chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to 3 patients of unknown age. The patients were vaccinated with 0.65 ml ZOSTAVAX (lot number 0564AE, expired date 21-MAR-2013) subcutaneous on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients were given ZOSTAVAX and had a similar reaction with "redness, swelling, pain and warmth at the injection site and the reaction was about 3" in diameter". It took about 2-3 weeks for their reactions to go away. The patients were recovered at the time of report. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
after 30 minutes, the patient had not regained consciousness; patient received her first dose of GARDASIL 9 and subsequently fainted; This spontaneous report was received from a medical assistant referring to a 14 year old female patient with asthma. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown by reporter.    On 15-AUG-2019, the patient was vaccinated with her first dose of the series with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R032768 (verified to be a valid lot number), expiration date reported and established as 31-AUG-2021, in her arm, as age-based recommendation. During this same visit, the patient also received meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO). Subsequent to vaccines administration, the patient fainted (syncope) and after 30 minutes, she had not regained consciousness (loss of consciousness); thus, she was taken to the emergency room. The patient was not admitted and was discharged this same day. The patient returned to the nurse's office on 16-AUG-2019 and reported there were no problems. It was unknown if any treatment was given for the adverse experiences or if any laboratory study was performed.  The causality assessment was not provided.  Upon internal review, syncope and loss of consciousness were considered medically significant event.
The pt woke from his nap and was unresponsive, staring out into space, would not respond to day care providers or Mom. The pt was limp "like a rag doll". This event lasted for 2 1/2 hours and then gradually the pt returned to normal.
36 yo recently activated with a history of hyperlipidemia presented 6 days after receiving multiple vaccines in both arms. Patient is left arm dominant and reports 1 day after vaccine receipt, she had right shoulder and arm tenderness which extended up the back of her arm and part of her back for which extended up the back of her arm and part of her back for which she took naproxyn. She reports that on Saturday, 2 days after her vaccinations, she noticed an abnormal sensation on her right cheek and that her right arm "felt heavy". She soon realized that she had a facial droop, right sided ptosis, muffled hearing on the right and altered taste. She sought medical attention at this time where she was diagnosed with Bell's palsy and was prescribed Valtrex, prednisone and hydroxyzine. Patient states that 4 days after vaccination, she returned for medical care because of increased right arm pain, swelling, and weakness. She was then sent for further evaluation. Patient denied any specific lower extremity involvement, although when pressure on this issue, she reports that her right leg may have felt heavy as well. Pt reports that her right arm feels weaker than her left and she continues to have altered sensation in her right face and right upper extremity that she described as stable. Her right hand has paresthesias primarily in 4th hand and 5th digits. Pt states that she normally uses solar and propane power only, lives with 3 dogs, 2 cats and raises 50 chickens for eating and eggs, and primarily eats only organic foods. Pt denies any similar episodes in the past, history of cold sores, photophobia, HA, meningeal signs, recent autoimmune disease, sick contacts; pt reports several had URIs. 03/30/07-record received with received with report. DC DX:partial nerve palsy of face, high TSH.  Symptoms right ptosis, decreased facial grimace. Hemibody numbness, right arm pain, right shoulder pain, stiffness, right facial droop/Bell's Palsy. Weakness and numbness of right arm, decreased reflexes. Occassional double vision. Right leg heaviness. Per 60 day follow up: Last contact 10/31/06.
No additional AE; MMRII had been administered Intramuscularly instead of subcutaneously; This spontaneous report has been received from a pharmacist, regarding a 49-year-old patient of unknown gender.  The patient's pertinent medical history, drug reactions, allergiesand concomitant medications were unknown.   On 11-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (therapy type recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection but administered intramuscularly for prophylaxis with lot number W009105, which had been verified to be a valid number; expiration date 04-DEC-2023, and upon internal validation established as the same date (incorrect route of product administration) (strength, dosage, vaccine frequency scheme and anatomical site of injection were not provided). There was no adverse events reported.
