chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash all over; Little pain in calf muscles; Itching; Pain; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 18Mar2021 as dose 1, single for COVID-19 immunisation.  Medical history and concomitant medications reported as none. On 18Mar2021, after received the vaccination, patient noticed but ignored and then started noticing after 18Mar2021, developed rashes actually all over body and was itching. It became more visible after 19Mar2021 and 20Mar2021, Patient took some allergy medication/antihistamines after that, but rashes were still there,  and had little pain in the calf muscle in lower leg and also had pain. So, patient took some Tylenol and aspirin. At the time of report, the events were not worsening, only little. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tired, dizzy, rash. BUT I always get this rash when I have been sick __ e.g. cold or flu.
DVT right leg developed 5 days after receiving booster. Xarelto - ongoing. Ivermectin x 4 days (.4mg/kg/d).  Verified thrombosis with venous occlusion right leg. Outcome unknown  at this point - still have leg swelling and remain on Xarelto.
4 X 3cm superficial erythema, warm to touch, non-fluctuating. RX: Benadryl 50mgm po X 1; HC cream.
child got an undiluted dose of Pfizer vaccine, instead of the dialuted dose of the pediatric dose (4 X the amount) Child is Mostly non verbal and Got 1st booster shot>>3rd in series>>5-11 Pfizer. Verified that it was the correct dose. Waited for 15 minutes per the mom, By the time she got to the car>>"she looked woozie", restlessness>>temperature>>tylenol>>Kept hiting herself in the arm, also diarrhea>>Stayed in bed until 2pm the next day... 3rd does of tylenol given>>Very quiet. Member got an undiluted dose, instead of the dialuted dose. (4 X the amount) Child is Mostly non verbal and "is on the spectrum" continues to have a lowgrade temp.
Day after vaccination which was given to my left arm, I started to have a painful swelling of lymphatic nodes under my left armpit. It took over 1 week for the pain and swelling to disappear.
This case was reported by a pharmacist via call center representative and described the occurrence of low back pain in a 59-year-old female patient who received SHINGRIX (batch number 524S7, expiry date unknown) for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st August 2018, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On 1st September 2018, the patient experienced erythema of extremities and extremities hot feeling of. On 2nd September 2018, the patient experienced low back pain. The patient was treated with ibuprofen and lidocaine (Lidoderm Patch). On 3rd September 2018, the outcome of the pain in arm, erythema of extremities and extremities hot feeling of were recovered/resolved. On an unknown date, the outcome of the low back pain was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the low back pain, pain in arm, erythema of extremities, extremities hot feeling of and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist was the patient. The healthcare professional (HCP) got the SHINGRIX vaccine at around 3 to 4 pm at her place of business which was a pharmacy and by 8 pm, her arm hurt and was so sore that, she could not even lift her arm. She also experienced redness of the arm and it felt hot a day after receiving the vaccine. Two days after receiving SHINGRIX, the patient had lower back pain which continued at the time of report. The patient used Ibuprofen and Lidoderm patches which did not relieve the back pain. The reported batch number for SHINGRIX 52457 did not exist and was updated to 524S7 as per sales database. The healthcare professional (HCP) did not have documentation of the expiry date. This case is linked with US2018166458, reported by the same reporter.
Fever (102), chills, sweats, body aches, headache, nausea
My upper arm, at the injection sight, started getting itchy, then a rash appeared, which turned into one big hive at the injection site.
Moderate/Severe Tinnitus and hearing loss in left ear,  unsuccessfully treated with medrol dose pack and 18 day course  of prednisone
Pain at injection site; Dehydration; Fatigue; Unable to sleep; Shaky/unbalanced; Shaky/unbalanced; This was the booster shot.; This was the booster shot.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the right arm on 19Sep2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown dates as a single dose for COVID-19 immunisation and reportedly no reactions to first 2 shots. On 19Sep2021 at 13:30 the patient experienced pain at injection site, dehydration, fatigue but unable to sleep, shaky/unbalanced. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, dehydration, fatigue but unable to sleep, shaky/unbalanced was not recovered at the time of this report.
Red blotches appeared on left arm (arm the vaccine was given in) appearing 2 days after vaccine: circle at vaccination site and blotches below. The red blotches were itchy, hot, tender to touch.
Extreme fatigue, shortness of breath.  Stopped eating within 2 days, stopped fluid intake 3 days later. Family notified on March 3. ery little fluid intake until Sun, when fluid intake stopped as well.  Death occured on mon, Feb 8 2021.
