chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache  Chills Sweating  Nausea  Pain in injection site Swelling Loss of appetite  Joint Pain Lethargic  Dry Cough
Increased arm swelling, redness, tenderness and warmth. Body chills and sweats.  ? subsequent cellulitis vs local reaction. tx with abx.
Cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills for 6 hours; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills for 6 hours) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Jun-2022, the patient experienced CHILLS (chills for 6 hours). On 15-Jun-2022, CHILLS (chills for 6 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2022, Body temperature: high.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  Patient stated that one hour after the vaccination, got a temperature and chills for 6 hours. And that patient would be getting their second dose on the 6-Jul-2022 .    No treatment information was reported.
pt recvd vax & exp numbness in feet progressed to legs, hands, mouth, face; dx w/ guillain barre synd w/ quadriparesis; resp failure & aspiration pneumonia; was fed by a tube until strong enough to eat;
About 12 hours post vaccine, I felt a little dizzy and a little nauseous.  About 18 hours post vaccine I hade a fever and difficulty walking short distance.  All symptoms were gone by 22 hours post vaccine.  Felt fine.
24hr p/vax c/o generalized itching all over body, hand itching, a flushed face & generalized flushing;took APAP;did not call MD;
Fatigue, shortness of breath, worsening orthopnea, leg swelling, chills, nausea, runny nose, productive cough, loss of taste
felt like his throat was being to close up; appeared to be gasping for air; lose sensation in his extremities; extremities tense and contracting; respiratory distress; This is a spontaneous report from a contactable nurse, reporting for her son.   A 17-year-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 20Apr2021 at 10:15 (Batch/Lot Number: EW0170) as a single dose (at the age of 17 years old) for covid-19 immunisation.  Medical history included anxiety from an unknown date. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included anxious reaction to Hep B two years prior (2019). The patient experienced respiratory distress on 20Apr2021 at 10:21 with outcome of unknown, felt like his throat was being to close up on 20Apr2021 at 10:22 with outcome of unknown, appeared to be gasping for air on 20Apr2021 at 10:22 with outcome of unknown, lose sensation in his extremities on 20Apr2021 at 10:22 with outcome of unknown, and extremities tense and contracting on 20Apr2021 at 10:22 with outcome of unknown.  Chronology of events was as follows: on 20Apr2021 at 1021: Patients mother alerted roving medic that son was experiencing respiratory distress. Medic immediately radioed and arrived at car at 10:22. At 10:22: Patient stated he felt like his throat was being to close up and appeared to be gasping for air. Patient also stated he was beginning to lose sensation in his extremities; extremities tense and contracting; denied changes in vision. At 10:25: 0.3 mg Epinephrine administer into left vastus lateralis. The patient underwent lab tests and procedures which included blood pressure measurement: 80/52 on 20Apr2021, blood pressure measurement: 111/57 on 20Apr2021 at 10:26, oxygen saturation: 89 % on 20Apr2021, and respiratory rate: 26 on 20Apr2021. The events resulted in Emergency room/department or urgent care. It was also reported that since the vaccination, the patient had not been tested for COVID-19; Sender's Comments: Based on current known drug safety profile, the reported events were assess as intercurrent medical events and thus assessed as not related to suspected drug BNT162B2 . Case will be reassessed pending  new information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
On 12/6, Patient received the influenza vaccine. As of 5:00 PM Valery was complaining on pain and did not want to leave her bed. Patient ran a high fever, had chills, diarrhea, lethargy, loss of appetite, and body aches. This continued for multiple days. On 12/10 we contacted our pediatrician for a follow up appointment and was informed by the doctor that there was the possibility of this occurring, after being informed at our initial visit that this was not a possibility. These symptoms continued until 12/13 when Valery was finally able to return to school. The doctor did not recommend any treatment, or suggest any course of action for attempting to deal with Patient's illness.
