chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had the red swollen arm (injection site) - it was a little bit later  - about 10 days after the vaccine. It kept getting bigger. It looked like a really bad mosquito bite that got huge. It was itchy Body aches and fatigue and headaches showed up about that time, too. Those symptoms lasted to the end of March and early April.  March 17 I blew out my knee - my right knee. I ended up getting x-rays before I came to him. He called and said to go see an orthopedic surgeon and that wasn't until later on. I did see the Orthopedic Surgeon on April 8th. He injected my knee with steroids that day and took x-rays at his location. He also gave me Tylenol. Before I got to see him, March 30th - I had a TIA - Stroke. I was home alone and I called my husband and doctor (but he didn't call back right away so it was about 4 hours) and he said I needed to go to ER - Hospital ER. The treatment was cholesterol medication and referrals to cardiologists or neurologist and also an Ophthalmologist. I did see orthopedic surgeon again, again and again. I went back to Primary care doctor, too. I saw cardiologist first - April 22, 2021. I was sent to Nutritionist - on Friday, May 28th - no treatment - she said I was doing well with diet and nutrition and she would see me in 6 months. Eye exam - on June 1st - going through more tests for that - something to do with the back of the eye. June 2nd - I saw the neurologist - that was for a consultation to go over all the results from the other tests. He said there was that had happened and that nothing was very conclusive and said I should just go on with my life. In the hospital when I was admitted for my TIA - stroke - they saw that I had a thyroid issue - and so I went to thyroid doctor June 2nd. - they added - Atorvastatin and Amlodipine.  I had surgery for the loop monitor for my chest on June 9th. Also there is a New nodule on my thyroid - big enough to Biopsy - on my Thyroid. On June 15th - I got the Shingrix vaccine - same arm as COVID vaccine - wild reaction from that within 24 hours that did go away the 2nd day. It was a full body flare - similar to COVID vaccine reactions but it went away quicker. I started a new medication for me called Rinvoq  - for the Rheumatoid Arthritis  - this replaces the Xeljanz that I had been taking. My balance is off still and I'm using a cane and I wasn't doing that before - possibly for my knee being weak. I'm getting ready for a knee replacement eventually. Since 10 years ago, I'm compromised on the right side - that is my Lymphedema side - hence all my vaccines, etc are on the left side. Otherwise, I'm feeling well now at this point.
Foggy brain, dizziness, fatigue, weakness, loss of appetite, depression, nosebleeds. diarrhea, groin pain (left & right), Sciatica (left & right) headaches, head pain,
INTESTINAL DISCOMFORT,  SORENESS, CONSTIAPTION INITIALLY, DIARRHEA BY THE THIRD DAY.  FATIGUE, MUSCLE ACHES, LOSS OF APPETITE.
Pain in left arm from neck to elbow since immunization, patient is unable to maintain normal activities.
This case was reported by a consumer via call center representative and described the occurrence of injection site stinging in a 78-year-old male patient who received SHINGRIX. Concomitant products included Baby Aspirin, finasteride, naproxen, Tamsulosin and fish oil. On May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 8th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site stinging, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site stinging was unknown and the outcome of the injection site swelling and injection site erythema were not recovered/not resolved. The reporter considered the injection site stinging, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter was wife of the patient. The patient received SHINGRIX in left arm. The patient experienced stinging at time of injection and then developed redness and swelling at injection site later that evening. The caller reported that the patient had red and swollen area that was approximately 3 inches in diameter around injection site. The reporter was unable to provided full demographics of prescriber or vaccine administration facility.
Left side of my face doesn?t feel right. Almost numb and my vision to the left is off.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Engerix-B (GlaxoSmithKline) for prophylaxis.  On an unspecified date on or before 16 February 2007, the subject received 3rd dose of Engerix-B.  At an unspecified time after vaccination with Engerix-B, on an unspecified date on or before 16 February 2007, a hepatitis B surface antibody titer was negative.  The pharmacist considered the event was probably related to vaccination with Engerix-B.  The pharmacist reported that two other subjects did not respond to immunization to Engerix-B.  Please see cases A0639944A and A0639945A.
Information has been received from a physician assistant concerning a 26 year old male who on 19, Mar 2007 was vaccinated with a 0.65 ml dose of zoster vaccine  live (Oak/Merck) instead of varicella virus vaccine live (Oak/Merck) (MSD). No adverse experience was reported. There was no product quality complaint involved. Additional information has been requested.
Patient had severe chills and shaking which lasted almost 24 hours. Husband is a physician and gave her diazepam to treat the shaking. Patient did not have any reaction after 1st dose. Patient completely normal after 24 hours.
24 hrs after receiving Menactra vacc left deltoid, pt experienced local redness at injection site, then felt numbness left upper and lower extremity and acute confusional state lasting 4-6 hrs. Pt also began vomiting and had transient (<30min) signs Bells Palsy. Recovered on 6 hours but brief recurrence all above symptoms 7 days later (lasted <1hr). Meds given Benadryl and Reglan. Exam on 8/18 entirely normal except very mild left facial weakness.
