chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large red patch (about 20 cm in length) with blanching erythema, not indurated, raised, swollen, warm, painful to touch, and decreased ability to move arm due to swelling and pain, starting 1 day after vaccination (8/22/12), and red patch still present but improving as of 3 days after vaccination (8/24/12). Fever, starting 1 day after vaccination (8/22/12) and resolving that day. Headache starting on day of vaccination (8/21/12) and present daily since then.
Severe muscle cramps, especially in both calf's.   One week after first vaccine, as I prepared to lift something at work I felt sharp pain in my upper left calf muscle and could no longer stand cause of the pain.  After going to Ortho urgent care, they determined partial tear in left calf muscle.     Before event, along with muscle cramps in calf's, I had an unusual sensations in my calf's, as if I had something like bugs moving in my calfs.  It should be noted, that I had the same sensations in my calf's after the second vaccine and booster shot, but to a lesser degree with both of the other shots.
This is a non serious spontaneous case from a nurse in the USA of PAPULAR RASH. The reporter causality is related to FluMist. This case is being submitted according to the VAERS accelerated reporting agreement for FluMist. At approximately 8:30 AM on 12/8/04, a 45 year old female received FluMist intra-nasally and developed a very fine rash on her neck and chest the following morning. She had linear papulae on her neck and the rash was slightly itchy. As of 12/15/04, the rash was beginning to resolve after use of hydrocortisone cream for treatment. The reporter determined the events to be definitely related to FluMist. The patient has not yet recovered.
Nine days post vax the pt developed approximately less than 50 generalized chickenpox lesions located mainly on his trunk and face. The pt was afebrile. On presentation to a physician he was placed on therapy with Benadryl and Aveeno lotion. Follow up information indicated that the pt recovered.
I developed a shingles outbreak on my neck. The diagnosing doctor asked that I report it.
Pt arrived with confusion, occasional cough denies SOB, covid positive 1/24, chest xray shows pneumonia, O2 saturation 93%, admit for treatment of pnemonia, pancytopenia and acute metabolic encephalopathy
Redness and Swollen at Injection site; Redness and Swollen at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and Swollen at Injection site) and VACCINATION SITE SWELLING (Redness and Swollen at Injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and Swollen at Injection site) and VACCINATION SITE SWELLING (Redness and Swollen at Injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and Swollen at Injection site) had resolved and VACCINATION SITE SWELLING (Redness and Swollen at Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Approximately 24 hrs post/vax, there was marked erythema, color  extending from the axilla & deltoid insertion superiorly past the elbow and into the upper forearm. Area clearly demarcated along facial planes, nearly encircling the arm.
Swollen lymph nodes under left armpit; administration date=30Sep2021/dose number=3; administration date=30Sep2021/dose number=3; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number FG3592), via an unspecified route of administration on 30Sep2021 11:15 AM (age at vaccination 49-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history was reported as asthma, known allergies (contrast dye and penicillin). The patient's concomitant medications included patient received Flu Shot vaccine on left arm within 4 weeks prior to the COVID vaccine on 24Sep2021 for immunization. The patient previously took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number ER2613), via an unspecified route of administration on 19Mar2021 administration time 11:00 AM as single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number EN6198), via an unspecified route of administration on 26Feb2021 administration time 11:00 AM as single dose for COVID-19 immunization. On 30Sep2021, patient received third dose of bnt162b2 (off label use, immunization). On 01Oct2021 03:00 PM, the patient experienced swollen lymph nodes under left armpit. Lab test was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. At the time of this report the outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Dizzyness for days after vaccine, then weakness, nausea, cramps, shortness of breath, trembling. and chest pain a few times a week
Got a headache for 4-5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "Just had some tiredness"; Bnt162b2 (Dose 2, Single), for COVID-19 immunization, reaction(s): "Just had some tiredness". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Got a headache for 4-5 days".  Additional Information: Reported as, he took the Pfizer-BioNTech COVID-19 Vaccine primary series 1 and 2. He states he just had some tiredness and then received his first Pfizer booster dose and got a headache for 4-5 days, 2nd booster had no side effects.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202300024481 same patient and reporter, different dose and event;
2 days after the 2nd dose, I noticed a rash below the injection site.  The rash was splotchy and a long band.  A few days later, it turned into hives.  It was itchy and tender.  It resolved on its own over the next several weeks but the pain lingered.  The pain was sore and tender and a knot would form.  This continued for a few months.  I had an ultrasound of my neck and everything is normal.  I also had an x-ray of my cervical neck and x-ray came back normal.   Starting in June/ July, the pain radiated from near the injection site and down to elbow and up to the shoulder. Now, its has continued down to my wrist and up to my neck.  On a scale of 1 to 10, the pain is a 6-7 when in motion or in use.  I have now limited use with my left arm.   I am currently in physical therapy to try to regain use of my arm.   I was prescribed a muscle relaxer cyclobenzaprine.
