chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2020 at 12:00 as dose 1, single (Lot number: EH9899), in left arm, on 07Jan2021 at 12:00 as dose 2, single (Lot number: EL1284), in left arm, on 01Sep2021 at 14:30 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 08Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FK9896) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Metabolic syndrome" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Hypertriglyceridemia" (unspecified if ongoing); "NASH" (unspecified if ongoing); "preDM" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 13Aug2020, stop date: 12Jul2022; SEMAGLUTIDE, start date: 07Nov2021, stop date: 12Jul2022; ROSUVASTATIN, start date: 13Aug2020, stop date: 12Jul2022; FENOFIBRATE, start date: 13Aug2020, stop date: 12Jul2022; CITALOPRAM, start date: 13Aug2020, stop date: 12Jul2022; TRAZODONE, start date: 13Aug2020, stop date: 12Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded.
Weakness and pain in legs/legs would give out at any time; Weakness and pain in legs; can't walk now without a walker or assistance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (medically significant), outcome "not recovered", described as "Weakness and pain in legs/legs would give out at any time"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Weakness and pain in legs"; GAIT INABILITY (medically significant), outcome "not recovered", described as "can't walk now without a walker or assistance". The events "weakness and pain in legs/legs would give out at any time", "weakness and pain in legs" and "can't walk now without a walker or assistance" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: tests: can't find anything wrong. Therapeutic measures were taken as a result of muscular weakness, pain in extremity, gait inability. Clinical course: The patient experienced weakness and pain in legs, can't walk now without a walker or assistance. Her legs would give out at any time, so she has undergone many tests and can't find anything wrong, so they were wondering if it's from the vaccine. Treatment of events included physical therapy, many tests, and walker. It was unknown if patient had Covid prior vaccination or if patient was Covid tested post vaccination. The 3rd dose received was reported as not bivalent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DELTOID MUSCLE PAIN COMES AND GOES, LIMITED ARM MOBITLITY AT 5 MONTHS AFTER VACCINE
L hand went numb upon receiving shot.  Subsided within 15 min, but came back 30 min later, for another 10 min. The next morning, L arm hurts a lot, and huge headache.
Patient presented to the ED and was subsequently hospitalized for hypertensive emergency within 6 weeks of receiving first covid vaccination dose.
sore upper arm, "flu like symptoms incl. myalgias, arthralgia, fatigue, decreased appetite.
Muscle in left upper arm ached for about 1 week and then had a bad cold which settled in same location and ached severely for 2 nights; responded to hot cloth application but still minimal aching on 3/1/01.
Initial and follow-up information has been received from an official concerning unknown number of patients who were vaccinated with GARDASIL vaccine (yeast) at the gluteal region. No symptoms were noted. It was not specified if the patients sought medical attention or not. Attempts are being made to obtain additional identifying information.
rash in his throat; boils in his tongue; swelling in his face and throat; swelling in his face and throat; headache; joint pain; A Spontaneous report was received from a consumer(patient) concerning himself a 63 year old male patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister and boils in tongue/tongue blistering.  The patient's medical history was not provided. Concomitant medications included blood thinner and meloxicam.   On 25 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:001A21A) intramuscularly in the left arm for prophylaxis of covid 19 infection.  On 25 Feb 2021, within the first 24 hours he had a headache and joint pain. Then, a couple of days after he experienced swelling in his face and throat, a rash in his throat, and boils on his tongue. Rash in the throat/oropharyngeal blister was considered medically significant and serious. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister were unknown. The outcome of the event boils in tongue/tongue blistering  was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient came in with a red, swollen arm.  I explained this was a pretty typical adverse event but she felt it may have been an infection from improper technique and lack of sterilization.  It appeared to be a fairly normal swelling reaction post Shingrix vaccination, however.
