chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Congenital Heart Defect" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Aug2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: Patient had Paxlovid Treatment from 26Aug2023 to 30Aug2023. The patient did not have any known allergies  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293516 same patient, different drug/event;
Reported on 2/22/01 hives on face, on 2/23 low grade fever, blue looking nails, lips. Seen in ER 2/22 for urticaria given Elocon 1% ointment. Seen by Dr on 2/24 treated with Benadryl.
pt called on 5/15/21 to hospital call center to report possible adverse reaction related to covid19 vaccine. Pt got pfizer vaccine on 4/22/21 for 1st dose and 8 days later pt developed flu like symptoms low grade fever, fatigue, sore throat and nausea. Pt consulted with PCP (outside) and she stated she tested negative for covid19, strep throat and mono. Pt's doctor ran blood test for pt and had elevated liver enzyme labs. Pt stated her LFTs were elevated and negative test for hep A,B,C done on 5/11/21. No additional medical or medication history provided by patient during call.  Pt states she is following up with her doctor for further evaluation.
Pale whole body, "spacy", eyes dilated, dec tone, no fever, lasted 15 min large BM @ end of episode;
Patient developed numbness in the arm where the injection was given about a 1.5 after receiving the vaccine and it was isolated to the right arm, proximal over the triceps region/deltoid.
Massive diaphoresis, fever 102.5 +, headache, photophobia, terrible demeanor, sore throat, sore arm, swollen tender arm but not red.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:17 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:17 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medications were reported.  On 03-Apr-2021, vaccines with batch number 030B21A were moved to the fridge. On 30-Mar-2021 vials were moved to clinic. On 03-Apr-2021 between 09 AM  vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Apr-2021.  Vial was stored in cooler 1, on 03-Apr-2021, temperature excursion at 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41, 1PM: 41 and  2 PM: 41.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigue in the evening. On 1/16/21, day two I had nausea after eating breakfast, extreme fatigue, muscle aches and joint pain. I also had a sore throat and odd sour taste in the morning, both days following the shot. This morning, day 3 I feel tired with less aches.
Patient was diaphoretic and dizzy approximately 10 minutes after receiving her first dose of the Pfizer vaccine. EMT went to the car and patient started having what appeared to be a seizure then the patient started slurring speech and had periods of a blank stare. Patient remained in car and EMT put seat back and continued to talk to the patient. The patient did not know what year it was or where she was. 911 was called and medical lead at site called. Medical lead continued to stay with the patient and talk to patient. Patient's speech and alertness eventually improved. When EMT arrived, patient was able to walk over to ambulance. Patient's speech and alertness to place continued to improve to baseline. VSS and patient did not want to be taken to hospital. Patient drove herself home with follow-up with primary care physician recommended. 2nd dose appointment cancelled.
24 hours after the shot, patient had a blood clot in her foot.  she went to a walk in clinic and was then sent to the hospital to get her foot scanned.  patient was released and told to monitor for any additional symptoms
w/in several hrs both arms became blue & swollen fingers were puffy; pt has hx of doing this several times when gets cold; so it may not have been reaction to immun specifically;
shingles; This is a spontaneous report from a Pfizer sponsored program received from a contactable female consumer (reported for son).  A male patient of an unknown age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on an unknown date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  On 16Apr2021, the patient experienced shingles. It was reported that the patient had first dose of vaccine 3 week ago. Caller is calling on behalf of her son who has been diagnosed with shingles last Monday, 19Apr2021. Caller said that her son had the symptoms of shingles since Friday, 16Apr2021. Caller also stated that her son has the 1st dose of Pfizer Vaccine 3 weeks ago but caller could not recall the exact date. The 2nd dose of the vaccine is scheduled on 27Apr2021. Caller asked if her son can proceed to get the 2nd dose of the vaccine as scheduled. Provided contact details of PMI. The outcome of the event was unknown.    It was unknown whether reporter was a healthcare professional or prescribing HCP. The reporter's contact information available to a sub-contracted party.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I got vaccinated at 945am. I immediately tasted metallic slimmy taste and dizziness. Within 20 min the arm pain started.The arm pain went to my elbow, clavicle and scapula this had started about 3 hours after the shot. Around 930 pm severe nausea and retching and abdominal pain I awoke feeling awful at 430 am on 8/14 whole body hurt tingling/sensation changes down from mid buttock, leg to feet(numb) and right side of my face(lips numb). Dizziness,Abdominal pain, nausea headache/pressure fatigue and right kidney pain. Spinal tenderness It is now 8/18 still having dizziness, tingling in my legs and  abdominal distress, pressure in back of head, short of breath with exertion
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
None, given dose out of vial that had been opened more than 6 hours, but kept refrigerated.
