chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Middle of the night on  (early hours of 12/11/21) Saturday started having itchy palms and scalp. Woke up with red marks on my chest, arms, armpits. Raised skin everywhere I scratched. Made worse with shower. Called PCP who instructed me to take Zyrtec twice daily. Helped some but symptoms continued. Went to the immediate care on Tuesday (12/14/21) and was told it was hives. Prescribed Prednisone 40mg for 5 days. PCP then ordered 7 days of 40mg. Still having hives if doses of medication are missed. No prior history of hives.
Patient woke up the next morning with a full body rash. She called her physician and was told to take Benadryl until it went away. She reported it to me 11 days later and rash has subsided. She said it was mostly gone within 3 days.
Dizziness and severe headaches. Headache intensified continuously; has no history of migraines. Elevated liver enzymes.
Information has been received from a pharmacist concerning a 66 year old female patient with no medical history or allergies who on 15-SEP-2007, was vaccinated IM into the left arm with a first dose of PNEUMOVAX (Lot# 658075/0962U).  Concomitant therapy included MOTRIN.  After the injection the patient experienced a painful arm that was too sore to move.  The patient reported a lump under the skin at the injection site that was hard to touch.  It was reported that the site did not appear reddened or swollen.  The patient went to the doctor.  No laboratory diagnostic studies were performed.  The patient was taking MOTRIN for the pain and applied ice and warmth to the site without pain relief.  It was reported that the patient is now doing physical therapy and her deltoid muscle was damaged.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information is not expected.
Single localized reaction to area of MMR and Varicella Immunization, Single Hive/Welt redness swelling
Triggered migraine with aura. My migraines usually start with reduced vision (like when your eyes are tired) and this was triggered while driving an hour and a half after I received my first dose. tiredness; mild muscle weakness in the shoulder the shotwent in; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 06May2021 at 17:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included occasional migraine and COVID-19 ( Prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included etonogestrel (NEXPLANON IMPLANT) left arm, ibuprofen (ADVIL) and fluticasone propionate (FLONASE); all on an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 19:00 the patient experienced triggered migraine with aura, her migraines usually start with reduced vision (like when your eyes are tired) and this was triggered while driving an hour and a half after she received her first dose, also, tiredness and mild muscle weakness in the shoulder the shot went in. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events triggered migraine with aura, tiredness and mild muscle weakness in the shoulder the shot went in was resolving at the time of this report  No follow-up attempts are needed. No further information is expected.
Patient called said she had uncontrol shaking that lasted about 40 minutes. She did not want to call to report except to pharmacy. She stated she has gotten flu shot for last 30 years with no problems.
FEELING POORLY; BODY ACHES; GENERALIZED WEAKNESS WENT TO THE ER DX UTI; THEN CAME TO DR'S OFFICE AND STARTED HAVING HEADACHE; FACIAL DROOP AND SLURRED SPEECH. WAS SENT TO THE ER AND DX WITH CEREBRAL INFARTCTION
ACUTE COR PULMONALE 3/26/2023 ACUTE PULMONARY EMBOLISM ACUTE PULMONARY EMBOLISM 3/27/2023 ACUTE PULMONARY EMBOLISM
Fever over 100.4; Injection site pain; extreme tiredness; Headache; Muscle pain; Chills; Joint pain; Injection site swelling; Nausea; Dizziness; No appetite; he had the Pfizer COVID-19 vaccine booster shot; This is a spontaneous report from a contactable consumer (patient himself). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 22Oct2021 at 17:00 (5:00 PM) at the age of 70 years old (Batch/Lot Number: EW0219, Expiration date: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient had no prior vaccination (4 weeks). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered on 20Mar2021, probably at 11:00 am at the age of 69 years old (Batch/Lot number: ER2613, Expiration date: unknown) as dose 1, single, and then administered on 11Apr2021 at the age of 69 years old (Batch/Lot number: EW0158, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The patient reported that on 22Oct2021, he had the Pfizer COVID-19 vaccine booster shot, so he was having fever over 100.4, injection site pain, extreme tiredness, headache, muscle pain, chills, joint pain, injection site swelling, nausea, dizziness, and no appetite, which were persisting. Therapeutic measures were taken as a result of all the events, which included 2 aspirins an hour prior reporting. At the time of the report, the patient had not recovered from fever over 100.4, injection site pain, extreme tiredness, headache, muscle pain, chills, joint pain, injection site swelling, nausea, dizziness, and no appetite.  Follow-up attempts are completed. No further information is expected.