I am experiencing severe headache and hearing  loss in both ears. Right ear has significant hearing loss while left ear is not as bad.   The feeling I feel is similar to going under water and have having water in your ears.
Chills, and body aches beginning at 11:30 PM on the day of injection, slept until 4:30 AM, then had fever of 101 necessitated missing work. Took TYLENOL and slept most of the day, awakened around 7:00 PM (fever at 100) and stayed up for few hours, then slept through the night. Felt better the following day.
I did not experience any adverse symptoms with the first dose of Pfizer-BioNTech vaccine with the exception of injection site pain after the first dose that began on day 2 through day 5 or for 3 days.  The first Pfizer-BioNTech dose was received on December 30, 2020, LOT EK5730. I would rate the pain as a 5 out of 10 on VAS on 12/31/20.  Please note that I completed the same pretreatment protocol 1.5 hours prior to dosing with Pfizer-BioNTech of Diphenhydramine 25 mg plus Pepcid 20 mg for both COVID-19 doses.  I elected to complete a self-administered pretreatment protocol due to a shellfish allergy and literature reports of anaphylaxis with COVID-19 mRNA vaccines in food allergy recipients.  I did not experience any adverse symptoms on Saturday afternoon after receiving the second dose of the Pfizer-BioNTech vaccine at 4:45pm on 1/23/21.  On Sunday morning 1/24/21, I awoke feeling "cold."  I dressed warmly, but the feeling progressed to chills by 3pm.  Malaise ensued around 1pm.  I also experienced injection site pain on the morning of 1/24/21 beginning at 7am.  The pain lasted until 1/25/21.  I would rate the pain as a 5 out of 10 on VAS ON 1/24/21.   I began to feel uncomfortable with malaise and chills at 6:15pm on 1/24/21 and self-administered one dose of OTC Aleve, Naproxen sodium 220mg plus one dose of Benadryl 25 mg.  I began to feel better by 9pm on 1/24/21.  I awoke on 1/25/21 without any symptoms or discomfort with the exception of some injection site pain (2 out of 10 on VAS).  I have been asymptomatic since 1/26/21.
The pt was very fussy that night and stopped breathing. He was on life support for 3 days before we let him go. Diagnosis in Hopital was  : Acute anoxic encephalopathy, status epilepticus, acute respiratory failure, syndrome of inappropriate ADH secretion. Per F/U states DOB as 10/27/01 not 10/29/01. Per F/U Cardio-respiratory arrest, bacterial infection, jaundiced, electrolytes abn, fine tremors, tongue fasciculations, hypertonic UE and LE. Pt seizuring when 1st examined. Tacycardia, neonatal hyperbilirubinemia.
Started with bleeding/bruising at injection site. Five hours after injection, she started getting cold feet. Went to bed and woke up with extreme shaking, teeth chattering, muscle soreness, gum soreness. She took ADVIL and helped some, but continued over next 8 hours. Went back to bed for 7 hours and woke up with scalp pain and back/spine pain.