Got a period after a year of menopause.; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: En6208, Expiry date: not reported) via an unspecified route of administration, administered in Left Arm on 15Mar2021 11:00 (at the age of 55 years old) as dose 2, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was non pregnant at the time of vaccination. Historical vaccine included: The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: El9266, Expiry date: not reported) via an unspecified route of administration, administered in right arm on 22Feb2021 at 11:00 (at the age of 55 years old) as dose 1, single for COVID-19 immunization The patient had no known allergies to medications, food, or other products. The patient had not received any other vaccine within 4 weeks. list of any other medications the patient received within 2 weeks of vaccination was no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced got a period after a year of menopause on 19Apr2021 at 12:00. The patient did not receive any treatment for the event. The outcome of the event was recovered on unspecified date in Apr2021.  No Follow-up attempts are needed. No Further information is expected.
Pt recv vax on 4/29/99; on 4/30/99 pt exp swelling/ redness of lt thigh
Information has been received from a physician concerning a 59-year-old male who on 04-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 11-FEB-2008 the patient developed shingles.  Unspecified medical attention was sought.  The outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Pt reports she had a covid-19 vaccine, unknown version. Two days later she was treated for NSTEMI at the hospital with minimal to no risk factors. Had normal stress test.
Redness with heat at site approx 140mm x 70mm on left arm.  Approximately 2cm nodule left axilla and tender to touch.  Will see Physician today, 2-14-2013.
101 temp for 3 days, sinus drainage, headache, sinus pain and pressure, sore throat 2 days after injection. Cough started slow and got worse and worse. Lasted 3 weeks. Went to the doctor and was given a heavy dose of steroids, antibiotics and codeine. Was told treating bronchitis. No testing was done of any other kind. Body aches and fatigue started after week 1. Shortness of breath, dizziness and headaches persisted with meds through week 3 after injection. Stomach issue started with bad headaches again. Bloating diarrhea, body aches, extreme tiredness for 4 days. Currently 4 weeks out from shot, still have sinus pain pressure, drainage, headaches and shortness of breath. I am a runner. I stopped all physical activity because of cough and shortness of breath.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: a patient passed out in the store today after receiving their 2nd shot and they hit their chin on a shelf in one of the isles when they were falling. An ambulance came and the patient left in the ambulance.  The patient was awake and alert when the ambulance arrived.  The patient was made aware to sit  and wait 15 minutes after the shot was given but the patient did not wait and preceded to leave but the patient did not wait and preceded to leave and that?s when he got dizzy walking
Subsequently post vax, the pt developed an injection site reaction characterized by a large area of redness, warmth, and itching. Later, the area developed a bruise. The pt recovered. This is one of eight pts from this facility who had an adverse event following receipt of vax.
itchy toes both feet similar to symptoms experienced with possible covid infection in past  sore arm at injection site    no treatment
tested positive for a HPV strain not covered by the vaccine; This spontaneous report was received from a consumer and refers to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On an unknown date, the patient was vaccinated 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) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis (she was unsure which vaccine was given).  On an unknown date, at a later point in time, the patient was tested positive for a HPV strain not covered by the vaccine. The outcome of human papilloma virus test positive was unknown. There was no causality assessment provided by the reporter.
Covid-19 Ad26 Vaccine administered to Left deltoid muscle per standard IM injection protocol.  Within a few moments after administration patient stated "Oh. I'm going to faint."  Pt. was assisted to supine position and observed to be unresponsive to name calling, appeared pale and slightly diaphoretic with a weak thready pulse. Clinic staff was notified of vasovagal syncope, patient self-revived within 30 seconds. Afterwards cool compress was applied to forehead and pt. provided with water for hydration and was also offered crackers and juice, which she declined. Pulse re-checked approx 2 minutes after pt. revived found to be approx 65bpm and strong, 2+  color returned to pt. face and she stated she felt much better. pt. was observed by clinic staff for full 15 minutes following vaccine administration and vasovagal episode without further issue. Pt. left exam room and clinic under own power in stable condition.
Described crippling pain at beginning but nothing at injection site.  Saw her again on 11/5 and has rash, site warm to the touch, swelling and headache.  Pain has lessened in the arm and no difficulty in breathing.
Dyspnea.  I was naive to the influenza vaccination. I have never had influenza vaccine before.  Dyspnea seem to have worsened in the last 2 weeks. Had recent examination 3 weeks ago and no new abnormalities was noted.
I received my shot at approx 5pm in the right arm, at about 630 as I was getting intot he bath, I noticed a large bruise covering my right thigh, which faded while in the tub. Friday 4/2 the bruise appeared again in the same location, and faded after the shower. I went to my doctor who ordered bloodwork which I got the next morning. Came back normal. Saturday  4/10 , monday 4/19 the same occured. I saw a hematologist as I was concerned, pending more bloodwork.
pt recvd vax 18OCT95 approx 10AM upon arising next am hands felt itchy-hives appeared chest tightness; to clinic 9AM given DPH inj & Hydroxyzine & Zantac
Soreness at the site of injection; Muscle Ache; Headache; Low grade fever / Fever; Chills; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2020, 8 hrs after receiving Shingrix, the patient experienced fever and chills. On 30th July 2020, the patient experienced injection site pain, muscle pain and headache. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the injection site pain, muscle pain, headache, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, headache, fever and chills to be related to Shingrix.  Additional details were provided as follows: The caller was a relative and GSK employee. The patient received Shingrix and had chills and low grade fever 99.5.  The patient had a fever of 100.5 the following morning along with headache, muscle ache and soreness at the site of injection.  The caller reported the patient took Acetaminophen prior to receiving the vaccine and again the next day.  Limited information was available. The reporter consented to follow up. Lot and expiration date was unavailable.