Still 7 days later, swelling; Still 7 days later tenderness; Still difficult to squeeze my arm against my chest wall; Realized in morning my left armpit/ lymph node area was extremely swollen, painful; Realized in morning my left armpit/ lymph node area was extremely swollen, painful.; Booster dose\dose 3 received; About 7 hours after dose 3 , I developed shoulder injection tightness.; Then middle of night, I woke with same arm, forearm pain; Deep throbbing into fingers; Tingling into fingers; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration on 15Oct2021 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 29Mar2021(at the age of 64-years-old), as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. On 15Oct2021, about 7 hours after dose 3,  the patient experienced  shoulder injection tightness, then in the middle of night, patient woke with up pain in same arm, forearm pain, deep throbbing into fingers, tingling into fingers. On 16Oct2021, the patient realized in morning left armpit/ lymph node area was extremely swollen and painful. On 20Oct2021, 7 days later, the patient still experienced, swelling, tenderness and it was still difficult to squeeze arm against her chest wall. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events about 7 hours after dose 3, developed shoulder injection tightness, then middle of night, patient woke with same arm, forearm pain, deep throbbing into fingers, tingling into fingers, the patient realized in morning left armpit/ lymph node area was extremely swollen and painful were resolving and the patient still experienced 7 days later, swelling, tenderness and still difficult to squeeze arm against chest wall  was not resolved at the time of this report.
Headache, chilly feeling, mild diarrhea, AF, severe dizziness, shortness of breath, loss of appetite, fast pulse, elevation of BP. Started on 1st day, better by 5th.
Nausea - From time of injection to end of day (approx. 9:45 am - 11:00 pm) - Mild Chills, feeling feverish - About 3-4 hours after injection, noticed around 1:00 pm. Mild at this point. Felt slightly cold, a little shake.  At approx. 5:00 pm, symptoms steadily worsened, to the point of being unable to hold objects nor perform basic tasks such as writing. I was unable to warm myself, even when wearing a winter jacket to bed under layers of blankets. This continued into the next day after I'd slept, though not as bad as the night before. The next morning (approx. 8:00 am), I was shaky, but still able to hold objects and write steadily. I was no longer feeling cold in the morning.  Breathing difficulties - pains in chest. Still present, off and on. Mild (as of now). On day of injection/dose, occasional pangs of pain in chest area- moderate pain for approx. 36-48 hours after injection/dose.
outbreak of shingles; A spontaneous report was received from a consumer (patient's wife) concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced outbreak of shingles.  The patient's medical history included shingles episodes.  Concomitant medications included multiple unknown medications.  On 5 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011A21A) intramuscularly for prophylaxis of COVID-19 infection. On the same day immediately following administration of the vaccine patient experienced an outbreak of shingles. The outbreaks occurred in the locations where patient had previously experienced shingles episodes.  Treatment details included Valtrex (valaciclovir) and cream for shingles.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event(s), outbreak of shingles was unknown.  The reporter did not provide the assessment for the event, outbreak of shingles.; 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 arrives with chief complaint of shortness of breath from her rehab center.  Patient is there for bilateral broken legs.  Patient does have problems with shortness of breath and is on home O2 at 7 L.  Patient says her shortness of breath got markedly worse today but she did not have chest pain.  Patient has an increase in her cough but she is not able to cough anything up.  Patient denies having a runny nose sore throat or ear pain or fevers.  Both patient's legs are in cast making it difficult to ascertain her fluid status.  Patient denies any history of MI cardiac stent or CABG.  Patient denies diabetes.  Patient has past medical history of hypertension and dyslipidemia.  Patient has A-fib but she is not on any blood thinners due to bloody noses. Patient past surgical history is positive for left wrist Patient is a former smoker that rarely drinks alcohol Associated Symptoms: cough, shortness of breath, wheezing
Pain and paralysis in all 4 extremities.   Burning and stabbing sensation, bulging veins in hand.  Was hospitalized from 2/28 until 3/5.  Left hospital with no diagnosis and no real relief
Receive vaccines (listed below) Monday, 5/19/14, c/o headache after receiving vaccines. WED 5/21 developed fever 103.9 and vomiting, malaise. Taken to ER for Eval. Had been with friends over WE and they were sick with similar symptoms - ER physician dx with viral syndrome exacerbated by vaccine.
