chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives over upper body and back of neck. It then spread to lower body, forearms, and forehead; This is a spontaneous report received from a contactable consumer, the patient. A 19-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The medical history included myopia and astigmatism. The concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 21:00 the patient developed hives. The patient reported that he developed hives over upper body and back of neck which started 32 hours after vaccination around 21:00 and it subsided a little after he went to bed. It then spread to lower body, forearms and forehead at 20:00 on 25Mar2021. The hives were nearly gone on the morning of 26Mar2021. At no point did the hives reached his throat or other vital areas to breathing. The patient received BENADRYL, ALLEGRA and PEPCID as treatment for the reported event hives. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the event hives was resolving at the time of this report.   No follow-up attempts are needed. No further information expected.
Information has been received from a physician concerning a female who was vaccinated with the second dose of GARDASIL.  On an unspecified date, eight hours after the administration of the second dose of GARDASIL, the patient's face and tongue got swollen.  The physician reported that her entire face was swollen the following day.  The patient took BENADRYL and went to bed.  She recovered with therapy.  The physician noted that the patient was around dogs and had her hair dyed on the same day as the administration.  Additional information has been requested.
A patient was administered an expired dose of the Moderna COVID-19 vaccine. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. No Medical History information was reported.On 10-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. There was no pertinent medical history. On 19-NOV-2013 the patient was vaccinated with ZOSTAVAX via of lot # J006156, expiry date 30-AUG-2014, single dose, 0.65 milliliters, via subcutaneous route. Concomitant medications were none. The pharmacist reported that the patient developed redness, swelling, and itching at the ZOSTAVAX injection site. The swelling was about 2.5 by 1.25 inches. The outcome of events was reported as not recovered/not resolved. No treatment was given for events and pharmacist was called by patient to seek medical attention. No lab diagnostic test was performed. Additional information has been requested.
Presented initially with SOB, found to have Covid-19 PNA and COPD exacerbation. Patient was given vitamins, steroids and Remdesivir. Patient was able to wean down from 6L NC to his baseline home o2 at 4L. Patient refused home health and was discharged home.
We have both come down with like Sciatica pain, both in our right knees both of us; both of us had the same shots and both of us came down with the same pain; This is a spontaneous report from a contactable consumer (husband). A 71-years-old female patient received second dose of BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient and her husband, both had their shots which had been Pfizer. Stated that, the consumer don't know the dates of when patient had her list. Stated that, they have both come down with like Sciatica pain, both in their right knees both of them and they had been trying also pain medication. It seemed really strange of both of them, had the same shots and both of them came down with the same pain. Consumer stated that, he remember a Pfizer community and he told his doctor about that was happening. He was talking to a pharmacist the other day and he told the patient to call you guys and give you the information. The outcome of the event was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021623543 Different patient, same drug/event.
Red and itchy on 10/9/2012. Progressed to more pain and itching.  Swollen and red on 10/11/2012. Size of reddened are is 4.5 x 5 inches on left tricep area.
Delayed cutaneous hypersensitivity, aka "COVID Arm", a red splotchy discoloration of the skin around the injection site.
Two roommates have at one point or another tested positive; Two roommates have at one point or another tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE, COVID-19, outcome unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858522 same reporter/vaccine, different patients, similar events; US-PFIZER INC-202101858696 same reporter/vaccine/event, different patients
I have swollen spot under my right arm.  My blood pressure is elevated.  I always have normal blood pressure, since Saturday it has been elevated.  Today at 1:15 my BP is 148/96, PULSE 79
After my 2nd dose, I could not sleep that night and since I have been experiencing high blood pressure of 165/95 (my normal is 140/80) and I am experiencing mild angina that rarely resolves (I have exercise induced angina that generally quickly resolves).  I believe this is a reaction to the vaccine.
I started experiencing frequent bouts of atrial fibrillation and after a few days of it, my heart began to ache. I was taking a drug called Propafenone 300mg once a day, but it wasn't working and that's supposed to put me back into normal rhythm, but it wasn't working. I got in touch with my doctor who told me to see the specialist. I saw him this past Friday and he also put me on Propafenone and he cut the dosage in half to 150mg twice daily and he put me on a second drug called Metoprolol 50mg once daily.