Diagnosed with the shingles; Developed a blistery looking rash on his left leg; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Diagnosed with the shingles) and RASH VESICULAR (Developed a blistery looking rash on his left leg) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced HERPES ZOSTER (Diagnosed with the shingles) and RASH VESICULAR (Developed a blistery looking rash on his left leg). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Antiviral treatment, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Diagnosed with the shingles) and RASH VESICULAR (Developed a blistery looking rash on his left leg) outcome was unknown.            No concomitant medications was provided.
Day after vaccination patient developed lip swelling, lip itching, rash to upper lip and sore throat x 3 days. Temp of 100 F x 2 days. Headache and eye pain x 3 days, increased weakness, fatigue. Patient took Benadryl and Tylenol. Applied triamcinolone to lips x  1 day, then Neosporin on days 2-3. Seen in clinic 5 days after vaccine and lip reaction, fever, headache resolved.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe
Following injection, patient started feeling a "shock" down her arm she continued to have pain at the injection site and applied ice. Upon waking the next morning, the patient reports continued pain and a "red area" around her left upper arm. Denies urticaria. Presented to office today noting improvement.
Red, raised, itchy rash around injection site.  Redness lasted 5 days.
SCRATCHY THROAT; SORE THROAT; COUGHING; WANT TO SPIT OUT MUCUS; BODY ACHING; FELT LIKE WORSE; LEGS AND KNEES HURT; FELT WEAK; SORE ARM; This spontaneous report received from a patient concerned a 52 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26.cov2.s (manufacturer not specified) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination.  The patient experienced unspecified adverse reaction when treated with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: 11-APR-2022) dose was not reported, 1 total administered to left deltoid on 30-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-DEC-2021, the patient experienced sore arm. On an unspecified date, the patient experienced scratchy throat, sore throat, coughing, want to spit out mucus, body aching, legs and knees hurt, and felt weak. The patient stated, she felt like worse after receiving booster (dose number in series 2) than before. Treatment medications (dates unspecified) included: Tylenol (paracetamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and had not recovered from scratchy throat, legs and knees hurt, felt weak, sore throat, coughing, want to spit out mucus, body aching, and felt like worse (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220116291.
The patient is a 26 yo RN who received smallpox vaccine on 22 Mar 2016 (VV03-019 lot # ) and states had a normal reaction with development of pustule. She states she was in the field and sometime between day 8-10 she developed a significant local reaction of erythema, edema, warmth and streaking with +axillary lymphadenopathy. She was seen by medical provider and treated with SEPTRA. The site resolved over the next few days.
Substantial cellulitis approx 3.5 inches in diameter around the inoculation site with streaking to medial biceps.  No constitutional symptoms.   Prophylactically treated for possible secondary infection of inoculation site and coverage for MRSA with Bactrim.
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-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 02-Mar-2021 at 3:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:12 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.60 for dose administered on 02-Mar-2021 and 67.67 for dose administered on 30-Mar-2021.  No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 to 36 degrees Fahrenheit from 09:00 AM to 03:00 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 02-Mar-2021. Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. 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 30-Mar-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.   This case was linked to MOD-2022-566976 (Patient Link).
Delayed Urticarial rash (itchy red skin, hives). I would get very itchy someplace on my body (location changed often) for about 30-40 minutes. Then rash would disappear and reappear somewhere else about 2 hours later.
WE CALLED PFIZER. THERE WERE NO SIDE EFFECTS BROUGHT TO ATTENTION BY PATIENT.
stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection, Blood pressure high and High cholesterol. Concomitant products included BENZOIC ACID, METHENAMINE, SALICYLATE SODIUM (CYSTEX [BENZOIC ACID;METHENAMINE;SALICYLATE SODIUM]) for Urinary tract infection, VITAMIN D [VITAMIN D NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death and medically significant). The patient died on 14-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication of the patient also included medication to treat her blood pressure and cholesterol. The had been taking her concomitant medications since a long time ago.  No treatment information was provided by the reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's age and med HX of HTN and high cholesterol are possible confounding factors.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's age and med hx of HTN and high cholesterol are possible confounding factors.; Reported Cause(s) of Death: unknown cause of death
Redness, swelling at injection site with asthma exacerbation (wheezing).
I?m 58 years old and I am pretty sure I?m in menopause but I am now bleeding enough to feel like I?m having a light period.
How bad my arm hurt after getting that exact vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 23-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "How bad my arm hurt after getting that exact vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported a rash on her abdomen began between 11/24/19 and 11/26/19. Patient reports that on 11/28/2019 rash spread throughout her trunk and groin. Patient complained of itching and pain. Patient went to her dermatologist on 12/2/2019 and was diagnosed with pityriasis rosea.