Pain in arm at location of Lymerix vaccine persisted for weeks after these vaccines.  09/09/1999 and 10/06/1999 arthritic symptoms - spine, neck, aches and pains, loss of concentration persist currently, unexplained rash and constant fatigue.
Chills; Feeling weak; Shaking; His temperature is higher; He is been bed ever since received booster shot; Running Fever about 102 Degrees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: FE3592) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (FIRST DOSE, Lot number, Administration date, Administration time and Vaccine location: Unspecified), for COVID-19 immunization; Bnt162b2 (SECOND DOSE, Lot number, Administration date, Administration time and Vaccine location: Unspecified), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; ASTHENIA (non-serious), outcome "unknown", described as "Feeling weak"; TREMOR (non-serious), outcome "unknown", described as "Shaking"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "His temperature is higher"; BEDRIDDEN (non-serious), outcome "unknown", described as "He is been bed ever since received booster shot"; PYREXIA (non-serious), outcome "unknown", described as "Running Fever about 102 Degrees". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Administration time of booster dose was 02:00 PM. Vaccine location was unspecified. Facility type Vaccine was unspecified. The patient had not received any other vaccine within 4 weeks. The patient had not covid prior vaccination. The patient had not covid tested post vaccination. Number and Expiry Date of BioNTech Covid-19 Vaccine was unknown. Treatment for AE was unknown. He was running fever about 102 Degrees, it started about 2 o clock this afternoon up until then he was fine.  No follow-up attempts are possible. No further information is expected.
With the 1st vaccine my upper, left arm/shoulder got very sore for about 3 days or so. However, with the 2nd shot my left arm/shoulder started hurting a lot by the next morning, which was 2/12/21. It felt like my arm/shoulder locked up and I could not move it. When I did try to move it , it would click and pop and had severe shooting pain with arm weakness. I could not reach out and grab anything over a pound or two. It continued to get worse, and the pain was 24/7. By the 3rd week it seemed to be improving slightly so I sent a message to my provider to report my side effects. She told me that it had affected her joints as well, but at 3 weeks she was improving. She recommended that if this continued another week or
Caller states she received her 2nd dose of covid vaccine on Friday afternoon. Saturday morning she started with Left arm redness, swelling and soreness. Today the redness and swelling measures about 4x6. She also reports noticing a swollen lymph node to her left arm today. She denies fever. She has been taking tylenol and motrin, but has not tried compresses to injection site. She will call her PCP to schedule an appointment for tomorrow.
Recieved dose #1 of Pfizer Covid vaccine on 18Dec2020 with very mildly sore arm at injection site.; This is a spontaneous report from a non-contactable nurse. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK798), intramuscular in the right arm on 18Dec2020 13:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included ergocalciferol (VIT D), ethinylestradiol, norethisterone (NORTREL [ETHINYLESTRADIOL;NORETHISTERONE]). The patient previously took and had allergies with Phenergan. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested for COVID-19 post vaccination. The patient received first dose of Pfizer Covid vaccine on 18Dec2020 with very mildly sore arm at injection site on an unspecified date with outcome of recovering. The event was reported as non-serious. No treatment received for the event.  No follow up attempts are possible. No further information is expected.
Injection site swelling, painful joints, difficulty swallowing, nausea, weakness, pyrogenic reaction, I.e. Favera
Repeated severe migraines occurring randomly up till 4-13. Pain managed with Excedrin migraine
autoimmune issues; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated she experienced autoimmune issues and she had received the first dose of the Covid-19 vaccine. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I administered 0.3ml of undiluted childrens bivalent covid vaccine instead of 0.3ml of adult bivalent vaccine.  I called pfizer.  I got lucky.  0.3ml of undiluted children's bivalent covid vaccine is same as 0.3ml of adult bivalent covid vaccine.   patient received correct dose
adverse event,side effects that I had; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse event,side effects that I had) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse event,side effects that I had). At the time of the report, VACCINATION COMPLICATION (adverse event,side effects that I had) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Allergy, unspecified on 2013-10-15, pneumococcal vaccine allergy on 2013-10-15, clinician comment: allergic reaction in arm that pneumococcal vaccine was given.