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022; No adverse event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 21-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022). No concomitant medications were reported. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. The vial did not undergo any temperature excursions. No treatment details were reported.
Information has been received from a registered nurse for the Pregnancy Registry for GARDASIL concerning an 18 year old female patient who on 26-Feb-2008 was vaccinated intramuscularly with a 0.5ml dose of GARDASIL (lot# 658100 / 0525U) , on 22-Apr-2008 with the second dose (lot # 657617 / 0384U) and on 02-Dec-2008 with the third dose (lot# 661530 / 0575X). On 02-Feb-2009 the patient developed lower back pain and went to the emergency room. She had an urine test and an ultrasound that showed that she was 31 weeks pregnant. She was given a due date of 07- Apr-2009 (LMP 01-Jul-2008). The patient had no signs or symptoms of pregnancy prior the ER visit. She had no complications thus far and will be having a baby girl. Additional information has been requested.
Severe intractable pain; nausea; vomiting; Inability to walk unassisted; Unable to tolerate food or liquids; could not get out of bed; slept most of the day; This is a spontaneous report from a contactable Other HCP (Patient).   A 49-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203) via unknown route of administration administered in left arm on 02Mar2021 1:30 PM (at age of 49 years) at single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included HTN, Post-Bariatric Hypoglycemia had allergic to PCN, SULFA, ERYC. Concomitant medication included Lisinopril (LISINOPRIL), Lexapro (ESCITALOPRAM OXALATE), Ativan (LORAZEPAM), Wellbutrin (BUPROPION HYDROCHLORIDE), Trulicity (DULAGLUTIDE) all taken for unspecified indication. Patient did not receive other vaccine in four weeks. Didn't had covid prior vaccination. Not tested covid post vaccination. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El9265) via unknown route of administration administered in left arm on 09Feb2021 1:30 PM (at age of 49 years) at single dose for COVID-19 immunisation. Patient experienced severe intractable pain, nausea, vomiting, Inability to walk unassisted, Unable to tolerate food or liquids, could not get out of bed and slept most of the day on 02Mar2021 09:00 PM. Treated in ER with Zofran, Tramadol, morphine and dilaudid, before she had some relief. It was reported that she tried some liquids, but it started a cycle of nausea and vomiting that lasted the whole day. Finally, today, Friday (dose was Tuesday), she tolerated some apple juice and tea. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
A few minutes after receiving the initial Covid shot, I experienced elevated heart rate, nauseated, and uncontrollable shaking. EMS was notified and they monitored me for 30 +mins with VS. My heart rate was 116 and BP was 164/109. I felt 100% calm inside, but my body was shaking all they way down to my feet, and I could not stop it. This was NOT an anxiety attack. I was breathing normal, just could feel my heart racing. My normal BP is never higher than 130/80.  I was given the  option to go to hospital or have someone drive me home. I declined , as symptoms stopped a little over 30 after vaccination. Lastly, for the future I was informed of the option for more monitoring for next dose, in 30 min reaction line.
1st dose: almost immediate loss of voluntary muscle control followed by involuntary jerking movements, lasted 1-2 minutes.  Nurse took pulse, paramedic administered oxygen.  Within two days large lump formed at injection site and a small one in front of my right ear; both resolved within 5 days.  2nd dose (4/11/2021@ 10:15 a.m., same location): almost immediate loss of voluntary muscle control followed by involuntary jerking movements.  Held for observation for 15 minutes & as my husband was driving out of the parking lot, involuntary jerking movements began again and continued off an on for 45 minutes with intense itching sensation from inside my thighs, hands, calf.  Two days later began getting severe headaches and tinnitus.  Headaches continued daily, but have lessened in severity.  Tinnitus continues unabated.
Low grade fever (100) starting the morning after being given the shot and lasting for about 48 hours.