Muscle aches; back pain; This is a spontaneous report from a non-contactable consumer. An adult male patient received first and second dose of  bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle aches and back pain on an unspecified date. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Angioedema to lips and Hives all over body; Angioedema to lips and Hives all over body; This is a spontaneous report from a contactable consumer or other non hcp. An 18-years-old patient of an unspecified gender received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 10:25 (Batch/Lot Number: EW0150) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Floppy mitral valve, hypersensitivity, environmental allergy; all from 2012 to Ongoing. Family medical history includes hypertension and GERD. Concomitant medication(s) included oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for hypersensitivity from an unspecified start date and ongoing; paracetamol (TYLENOL) taken for pain from 05Apr2021 to 05Apr2021. On 06Apr2021, The patient experienced angioedema to lips and hives all over body. Patient received Benadryl 50mg and Claritin 10mg as treatment for adverse events. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Fever over 100.5 first 24 hours.   Fever 99.5 second day.   Joint aches and pains. Swelling and increased temperature and redness at injection site for 2-3 days and upper arm
four weeks of off and on extreme fatigue, 4 months of joint pain and six months of muscle soreness. None.
Given Flu vaccine then 30 min later with reported emesis x 3, flushing. No prev issues, seen at ED for care. Electrolytes WNL. Bolus fluid discharged with no further issues. Noted 4 x 5 cm bruise (L) arm. 60yo female presents with complaints of vomiting after receiving a Flu vaccine this morning while at work. Symptoms started within 30 minutes of the injection. Now feeling better. No CP/SOB. Denies abd pain. Vitals stable. Patient awake and alert, clinically dehydrated. Heart regular and lungs clear. Abd soft and nontender. Neuro intact. Will fluid hydrate and medicate with IV ZOFRAN while checking a BMP. Diagnostic studies pending.
10 hrs after injection - eyes swollen, hives on chest. Swelling increased to whole face - eyes swollen shut - hives from eyebrows to below rib cage by day 3 steroid injection, Prednisone, BENADRYL.
Pt woke up on Saturday with headache.  Pt broke out in shingles on Monday and was diagnosed today with Herpes Zoster
Day 2 had fever of 101.9, chills  nauseated Since getting 2nd shot both eye are itchy and sight seems blurry.  My eyes were check in December
Five days after shot the nerve that runs from my left shoulder blade to my fingers felt raw and like it was on irritated.  I could feel the nerve pain from my shoulder blade to my fingers.  One to 3 fingers numb.   Lower back pain 5 days after shot in the small of my back.  It seems to effect the nerves.
Had some diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "PTSD (Post-traumatic stress disorder)" (unspecified if ongoing); "Mitral valve prolapse" (unspecified if ongoing); "Kidney issue" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Hypersensitivity" (unspecified if ongoing); "Non-Hodgkin's Lymphoma", start date: 2005, stop date: 2005. The patient's concomitant medications were not reported.  The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Had some diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expired vaccine. No temperature excursion occurred. Moderna determined vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration." No adverse reactions reported.
Patient said injection site has remained sore since it was given and now has trouble lifting it over her head. Concerned.
Patient came into office for injection only visit to receive 3rd Hep B injection to complete series for Nursing School. The nurse pulled vaccine from the correct fridge but pulled the pediatric dose Hep B (Engerix-B) instead of the adult. Provider FNP was notified and instructed for patient to come back in and receive adult dose to complete her series. Patient was called and notified of this finding and she agreed to come back in to receive the correct vaccine.
3/10/2021 - Yearly blood test.  (see Item 19); 3/11/2021 - First dose Covid-19 vaccination @ 11:00 a.m.; 4/01/2021 - Second dose Covid-19 vaccination@ 11:00 a.m.; 4/01/2021 - By 1:00 p.m. I became exhausted and went to bed. 4/02/2021 - Exhausted and in bed; 4/03/2021 - Exhausted and in bed; 4/04/2021 - Exhausted and in bed; 4/05/2021 - Exhausted and in bed; 4/06/2021 - Exhausted and in bed.   (Continued)
6 hours after vaccine chills, teeth chattering, felt very cold.  Throughout the night fever spiked to 102.7 Fahrenheit. Patient was better after 24 hours.
5MAR97 pt presented of office w/vomiting x8hr & fever of 100 x 24hr;pt referred to pvt pediatrician;pt was then hosp on 7MAR97;
Fluvirin w/ Thimerosal given to OB pt. EDC = 3/20/2010. Pt does NOT have an OBGYN. Pt notified on 11/5/09. Denies any adverse effects. Pt NOT hospitalized after receiving H1N1 vaccine.1  1/17/09 Medical records received. OB records.   24 week IUP.
