chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several cramps occurred in both right and left calf muscles; Left calf muscle tight; Left calf muscle sore/ soreness in left calf; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Aug2021 at 16:00 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to Cashews. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 13Aug2021 at 00:00, 4 days after the first Pfizer shot, the patient experienced several cramps occurred in both right and left calf muscles. Left calf muscle remained tight and sore. (It had been 1 week of tightness). The patient went to the ER to check for blood clot in leg-nothing found. Went back to get a D-Dimer to see if something was missed due to continued tightness / soreness in left calf. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event.  The clinical outcome of the events several cramps occurred in both right and left calf muscles, left calf muscle tight and left calf muscle sore was not resolved at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client developed a fever of 103*F on 05/09/23 while at school between the hours of 9:00a.m. and 11:00a.m.. The mother reported that the child was able to recover from the fever and reports that her child has not had a fever since 05/09/2023. The client did not report to a doctor or emergency department. The mother stated that  the client is feeling much better today, 05/10/2023.
Donor developed rash at site a day after immunization was given. Site is warm to the touch, red, and has little raised bumps.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of oral ROTATEQ lot # L020859, expiration date: 19-JAN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 48.6 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. Concomitant medications were not reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Minor chest fluttering few minutes after shot. Later that day, yesterday and less today dizziness, weakness, stumbling, few words not coming out quite correctly.  These challenges seem to be improving.  Tiredness, headache, unwell feeling, arm pain, fever.
Mother describes a reddened area on upper arm, grew to the size of a "face cloth".  Had a hard center, numbness at site of injection and down the arm.
pt recvd vax 18NOV92 & devel a pregnancy complication of atrial fibrillation; 8AUG93 pt delivered a full term nine pound, 11 oz nl male;  pt vaxed w/2nd & 3rd dose of vax 12OCT93 & 17DEC93;
One week post vax, the pt developed a rash at the injection site. The most recent information received reports the condition of the pt is unknown.
Received vaccination on 07/02/2007. Symptoms started on 07/10/2007, went to emergency room on 07/12/2007 and mis-diagnosed with "rib pain", given prescriptions for vicodin and flexeril. On 07/17/2007 was diagnosed with Shingles and given a prescription for Valacyclovir for a 7 day course of therapy.
On 12/24/04, vaccine administered and 2 weeks later rash under left breast, which subsided after 1 week. Rash was itchy and brown. On 01/24/05, dose 2 administered, rash presented 3 weeks later, itchy and brown. Rash is still present. No treatment sought for this but patient will make appointment for next week.
Patient was given an expired ActHib by one of our Medical Assistants.  Vaccination expired on 8/11/2023 and was administered on 8/16/2023.  This was not discovered until injection was being documented/entered into system.
patient started reporting tingling in the throat and tongue after receiving vaccine. patient was given 25 mg of Benadryl and was then assessed by a physician. After 1st Benadryl, pt reported that tongue tingling improved but lips felt itchy. On exam, pt had a perioral rash. Benadryl 25 mg x1 given. 10 minutes later, rash was still present. Kenalog 40 mg IM was given. 30 minutes later, rash improved and patient doing well. she was discharged on prednisone 20 mg daily x 3 days.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a pharmacist at the pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would 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; a 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 the event was considered as not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Soreness in upper left arm near site of injection. Rash across abdomen, back, and chest, fatigue. Rash started morning of 11/6/20. No medication yet.
Vaccinated pt admitted with covid infection. No info available on type of vaccine, location, date, etc.
515 Injection given. 525 She was complaining of feeling shaky (none noticed) color pink - skin warm & dry alert & oriented - she ate pasta - chicken just before she arrived - not on meds - BP/Diabetes. 530 Apple juice given (refused orange) resting - no improvement BP 160/100 - 80 ? accurate - she had a very Lg arm - I did not have a Lg BP cuff - she did not know what her normal BP was no diff breathing - swallowing - hives - or even a local reaction I asked her to lie flat - could help - she declined. 545 - Supervisor called. 600 They brought her to a provider room to rest - not be around the "shots being given" quite area. At the same time we called "Supervisor" she told "admin" only the plan - treatment is to call 911. I was not comfortable with her symptoms - They could have been related to many other conditions. 645 We saw rescue arrive at the back door - I went to that area. Supervisor stated they called 911 as she also was c/o nausea no meds given to hospital ? family notified.
Slight fever (99.8), severe body aches and fatigue, sore arm at injection sight. Lasted for 24 hours then gone.
This spontaneous report as received from a vaccine coordinator refers to a currently 14 years old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates in 2018, (reported as on or after 24-OCT-2018), the patient was vaccinated with RECOMBIVAX HB lot # R004185, expiration date 06-NOV-2020 (dose number, anatomical location and route of administration were not provided) that was improperly stored. It was reported that the vaccine was exposed to a temperature below of 32 degrees Fahrenheit (30.7 F) for 15 hours and 45 minutes. There was a previous temperature excursion of 32 degrees Fahrenheit to 35 (33.2 F) for 27 hours. No adverse event reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA004847.