Pt given Pediarix, PCV, HIB, Rotavirus-approx 5 min after vaccine, pt pale, Bil. eye deviation, pulse 60, nonresponsive. O2 given-transferred to ER - transferred to PICU  3/25/08 Reviewed hospital medical records for 3/11-3/13/2008. FINAL DX: ALTE, likely vagal response from vaccines.  No D/C summary available. Records reveal patient experienced crying/screaming immediately s/p vaccine but then turned pale, hypotonia, unresponsive & stopped breathing.  Pulse 60.  Seen in outlying ER & transferred to higher level of care.  Initially in PICU then transferred to floor.  Exam was WNL.  Neuro & cardiac consult done & completely WNL.  No further episodes in hospital.  D/C to home.
Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021).  Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes.  Debilitating and confusing.    Glad to have received the vaccine in any case (small price to pay).
lt arm 10cm erythema/warmth, redness 5cm induration from shoulder to inj site 24hr p/vax;tx cool compress to site, motrin, no further IPV, plan recheck no better 48hr;
tested positive on both a rapid and PCR COVID test; tested positive on both a rapid and PCR COVID test; tested positive on both a rapid and PCR COVID test; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 24Nov2021 (Lot number: 30145BA) at the age of 50 years as dose 3 (booster), single, intramuscular, administration date 05Apr2021 (Lot number: ER8733) as dose 2, single and intramuscular, administration date 08Mar2021 (Lot number: EN6206) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: IMMUNISATION (medically significant) with onset 24Nov2021, outcome "not recovered", VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Dec2021, outcome "not recovered" and all described as "tested positive on both a rapid and PCR COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (21Dec2021) positive, notes: Rapid; sars-cov-2 test: (21Dec2021) positive, notes: PCR. Therapeutic measures were not taken as a result of vaccination failure, covid-19.Clinical comments: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered is Workplace clinic.  No follow-up attempts are possible. No further information is expected.
she did have a reaction to it years ago; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case involves a 76 years old female patient and she did have a reaction to it years ago while receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  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 Influenza Quadrival A-B High Dose HV Vaccine formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date she did have a reaction to it years ago (immunisation reaction) (unknown latency) following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event she did have a reaction to it years ago.  At time of reporting, the outcome was Unknown for the event she did have a reaction to it years ago.
Adverse events; Rash on the right arm about 6 inches diameter, fever, body ache, headache, diarrhea,  high blood pressure, high blood sugar. Treatment; 1-Acetaminophen (OTC) 2-Diphenhydramine (OTC) 3-Cephalexine 500mg  Outcome; On 6/28/2019 patient stated that her symptoms are improving .
Pt recv'd influenza & pneumococcal vax on 10/12/99. Pt stated that on 10/13/99 her arm near the pneumo vax site was hot & swollen up to armpit. On 10/14/99, pt came into clinic w/ swelling,redness,& heat at inject site.
Approx. 15 minutes, post vax, pt complained of feeling dizzy. She slumped to the floor in the restaurant down stairs. She didn't respond to her name. Her eye were closed. She was lifted off the floor and immediately fell again, unaware of her surroundings. She was taken back into the doctor's office. Missing vaccine information not available.
Patient mother fraudulently wrote DOB as 09/03/2009 on a vaccine consent form, vaccine was administered under the assumption that this was the correct DOB. Upon processing the RX, an exact patient match was found, but the birthday was listed at 12/03/2009. The patient received at influenzas  shot at a different pharmacy, so patient's previous records was available.  Upon reviewing the registry, the same patient was listed with the DOB of 12/03/2009, and the influenzas shot matches previous our previous records. Additionally when submitting the claim for the COVID shot to third party, the claim rejected saying non- matched card holder ID, and rejection typical present when there is a mismatched DOB. Patient has no adverse events following the vaccine, and further communcation with the patient has not be conducted.
If it was administered wrong; injection site leaking clear, watery liquid; A spontaneous report (United States) was received from a consumer concerning a female patient, of unknown age, who was administered Moderna's COVID-19 vaccine and it was leaked out and administered wrong.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration in the arm for prophylaxis of COVID-19 infection.  On 28-Jan-2021 at 3:30 pm the patient had her first dose of the Moderna vaccine. She felt the needle go into her arm; however, when the person removed the needle, she said the patient was bleeding. The patient immediately put her hand over the area on her shoulder and then looked at it. Per the patient, her hand was wet, not a few drops, but her whole palm was wet with clear watery looking liquid, there was no blood. The patient tried to call the pharmacist same day at 6:30pm but the pharmacy was closed. On 30-Jan -2021 patient got a Covid nasal swab done for work and came negative. Patient asked doctor at the clinic if she should have had that much of leakage that filled her hand and doctor replied no. The patient spoke with the pharmacist on 31-Jan-2021 regarding this issue. Patient was concerned if she should get another vaccine or if okay to get 2nd dose on 25-Feb-2021. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, vaccine leaked out and administered wrong, was considered resolved on 28-Jan-2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number: unknown)  with no associated AEs.
