chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe fever; chills; severe night sweats; hives throughout my body; a rash on my face; This is a spontaneous report from a contactable nurse. This nurse reported for helf that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2, product: COVID 19, brand: Pfizer), via an unspecified route of administration on Left Arm on 19Dec2020 10:30AM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known Allergies to medications, food, or other products:Cocoa butter. Concomitant medications were unknown. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that "Starting seven hours after the vaccine, I experienced severe fever and chills. The next morning, despite multiple anti-pyretics, the fevers/chills were worse. Also I experienced severe night sweats, likely related to the fevers. Three days after the vaccine, I began to have hives throughout my body and a rash on my face. Responds to Benadryl, but eventually reappears." The event started from 19Dec2020 05:30 PM. Treatment was received for the adverse event included Anti-pyretics, anti-inflammatories, anti-histamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility type vaccine was hospital. No other vaccine in four weeks. The patient recovered with lasting effects. No Covid prior vaccination. No Covid tested post: vaccination. The outcome of the event was recovered/resolved with sequel in Dec2020.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The reported events severe fever and chills, severe night sweats, and hives and a rash on face were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course.  The case will be reassessed should additional information become available.  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.
1/26 evening I developed body aches, lower back pain, nausea, brain fog, fatigue.  On Friday I started my period a week early and it was unusually heavy (this hasn?t happened much since I was a teenager) on Saturday I was bleeding so heavily and had lightheadedness, near syncope, headache, nausea, weakness, fatigue and brain fog. Usually menstrual cycle is not as heavy and doesn?t come early and I don?t experience these types of symptoms (usually just bad cramps and back pain with less heavy bleeding).
Pt received DTaP and Hib on 12/29/2016. Mother reports on AM of 1/4/17 pt "not acting right". Awoke at 6 AM unable to bear weight/walk/collapsed/"limp" on left side of body. Smiling and interactive at this point - vomited x 3 with eye rolling. Very sleepy afterwards. Episode over 30 min. Mobility returned by end of day. No tonic clonic activity, afebrile.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment  This is a spontaneous case reported by a consumer, concerning an adult male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 with a positive SARS-CoV-2 test, unknown  days after receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Concurrent medical conditions included Psoriatic arthritis. On an unknown date the patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) injection at an unspecified dose for Psoriatic Arthritis. Details of risk factors, other co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of covid 19 was resolved. Ongoing Covid 19 pandemia, and use of Adalimumab could be considered as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning an adult male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 with a positive SARS-CoV-2 test, unknown  days after receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Concurrent medical conditions included Psoriatic arthritis. On an unknown date the patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) injection at an unspecified dose for Psoriatic Arthritis. Details of risk factors, other co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of covid 19 was resolved. Ongoing Covid 19 pandemia, and use of Adalimumab could be considered as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
lower back pain; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 20Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced lower back pain (non-serious). The patient received the first dose of the Pfizer vaccine on 20Feb2021 and was having lower back pain when he would bend.  The patient was having surgery the day after the initial report.  The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Started getting a head ache that hasn't completely gone away; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8734) via an unspecified route of administration on 04Apr2021 (at the age of 44-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0170) via an unspecified route of administration on 26Apr2021 at 09:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. On 14Apr2021, two after his first vaccine the patient started getting a headache that had not completely gone away. Patient reported that it had got worse after only half a beer, which was never the case. On 04Jun2021, the patient underwent SARS-COV-2 test and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event headache was not recovered at the time of this report.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Medium, Systemic: Vomiting-Mild
Rib cage pain, particularly in sides, sternum and front of armpits.  Bruising on chest/front of armpit on right side.  Numbness/Pins and Needles/Weakness  that comes and goes in arms, thighs and face from nose down through neck.   Headache.
Contacted Covid; Contacted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 22May2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "recovered" and all described as "Contacted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible. No further information is expected.
31MAR-no fever just sz;pt clenched fist & drew arm toward chin,turn head to side & tongue sticks out;4 sz this day;1APR95 sz;2PAR sz-saw MD;3APR sz;4APR 9 sz saw a neurologist
Tuesday 1:00 AM, woke up with headache, sweating, vomiting, fever. Taken to hospital; stayed until Thursday. Did lots of testing; could not find anything. Ruled out all except flu shot (per wife). Discharge Summary received on 1/3/2005 states pneumonia, cough, anorexia, and vertigo. Medical Record received on 1/3/2005 states pneumonia, cough increased, anorexia and vertigo.
Pt experienced inj site rxn:" Entire upper R Arm was red, hard and swollen for 2 days." She took Aleve and feels much better this AM 10/09/2016. She didn't think it was the technique but some type of allergic rxn to the content. She also had some mild itch at the site.
Breakthrough COVID infection. Positive test 10/26/2022.  Cough, fatigue, and shortness of breath noted. Unsure symptom onset.