Joint pain all over body, throwing up, headache, eye sensitivity, rashes, stomach issues, numbness around joints, memory loss.
61 y/o female patient refers feelings of dizziness and "strangeness in her body" after receiving the second dose of pfizer vaccine.
Swelling on Left arm, pruritis, 3/10 pain upon palpation, swelling spreading to left side of face.
I went to bed last night around 11pm (day I received vaccine) with an extremely sore arm. When I woke up around 5am my left arm was still really sore and I have a knot that has appeared on my wrist. Its hurts to touch it. I did not bump, hit, or drop anything on my wrist or do anything that would cause a knot on my wrist. I am not saying that the knot is caused by the vaccine, but I do know that there were no signs prior to me receiving the vaccine of a knot and no visible signs of the knot before bed. I have not been to visit a doctor for evaluation.
no adverse effects; 17 year old patient was administered an adult dose of Vaqta; This spontaneous report was received from a registered nurse and refers to a 17 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  The reporter stated that on 08-OCT-2019, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) lot # S001360, expiration date on 06-MAR-2020, for prophylaxis (strength, dosage, frequency and route were not provided) (product administered to patient of inappropriate age).
Severe platlet reduction,to under 2 for two months with three hospitalizations compounded by metastisis in the brain. Two life threatening events with very expensive medical bills in two months since the Covid shot. Issues are yet to me resolved.
I had a fever of 99.5 F the next day 5/27/2019 I felt very tired the next few days. I also had sore left arm for 5 days
Bad Headache  Chills Body and Muscle Aches  Extreme fatigue   Pain at Injection site
PT PRESENTED TO PHARMACY 48 HOURS AFTER VACCINATION WITH A CLEARLY DEFINED RED, SWOLLEN AND HOT AREA SURROUNDING THE VACCINATION SITE. ADVISED PT TO MONITOR FOR PROGRESSION (BETTER OR WORSE, CONTACT PHYSICIAN, AND TO USE OTC PAIN RELEIVER (IBU OR APAP), AND TO APPLY ICE.
Pain at injection site; Limited range of motion of arm without pain; severe headache; This is a spontaneous report from a contactable consumer. This 63-year-old (age at vaccination)  non- pregnant female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6202) via an unspecified route of administration on 11Mar2021 at 11:00 am in left arm at dose 1, single for covid-19 immunisation. Patient's medical; history included hypothyroidism, Asthma, osteoarthritis, high blood pressure, known allergies; wheat, sulfa and Covid-19. Patient also received second dose of BNT162B2, lot number: EW0151 via an unspecified route of administration on 09Apr2021 at 11:00 am in left arm for covid-19 immunisation. No other vaccines were administered in four weeks. Other medications in two weeks: Fluticasone propionate/salmeterol; Albuterol Sulfa. Adverse event 1st dose - severe headache; Pain at injection site; limited range of motion of arm without pain. 2nd dose - Fever of 99.4 usu. 97.5; Pain at injection site; Limited range of motion of arm without pain; tiredness. Adverse event start date was 09Apr2021 at 5:00 pm. AE did not result in ER or physician's office. Treatment was given for the AEs. ae treatment acetaminophen; Biofreeze spray. Patient was not pregnant at the time of vaccination. Patient had covid prior vaccination. Patient was not tested for covid post vaccination. Vaccine Facility information available. Ethnicity information is available. Race information is available. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Its been exactly two weeks since I received the second dose of my vaccine, and I started with chills; Its been exactly two weeks since I received the second dose of my vaccine, and I started with chills and fever, but no other symptoms.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0169) via an unspecified route of administration in the arm left on 27Apr2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The medical history included allergy to most allergy medicines. 