Information has been received from a physician concerning a 12 year old female who on 24-JUN-2008 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL vaccine (yeast) (Lot #660555/0279X). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). On 24-JUN-2008, after receiving the first dose GARDASIL vaccine (yeast), the patient fainted. On the same day the patient recovered from the same event. Unspecified medical attention was sought. Additional information has been requested.
Pt developed fever of 102 degrees F with achiness and weakness. Left arm with erythema and warmth 4.5cm x 2 cm at the location of pneumovax site
Bled in to a golf ball size hematoma; This is a spontaneous report from a contactable pharmacist. A 34-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported; Expiration Date: Mar2021), via an intramuscular route of administration, administered in Arm right on an unspecified date (at the age of 34-years-old) as 0.3 ml dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Height and weight information was unknown. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, as single for COVID-19 immunization. Investigation assessment was not provided. On Jan2021 (about 3 weeks to a month ago) the patient experienced bled into a golf ball size hematoma. Reporter said that the medical assistant gave the injection too low and hit a blood vessel. Reporter wanted to know about the affect the efficacy and the mechanism of action of the product and revaccination. The reporter highlighted the term and considered the events as non-serious. The outcome of the event was recovered on Jan2021.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Bruise on inner aspect of arm approximately four inches from injection site with red rash in area approximately three inches in diameter. Nothing at injection site.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 14Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) and on 17May2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient presented for her first Moderna COVID-19 on 3/4/21, Lot# 030A21A and was administered at Medical Ggroup.  Following vaccination, she experienced significant nausea, as well as a severe headache and exhaustion for several days.  She had no oral lesions at that time.  She had 2nd Moderna COVID-19 vaccination, Lot # 038A21A date administered on 4/1/21 at Medical Center.  Following this second dose, she had no adverse effects.    The third Moderna COVID-19 vaccination was administered on 11/27/21, Lot # 013F21A.  Two weeks following the administration of the booster, she developed a white patch the size of the nickel on her tongue.  She presented to Dentistry and they diagnosed her with leuoplakia and recommended a biopsy.  A biopsy was conducted on 1/4/22 and revealed mild dysplasia.  She was referred to an oral surgeon for further evaluation at Hospital, and then was referred for a further evaluation at facility. In February, 2022, she met with the oral surgeon and on 3/14/22 she had laser surgery in which the area was burned off.  In mid April, she was diagnosed with COVID-19.  She started with a slight URI, cough, and sniffles, and then had 7 days of diarrhea as well as abdominal pain.    In June 2022, she was re-evaluated by the oral surgeon at facility and the white patch recurred.  It was the exact same location and the size of nickel.  She presented back for follow-up in October/November, 2022 as recommended for repeat biopsy which revealed squamous cell carcinoma of the tongue.  She underwent an extension surgical resection (partial glossectomy) in December 2022.  All lymph nodes were negative and final report revealed well-differentiated squamous cell carcinoma of the tongue.  It was also HPV negative.
Mother PHONED 5/5 @ 1 pm.  Reports that at 3am.  Child awakened screaming & banging head.  Head hot, no fever & remainder of body not warm.  Gave TYLENOL.  @ 7:15am, head still hurts.  @ 12 noon complained of head & "tummy" hurting.  Pt to mother 5/6 states by 5pm yesterday child had no further symptoms.  10 day playing without problems.
I had my vaccine aroung 4:20PM and did not feell any pain nor side effect until around 9:00 PM; my blood pressure went up to 180/88 and feel dissy so I took extra blood madication seem to calm it down and I did not contact my health care provider.
Dizzy 15 minutes after shot administered. Chest pain, GI issues, fever SOB followed at around 4:00 pm the same day
11/1/2021 Onset of Visual anomaly, sometime in the afternoon - large blurry patch across left field of vision 11/4/2021 Eye appt with Dr. - diagnosis Posterior Vitreous Detachment 12/2/2021 Follow-up eye appt with Dr. - confirmed no further deterioration  mid-Dec 2021 Onset of left hand pain and looseness of thumb joint 1/11/22 Appt with Dr. - diagnosis osteoarthritis left thumb CMC metacarpal 3/2/2022 Follow-up appt with Dr. - improvement of initial flare but will need to manage condition
ROUND RED, WARM SPOT SIZE OF HALF DOLLAR AT INJECTION SITE. PERSISTED FOR 6 DAYS.
Tingling of tongue and lips approx. 30 mins after receiving the vaccine. Shortness of breath started 3-4 hours later. Did not see treatment until 1/12/21. Employee health nurse was made aware of side effect and lingering shortness of breath which persisted.
Vaccine given at 6:30 PM, by 7:55 PM tight feeling in throat, tongue felt thick. Benadryl given with no progression of symptoms. Medical records confirm allergic reaction. msv
Local, redness, firm and warm to touch, area of approx. entire deltoid (site of injection).  Pt. reports itching at site and responds to touching at site.  Vaccine administered 24 hours prior.  Mom applying warm packs prior to RN assessment; cool compresses recommended.
