chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Began to itch on left arm at site of injection. I scratched it, went to look in mirror and I have 4 bumps like the old TB test we used to get, at the vaccination site. And I have one large raised bump about an inch below. Itching stopped and now area is warm. Itching has come and gone over last few minutes
No adverse event; Expired vaccines, with the same lot and expiration date, were administered to two different patients; This spontaneous report was received from a healthcare professional, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 06-MAY-2022, the patient received vaccination with an expired Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis, lot number #U003464 and expiration date 02-MAY-2022 (strength, dose, frequency and route of administration were not reported).   No adverse events were reported.   This is one of 2 reports received from the same reporter (MARRS #US-009507513-2205USA003700) ; Sender's Comments:  US-009507513-2205USA003700:Case Number: 02164360
shingles; Information has been received from a female patient of unknown age and a lawyer referring to the patient. The patient's medical history, concurrent condition and concomitant therapy were not reported.   On or about 27-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. The outcome of the event was not recovered. The patient had received treatment. The reporter considered the event was disability.   The reporter considered the event was related to zoster vaccine live (ZOSTAVAX)
After waiting in the waiting area for about 20 minutes following the vaccination, I left to return to my car and go home.  While walking through the hospital, I started to feel weird - almost light headed and fuzzy.  By the time I got to the hospital entrance, my tongue had started to tingle and swell (I don't know that it ACTUALLY swelled, but that's how it felt) and I was concerned about losing the ability to breath.  I started going back to the vaccination site, but the feeling started to subside.  After about another 15 minutes, the feeling was gone.  I did NOT report this to the vaccination site and instead just proceeded home.
Extreme shakiness; was unable to walk well; vomiting; pain injection site/soreness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Extreme shakiness), GAIT INABILITY (was unable to walk well), VOMITING (vomiting) and VACCINATION SITE PAIN (pain injection site/soreness around injection site) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain injection site/soreness around injection site). On 05-Feb-2021, the patient experienced TREMOR (Extreme shakiness), GAIT INABILITY (was unable to walk well) and VOMITING (vomiting). At the time of the report, TREMOR (Extreme shakiness), GAIT INABILITY (was unable to walk well), VOMITING (vomiting) and VACCINATION SITE PAIN (pain injection site/soreness around injection site) outcome was unknown.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In or about 2015, the patient's healthcare provider at a clinic/family health center administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 26-FEB-2016, the patient was treated by a physician at the clinic/family health center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Malaise, Fever to 102.5, Headache, Myalgia, Rhabdomyolysis.
pt recv vax 2JAN97 & devel sx of Bells palsy-sx had been getting better p/1st hep b vax then regressed approx 2wk p/2nd dose;
No adverse effect; improperly stored vaccine administered; This spontaneous report was received from a Nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 13-SEP-2019, the patient was adminstered one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) for prophylaxis (lot # R030924, expiry date: 10-JUL-2020). The vaccine was stored at 0.24 C (multiple) for 5 hours 30 minute. There was no previous temprature excursion. No adverse effect reported. It was reported that, this call was because of data logger. No PQC involved. No additional information available.
I had a pain in my back and right shoulder, I went to the doctor and testing was done. The results showed high levels of liver enzymes. I had chest pain and what felt like a panic attack. I had a follow-up and the results showed I had high levels of pancreas enzymes. I did a home test and I tested positive for COVID, I only had symptoms of body aches.
Immunization red, swollen, hot 2" diameter around injection site left leg. Observed for 30 min. Received 0.5tsp Benadryl Elixir.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient has pas history of fainting during a blood draw years ago.
pt given vax 26AUG97 & reports to office on 29AUG97 for MD eval;by MD eval rt deltoid tender, firm, minimally erythematous w/o evidence of abscess;
Below obvious injection sites 2 in deltoid 1/2 inch down. Large, red, swollen: warm to touch 3x4" round: noted evening 10/26. More inflamed am 10/27. Tender small bruise at injection site Treatment: cold compress and Advil.
Developed a mild fever that changed over to a moderate fever after 24 hours (04/04/2014 07:00pm) and then subsided about 36 hours after that.
stroke; feel "foggy"; This is a spontaneous report received from a contactable consumer (Patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204), via an unspecified route of administration in left arm on an unspecified date in Mar2021 at 11:00 AM as single dose for COVID-19 immunization. Medical history included none. Allergies to medications, food, or other products: No. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Other. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced feel "foggy" on Mar2021 with outcome of recovering, stroke on 14Mar2021 20:30 with outcome of recovering. Clinical course: About an hour after receiving the shot the patient began to feel "foggy", the feeling continued over to the next day. The patient didn't remember how long after that it continued. The patient then had a stroke 5 days after receiving the vaccine. The patient had no health risks prior to the vaccine and the hospital was unable to find a cause or leading indicator of what could have triggered the stroke, leaving the vaccine as the elephant in the room. Treatment received for the adverse events: Everything. The evens resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for feel "foggy" and stroke for 2 days. Seriousness criteria-Results in death/Disabling/Incapacitating/Congenital anomaly/birth defect: No.
Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (lot # J009788, expiration date 17-MAR-2016, dose and route were unknown). The temperature excursion for the vaccine was 47 F, time frame was 36 hours. There was no previous temperature excursion. It was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Hives covered body and vomiting. Lasted around 8 hours. Took Benadryl which did not seem to help in any way.
Received 7/15/08, around 2 pm (Hep A #2) (Pneumovax). next day 7/16/08, felt dizziness and headache. Seen for f/u 7/17/08 (had fever 102), recommended to be seen at ER in a hospital. Symptomatic treatment recommended.
Itching: neck, arm, torso; no hives, no angioedema/wheezing Given po beandryl 25mg and cold water bottle Much improved within 20 minutes; resolved
14APR93 pt was given vax & t102; mom took pt to hosp by time got there t105; pt was adm to hosp & stayed until 17APR; MD state pt had reac to DTP;
Extreme Chills took 2 Advil at 9:00 pm and 2 more at 11:00 pm on 03/06/2021.   Fever 101.5 took 2 Advil at 1:30 am on 03/07/2021 - current. Flu like aches started at about 9:00 pm on 03/06/2021 - current.
I began to feel symptoms on Sunday, December 18, 2022. I felt fatigued and had a cough. I got worse each day and went to urgent care December 21, 2022. I did not have a fever. I was diagnosed with Influenza A and an ear infection. I was prescribed TAMIFLU for flu symptoms; ROBITUSSIN for my dry cough; azithromycin for ear infection. By that evening I felt worse and in the middle of the night I had a fever of 102 but was 99 when I woke up. I had been taking NYQUIL at night to help sleep. As the days progressed, I got better but my cough got worse, and it was more productive. Two weeks after this, about January 9, 2023, I returned to the same urgent care center for the cough. I was diagnosed with chronic bronchitis. I got another prescription for antibiotic and an inhaler to help with my cough. As of today, I still have a slight cough that feels like tickle in my upper lungs that is sometimes voluntary but also involuntary.
After 8/15/18 immunizations, started feeling bad in Mid Oct 2018-C/O Headache, Body aches-Mom took Pt to Immediate Care and told Pt had ear infection - Pt. continues feeling bad - Took Pt to Hospital E.R. on 11-30-2018 - was told had UTI. Follow-up visit at Med Clinic 12-12-18 - was told Pt has Mono and tested positive for Epstein-Barr virus - Mom says this came from Immunizations.
It looks like Myocarditis, where I got shortness of breath while I sleeping 3 times on the first time of onset. I did the proning technique and continue sleeping. The second day of onset, I got shortness of breath one time and I resolved it by proning again afterwards. Both instances happened at night (11PM to 12PM) during my sleep. I did COVID-19 test twice and it was confirmed NOT the COVID-19.
NAUSEA, FEVER, HOT FLASHES, AND SWOLLEN LEFT ARM.
Low grade fever, body aches, chills No treatment-Health was good by 3/21  6:00am.
I am not sure this is an adverse effect but thought it should be recorded since I have no diagnosis and still have this condition after almost 5 months.  The symptoms I have experienced are very similar to Erythema Nodosum, although all the doctors I saw never were able to diagnose anything. My GP said it sure looked like this condition.  Since a little over 2 weeks after the last vaccine, I started getting very painful nodules under the skin on my legs, feet, ankles and under my feet as well.  Started with a slight fever the first few days.  As the weeks progressed the ankle joints also got painful. I kept having flare-ups of new nodules over the course of a few months. Difficult to walk, exercise, be on my feet for very long etc. Would bring on a flareup. Hot feet and legs, also lots of muscle twitching.  NOTE: I also was stung or bit by a bug or something in my yard right before the pain started all over my leg, so that could be the issue, or something else. But skin biopsy at that site only gave "inflammation" as a finding.
On 3/13/15, mother reports RD has a red lump the size of a golf ball. Instructed to apply ice pack to site an give ibuprofen (pt allergic to TYLENOL). Also can give BENADRYL. If site worsens, go to nearest urgent care.
nodule; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of NODULE (nodule) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYALURONIC ACID (RESTYLANE) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NODULE (nodule). At the time of the report, NODULE (nodule) outcome was unknown.        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 treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up information was received and confirmed that the vaccine was Moderna.
(R) thigh, half dollar size rash. No fever, no behavior changes. 12/27/18.
