chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore upper arm the first day after; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) via an unspecified route of administration in right arm on 16Mar2021 at 11:00 hours (at 64 years) as an unknown, single for COVID-19 immunization. Patient's Medical history was not reported. Concomitant medications included Synthroid, atorvastatin (MANUFACTURER UNKNOWN), olmesartan medoxomil (MANUFACTURER UNKNOWN) for an unknown indication. Patient did not have any Known allergies and other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Mar2021 at 02:00 hours the patient experienced sore upper arm. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. On unknown date in Mar2021 the patient recovered from the event sore upper arm.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's First Name, Patient's Age/Units, Relevant Med History, For Suspect vaccine; Indication "Covid-19 immunization" captured twice, removed one, No Drug Code for Con-Med "Olmesartan Medoxomill": Re-coded as "OLMESARTAN MEDOXOMIL" in tab, Treatment Received, None removed from Concomitant Therapy since Con-Meds already coded in Product tab, Information "if other vaccine in four weeks" missed in consolidated narrative and Initial information and event tab details reviewed and updated.
I had no adverse reaction to the vaccine.  This summer I developed a sinus infection.  Because of the Covid scare, I finally decided to go to the doctor to make sure I wasn't a mildly asymptomatic vaccinated person.  The doctor did a covid test and unfortunately the results were inconclusive (something the doctor said she had never experienced) - neither positive or negative.  I stayed isolated for 10 days, treated with Sudafed and all symptoms went away.  No one around me ever got sick.
progressive idiopathic neuropathy; This is a spontaneous report from contactable consumers (one is patient). This male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199) via intramuscular at single dose in left arm on 02Mar2021 for covid-19 immunisation. The first dose was on 08Feb2021 (Batch/Lot number: EL9262) via intramuscular in left arm and experienced some numbness in both knees. Medical history included peripheral neuropathy from 2005 and ongoing, very mild on bottom of both feet, began in 2005 but did not advance or change until patient had the vaccine. Prior vaccinations (within 4 weeks) was none. Concomitant drugs was none. After 2nd dose in March, feet became numb and some neuropathy symptoms in both arms (numbness, tingling, feeling of warmth in right arm) in Mar2021. Tingling and numbness had intensified some what to this date (14Oct2021). Patient was diagnosed by neurologist with progressive idiopathic peripheral neuropathy. No treatment prescribed by medical doctors. Specific relevant test for thromboembolic events with thrombocytopenia was unknown. The outcome of event was not recovered.
Vaccine given 8/17, noticed 4 days later, (R) arm swollen, warm, tender to touch, firm. No fever no chills raised papular rash noted, skin intact.
Patient complained of tightness in throat and face after receiving vaccine.  benadryl given. VSS. No other symptoms.  Symptoms resolved automatically.
I have been seeing a PCP and Cardiologist since my vaccine, I have suffered from an Irregular Heart Beat. I had an EKG done which showed my irregular heartbeat. I was referred to have a cardioversion done.  I am just waiting to see if the cardioversion works if it doesn't I will have to have an  ablation done. I have seen a neurologist (Dr.) for my headaches. He ordered an MRI of my head which I had done yesterday (6/29/21). I am on Eliquis 5mg 2xday due to my irregular heartbeat.
Patient became hypertensive and had to visit the ER. It isn't conclusive that vaccine caused symptoms, but patient came in to tell us considering he had just had the vaccine the previous day.
Three hours after receiving the pfizer vaccine i woke from a nap with a swollen tongue .   later I had one hive.   The tongue swelling resolved on its own an hour later
Stated he was getting a sore throat and headache shortly after receiving injection. Red at injection site. Fever followed.
This spontaneous report as received from a pharmacist refers multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies/reactions or concomitant medications. On an unknown date, the patients were inadvertently vaccinated with improperly stored ZOSTAVAX lot # reported as M035697 with expiration date of 07-NOV-2017, for prophylaxis (dose and route of administration were not reported); diluted in sterile water diluent, subcutaneously, for prophylaxis (lot number and expiration date were not reported). No adverse effects reported. No additional information was provided. Administered doses of vaccines experienced the temperature excursion of 15-46 degrees Fahrenheit (27.6°F) for 2.5 hours. Data logger was not involved. There were previous excursions of 6-14 degrees Fahrenheit (12.8°F) for 1.5 hours. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA000311.
8 days from the date of injection, my arm again became sore to touch at the injection site.  At the same time, I also developed a red area (about 2 inches wide) at the injection site, which is warm to touch.  This is accompanied by a mild dull ache throughout my left arm.   This started yesterday (the 8th day since receiving the vaccine) and is still present today (9th day since vaccine)
syncope; POTS; fatigue; headache; dizziness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 11-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2013 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS), fatigue, headache, dizziness, and syncope. At the time of the report, the patient's outcome was unknown. According to reporter, the events were related to the suspect therapy.   Upon internal review, the event of syncope was considered medically significant.
h/a, nausea, fever to 104 beginning 8hr p/vax lasting 4 days;
Pt's left leg was red, swollen, warm to touch with a hard area around the injection site.