At 2 months with limb swelling at site of Prevnar and IPV; Prevnar given at 4 months without a problem on 10/30/03. IPV given 11/4; local reaction with erythema, no induration.
12:30pm-c/o lt. arm discomfort + itching.  150/100, H 73, O2Sat 98%, left arm without redness or swelling.  EMS at site front gate station.  #7 12:45pm-Advised if symptoms continue seek med. advice.
Continued site redness, swelling and tenderness with Headache and joint pain to left elbow
It was reported that a 2 1/2 yr old rec'd vaccinations. Pt experienced redness and swelling on L leg, and also was irritable on 7/15/02. This reporter has 2 more pt's who experienced similar reactions. From additional correspondence rec'd 12/18/02, no new medically significant info was reported. This case is closed.
The pt had bilateral auditory changes approximately one hour after vaccination. The pt reported that sounds and patient/employee voices sounded like they were coming out of a synthesizer. This lasted for approximately two and a half hours before completely resolving.
Fever, nausea, headache developed over night. Fever subsided within 24 hours. Headache and nausea decreased over 3 days. Left arm was sore for 5 days. All symptoms gone after 5 days.
Patient got a terrible headache after receiving her vaccines on 7/30/2018.  Her headache remained for nearly a year causing her to miss several days of school.  Headache medication didn't even touch the pain she was experiencing.
I did not have an adverse reaction to the vaccine. I was exposed to COVID-19 on an airplane going on vacation. I went to a doctor upon arrival to confirm that I was COVID-19 on 03/28/2023.  I was given prescriptions for mainly my sinuses. As of today, I still have some congestion with a little tightness in the chest. This could be due to allergies too.
Suffered a stroke 1 to 1.5 hours after vaccination. He was driving when according to my grandmother he couldn't deccelerate and was having trouble communicating. Grandmother had to take control of the wheel and somehow stop the car by driving it off the road. Patient was combative with healthcare and had to be restrained and was confused about why he was there. he no longer remembers the events that lead to his hospitalization.
This case was reported by a consumer and described the occurrence of legally blind eye in a female patient who received ADVAIR multi dose powder inhaler for asthma and fall allergies. A physician or other health care professional has not verified this report. Co-suspect medication included VENTOLIN and azithromycin. Concurrent medications included blood pressure medication, NASONEX, PATADAY, SINGULAIR, ALLEGRA, PLAVIX, losartan, amlodipine and PROAIR. The patient's medical history included asthma, fall allergies and allergy to antibiotics. The patient started having allergies in her 40s. She got allergy shots in the past but they did not help. On an unknown date, the patient started ADVAIR (inhaled) at 1 puff(s) twice per day. Sometimes, the patient forgot to take ADVAIR and used VENTOLIN if ADVAIR did not work. The duration of therapy of ADVAIR was 8-10 years and the duration of therapy of VENTOLIN was 10 years or more. In 2008, the patient was diagnosed with non-Hodgkin's lymphoma which had weakened her immune system. In October 2013, the patient received an unspecified dose of influenza vaccine (unknown route and injection site). On 25 December 2013, at an unknown time after starting ADVAIR and VENTOLIN and 2 months after vaccination with influenza vaccine, the patient experienced influenza that turned into sinus infection. This case was considered as a vaccination failure. In June 2014, the sinus infection was diagnosed. The subject did not feel good and required to use more albuterol. She lost a lot of weight, legally blind eye, slime in throat, whole head feels plugged, headache that she felt like a balloon and bad breath. The patient also had 2 strokes in right retina. She had tests done on carotid arteries and the man pressed harshly and she believed something broke loose and resulted in stroke. The patient was treated with azithromycin for sinus infection which caused throwing up. This case was assessed as medically serious by GSK. At the time of reporting, the sinus infection was unresolved.
No adverse effects; Improperly stored; This spontaneous report was received from a nurse regarding a patient of unknown demographics. The patient's medical history, concurrent conditions and drug allergies were unknown. On 14-AUG-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection lot # R031681, expiry date: 01-NOV-2020 (dose number, anatomical location and route of administration unknown) for prophylaxis which was reconstituted with a properly stored sterile diluent (product storage error). No adverse effects were reported.  The vaccine underwent temperature excursion of above 47-degree Fahrenheit (48.1 F) for a time frame of 7 hours without a previous temperature excursion. A digital data logger was involved. No product quality complaints (PQC) were involved.
After getting my second shot, the following day4/7/21, I had a 99.5 fever for about 10hrs eventually going away. On Saturday, 4/10/21 I started noticing  hive on my upper arms, upper legs and forearms. Took claritan and they disappeared after 4 hours. That night at 9pm they started to show up in different places. In the morning they were on my forearms, knees, body. I took more claritan and went on a 12 mile hike. As I hiked they got worse and then, about 2pm they had disappeared significantly from knees and forearms. Took a shower at the house around 4 and saw hives all along torso, shoulders and upper arms. Took 2 Benadryl?s around 5 and it all seemed to disappear. In the morning, 4/12/21, went to work and saw that hives were only on my hands, and my hands were now swollen too. Perhaps too much sun on my hands, didn?t sunblock them well. Took another Benadryl at 6am, no effect. At work put Benadryl cream on hands, no effect.  At noon, took a claritan no effect. Hives never left hands today. At end of day, some hives traveling up forearms.  Took a Benadryl and crashed for the night. Hands still have hives and swollen. Palms swollen.