The morning following the vaccine, the patient developed a fever of 101.2, but noon that day it got up to 103.5. I treated her with ibuprofen and a bath. After her nap that afternoon she woke up around 5:30 with a 104.2 fever. I took her to the ER and they treated her with ibuprofen. Her temp went down to 99.8 and they discharged us and said to follow up with her doc if it got worse.
Patient reported severe rash and hives all over chest, back, neck and abdomen. Also experienced, sore arm, fatigue and running nose. Recommended patient to take Benadryl, however she has not taken any medications yet.
Patient became near syncopal while at work in surgery department.  Felt hot, got dizzy, with nausea while standing and noted she could no longer see/focus on monitor in front of her.  Sat down, became pale and diaphoretic. Prodromal symptoms lasted 3-4 minutes before feeling better.  No LOC.  No change in normal daily routines prior to this event.  Proceeded to ED and received fluids/meds and discharged home.  EKG, labs completed.
- Pain going down left arm - Swelling in hand - Gave oral BENADRYL - Instructed to acp cold compress per verbal conversation w/Dr. at ER
pt recv vax 21APR99 & thigh swollen 22APR99;
This spontaneous report as received from a nurse via company representative refers to a 17 year old male patient. On an unknown date, the patient may have been vaccinated with a dose of (Merck) VARIVAX (Lot number, expiry date, route and dose were not reported) was diagnosed with shingles approximately on an unknown date in October 2012(reported as 6 months ago). The nurse was unable to confirm if the patient had received (Merck) VARIVAX. The patient sought medical attention for the same (Office visit).On an unknown date, the event shingles was recovered/resolved. Additional information is not expected.
myalgias & fever 24 hrs p/inject; later nausea, h/a, poor appetite, swelling & aching & erythema @ inject site; fever persisted 48 hrs myalgias persisted 5 days;
On 5/7/2021 Patient was admitted into the ER then later the ICU for a Cerebral Edema. Patient was also hospitalized for Acute Respiratory Failure and Hyponatremia. Sodium Level was 105. She was unconscious and intubated for 36 hours with massive swelling to her Brain. All the symptoms that took us to the hospital on the morning of 5/07/21 started on 04/30/21.
Vaccines given 9/17/18. Patient returned to clinic 12/13/18 with an ~5 mm subcutaneous nodule on left lateral thigh at site of injection. Unknown how large lump originally was after injection.
Utilized NACL 0.9% Bacteriostatic as a diluent NDC # 00409-1966-01
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 14-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administered 7/31/23. 08/05/23 stool changed substantially. 08/12/23 vomiting started and continued intermittently until hospitalization on 8/15/23 with fever of 101.3. Digestive supporting care was provided including IV fluids and food restriction. Not yet fully resolved.
On 04/13/22 while traveling out of state, I began to experience the following symptoms: light fever, fatigue, general achyness, deep unproductive cough and sinus congestion. Upon arriving home that evening I took a BinaxNOW Antigen Self Test, which came back Positive for Covid-19. Over the of course of the weekend I treated the symptoms with rest, plenty of liquids,  and Tylenol. additionally I took Vitamin D gels, Equate Sinus Congestion PE tablets, and Equate Black Elderberry Cold + Flu Relief Tablets. On 04/16/22 I called my PCP Dr's office and notified them of the positive RAT. I had a telemedicine  Zoom call with Dr later in the morning. He advised that I continue my current treatment regimen and stay in isolation for 10 days.  As the week progress symptoms became milder and mostly cleared up except the deep unproductive cough  which hung around for about two weeks. As of today 06/16/22 I consider myself fully recovered.