Sudden pixilated/blurred vision, primarily right eye peripherally.  After 20-30 minutes of obstructed vision, onset of headache.  Sharp pain in temples, and strain/tension in neck.  No soreness/tenderness at injection site.  Eyesight restored around 6:00pm, headache continued.  I took 3 ibuprofen, drank 4oz of gatorade, at two clementines, and 5 ride crackers.
Fever; chills; muscle aches; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). This 51--year-old female nurse reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1283/expiration date: unknown), via unknown route of administration, on 07Jan2021at 12:00 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 immunization at workplace clinic. Relevant medical history included chronic Fatigue. The patient have known allergies to penicillin (PCN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ferrous sulfate 65 mg, daily. The patient previously received the first dose of BNT162B2 (lot number: EJ1685/expiration date: unknown) on 17Dec2020 at 01:00 PM (at the age of 51 years old) as a single dose in the left arm via unknown route of administration for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021 at 12:00 AM, after the second dose, the patient experienced fever, chills, muscle aches, headache, fatigue. No treatment was received for the events fever, chills, muscle aches, headache, fatigue. The outcome of the events fever, chills, muscle aches, headache, fatigue was unknown. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 11-JUN-2021, the patient was vaccinated with incorrectly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (lot# was 1707457 or 1707460: lot# 1707457 has been verified to be a valid lot number, expiration date reported as 22-FEB-2022, but upon internal validation established as 23-FEB-2022; lot# 1707460 has been verified to be a valid lot number, expiration date reported as 13-MAR-2022, but upon internal validation established as 14-MAR-2022) (strength and dose were not reported) (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.
pt recvd vax;t 101-102 noc of 19sep;20sep t up to 104;during noc,had hard time breathing;was fussy for 3 days but cont to eat & drink; did not see MD;
This case was reported by a nurse via sales rep and described the occurrence of local swelling in a 12-year-old male patient who received FLULAVAL TETRA 2018-2019 season (batch number 4DY9K, expiry date 7th June 2019) for prophylaxis. On 19th September 2018, the patient received FLULAVAL TETRA 2018-2019 season. On 20th September 2018, 1 days after receiving FLULAVAL TETRA 2018-2019 season, the patient experienced local swelling, localized erythema and welts. The patient was treated with BENADRYL. On an unknown date, the outcome of the local swelling, localized erythema and welts were recovered/resolved. It was unknown if the reporter considered the local swelling, localized erythema and welts to be related to FLULAVAL TETRA 2018-2019 season. Additional details were provided as follows: This case was reported by the patient's mother. After receiving FLULAVAL TETRA, on the next day, the patient developed localized redness and swelling and welts below the vaccination site. The patient's mother reported late on the 20th that inside of 20 minutes the welts disappeared and the redness, swelling were also gone. They never had any respective concerns.
Vaccine was administered on 01/07/2002. On 01/21/2002, pt developed quarter sized rednes around the site of Varivax which was administered on the left thigh.