Pt recvd 1st & 2nd dose of vax on 25FEB91 & 15MAY91; On 3FEB92 devel a fever of 104.9 & on 5FEB92 seen by MD w/inc sleepiness & dec appetite; pt was hospitalized; BC & CSF pos for HIB on 5FEB92; 18FEB92 PE-nl;
He presented with shortness of breath, and fever, cough.  Acute respiratory failure on 4 L oxygen at this time..  Given  dexamethasone and remdesivir
pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 01M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her arm). At the time of the report, PAIN IN EXTREMITY (pain in her arm) outcome was unknown.            Concomitant medications reported were Blood pressure medicine. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD21-050363, MOD-2021-039063 (Patient Link).
Onset about 1 hour after injection with mild left deltoid pain. Then over course of 3 hours developed left arm pain, frontal headache, and posterior neck pain. No rash.
BODY ACHES; JOINT PAIN; HEADACHE; INJECTION SITE PAIN /SEVERE ARM PAIN; PASSED OUT AT INJECTION; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vonn willebrand's disease, non-alcoholic, non-smoker, and needle phobia, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced passed out at injection. On 12-MAR-2021, the subject experienced injection site pain /severe arm pain. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, joint pain, and headache on 15-MAR-2021, had not recovered from injection site pain /severe arm pain, and the outcome of passed out at injection was not reported. This report was non-serious.
Non-emergency shortness of breath and upper back pain (as if my lungs hurt). It started about 24 hours after receiving the vaccine and has lasted about 8 hours so far. Non-emergent but does feel exactly like it did when I had covid 4 months ago.
This spontaneous report was received from a medical assistant referring to another medical assistant, a patient of unknown age and gender. There was no information reported regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-DEC-2018, an unspecified amount of VARIVAX (lot # R017637, expiration date 20-JUN-2010) and sterile diluent  (lot # and expiration date unknown by the reporter) "squirted" into the patient's eye while she was administering a dose of the vaccine to an unspecified child who "moved during administration" (Occupational exposure to product). No adverse effects reported, and no additional information was provided. This is one of 2 reports from the same reporter (information captured in MARRS case # 1901USA000226); Sender's Comments: US-009507513-1901USA000226.
high temperature of 108, chills, sore arm, headache, both feet felt uncomfortable with shoes on, pain in left chest area, around 11:45 pm breathing was difficult
This spontaneous report was received from a medical assistant via a company representative and refers to a 51-year-old male patient (the reporter's husband). The patient's concurrent conditions were not reported. On an unspecified date in October 2016, the patient developed shingles in the cornea of the left eye. The field representative reported that the patient saw an unspecified physician and was treated with acyclovir 800 mg 5 times daily, and 1% prednisone eye drops 4 times daily. On an unspecified date, the patient was taken down to a maintenance dose of acyclovir 800 mg once daily and 1% prednisone eye drops once daily. On 08-JUN-2017, the patient was vaccinated with ZOSTAVAX (lot # M034764, expiration date: 26-OCT-2017, dose and route of administration were not reported) for regular immunization. On 08-JUN-2017, immediately after administration of ZOSTAVAX, the patient started to experience pressure in the eye and the shingles returned in the cornea again. The patient visited an unspecified physician who put the patient back on the higher dose of acyclovir 800 mg 5 times daily and 1% prednisone eye drops 4 times daily. On an unspecified date, the patient was seen by an unspecified physician, who lowered the dose of the acyclovir to 800mg once daily and discontinued the prednisone eye drops. On an unspecified date, the shingles in the eye started getting worse and the patient was treated with acyclovir 800 mg once daily and 1% prednisone eye drops 4 times daily. At the time of reporting, the patient was feeling better, but he could not tolerate the light, his vision was blurry and his eye and face were droopy (onset date not reported). The outcome of facial paralysis and eyelid ptosis was unknown. The outcome of ophthalmic herpes zoster was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the events of ophthalmic herpes zoster and facial paralysis were considered to be medically significant.
Client developed rash and pruritus on arms and legs there days after 2nd Twinrix administered. Client given Prednisone 1 pill x 5 days (dose UNK)
p/vax pt devel T104; & an inj site rxn covering 3'' area described as cellulitis
big lump on the bottom of her armpit; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) dose 3 via an unspecified route of administration on 20Sep2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced big lump on the bottom of her armpit on an unspecified date. Caller received a booster dose of the Pfizer COVID-19 vaccine on September 20, 2021. She noticed a big lump on the bottom of her armpit on the side where she got the vaccine. Caller wanted to know if this is a normal side effect or has anybody reported such side effect post vaccination. She got the injection and was wondering if anybody had the same issue and what could she do to get it to ease out or anything; caller aware Pfizer unable to offer treatment recommendations or medical advice. Dates and seriousness for has a big lump on the bottom of her armpit on the side she got the injection was reported as unspecified. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information expected.