Information has been received from a nurse concerning her 19 year old female cousin who on an unspecified date was vaccinated with a first dose of GARDASIL vaccine. Concomitant medications were not reported. A nurse reported that her cousin received the first dose of GARDASIL vaccine and fainted in the waiting room. She recovered in 5 minutes. She had no reaction to her second vaccination with GARDASIL vaccine. Medical attention was sought: in office. There is no product quality complaint. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 7/15/2008. Follow up information was received from a nurse concerning her 20 year old female cousin with no medical history and no known allergies, who on 18-DEC-2007, at noon, was vaccinated with a first dose of GARDASIL (Lot # 653735/0688F) intramuscularly into the left deltoid. The patient fainted 5-10 minutes post vaccination. The patient recovered the same day. There was no illness at the time of vaccination. No relevant diagnostic/laboratory tests were performed. It was reported that two subsequent doses of GARDASIL caused no adverse effects. No further information is available.
My arm hurt immediately. By Sunday morning, I went to emergency room. I had severe pain down my entire right arm from the shoulder. I couldn't sleep because of the pain. It still hurts.
PATIENT PRESENTED TO CLINIC FOR PFIZER COVID VACCINE DOSE 2 (LOT FF2587, EXP 12/31/21).    AFTER RECIEVING DOSE 2 OF COVID VACCINE, PATIENT BEGAN TO HAVE SYSTEMIC ITCHING.  PATIENT ALSO HAD RASH ON TORSO.  PATIENT STATED HE FELT SLIGHTLY LIGHTHEADED.  PATIENT WAS ESCORTED TO EMERGENCY DEPARTMENT.  PATIENT DECLINED WHEELCHAIR AND STATED HE WAS ABLE TO WALK.  ESCORT STILL BROUGHT WHEELCHAIR WITH PATIENT IN THE EVENT SYMPTOMS WORSENED.    PATIENT STATED AFTER FIRST DOSE OF COVID VACCINE, HE HAD A SMALL RASH PRESENT ON TORSO AND WAS SEEN BY PROVIDER.  PATIENT STATED HE WAS CLEARED BY HIS PROVIDER TO RECIEVE DOSE 2.
Patient?s first dose of the COVID vaccine was Moderna but on the second dose, he was accidentally given the Pfizer vaccine. The nurse realized she had given the wrong one when she went to fill out his card.
Patient went into full cardiac and respiratory arrest around 3:30 PM on 06/15/2004. He suffered a sub arachnoid hemorhage as well as some retinal hemmorages.  Also there are areas of watershed infarcts due to severe hypoxia.  He is currently in the ICU in a comatose state. Information receive from annually follow up states Seizure disorder, gastrostomy tube dependent , visual impairment, hypertonic, inability to sit or stand at approx. 17 mo old, does not speak, prognosis unknown. These shots nearly killed my son and anyone needing or wanting to contact me about this is more than welcome to these specific shot/lots are dangerous.
Was given Hib Rotavirus, DTP, Hep B. Immediately started hysterical crying as soon as the vaccine was given. Continued from 11:00 to almost 4:00 that day when he finally fell asleep- would not nurse and could not be consoled. Assured that this is normal. Fever of 104 that evening and continue for the next three days and then it decreased to 101 for about three weeks. He continued getting fevers 99-101 degrees several times a month lasting for several days for the next five months (August 2007). Had no appetite for those three days and would drift in and out of sleep. Eyes were glassed over and he was not interactive (Which was very unlike him). He had been sleep for 6 -7 hours at a time prior to the vaccine and started only sleeping 1/2 hour up to 2 hours at a time if I held him. Very fussy when awake. What appeared to be seizures began after the first week. He would be completely unresponsive, put his fisted hands next to his head and shake with a blank stare. He would also begin shaking while nursing off to sleep. These seizure like behaviors continued until late August 2007 (about 5 months after the vaccines were given. He had horrible stomach pain and diarrhea that continued until he was almost three years old (October 2009). Was given Zantac which aggravated the problem. Was also tested for allergies. None were found.