Patient is fully vaccinated including a booster on 8/21/2021.  Pt admitted for SOB.  84 year old vaccinated female on immunosuppressants and dialysis  presented with concerns for shortness of breath and coronavirus.Dx of COVID 19 pnuemonia, RUL opacity. acute hypoxic respiratory failure, worsening.  Patient treated with Decadron, Lovenox, supplemental oxygen (15L HFNC and NRB). anticoagulation with SQ heparin. ESRD on dialysis.  Patient's condition ultimately declined, with family deciding on hospice care 12/16/21, passing away later that night with family at bedside.
A 19 year old female patient received a subcutaneous injection of Menomune, in the left arm on 09/07/2005.  Four days later she complained of severe pain and stiffness in the back of the neck area.  No fever, headache or other illness was reported with this event.  It was not reported if this patient had received any treatment for this event.  The patient has a pre-existing history of codeine allergy and was not taking any other medications at the time of the report.  The patient has not recovered from these events.  Followup information received on 10/28/2005.  The patient had no adverse event following prior vaccinations.  The patient had no other vaccinations within 4 weeks of receiving Menomune.  The duration of the neck stiffness was 3 days.  No diagnostic tests or labs were performed.  The patient did not require treatment and did not seek medical attention.  The patient recovered.  No further information is expected.
Patient reports at 1302 with mild dizziness after receiving her 2nd dose vaccination. Pt is taken to treatment are to be further assessed. Initial Vitals: 1304 BP: 126/72 HR: 66 Sat: 95% RR:18  Pt was given water to drink and approximately 10 min later pt reports feelin "much better and no longer dizzy"  Vitals were repeated at this time and are as follows:  1314: BP: 128/78 HR:61 Sat: 95% RR :17  Pt was given instructions if symptoms reoccur to consult PCP or call EMS. Pt verbalized understanding and was escorted to the car with husband without further incident by RN
No adverse events.  Patient created an appointment to receive a 2nd booster. Upon reviewing his profile post vaccination,  noticed he was not qualified based on the current CDC second booster eligibilty guidelines. Per pt, thought overweight and high BMI was qualified as part of immunocompromised status.I added overweight and high BMI as part of the health conditions post vaccination. Monitored patient for 15 minutes and no reactions.
Fever of 101 and higher with vomiting and dizziness.  Given Children's Tylenol and fever dropped slightly, but not completely.
My son was having a very difficult time breathing and swallowing. He didn't eat or drink anything even water and applesauce was too much for him. He also had a temp of 101.8 later that morning around 4:30 AM.
Feeling  very unwell, nauseated and cold   (Not chills)   No treatrment needed
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (got moderna booster and had side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got moderna booster and had side effects). At the time of the report, VACCINATION COMPLICATION (got moderna booster and had side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
I have recently noticed an unusual bruise above my left eye, in the gap between my upper left eyelid and my left eyebrow.  The bruise was dark brown in color, about 2cm x 1cm  This is a hidden area, unless I close my left eye or pull my left eyebrow upward.  My son noticed it on March 27th, but it may have been there longer than that.  Today I noticed the yellow-greenish color surrounding it today, so it appears to be somewhat new.  I have not noticed unusual bruising anywhere else.  It is possible that the bruise resulted from a mild physical impact from my son during play, but I do not recall any unusual impacts of note.
3x4 inches diameter of redness with induration. 4 hives located in center area, measured 3-4 mm. No pain or palpitation. Benadryl 1 tsp PO Q6 PRN
On April 16th at 1:00AM I woke up to pain in my left foot.   When I got up to take a look I was unable to put full weight on my left foot.  The side of my foot by the small toe is red and swollen.
Did well on ASA until Jul91 had diffuse pain rt shoulder & neck that progressed to persistent joint swelling tx w/ NSAIDS,pred,gold;disease became debilitating & pt dx as having a connective tissue (collagen vascular) disease (ANA-neg);
Nausea and vomiting within minutes of vaccination; lightheadedness and hypotensive (86/66; 93/70). H20, food and rest provided. Recovered within 30 minutes.  States history of anxiety related to "needles".
While administering vaccine patient moved unexpectedly causing patient to prick her right thumb with needle. She had not had the opportunity to retract the needle. Both patient and immunizer were tested and cleared.
Inflammation and tenderness at site of injection on left arm.  Inflammation spreading on the upper arm.
No symptoms were seen at time of vaccination. The patient was talking and laughing afterwards. The patient waited for 3-5 minutes before walking out of vaccination room.  When patient reached outside of the store, she passed out in the front of the store. The patient was able to get up and sit in a chair that was provided to her.  The EMS team arrived at the scene and noticed the patient had given blood prior to the vaccination in which the patient noted on the system that she has not given any blood. The patient did not verbally communicate prior to vaccination about giving blood before coming to the store. They checked BP and found it to be profoundly low.  The patient is conscious and is somewhat communicating with EMS, transporting her to nearby facility for further observation.