Sweating out of blue; Completely run down; Swollen arm; Injection site really red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating out of blue), DEPRESSED MOOD (Completely run down), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Injection site really red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-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 16-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating out of blue), DEPRESSED MOOD (Completely run down), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Injection site really red). At the time of the report, HYPERHIDROSIS (Sweating out of blue), DEPRESSED MOOD (Completely run down), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Injection site really red) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
Night of vaccine pain in injection site and body aches followed by a long stretch (nearly 24 hrs) of intense body aches, nausea, cold and hot flashes, shivering etc. Treatment was increased hydration and Tylenol. Symptoms gradually faded but did not completely improve until 3 days after injection. Hot/cold flashes and body aches (especially neck stiffness) lasted, although much less extreme.
My period was two months late and when it came back, I had very heavy bleeding. To this day, I still have heavy bleeding. In addition, in the mammograms a possible breast cancer has been seen, but in the biopsies everything seems to be fine.
Menstrual cycle was  4 days late and it is NEVER irregular. Severe uterine pain before onset of period . The severe Uterine pain lasted for three days and was so excruciating that I was near calling an ambulance several times and this has never happened to me before.  On November 1st my period came and the pain stopped.
Large red rash around injection site that became itchy within 24 hours of injection. Reported back to pharmacy on 6/28 where pharmacist directed patient to apply Benadryl cream topically 2-3 times daily until resolved. Rash reduced to quarter size and less itchy upon follow-up on 7/1.
mother requested this form be submitted.  she believes that the cough, shortness of breath, wheezing and green rhinorehea that he suffered begining about 8/7/08 and going through 8/15/08 coub be a side effect if immunization.
7 days after receiving the vaccine, I developed a large, warm red blotch about 3-4in in diameter on my left deltoid. The following day, this blotch spread more than an inch down my arm and developed a prominent red ring around the border.  For a couple days, I took Zyrtec, thinking I may have been bitten by something, which had no effect. 10 days after getting the vaccine, I had an in-person appointment with my PCP who examined my arm and reported to me that this has been seen in patients who received the Moderna vaccine, usually appearing 5-7 days following vaccine administration. Today (11 days after the vaccine), the blotch continues to spread but appears less red and is clearing in the center where it originated. No fever, minimal swelling, hot/warm to the touch at times, no itching, border is slightly raised at times. I was told to monitor and call if I see red streaks traveling from the area indicating infections.
When asking the patient about her previous doses, she mentioned that she had no side effects with the 3rd dose. However, her blood pressure was elevated, she went to clinic and saw Dr., and her blood pressure medication was changed. The blood pressure normalized within a few days. She is unsure if the increase in BP was vaccine related.
TWO NURSING STAFF DECIDED TO GIVE FLU VACCINE TO EACH OTHER.  CHOSE THE WRONG FORM OF VACCINE AND ADMINISTERED IT NASALLY INSTEAD OF IM.  STATE NO ADVERSE EFFECTS EXPERIENCED TO DATE INSTRUCTED TO REPEAT FLU VACCINE DOSE AS SOON AS FEASIBLE
This spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 63-year-old, adult female patient. The patient had no medical history and had not received any concomitant medications. On 28-Sep-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019 and anatomical location: not reported] (explicitly coded as inappropriate age at vaccine administration). The patient had no adverse reactions after administration of the vaccine. The reporter assessed this case as non-serious.
TC from mother. Mother stated son had reaction to hep B vaccine. He began with SOB, increase HB, dizziness, soreness and redness to site, son felt warm and had restless night. Today did not take him to local ER for shortness of breath. She did not feel it was urgent for ER visit, child OK today. Mother requesting note for school for exception from RC hep B vaccines. He slept late this morning. He still feel warm this morning and has slight swelling and redness at site. He had breakfast this morning. No nausea, mother stated she read all info on VIS form and decided to call to report reaction.
Patient passed out approx. 3 minutes after vaccines were administered. Pt. oriented after passing out. Vitals good. Pt. given juice and crackers and made to lay down for 1/2 hr. or so. Pt. left office stable, oriented and alert.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) lot # L035105 expiration date 14-MAY-2017, dose and route were unspecified. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree (also reported as Celsius degree). The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree (also reported as Celsius degree). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Raised red rash on upper left arm at injection site, unchanged with OTC Benadryl , rash spread over the course of 6 days so far, beginning one week after injection
Patient had varivax administered on 8-14-06 and that evening developed redness at the injection site. Redness worsened the following 48 hrs and she was examined at 48 hrs. Erythematous area over deltoid 2 inches in diameter. Patient complained of "swollen throat" 36 hrs after administration but had no breathing difficulty. Cool compresses and benadryl recommended.
I developed a large rash with multiple bumps along my back and side. This occurred on both sides. I also have an infection in my right arm pit.