Patient was scheduled to receive second dose of Moderna vaccine.  Inadvertently received dose of Pfizer.  Patient made aware of situation,  provided with education on both vaccines, given CDC info on mixed dose series of mRNA, reassured.  Pt had no questions. Pt in no apparent distress during or after 30 minute observation period.  on discharge to home: BP 122/84, HR 66, SaO2 98%, T=98, RR 16.
Pt. c/o fine rash over entire body for last 4 days. Has no swelling of glands or fever.
I GAVE AN ADULT DOSE OF VAQTA-DOCUMENTED AS HAVRIX (WE DO NOT HAVE THIS IN OFFICE) TO A PEDIATRIC PATIENT.
MMR, VARIVAX and PREVNAR given Thursday. Monday night without other signs of illness developed a rash. Tuesday morning I saw him an it covered his entire body and was clearly erythema multiforme.
Injection was administered in the gluteal muscle instead of the deltoid. Previous vaccine had been given in the same location. Patient did not report any adverse symptoms post injection.
ABOUT 1MIN After recieving vaccines child complaining about nausea,vomited right after.looked tired and sleepy.HAD NOT had anything to eat since this am.MOM states child must be tired after travelling for 25 hrs. head placed between legs, sugar offered per Dr.B/P 100/55 PULSE 88.CHILD checked by Dr who said child is dehydrated.encourage to push fluids po,if condition continues,take to ER,IF SEVERE CALL 911 CHILD APPEARS BETTER AFTER 5 MINS.LEFT wirh parents.
After having started a prescription for Diltiazem 120mg ER on Jan. 3, developed severely itchy, red skin rash, breaking out beginning Jan. 12. Had also received second Shingrix injection on Jan. 8 (no reaction to first shot, other than fever and aches on day after, same had occurred after the second dose). Rash was sufficiently alarming to cause a visit to urgent care (prescribed topical steroid cream and suggested using Benadryl) on Jan. 12; visited primary care doctor on Jan. 13 as rash continued to spread, covering trunk, arms and legs to knees. Doctor prescribed a course of oral prednisone plus continuing Benadryl. Itching stopped in a couple of days; rash gradually faded over 3 weeks. I had stopped Diltiazem on Jan. 12, on my own decision; primary care doctor agreed as did cardiologist on Jan. 13.
Patient received vaccine to left deltoid. As I was handing back her vaccination card and giving her instructions about heading to the Observation area she reported " I feel a little dizzy". I immediately guided her to the cot next to the chair she was on. She lied down and I called for help to gather equipment for vitals and get an ice pack. She explained that she was hearing me in the distant and that her vision was somewhat hazy. Her vitals were taken x3 and were as follows: 1st set: BP 110/78 P:64 R:18 O2:99%RA 2nd set: Bp 110/78 P:59-61 R:18O2: 99% RA 3rd set: BP 110/78 P:59-64 R:16 O2: 98-99% RA She remained alert and oriented. She shared she was coming from a dental appt and had not had any food yet and feeling anxious about the vaccine. She was provided fluids and said she was feeling better. She was assisted to a sitting position and then to stand. She appeared well and said she was feeling better.
Complex febrile seizure (2 episodes in less than 24 hours).  Seen in ED, Labs, CSF studies, Head CT all normal.  Admitted and monitored for 3 days?  Discharged home without further incident.
10/16 afternoon started to develop sore throat, 10/17 am started to develop fever which has ranged from ~100-103 on 10/17-10/18, aches, headache, mild dizziness, cough. Did not visit physician. Of note I am a pharmacist and have been exposed to many people with flu-like illnesses over the last week or two. Symptoms are beginning to improve pm of 10/18 though I still have a fever over 100F.
Intense metal taste in mouth affecting sense of taste and resulting in loss of appetite.  Mild nausea.  Fatigue.  As of 1/12 sore/burning sensation in back of mouth/throat.  Note sense of smell not affected.  No treatment sought.
nausea, vomiting, diarrhea.  required supplemental O2 started on remdesivir and decadron
Moderna vial was punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vial was punctured more than 20 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vial was punctured more than 20 times). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vial was punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
lt leg became red & indurated & tender;p/tx pt adm & had similar rxn but not so severe w/last DTAP vax;
COVID-19symptoms started on 11/26/21, tested positive with PCR on 11/30/21. Tested negative on all home tests throughout all of COVID-19. I had loss of taste and smell that lasted until 03/2022. I had fatigue, congestion, very little cough at the end, and the congestion was minimal. I had brain fog and insomnia as well. I was taking zinc, vitamin D, multivitamin, and Tylenol and that was about it. I had heart palpitations as well and that's what I was being watched for. The other symptoms lasted 3 weeks.