This spontaneous report was received from a physician referring to 15-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 26-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
I caught a kind of flu the middle of May and was sick for a couple of weeks. COVID test came back negative. After my second vaccination, on 6/8/2021 I started to experience gastric distress that caused pain and caused me to lose sleep. After 2 nights I checked into the ER. Thursday 6/10/2021 they determined I had an infected gallbladder and removed it immediately. I was discharged 6/11/2021.
Developed bald spots on my head days later after my second dose. Dermatology biopsy confirmed Alopecia Areata and she stated this was triggered by being exposed to a virus. I am currently still being rigorously treated with steroid injections into my scalp every 4 weeks.
I developed severe cough and shortness of breath since the vaccination. I have been receiving various treatments including breathing treatments, antibiotics and Prednisone.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Merck). On an unknown date the patients received improperly stored PROQUAD (Merck) (20 doses) that were exposed to 32F for 12 hours. No adverse effects were reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Arm and shoulder locked, unable to have mobility. Severe pain if trying to move arm.  Chills Headache
gave a ACT-HIB to an individual and it was reconstituted with sterile water instead of the appropriate diluent; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown demographic patient who was vaccinated with HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] lot number not reported via unknown route in unknown administration site on an unspecified date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong solution used in drug reconstitution. It was reported that someone who gave Act-HIB to an individual and it was reconstituted with sterile water instead of the appropriate diluent.  It was unknown whether the individual had any adverse event or not.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Patient called and stated that the day after she received Tdap vaccine, she started experiencing 104 F temperature and sore, red, indurated arm where vaccine given - area size of quarter, hard and hot to touch - saw PHP today (5/9) and was given CIPRO 500mg for 10 days for possible infection.
Received 4 vaccines on 05/04/2005. Six days later,  child began with fever and red rash, seizure at home with temp 101.9 D Fahrenheit- Seizure @ hospital with temp of 103.5. "tests were done, but inconclusive. Temp up to 105 degrees Fahrenheit. At d/c temp was <100. Continues with fever to 103.0.
on 3/11/21 at approx 9pm,  I presented to ED for right upper quadrant pain, negative x-ray, given Toradol injection and sent home to follow up with PCP.   When I awoke the next morning I had bruises and nodules on inside arch of both feet, along outside of left foot, this progressed into toes and ankle and progressed to swelling of my feet/ankles (4+pitting edema) This continued for approx 7-8 weeks.  PCP made educated guess of Erythema Nodosum, prescribed steroid regimen two separate times.  THis seemed to help, but it came back as soon as steroid cleared. PCP suggest Derm appointment for possible biopsy, I opted not to take this course of action.  Eventually the majority of symptoms resolved on their own.  Do still have some tenderness in both great toes, as well as occasional swelling (minimal)
9/9/21 PMH significant for alcohol abuse, cocaine use, multiple GIB, cirrhosis, Hep C who presented to hospital for hematemesis
Client called my home phone four days after receiving his flu vaccination. Client stated that when he got to thinking about it, he decided he better report the reaction he had. Client stated that after receiving vaccine he went home and was feeling tired. He had been dealing with some type of cold so he took a nap around noon. When he woke up his eyes were burning, watering and swollen, his throat was sore and it hurt to swallow. Client states he took some Benadryl and lay back down and when he soke a couple of hours later he felt fine.
There is a lump on my left breast like armpit as well; There is a lump on my left breast like armpit as well; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose unknown via an unspecified route of administration, administered in Arm Left 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. On an unspecified date, the patient experienced a lump on left breast like armpit as well. The patient stated that got the Pfizer vaccine on Wednesday the 11th, the last week. And knows it has the side effects like headache or tiredness or dizziness. And asked if a lump on left breast like armpit as well is one of the side effects of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
A report received from a pharmacist on October 5, 2001, concerning a female patient who experienced severe reaction which started the previous year (2000), after receiving Fluvirin vaccine. There was insufficient information to determine the reporter's causality assessment. PJP-2001-00306 was deleted when determined to have been entered twice and to be a duplicate of this case.  This case remains the master report.