Multiple visits with OB for extreme bleeding during menses, and vaginal pain that?s constant, not just during menstrual cycle.  I have had multiple labs done to check that all levels are good. I?ve also had transvaginal and pelvic ultrasound done to insure there was nothing irregular.  All findings were normal. Next course of action is having an endometrial ablation on 2/14/22.
Her arms swelled and was red and painful for 48 hours after the event, by 1/17/19 there was still redness but no swelling.
Loss of Vision for about 2 minutes;  vertigo(stumbled and fell into wall ); exhaustion(very tired no energy); injection site pain(huge lump)
Information has been received from a physician and a nurse manager concerning a female child who in approximately March 2007, was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of a dose of Varivax. Unspecified medical attention was sought. A product quality complaint was not involved. The nurse reported that the shipment of Zostavax normally comes in a box that is labeled for another department in their building called "adult medicine." This shipment of Zostavax came in a box labeled "pediatrics" and therefore, came to the nurse's department. It was assumed that this was their normal shipment of Varivax and was therefore dispensed to the patient. She noted that they would be following the normal Varivax schedule and the patient would be given the scheduled booster dose. This is one of several reports received from the same source. Additional information has been requested.
Patient in clinic to receive first dose of COVID-19 Vaccine. Per vaccinator patient oriented/alert, behaving and talking normally prior to vaccine administration. Pfizer dose administeredd in left deltoid, patient completed 30 minute observation period due to her medical history and previous allergic reactions (swelling after pain medication at dentist, anaphylaxis with carbonated drink and tuna). Per patient's report: was getting in to her vehicle ready to leave and vision in right eye became blurry, came back to clinic. Patient reports this is not the first time the blurred vision has occurred, reports blurry vision to right eye occurs anytime she is stressed or tired and typically lasts about 20 minutes.
Onset of bilateral profound bilateral brachial weakness approx. 6-weeks after having received the split influenza vaccination (injectable).  Vaccine was administered on 8-Jan-2009.  Onset of symptoms approx. 15-Feb-09.  Patient hospitalized on 5-Mar-2009. 3/13/09 MR received for DOS 3/5-xx/2009 (not yet d/c). DX:  Bilateral Brachial Plexopathy.  Pt presented with 3 week hx of bilateral upper extremity sensory and motor loss.  Initially began as R arm muscle pain and progressed.  While running on 2/20/09 pt developed problems breathing which then progressed to R neck, shoulder and arm pain.  later developed BUE weakness and numbness. Markedly decreased exercise tolerance. Admitted to r/o GBS/demyelinating process. 15 lb wt loss in last 2 weeks d/t decreased appetite. Neuro exam (+) for decreased stength 0-2/5 in UEs. UE DTRs absent R, diminished L. Sensory loss bilaerally of UEs.  Resting O2 sat 93%.  Tx with IV steroids with little improvement. Continues with breathing difficulty when supine.
Information has been received from a health professional concerning a 12 year old female with no pertinent medical history who on 14-MAY-2007 was vaccinated IM in the deltoid ("which arm unknown") with the first 0.5 ml dose of Gardasil. There was no concomitant medication. On 14-MAY-2007, the patient developed pain. Unspecified medical attention was sought. Subsequently, after a "couple of days" the patient recovered from pain. On 17-JUL-2007, the patient was vaccinated IM in the buttocks with the second 0.5 ml dose of Gardasil (lot #657872/0515U). This is one of two reports received from the same source. Additional information has been requested.
3/27 the morning after the shot Large Scarlet colored blotches were noted all over face and neck.  These blotches were 3 to 5 inches in diameter.   Face felt "burning hot"  Also present were Extreme full body heat flashes, lightheadedness and dry mouth. 3/28 the blotches were not faded but started to become raised. 3/29 the blotches became dry and irritated. Treated with increased water intake and 25 mg Benadryl at night.   Cool rags to the face to relieve the heat.