6 out of 10 got COVID; 6 out of 10 got COVID; 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 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 out of 10 got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Got Covid.  After receiving booster-sat at dinner and 6 out 10 & 5 children got Covid. I was told later by specially Pharmacist. Humira weakens effectiveness. I should have been told soon I would have suspend Humira immediately. I am 65 w/COPD + Psoriatic arthritis.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pentacel was administered without mixing the ActHIB component/ no adverse event; Initial information received on 20-Jan-2020 regarding an unsolicited valid non-serious case received from a physician assistant.  This case involves a 2 month old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing the ActHIB component (Product preparation issue).  Patient's medical history, treatments, family history not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), HEPATITIS B VACCINE (HEPATITIS B VACCINE)  and HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) for Immunisation  On 20-Jan-2020, the patient received a first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE 0.5 ml (lot U6629AA, Expiration date: 20-May-2021) via intramuscular route at an unknown side of leg (right or left).  It was a case of actual medication error due to Product preparation issue.  At the time of report no adverse event reported.  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.
Light headed, dizzy; Vertigo; Rash on lower arm of injection site; Extreme fatigue; This is a spontaneous report from a contactable other healthcare professional, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 05May2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 07May2021, the patient had rash on lower arm of injection site and extreme fatigue at the beginning of the same day. On 08May2021, the patient experienced light headedness, dizzy and vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, 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 rash on lower arm of injection site, extreme fatigue, light headedness, dizzy and vertigo was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Began with soreness at injection site, fatigue, body aches, shivers. No sign of fever. Then rash developed at the site the next day, which progressed to other upper arm, shoulders, back, lower face, and some on legs. Rash continues. There also continues a light itch at the site.
term getting the second dose outside of the 42 day timeframe; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (term getting the second dose outside of the 42 day timeframe) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (term getting the second dose outside of the 42 day timeframe). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (term getting the second dose outside of the 42 day timeframe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported . No treatment information was provided.
Pain and intense itching in muscle area of injection onset eight days after injection starting with mild itching progressing to intense itching and pain with minor relief from topical corticosteroid cream
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved or COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
2/14/23  I started with a mild cough. The next day I tested positive with an at home COVID test. I was coughing more, was very tired and had a low fever. I talked to my son in law who is a physician.  He prescribed Paxlovid and I began taking it on 2/16/23. Within 24 hours, I felt better, not great, but it was an improvement. Five days after I started the light coughing, I felt much better.
No Energy, weak, loss of bladder control.    Drank lots of water. 99% better next morning
Symptoms began with severely sore muscles about 3-4 hours after the vaccine.  I'm healthy and 40 years old and I was barely able to walk to my bed, like a 90 year old.  Followed by uncontrollable shaking for 1-2 hours (like extreme chills, though I wasn't cold and was covered in blankets).  Following that,  I was unable to walk or crawl and almost any movement of any part of my body was excruciating, including picking up a glass of water and even wiggling my toes.   It felt similar to the physical trauma of recovering from a car accident, when every muscle is tensed for impact. That severity decreased within 24 hours of the vaccine.  Muscle pain, extreme fatigue, headaches and dizziness have continued for 4+ days and are still present and prevented me from working and going about day-to-day activity.
Symptoms include: flu shot and hep A given 5 days prior on 10/18/18 and then on 10/19/18 she had dizziness and headache and had to lay down and rest, each time she would get up she felt a little dizzy so she would lay down and rest and drank some juice. No fainting, no fever, no loss of consciousness, no emesis. Rested and felt better on 10/20/18 with no symptoms. Then on 10/20/18 at church in the morning felt stomach ache and so laid her head in moms lap and then said she "couldn't feel her midsection" and had loss of bowel and bladder control-stool and urine all came out. In 10-15 min, she was able to walk out of church holding onto mom. Went home and showered independently and abd pain got better as day went on. Ate dinner last night and ate this am and has some pain below belly button but no diarrhea, no emesis. Hasn't tried any medicine. When mom asked her if she would have been able to get up and leave if the church has been on fire she said she would not have been able to walk.
another attack 3 years later/ Suspected vaccination failure; suffered another attack 3 years later; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain (for three weeks) and shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: another attack 3 years later/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: suffered another attack 3 years later) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUL-2023 This case was reported by a patient via interactive digital media. The patient had pain for three weeks and it had hurt.  He/she got a shot for shingles after he/she healed, suffered another attack 3 years later. The reporter thanked God that it was less painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Before vaccinations were given, I questioned mother concerning the small amount of rashes noted on pt's arm and shoulder. Mother stated when the baby feels hot there will be rashes on her body. The child was active and had no temperature when the vaccines were given, but after 1 day of IZ's, mother called and said child had more rashes all over body and appears red and stated no temperature and no other problems, only the rashes.
Patient's wife called today 8/4/19 to state that he experienced redness, swelling, pain at the injection site, and lethargy