Patient had received an extra dose of COVID Bivalent Booster, making it his 6th COVID vaccine. These are the dates that he received vaccine: 02/06/2021, 02/27/21, 03/27/21, 10/6/21, 09/22/22 (bivalent) and 10/7/22 (bivalent). Pt's wife did bring this up to us, however has not had any reported adverse events at this time.
Localized Rxn. Redness, Swelling & injection site 9X8 cm.  Systemic Rxn vertigo, mild headache, nausea.  Chills, Bodyache.
Pt began to have fever 9-8-10 was brought to office with 103.0 R temp TYLENOL & MOTRIN given temp went down to 102. Cooling measures were done.
The patient was administered Pfizer dose two instead of Moderna dose two. Patient previously received Moderna dose one 4 weeks prior.
12 month old male came in office on 1/4/2021 and was given the above vaccines. Patient returned to clinic on 5/4/2021 stating child has had a big lump on both thighs since injection date. Mother stated she has been giving Tylenol and putting warm compresses because she feel like he is in pain. provider ordered an Ultrasound and gave antibiotics, and informed patient if not feeling and looking better withn 3-4 days take to the ER.  patient had ultrasound on 5/17. Provider called patient on 5/21 to inform patient of results (Hematoma).  Patient was seen in ER on 5/26/2021. patient underwent incision and drainage in both thighs
A physician reported that a 6 month old male received his 1st dose of Prevnar and his 3rd dose of DTAP vaccines on 3/15/01. That day, he developed hives, irritability and lethargy. He was seen in Urgent Care and treated with diphenhydramine. He recovered.
Patient was doing fine at the facility but reported having hives after he arrived home. We consulted him to take benadryl or possibly call his doctor if it gets worsen.  Called patient the next day and he said he was much better today and very little hives left.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 16-MAR-2015, the patient was vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneously, (anatomical location, lot number and expiration date were not reported), which underwent a supported temperature excursion. No adverse experiences were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Right thigh redness, hot to touch, swollen . No pain. DTaP was given 2 days prior.
Tinnitus.  Significant, constant tinnitus started 6 hours after my second dose of covid-19 vaccination. It has been 6 months and there has been no relief. The tinnitus is in both ears. The volume level is about 2 sones.
he had sweating; he cannot smell; he had headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (he had sweating), ANOSMIA (he cannot smell) and HEADACHE (he had headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (he had sweating), ANOSMIA (he cannot smell) and HEADACHE (he had headache). At the time of the report, HYPERHIDROSIS (he had sweating), ANOSMIA (he cannot smell) and HEADACHE (he had headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided.
High fever (over 101 degrees F) with Advil starting at 11:30pm on 4/9/21 (less than 12 hours after injection), which subsided by the following morning. Hives and itchiness all around front and back torso, shoulders, and neck starting at 10:45am on Sunday 4/11/21 (47 hours after injection), which began clearing up the following morning after taking Allerclear on 4/11/21 at 11pm. Itchiness has remained, but hives are no longer present.
cried for more than 8 hrs-loud, shrill crying/screaming; low grade temp-leg sore & some local swelling; Tender & sensitve x 24 hrs;
Arm pain at injection site and trending towards elbow that lasted approximately a week; Body temperature drop to the point of chattering teeth beginning on 11/19 at 10 am; took ibuprofen and ate hot lunch at noon, which abated the body temp issue for about 6 hours, then the chills returned 911/19-18:00) followed a hour later (19:00) by a fever of 102.4 F and my skin hurt to the touch, not just portions of the skin, but all of my skin.  I soaked in a hot bath and went to bed.  Next morning, the fever and chills were gone. 11/24/21 - RA dr identified enlarged lymph node in neck, left side;  11/26/21 late PM, right leg pain started, 11/27/21 02:00 - 06:00 excruciating pain associated with the varicose veinson my right leg from ankle to groin that could only be mitigated by pressure on the vein and massaging of the vein areas; ibuprofen lessened the pain, but did not eliminate the pain.  11/27/21 12:00 pain was manageable and lessened with movement (jogging on treadmill); 11/28/21 early PM body temperature flux, similar to what my mom has described as hot flashes, but changing like someone was flipping a switch every few minutes.  This continues to occur intermittently.  11/28/21 - PM significant hair loss noted during evening shower, handfuls of hair shed during and after showering, similar to post-pregnancy quantities, continues to date.  Additionally, the relief of joint issues I typically see following my Simponi Aria infusion (11/24/21) was not observed, almost as if I hadn't received my medication.  I have notified my primary care doctor of the details presented in this section and have requested direction concerning my thyroid issues that continue.