23 year old male contacted hospital on 6/13/2008 with following history: 1.  New onset headaches within 1.5 hours of receiving initial dose AVA in Feb 2008; no N/V, dizziness, or visual deficits; denied history of head trauma; not worsened with subsequent doses, but persistent to date on order of 1-2 headaches/week.  2. New onset migratory joint pains, worsening of previous bilateral knee pain, and myalgia within a week of receiving each dose AVA #1-3; no associated joint erythema, swelling, warmth, or deformity; denied history trauma or overuse; not worsened following subsequent doses but persistent to date.  3. Unusual fatigue onset within 72 hours following receipt of second dose AVA in Mar 2008 - Initially felt like "hit by truck", now with mild persistent fatigue; not worsened following subsequent dose.  4. New onset chest pressure 1-2 weeks following receipt of second dose AVA in Mar 2008 - Intermittent non-radiating substernal pressure, associated with "labored breathing" and sensation of throat tightness; occurs during both rest and exertion, on order of 3-4 times/day; not worsened following subsequent dose but persistent to date.  No evaluation of above to date; hospital recommended patient obtain medical evaluation as soon as possible.
New onset headache, eye pain, paresthesias, and urinary retention 2 weeks after getting covid-19 vaccination on 5/14/21
redness around injection site; itching around the injection site the top of the arm down to the elbow,; swelling in both arms/swelling in both legs; pain in both legs / pain in her legs / pain in both feet; hip pain /  pain in her hips; she had to use a walker; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation, hip surgery and shingles. Previously administered products included Shingrix with an associated reaction of peripheral swelling (received 1st dose in August 2020, refer case US2020210332).   On 9th October 2020, the patient received the 2nd dose of Shingrix. On 9th October 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site itching, swelling arm, leg pain and pain in hip. On an unknown date, the patient experienced walking difficulty. The patient was treated with hydrocortisone and neosporin (nos) (Neosporin). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site itching and walking difficulty were unknown and the outcome of the swelling arm, leg pain and pain in hip were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, swelling arm, leg pain, pain in hip and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and had swelling in both arms, itching around the injection site from the top of the arm down to the elbow, redness around the injection site, hip pain, pain in both feet, and swelling in both arms and these have resolved at this time.  The patient reported the same day she received the second dose she had pain and swelling in both legs and these are still ongoing currently.  The patient reported she was still having to use a walker due to the pain.  The patient reported she used Neosporin and Hydrocortisone cream for the itching around the injection site. The reporter consented to follow up. Emergency room visit required. The Patient did not had lot number or expiration date information to provide.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020210332:same reporter
This patient also tested positive for COVID; This patient also tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 7-year-old female patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 1 (orange cap), single (Lot number: FK5127) and on 03Dec2021 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 6 years for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies", start date: 2019 (ongoing). The patient's family history included: "gestational diabetes" (unspecified if ongoing), notes: mom has gestational diabetes. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Sep2022, outcome "recovered" (2022) and all described as "This patient also tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The report was not related to a study or program. Last known weight was taken in Jul2021. This event was not ongoing, but caller did not see any follow-up or information about when or how this event resolved. She thought this was tested for at school. The patient received third dose (lot: FL2757, expiry: 30Sep2022). Patient has not had any relative treatment or medical intervention to caller's awareness. Additional vaccines administered on same date of the Pfizer suspect, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: None. AE(s) following prior vaccinations: None that she was aware of.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201212817 similar report from same reporter;
a patient inadvertently received only the DTaP-IPV portion of Pentacel; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Child patient who received only the DTaP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without Act-HIB component.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported.  It was of actual medication error case due to  inappropriate reconstitution technique.  It was unknown if adverse event was experienced..  Information on the batch number was requested:  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Donor reported the day after the vaccine was given, she noticed a lump in her right deltoid, surrounding area was uncomfortable, red/warm.  Approximately 3 days later she states the symptoms went away and today there is a small nodule on deltoid.
patient described that after leaving pharmacy approximately 15 minutes later she experienced tingling  and numbness in all her finger tips and felt very strange. She was in another retail establishment and stated she just stood quiet for 10 minutes or so and then felt better so went on her way.  No treatment was sought out and no other symptoms occurred.
Information has been received from a physician concerning a pt who was vaccinated with a dose of Rotavirus vaccine. It was reported that the pt experienced a stomach ache. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has beer requested. This is in follow-up to report(s) previously submitted on 11/14/2006.  Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ.  It was reported that the patient experienced a stomach ache.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
It was reported that a pt rec'd a Menomune A/C/Y/W-135 (lot#UB245AA) vaccination given sq in his L arm at 6:06pm on 11/6/02.  Reportedly at 6:25pm the pt passed out, fell and hit the back of his head on the floor. Pt came back to observation area, pt was seated and ammonia inhalant was administered. Pt was awake and oriented, vital signs stable. a cool cloth was placed on his head and cool water was given to drink. Pt was advised to call for help if he did not feel well later in the night and to check in with the student hlth ctr in the morning. Reportedly the pt recovered from this experience. This case is closed.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Presented 1/29/03 bruises on body; petechiae as well. Negative exam otherwise. The discharge summary states epistaxis, conjuntival hemorrage, mucosal bleeding, and purpura.