She got her vaccine, felt like she was getting contrast like an MRI, they asked her if she needed some water and kept her for 45 minutes. She did get some side effects and took the next day of work off due to them.   She was then okay, and then about 1 week later she got her period and she was bleeding profusely, which definitely was not usual for her.   She had a telehealth appointment with her Gynecologist on 6/17/21 and called them and explained what was going on, and they told her to go to the ER.  She then passed out/fell asleep and they continued to contact her and told her that she needed to get to the ER.  While in the ER they captured her blood to see how much she was loosing which was significant to determine if she needed a blood transfusions.  He then told her that he contacted her doctor (PCP) to tell him what he needed to test for.   On 6/18/21 she went to the PCP and did blood work and on 6/24/21 he called her and diagnosed her with Von Willibrand disease.  Immediately her first words were did it come from the vaccination and he said that it was something that she was born with, which she questioned it as she has been to many specialist throughout her life and has been undiagnosed and been his patient for over 20 years.  She questioned since he didn't find it before, and has never bled like this before, and how can this all of a sudden happen.    He then sent her to a hematologist, and cannot get in to be seen since July 2021.   Her PCP within the last couple of weeks again asked if she had seen a hematologist and they were going to see about getting an appointment ASAP.  Her levels were in the 180's, and 200 is the highest for this disease.  In September she was referred to an ENT due to constant runny nose, which they put her on medication for that.    She is now on Adderall, Trazedone.    She has never had any vaccines until this time and not able to get any as a child as she was born very prematurely and was exempt from all vaccines, but was able to go to school without them.  She did get a tetanus shot.   When she got her records as an adult she asked her mother why she didn't get vaccines and she told her due to being sick as a child.    She believes that this is all from the vaccine.
fatigue for 3 days; feverish after 2 weeks; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration, administered in Arm Left on 05May2021 17:00 (At the age of 34 years) as DOSE 2, SINGLE for covid-19 immunization. The patient was not pregnant during vaccination. The patient took no other vaccine in four weeks. The patient had took other medication in two weeks. The patient medical history was not reported. The patient previously took bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration, administered in Arm Right on 14Apr2021 04:45 (At the age of 34 years) as DOSE 1, SINGLE for covid-19 immunization. The patient experienced fatigue for 3 days on 05May2021 18:00 and feverish after 2 weeks on May2021. At the time of reporting the outcome of the events was unknown. No follow-up attempts are possible. No further information is expected
Received a spontaneous report on 23JAN2018, 24JAN2018 and 25JAN2018 from personnel. The physician reported that on 23JAN2018, a patient who was overseas, received 5 ml of BIOTHRAX vaccine injected into the deltoid rather than the prescribed 0.5 ml amount. The subject experienced soreness at the site, and then developed mild headaches approximately 8 hours after the injection. No other complications were reported after 24 hours observation. The subject was restricted from caffeine and working out for the first 72 hours. It was also noted that he received a flu shot on 19DEC2017 and was on doxycycline for malaria prophylaxis. FOLLOW UP Information was received on 16FEB2018 from the physician. The physician reported that the patient was evaluated by medical personnel and no evidence of lingering side effects was found. It was also noted that the patient felt excellent, had no signs of complications at the sight, and no signs or symptoms that would lead one to believe he is not in perfect/usual health. No additional information is expected.
Complained of pain radiating from injection site in left deltoid down to her hand diminished grip strength, normal sensation.  No s/s inflammation.  Ibuprofen 400 mg of 8 hrs next 24 hrs.  Follow up sooner if worsening pain or increasing weakness.
Received both Shingrix ( second in series) and Moderna booster at same time. First symptoms that evening. Spent most of the night chills followed by fever. A similar episode repeated itself with no warning two more times in the period 12/28/21 and 1/22/22. Both repeat episodes occurred at night and lasted 5-6 hours. Covid infection was ruled on on each occasion. No treatment has been sought and it is unknown how long they will continue.
Extreme body aches; extreme fatigue; headache; low grade fever. Treated with ibuprofen, acetaminophen, or Excedrin.
Developed flu like or COVID like symptoms: headache; body aches, chills, felt feverish but did not show fever when temperature taken; extreme fatigue; dry cough. This has been happening for 5 days now.
COVID-19; This spontaneous report received from a consumer via other manufacturer (Private group) concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in OCT-2021, the patient experienced covid-19 (Dose number in series 1). The patient additionally received booster dose of non-company vaccine included: Pfizer biontech covid-19 vaccine (Tozinameran) (dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on an unspecified date in DEC-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Pfizer biontech covid-19 vaccine (Tozinameran) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious.