chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red itchy area at injection site at time of vaccination, day later injection site had red swelling that was warm to touch with itchiness. Pt saw their PCP but no action was needed.
On the evening of the 28th the patient's arm became red and tender at the injection site.  It had some induration.  Recommended no boosters of pneumovax.
Patient was being administered flu shot by RN in clinic. Patient received seasonal influenza shot via IM route to left deltoid. Patient was standing and talking and reported that her stomach hurt. Patient reports she was having difficulty breathing. Patient reports she had tingling throughout her body,  felt nauseous, and felt she was going to pass out. She was assisted to seated position. Face appeared flushed. Cold pack applied to her neck. Vital signs obtained. Provider called. Within minutes, face was no longer flushed.  She denied nausea. She reported feeling improved.  She tolerated a snack and fluids. She was able to stand and ambulate without assistance.
On 03/15/2021, patient reported that about 24 hours post vaccination she experienced the normal site of injection discomfort along with warmth and redness. The area spread, was itchy and enlarged over a 1 week period. At that time the patient sought medical attention with her PCP on 03/13/2021. She was prescribed a course of CEPHALEXIN 500MG TID for 7 days and PREDNISONE 20MG d for 3 days, then 10MG d for 4 days.
Severe hives on lower body, face and arms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Lot number: FJ8762) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: sulfa; "pears" (unspecified if ongoing), notes: pears. The patient took concomitant medications. Past drug history included: Known allergies: amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Known allergies: ampicillin, reaction(s): "Known allergies: ampicillin", notes: Known allergies: ampicillin; Known allergies: baxtra, reaction(s): "Known allergies: Baxtra", notes: Known allergies: Baxtra. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 04Apr2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 14Mar2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Severe hives on lower body, face and arms.". The event "severe hives on lower body, face and arms." was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria. No follow-up attempts are possible. No further information is expected.  Follow-Up (20Jan2022): Follow-up attempts are completed. No further information is expected.  Additional information: 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 not been tested for COVID-19.
Received Pfizer booster.  Vomiting, fever, dizziness, left arm useless, no hunger.   My Gabapentin for my neuropathy ceased working. My feet are  so incredibly painful. Was wondering any interactions?
Developed shingles on back and chest; This is a spontaneous report from a contactable consumer. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the right arm on 15Mar2021 at 15:45 (at the age of 75-years-old) as single dose for COVID-19 immunisation. Medical history of the patient included diabetes, COPD (chronic obstructive pulmonary disease), stroke, kidney disease and the patient had a history of allergy to cheap gold. The patient received unspecified medications within two weeks prior to the vaccination for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the patient developed shingles on back and chest. The patient received treatment for the events with VALTREX. Adverse event resulted emergency room/department or urgent care. The clinical outcome for the event of developed shingles on back and chest was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
My daughter started having strained breathing, mid grade fever, fits of crying, troubled sleep for a few days.
My girlfriend had a bad reaction to the Moderna Booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My girlfriend had a bad reaction to the Moderna Booster dose.) in a female patient of an unknown age 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 09-Dec-2021, the patient experienced VACCINATION COMPLICATION (My girlfriend had a bad reaction to the Moderna Booster dose.). At the time of the report, VACCINATION COMPLICATION (My girlfriend had a bad reaction to the Moderna Booster dose.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
About a week after 2nd injection, I experienced pain in both wrists if I put weight on the wrists or turned the hands in a certain way.  The right wrist eventually stopped hurting, I self medicated with advil, braces and ice.  The left wrist continued to cause pain and after about a month I was able to get in to seethe doctor on April 9.  He recommended having PT build a brace and PT for 8 weeks.  I started with about a week later.  After 8 weeks and very little change, on June 28 I saw Dr again and he ordered an MRI with contrast. .  I had the MRI on July 28 with inconclusive results.  Met with Dr August 2 to discuss MRI.  Left wrist is still painful, sharp pain if moved in a certain direction, pain anytime typing and/or using pinkie finger and ring finger.  Wakes me up at night, no strength, unable to use wrist/hand for many normal activities.  Unable to put weight on hand.
Awoke in the morning and noticed a large gray colored swath across my right eye diminishing my vision by approximately 50%. I sought medical attention the following week when it did not improve.
Bruise at injection site. 2.5 days after injection, large red warm raised area below injection site about 8" long and 3" wide, sore and warm. No treatment sought at this time.