nauseated; vomited; This is a spontaneous report from a contactable nurse. A 78-year-old male patient (reporter's husband) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in the right arm on an unspecified date at a single dose for COVID-19 immunization. Medical history included dialysis from an unknown date (also reported as started about two years ago). There were no concomitant medications. The patient got real nauseated and vomited, states he got sick last night on 18Jan2021 and today it was much improved. Outcome of the events was recovering.
Coughing, itching on lower torso, upper thighs,  This reaction also occurred with the previous shot (Moderna booster, shot #3 in November 2021).  Nighttime coughing, daily.  Daily hives covering inner thighs, parts of legs, buttocks, stomach, for 3-4 months, tapering to only cough  7 months after shot.  Coughing prevents sleep at night.  Non-productive to moderately productive cough, sometimes with sneezing. No asthma, COPD or other respiratory illness present.  Non-smoker.
Patient reported feeling funny after shot. Mom sat her down in chair and we continued to immunize her other child. About 3 minutes after patient received the shot she fainted face down on the floor and started convulsing. We immediately called 911. She was unconscious for ~15 seconds and then she woke up. She was aware of what happened and was just dizzy. She busted under her eye open and had a welt on her forehead. Paramedics arrived about 10 minutes later and she went to the hospital.
Pt and her mom came up asking for a COVID vaccine. Pt also brought her child (3 years old). The pt and her mom both filled out consent forms for the Pfizer vaccine. After reviewing the form for Patient and seeing no contraindications to vaccination, I pulled her dose of 0.3ml. I came out with my hand-held, vaccine supplies, and vaccine. Prior to the shot, I went over possible side effects including fever, chills, headaches, body aches, sore arm, upset stomach, and tiredness. I mentioned that we would have to wait for 15 minutes after in front of the pharmacy and make sure she didnt have a reaction to the vaccine including: difficulty breathing, feeling like she would pass out, throw up or feeling itchy all over.  Then I gave her the pfizer vaccine in her left arm at 3:29pm. During this whole process, her son was a little upset and kept running all over the place and she was a little distracted when I asked her if she had any questions. I told her she could take a seat up front and we would check in on her in a few minutes. During this time, I had several other vaccines and in-store prescriptions. I had other technicians check on them. At one point (around 3:43pm) she mentioned she felt dizzy and I recommended she stay a little longer (for the full 30 minutes). She got up and left shortly after, assuming she was getting her stuff from the back (without asking or telling us that she was doing this). She came back about 10ish minutes later with a backpack, without her store vest, and with a pink jacket on and sat down in the post-vaccination chair. Since I was busy,  a pharmacy tech checked on her. This was when I was first alerted to her feeling chest pain. I went out to talk to her myself, she mentioned chest pain, feeling dizzy and like she was going to cry. I went back to the pharmacy and grabbed an ice pack and thought maybe this was anxiety. Then within a couple minutes, I had a technician take her blood pressure with our automated cuff. The first reading we got was around 180/100. I mentioned she would need to go to the hospital since her BP was so high. Then the patient was brought over to the store's blood pressure machine to double check her BP a few minutes later. The second reading was about 140/90 and then mentioned to the technician numbness in her arm. I said she should go to the hospital around 4:00pm then we called 911.  The paramedics came and took her out on the stretcher and mom and son left with her. No further update has been provided at this time
About 7 hours after vaccination, he stated that his arm started hurting and throbbing like he had been stung by a bee. He said his whole body was shaking and continued to all night. He checked and he did not have a fever. His heart rate was racing and about 110 BPM when he checked. The next morning he said he is feeling okay. His arm does not hurt as bad, but there is soreness.
Information has been received from a healthcare worker (immunization official) referring to a 18 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-JUN-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # K010440 (expiration date, dose and route not reported). which was improperly stored. No adverse effects were reported. This is one of several reports received from the same  source. Additional information has been requested.
Patient had BEXSERO dose 2 at 0930 7/2/2018. At 1510 patient's mother phoned stating he had a fever of 104 at 1330. TYLENOL was given and fever came down to 103 within the hour and down to 102 at 1520. Mom chose to give TYLENOL routinely and moniter patient. Phoned patient's mother.
lt lower deltoid muscle swollen p/14 days not red or hot but tender to touch;