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 medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the arm left on 06Apr2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient previously took pseudoephedrine hydrochloride (SUDAFED) on an unknown date and experienced allergy. On 10May2021 at 20:00, two weeks after the second dose of vaccine, the patient experienced chills and fever and no other symptoms. It was little over 24 hours and the patient was having low fever at the time of the report. The patient reported that she did not have any side effects to the vaccine the day of or the day after receiving both doses of the vaccine. The patient asked that was it possible to have delayed side effects to the vaccine or did she got sick from something else. The adverse 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 event chills and fever was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Tiredness; He needed assistance to go to bathroom; tired and weak; Clammy; Very hot; First 24 hours was extreme reactions; 6 hours after 2nd dose, chills/teeth chattering; Fever, initial was 103 and reached to 104 over the night,fever went down to 102; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (He needed assistance to go to bathroom), ASTHENIA (tired and weak), COLD SWEAT (Clammy), FEELING HOT (Very hot) and ADVERSE REACTION (First 24 hours was extreme reactions) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced BALANCE DISORDER (He needed assistance to go to bathroom), ASTHENIA (tired and weak), COLD SWEAT (Clammy), FEELING HOT (Very hot), ADVERSE REACTION (First 24 hours was extreme reactions), CHILLS (6 hours after 2nd dose, chills/teeth chattering) and PYREXIA (Fever, initial was 103 and reached to 104 over the night,fever went down to 102). On 15-Feb-2021, the patient experienced FATIGUE (Tiredness). On 14-Feb-2021, BALANCE DISORDER (He needed assistance to go to bathroom), COLD SWEAT (Clammy), ADVERSE REACTION (First 24 hours was extreme reactions), CHILLS (6 hours after 2nd dose, chills/teeth chattering) and PYREXIA (Fever, initial was 103 and reached to 104 over the night,fever went down to 102) had resolved, FEELING HOT (Very hot) outcome was unknown. On 15-Feb-2021, ASTHENIA (tired and weak) had resolved. At the time of the report, FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 antibody test: protein spike 0 (Inconclusive) Protein spike 0.         The concomitant medication was not reported. Wife of patient reported during follow-up that "symptoms subsided completely with(in) 48 hours". The list of symptoms provided did not include feeling hot and fatigue/tiredness.  The treatment history was not reported.   This case was linked to MOD-2021-063829 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up email received and contained updated event outcomes
I started to have swelling in my left knee, joint stiffness in my left ankle and thumb. I went in to see the doctor and received cortisone shots in my knee, and a hyaluronic gel injection once a week which has helped with my swelling.
presents to the ER for evaluation of hematochezia. Patient reports that the nursing home staff has been telling him that he has blood in his stool for the past couple of days. He also reports pain in his backside
The patient experienced agitated behavior, personality change, insomnia and hallucinations on 2 occasions following HepB vaccines.
This spontaneous report was received from a nurse refers to a 13-year-old patient. The patient's medical history, concomitant medication and concurrent conditions were not reported. On 09-MAR-2017, the patient was vaccinated with first dose of GARDASIL, lot# K006960, expiry: 19-FEB-2017, for prophylaxis. The patient then received second dose of vaccine, lot# K011562, expiry: 08-APR-2017, on 08-MAY-2015 and the third dose, lot# K016966, expiry: 10-MAY-2017, on 08-JUL-2015 (inappropriate schedule of drug administration). No adverse reactions reported. Additional information has been requested.
Extreme fatigue, which continued for two weeks. I went to Urgent Care who gave me a COVID-19 test which proved negative, I  was so tired, I was sleeping 16 hours a day and needed a nap during the day too. After about a week I went to my PCP who gave me tick-borne disease tests and also tested my TSH levels. They found that these were very low, so reduced my dose of Levothyroxine. After about a week, I seemed to recover a bit, but I am still fatigued. I have no idea if it is a long-term result of COVID-19 or not.
arm pain (immediate, severe pain within 12 hours and lasted 16 hours), arm swelling, redness at injection site, headache (severe for 48 hours), fever, chills, left lymph node swelling/pain (started within 2 hours, ongoing), nausea (for 48 hours), lack of appetite (for 48 hours), fatigue (for 48 hours), muscle and joint pain (moderate started within 12 hours, lasted for 16 hours).
After VAR given on LL child developed fevers and "blister like bumps over LL/torso/face". Call made to HD.
PT HAS SOME ITCHING, REDNESS, AND BLISTERS ON HIS BACK, RT FOREARM AND LT HAND.
sore throat; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 28-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
severe flu symptoms with lethargy for 2 days.  Then development of 2nd degree Heart Block, Type 1 for 72 hours
Rash, redness, hot to the touch(fever feeling), swelling, and severe headache
Started with cold symptoms, coughing, fever, generall ill feeling. By 04/01/2015 he could not breathe well, was retracting and his O2 was 92% taken to ER.