The day before my vaccine I had a colonoscopy the day prior with anesthesia. 04/11/2021 Post second vaccine, I woke up and could not hear out of my right ear. The urgent care I went to stated that I should go to an ENT for further workup. I then saw the ENT and then they did not find anything wrong. I was prescribed prednisone for two weeks. After finishing prescription the hearing did not return. Sudden sensorineural hearing loss was the diagnosis, after a few weeks and receiving another hearing test, the ENT specialist performed a micro wick procedure to attempt to bring back my hearing however that did not work. May 26th was my last visit with them. June 2nd I then saw another physician afterwards, they pulled out the micro wick and it left a puncture in my eardrum still. By August 13 it had still not closed, and had formed a ring of scar tissue which prevented it from healing, and was told that I would need surgery to close it. MRI done found a collapsed sinus however, no tumor causing hearing loss. Scheduled for surgery in October however it did not need to be done and instead they did not go through with the surgery. Follow up appointment with Eye and Ear. I was advised to get the Pfizer booster instead and to avoid the Moderna vaccine, which I went ahead and did so.
COVID-19; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 58-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS) and Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS). Concomitant products included ADALIMUMAB (HUMIRA) from 27-Apr-2022 to 12-May-2022 for Plaque psoriasis and Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (COVID-19) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The reporter's causality for event COVID-19 with respect to Humira was not provided. The reporter's causality for event COVID-19 with respect to Pfizer was related.  The patient experienced COVID-19 and sinus congestion in 2022. Treatment information was not provided. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. It was reported that the primary reporter did not have lot number information, because the package was discarded. Company comment: This is a spontaneous case concerning a 58-year-old female  patient with rheumatoid arthritis and plaque psoriasis, who experienced the non-serious unexpected event of COVID-19 (AESI),  on an unknown lapse of time after receiving an unspecified dose of mRNA-1273 vaccine. Patient also receive a dose of COVID-19 vaccination with Tozineram Pfizer Biontech. Sinus congestion was reported as an associated symptom.  Clinical course, diagnostic test and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 58-year-old female  patient with rheumatoid arthritis and plaque psoriasis, who experienced the non-serious unexpected event of COVID-19 (AESI),  on an unknown lapse of time after receiving an unspecified dose of mRNA-1273 vaccine. Patient also receive a dose of COVID-19 vaccination with Tozineram Pfizer Biontech. Sinus congestion was reported as an associated symptom.  Clinical course, diagnostic test and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
As soon as I received  vaccine I left for a 2 1/2 car trip.  As soon as I stood up to get out of the car I starting shivering violently.  I fainted and fell onto my left foot which broke my foot. I have never fainted before.
Developed pain in back and neck under 48 hours after infection. This turned into spasms and neck pain, fingers tingling and left arm falls asleep if positioned in certain position. Sleep is uncomfortable
After 12+ hours, the injection site is the size of a softball. It is sore and warm at the site of injection. Not in pain, but uncomfortable. Had the shot 10/15/2022 and as of 10/19/2022, the side effects haven?t subsided.
Knot and swelling at site of injection (left arm) when woke up next morning. Began taking Benadryl and also saw physican on Saturday 10/24/15. No systemic sx's (fever or chills)- just pain, redness and swelling. Improved Saturday, then worsened again sunday with pain, increased redness. Decreased appetite. Headache. Saw patient today - no cellulitis, not toxic. Left deltoid area with redness 10cm x13cm induration, warm, red, painful to touch.
Pt was given Pfizer Covid booster dose on 9/1/22 and the recommendations had changed on 8/31/22 to use Bivalent boosters going forward.  Pharmacy was not aware of the changes that had gone in place yet and did not have the Bivalent Booster is stock.
I have had two adverse reactions.  The first was one week after the second vaccination.  The second was yesterday (06/16/21).  In both cases I encountered severe swelling in my lips.  In the first case, my lower lip swelled.  In the second case, the swelling began in the lower left lip, then moved to the upper lip, and finally moved to the lower right lip.  In both cases the swelling subsided by 90% within a day and fully within two days.
no additional AEs were reported; 20 year old patient missed third dose of GARDASIL 9; The patient received first and second GARDASIL 9 doses 4 years ago and came into the pharmacy today to receive the third dose; This spontaneous report was received from a pharmacist concerning a 20-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date in 2019 (also reported as 4 years ago), the patient was vaccinated with the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported). On 17-AUG-2023 (also reported as today), the patient went to the pharmacy to receive the third dose, the pharmacist wanted to report a missed dose (Product dose omission issue), the patient had not had the third dose yet (Inappropriate schedule of product administration).  No additional adverse events were reported (No adverse event).
Left upper posterior arm pain, at injection site, refers to deltoid. Minimal induration. Headaches. NSAIDs and cold pack.
Began as a circular bruising pattern. By day 12, a circular outline remains. Pain reported by patient as radiating towards back, but not increasing in intensity throughout course. Pain and bruising has decreased, but still remains causing concern. Pain specifically surrounding left shoulder area causing issues with sleep.
7/24/17 returned to clinic-c/o diarrhea, watery, green at least 8x/day) since receiving vaccines on 7/18/17. Pt had f/u visit on 7/28/17 at which time diarrhea had resolved. Prolonged diarrhea of 9 days, presumably from the Rotavirus vaccination.
Little SOB, rhinitis, fatigue,injection site pain and swelling, joint pain (hip) Narrative:
tonsil irritation; stomach ache; Tonsil dryness; Rash; headache; I had a lot of itching at the injection site; Injection site redness; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR INFLAMMATION (tonsil irritation), ABDOMINAL PAIN UPPER (stomach ache), DRY MOUTH (Tonsil dryness), RASH (Rash) and VACCINATION SITE PRURITUS (I had a lot of itching at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (injection site swelling). On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (I had a lot of itching at the injection site). On 01-Feb-2021, the patient experienced TONSILLAR INFLAMMATION (tonsil irritation), ABDOMINAL PAIN UPPER (stomach ache), DRY MOUTH (Tonsil dryness), RASH (Rash) and HEADACHE (headache). On 28-Jan-2021, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (injection site swelling) had resolved. At the time of the report, TONSILLAR INFLAMMATION (tonsil irritation), ABDOMINAL PAIN UPPER (stomach ache), DRY MOUTH (Tonsil dryness), RASH (Rash), VACCINATION SITE PRURITUS (I had a lot of itching at the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported. Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: contact info updated
shingles; Information has been received regarding a case in litigation, referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot# and expiration date were not reported). On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
2 DAYS AFTER SM RECIEVED HIS MODERNA VACCINE IN HIS LEFT ARM HIS RIGHT ARM TURNED BLUE. HE WENT TO THE EMERGENCY ROOM TO FIND OUT HE RECIEVED A BLOOD CLOT WHICH THEY THINK WAS CAUSED BY THE VACCINE. HE WAS PUT ON BLOOD THINNERS THAT DAY AND SENT HOME 6 HOURS LATER. HE WILL BE ON BLOOD THINNERS FOR UP TO 6 MONTHS.
This spontaneous report was received from a nurse practitioner, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse practitioner informed that on 22-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dosage, strength and lot# were not reported), that expired on 21-OCT-2015. No adverse effect reported. There was not product quality issue. Additional information has been requested.
Started with aches at injection, turned into fever, chills, muscle aches.  Muscle pain spread to all four limbs which resulted in about 2 weeks of bed rest and walking was painful and difficult.
little bit of a sore arm/like I've had on the other Pfizer shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 70 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: He takes his regular medications, like he takes a blood pressure pill and a tablet for urinating; "urinating" (unspecified if ongoing), notes: He takes his regular medications, like he takes a blood pressure pill and a tablet for urinating. Concomitant medication(s) included: SERTRALINE taken for urinary incontinence. Past drug history included: Sertraline, notes: taking all of them for 4-5 years and didn't have neck spasms. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route of Administration: intramuscular. , Batch/Lot number: EL9269. NDC/EXP not provide on handwritten vaccine card.), administration date: 13Feb2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "little bit of a sore arm/like I've had on the other Pfizer shots"; BNT162b2 (DOSE 2, SINGLE, Route of Administration: intramuscular. , Batch/Lot number: EL9262. , NDC/EXP: not provided on handwritten vaccine card.), administration date: 07Mar2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "little bit of a sore arm/like I've had on the other Pfizer shots". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "little bit of a sore arm/like I've had on the other Pfizer shots". Therapeutic measures were taken as a result of pain in extremity. Additional Information: He takes his regular medications, like he takes a blood pressure pill and a tablet for urinating, and he takes Sertraline. Caller said he doesn't feel those are relevant, he had been taking all of them for 4-5 years and didn't have neck spasms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201348782 same patient, different vaccine dose number/event;
My partner and I took the flu vaccine on Friday afternoon and became very weak and sick the next day. It's now Monday and we are still extremely weak. I think the vaccination gave us the flu
This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 69 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 16/40 which was not suggestive of malingering (<6). The patient was diagnosed with anosmia. The PEA (phenyl ethyl alcohol) test score was -2.00 bilateral. The Whole-Mouth test identification test score was 80% correct. The outcome was not reported. Reporter's comments: The authors reported that the smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.