Emergency room with penumonia. The next year the same thing; High fever; lungs plugged, the whole thing; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for prevention. The patient's medical history and concomitant medications were not reported. The patient got a vaccine for pneumonia and within a week the patient had the disease. At a regular check-up the patient got the pneumonia vaccine as recommended. One week later, patient was in the hospital with pneumonia. He though just coincidence. The next year, the same thing. One week after the shot, in the emergency room with pneumonia. High fever, lungs plugged, the whole thing. The outcome of events was unknown.   Information on the lot/batch number has been requested.
This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB, (dose, route, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
2 swollen lymph nodes occipital and posterior left neck; This is a spontaneous report from a non-contactable Other Health Professional. A 61-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via intramuscular on 07Jan2021 at 16:45 at single dose on left arm for covid-19 immunisation. Medical history was none. Historical vaccine included 1st dose of bnt162b2 (lot number: EH9899) received on 18Dec2020 at 10:00 am via Intramuscular on left arm for COVID-19 immunisation. The patient's concomitant medications were not reported.  The patient experienced 2 swollen lymph nodes occipital and posterior left neck on 15Jan2021 with outcome of recovering. Therapeutic measures were taken as a result of 2 swollen lymph nodes occipital and posterior left neck.  No follow-up attempts are possible. No further information expected.
I got the vaccine ..was allergic to it; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered with Shingrix and had allergic reaction. No other information was provided.
Patient received Td on July 13, 2006, returned today and stated that her left deltoid is sore. Noted slightly reddened area and skin slightly swollen at the site of injection. Denies any pain, but stated "it itches." Note: Our tetanus is a "purchased vaccine - not from State."
Soreness at the injection site; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported, solution for injection), via an unspecified route of administration on an unspecified date at a single dose as Covid vaccine. The patient's medical history and concomitant medications were not reported. The patient experienced soreness at the injection site on an unspecified date. The outcome of the event soreness at the injection site was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient brought in by father due to swelling on her eyeballs. She have H1N1 Flu mist 10/25/09 with no reaction.
Since receiving a single dose of Pfizer-BioNTech three days ago on May 5, 2021, I now have Tinnitus as loud as the construction noise coming from a crew that's building a 3-story house 100 feet away from our home. Another comparison of the Tinnitus noise level I now experience is this: if you've ever boarded a jet from the tarmac while the jet's engines are running, that's the noise I hear now.
Patient has multiple existing conditions including breathing issues. Patient complained of numbness to lungs. Audible wheezing was heard upon talking to the patient. Patient was very agitated and upset over the situation. Patient's mother administered albuterol breathing treatment via nebulizer while medical staff arrived. Patient was also receiving 4l of supplemental oxygen.  Patient vital signs showed elevated blood pressure. Patient requested hospitalization. Patient does have a diagnosis of asthma, for which an asthma attack may have been triggered by the vaccination. Stood by with patient for over 30 min and continued complaint of pain in lungs, but diminished audible wheezing hard. Patient transferred to Hospital via Care Ambulance, Firestation also responded to the scene.
Moderna 9/16/21, 10/15/21. Positive on 11/29/22
poor blood circulation in extremities; numbness; tingling; This spontaneous report was received from a consumer and refers to herself, a 15-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2012 (reported as 10 years ago), the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (reported as an unspecified HPV vaccine), intramuscular injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2013 (reported as 1 year after vaccination), the patient experienced poor blood circulation in extremities, along with numbness and tingling. The patient had seen rheumatologist and had had several workups, even 4 days in hospital, to diagnose her symptoms. She had been referred to neurologist and psychologist at this time, as no diagnosis had been made. The patient found literature that suggested her symptoms could be related to HPV vaccine received. At the time of reporting, the patient had not recovered from any event.   The patient did not complete her hpv vaccine (unspecified) series due to the adverse reactions.
ADMINISTRATION OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 07-SEP-2021) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced administration of expired vaccine. On 08-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from administration of expired vaccine, and the outcome of off label use was not reported. This report was non-serious.