Covid symptoms started 04/23/22, tested positive 04/28/22. Symptoms included sore throat, congestion, achiness, chills, and it lasted around 5-7 days. I called my Doctor and they offered oral treatment but I was feeling better at that point and just used regular at-home decongestants and maybe Tylenol. I had a very mild case. I did have Covid in March 2020 before vaccines as well.
Information has been received from a physician concerning an 8 year old male who on 12/6/00 was vaccinated with a first dose of varicella virus vaccine live (lot # 635451/1143K). Subsequently, the patient developed a rash on the back and abdomen to which his father, an immune compromise organ transplant patient, was exposed (WAES0505USA00034). Additional information was received from a physician who indicated that on 3/24/05,. the patient developed break through varicella zoster virus illness after exposure to a child at elementary school with either vaccine type or wild type varicella rash. It was noted that the patient was seen by the physician or in the emergency room and was hospitalized. Subsequently, the patient recovered on an unspecified date. Additional information was received from a physician from a physician who reported that the patient had been vaccinated years before and had contracted a break through infection. The physician confirmed that the patient's case was non-serious. The reporter ntoed that there were five to six previously vaccinated children at the patient's school who had break through chicken pox. No further information is expected.
pt recv vax 24JUL98 11AM & pt would not walk normally immed p/vax;mom states pt moved leg as inject given;by 1145Am lt thigh began to swell & was red-swelling eventually extended from inject site to knee;advised to use APAP & warm compress
Sore arm; Exhaustion; Chills; Sweats; Tense muscles; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 03Jun2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW077) via an unspecified route of administration in the left arm on 12May2021 at 16:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Jun2021 at 22:00, the patient experienced sore arm, exhaustion, chills, sweats and tense muscles. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore arm, exhaustion, chills, sweats, and tense muscles were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
(R) arm/deltoid - pain, soreness, warmth, erythema, swelling, induration - extending around front of arm, and toward elbow.
Pt recvd vax on 10JUL92 w/no noted problems; On 7AUG92 pt vaxed & 15AUG93 pt exp feeling of warmth on upper torso, arms & neck; 8SEP92 exp a generalized feeling of warmth; exp h/a & numbness on the lt side of face;
My symptoms started at noon on the 17th.  Severe dizziness.  I could not open my eyes due extreme light sensitivity which caused more vomiting  had to have a wet wash cloth over my eyes at all times.  turning my head caused vomiting which resulted in dry heaves.  could not go to the bathroom to urinate because i could not move. this caused severe cramping and crying. I couldn't move my head for several hours. drinking water caused more vomiting.  after about 8 hours, my husband managed to guide me to the bathroom.  i had to have my eyes covered the entire time.  trying to help me keep my head steady and removing my pants was nearly impossible.  he was able to guide me upstairs to the bedroom where the bathroom was more convenient for later usage. the dizziness and vomiting   went on until about midnight.  The next day my entire body felt "beat up."  i was severely dehydrated and drank water all day.  i ate lightly. On the 18th, in the morning my lower lip trembled from time to time.  my hands were a little shaky.  due to lack of food and water on the 17th, i still was having stomach cramps most of the 18th.
This spontaneous report as received from a consumer of unknown age reporting on himself who 20 years ago, in 1994 was vaccinated with the first dose of pneumococcal vaccine. Since his first vaccination, the patient had received 3 booster doses of PNEUMOVAX 23 (doses, routes and lot numbers not reported) (also reported as unspecified pneumococcal vaccine). No adverse events were reported. Additional information is not expected.
I've been extremely tired the last few months, I've had unexpected weight gain (12 lbs) even though I eat very healthy and exercise regularly, problems concentrating, constipation, loss of motivation, memory loss, irritability, night sweats and this weird feeling like I'm going to wake up and be sick, but then I don't get sick. It's hard to explain, but it feels like I'll wake up with a dry, barking cough. I haven't had even the slightest cold in over 3 years so this is strange.
Patient seen in the ED on 7/12 after a fall at her assisted living facility. At times in the ED she was hypoxic, and COVID-19 PCR swab was done which came back positive. Ultimately patient was admitted from 7/12-7/25 with COVID-19 pneumonia with concurrent bacterial pneumonia. She was placed on 1-2L supplemental O2 during admission. At time of discharge she was off oxygen.  She has been vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
Information has been received from a woman concerning her granddaughter who was vaccinated with varicella virus live. That same day, the pt experienced soreness and swelling of the arm.
Left shoulder cellulitis seen the next day, advised to use ibuprofen for pain and discomfort.