Symptoms began evening after receiving vaccine. Patient reports headache which progressed into the next day to fever, fatigue, intense chills, chest pain. Patient had these symptoms over 2-3 days and had began to experience arm tingling in arm where vaccine was administered, which then spread to both arms. Patient reports arm tingling will come and go. Patient reports taking OTC medication (ibuprofen). Patient called a nursing line and was told to go to the ER. Patient went to ER on 4/14 and was admitted for observation. Chest X-ray was done with no remarkable findings. According to patient, additional testing was done. Patient was discharged on 4/15 and was told to return if arm tingling returns and does not go away.
Shot itself was virtually painless, but I did think the doctor injected it very high up my left arm, near my shoulder. The next morning the area was sore and got progressively work, limiting movements of my left arm.
initial swelling, progressive /w redness, tenderness and pain in rt arm to pectoral area.  Generalized MP morbilliform rash, night of 12/7/94.
Almost immediately I got a headache. The headache intensified and muscle pain ensued. The muscles in my arms, legs and even the headache felt as if something inside was vibrating. It has been eight days, and none of the symptoms have abated.  I am now very uncertain ifI can tolerate a second dose on March 20.  I cannot take anything except Tylenol, and that doesn't touch the pain.
Patient passed out in clinic hallway hitting head on wall after GARDASIL was given. LOC < 1 min. Cool wash cloth applied to neck. Pt assisted to exam room and monitored x 30min. Alert and orient.
Pt was given the Moderna vaccine as the second dose in the covid series, however they received the Pfizer vaccine as their first vaccine
Approximately 4 hours after receiving the vaccine I started having some flu like symptoms. Headache, lightheaded, feverish. Took TYLENOL went to rest still wasn't better when I woke up. I struggled to sleep through the night woke up in the morning with severe pain all over. My entire body is aching head, neck, shoulders, arms and legs feel worse than anywhere else. Took TYLENOL again and reached out to the office where the shot was administered. A Physician contacted me we discussed my symptoms and I was told that the vaccine would not cause me to feel this way and it could be a possible virus. It's just a coincidence, so contact my primary care Dr.
CLOTS; This spontaneous report received from a physician concerned a male of unspecified age. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The physician reported that on an unspecified date, the patient experienced clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210456400.; Sender's Comments: V0.20210457363-COVID-19 VACCINE AD26.COV2.S -Thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 07-OCT-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, intramuscularly, lot # L003228, expiration date 30-JUL-2016 (dose and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. No further information was provided. Additional information has been requested.
noticed a rash on her back early in the morning. She said it is very itchy especially around the right shoulder. The rash is visible but not extremely noticeable without taking a close look. It looks like there are some hives.
Fever, severe chills limbs aching, headache, lethargic, nausea -  Lasting 3 days Swelling of arm, redness - started on day 3 Headaches - 6 days and counting
Fever; Chills; Injection site raised n red; This is a spontaneous report from a contactable consumer (patient). A 47-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 09Mar2021 10:00 (Lot Number: Ep6955) (at 47 years old) as first dose, single dose for COVID-19 Immunization. Medical history included COVID-19 and known allergies: Cillins; both from an unknown date. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid test post vaccination. On 10Mar2021 07:00 PM, the patient experienced fever, chills and injection site raised and red. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Left upper arm edematous, erythematous to upper portion of arm above elbow. Dr. evaluated on 11/1/2016 - ordered BENADRYL 25 mg q 6 hours. Pt returned on 11/2/16 - given BACTRIM DS bid x 7 days - Prednisone 20 mg q d x 5 days.