Left thigh where 4th DTaP  and 4th DTaP given. Some bruising, induration, some redness. Early cellulitis secondary to above.  Warm compress and antibiotic (Amoxicillin)
w/in 24hr of vax arm swollen from elbow to shoulder;red skin & warm to touch on lt arm-recv DT;tx COD compresses, antihistamine, APAP;swelling & pain lasted x 5 days
Postsyncopal episode; Hypotensive; CHF exacerbation; Sepsis; pyelonephritis; E.coli bacteremia; This is a spontaneous report from a non-contactable pharmacist.  A 64-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 08Apr2021 at the age of 64-years-old (Batch/Lot Number: ER8729) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included atrial fibrillation, diabetes, coronary artery disease (CAD), heart failure with reduced ejection fraction all from an unknown date (HFrEF). Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported.  It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. On 08Apr2021, the patient experienced post-syncopal episode, hypotensive, CHF (Congestive heart failure) exacerbation and sepsis. Diagnosed: pyelonephritis and E.coli bacteremia, given abx coverage. 11Apr nephrostomy tube placed. 20Apr patient stable to discharge to LTAC. The patient was hospitalized for the events from 08Apr2021 to 20Apr2021. Therapeutic measures were taken included antibiotics, fluid, cardizem, nephrostomy tube. The outcome of the events was resolved in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available clinical data, reported events were most likely intercurrent medical conditions not related to vaccination with BNT162B2. Patient's history of diabetes, atrial fibrillation and heart failure are known risk factors for the occurrence of events that patient experienced.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
BROKE OUT IN HIVES. REACTION SUBSIDED WITH LIQUID BENADRYL
pt recv vax 29DEC97 & 30DEC97 pt devel hives & itching;
After first vaccination on 11/13/21 swelling in right arm and numbness lasting 12 hours.    After second vaccination on 11/3/2021 swelling of both arms, and numbness,  unable to hold onto things with right hand.  Numbness and tingling from shoulders into fingertips, tingling and pins and needles feeling in feet.   Symptoms are getting better, but there is still tingling in right arm.
Cellulitis at the site of infection. Patient was prescribed Levaquin 500mg for treatment.
Red swollen pain from top of shoulder area where vaccine was given, migrating down arm with pain into the hand.  Not able to use arm, at all.  Pain took about 5 hours to travel to hand.  Still having pain from shoulder to elbow.  Also having nausea, fatigue, fever, and kind of out of focus of reality.
Event occurred after vaccination. Patient was diagnosed with COVID Tylenol, Remdesivir Discharged
Flu shot at Dr office. Pt reports pain is severe and has lasted  now for 10 weeks. Reports indentation in the tricep where the shot was given. The muscle goes into spasms at times and will sometimes twitch for 10 to 15 minutes at a time, the muscle is sore to the touch. The muscle feels like it is getting weaker.
pt recv rash-sunburn type- DPH given w/urticarial wheal over shoulders +two patches on upper chest also @ varivax site & starting @ temple less than 24 hrs hairline
Pt called in on 1/22/14 to have his (R) arm looked at. Persistent pain for 3 days - since the pneumonia shot (8/10 pain scale) at shot site. No visible sign of irritation. Pain radiates up to shoulder.
Pt experienced syncope and collapse, was admitted for pericardial effusion without cardiac tamponade. Treated for suspected inflammatory pericardial effusion with colchicine 0.6 mg daily for 3 months, ibuprofen 600 mg 3 times daily for two weeks.  Patient was discharged home from hospital in good condition 2 days after admission, scheduled for follow-up with cardiology. Additionally pt was treated for a scalp laceration from collapse with staples to posterior scalp.
Swelling of knees which started about 2 weeks after MMR. Patient has been using OTC Diclofenac Gel on and off to control pain.
A spontaneous case report was received from a nurse for two patients (husband and wife) on 12-Jul-2017. Based on the information obtained from the nurse, two individual case safety reports PVX201707-000601 (PVX2017-2334; husband) and PVX201707-000602 (PVX2017-2343; wife) were created and cross-linked in the database. This case report describes an elderly female patient who "took Vaxchora in her 70's". The patient was receiving oral Vaxchora for an unknown indication. It was reported that the patient administered Vaxchora in the age of 70's on 11-Jul-2017. The action taken with Vaxchora with respect to the event "took Vaxchora in her 70's" was not applicable. The clinical outcome of the event "took Vaxchora in her 70's" was unknown. Company's comment: The causality of the event "product use in unapproved population" was considered as not applicable.; Reporter's Comments: The causality of the event "product use in unapproved population" was considered as not applicable.; Sender's Comments: The causality of the event "product use in unapproved population" was considered as not applicable.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 9:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:25 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.44 for dose administered on 27-Feb-2021 and 70.52 for dose administered on 27-Mar-2021. No concomitant medications were reported. Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 35 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. 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.
a moderna vaccine was given to a 13 yr old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a moderna vaccine was given to a 13 yr old) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported. .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a moderna vaccine was given to a 13 yr old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a moderna vaccine was given to a 13 yr old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were provided.  No treatment medication were provided.  No lab data has been provided by the reporter.