chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EC31W1 and expiration date: not reported), via an unspecified route of administration, in Right Arm, on 23Aug2021, as DOSE 1, SINGLE for covid-19 immunization. Medical history included breast cancer and lymph node removed 10 years ago when patient had breast cancer. The patient experienced headache and regular symptoms after words the entire forearm pain on an unspecified date. By the 3rd day afterword patient was fine. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
inconsolable screaming x 3hrs p/shot, followed by very irritable behaving x 3 days;mom gave APAP, did not call MD or take pt to ER, reported it today
First, redness and swelling in left arm for about a week. Followed by blurred vision in right eye.  Difficulty in driving. Cornea transplant in 2011. Followed by December and February doctor appointments and prescriptions. Has improved, but still under Dr care.  Will see again in March.
Patient was given vaccines, MCV, MMR, on 10-06-2014 In Left deltoid. Father bought patient in today at 0800 c/o pain, itching, redness swelling at site. Dr. assessed patient and order given to give Benadryl 50mg po. and was given and ice compress applied. And prescription given for Benadryl and instructions given to apply cold compress as needed for pain and swelling and that Benadryl could cause drowsiness and to return if condition worsens.
A non-serious, spontaneous report of right ear pain and bloodshot left eye has been received from a pharmacist concerning a four-year-old male patient, which occurred one day after receiving FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient has no prior medical history and was not taking concomitant medication at the time of the event. The patient received FLUMIST on 06-Oct-2009. While patient was given FLUMIST, the office staff had instructed his son to actively inhale twice after receiving the vaccine. On 07-Oct-2009, the patient developed right ear pain and blood shot left eye. The patient had no sniffle, fever or sore throat; he was active and playing. On an unknown date the right ear pain and blood shoot left eye resolved. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.
Measures 10cm x 10cm Flat with raised middle, reddened and warm to touch. Advised pt to apply cool compress and massage every 20 minutes
Moderna Covdi-19 Vaccine EUA Large raised red rash approx the size of a tennis ball at the site of the injection. Injection site was slightly itchy and felt hard to the touch.  No other side effects leading up to the rash. The following day, the area is still raised but no longer red.
I threw up; Fever; Chills; Full body aches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (I threw up), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Full body aches) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (I threw up), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Full body aches). At the time of the report, VOMITING (I threw up), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Full body aches) outcome was unknown.            No concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2021-368918 (Patient Link).
Information has been received from a nurse concerning a 13 year old female who in October 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot no., route and site of administration were not reported). On an unspecified date, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot no. and route of administration were not reported) on her left arm. After receiving her second dose, the patient developed a "white ring" at the injection site. This "white ring" area does not tan with sun exposure. Both dosed were given at a location other than this nurse's office. The patient went to office and sought unspecified medical attention. No other information is available at this time. Additional information has been requested.
Breakthrough case admission after two vaccines 5/29/21 Pfizer EW0172 6/19/21 Pfizer EW0164
Patient's wife called 8/3/15 - said the injection site is hot, hurts, is swollen, and is bright red in a 3 in diameter. Told patient to take some ibuprofen and to see a physician if it gets any worse/spreads.
At 2:47 am woke up with severe chills, muscle cramps, joint pain, headache and foul (rotting) taste in mouth. Over the next 30 hours experienced intermittent low grade fever and sweats alternating with chills. At 7:30 pm noticed gum tenderness and mild bleeding.  At 9 pm noticed red weals on left arm from injection site to elbow level. Treated most symptoms with acetaminophen  with minimal results. Treated mouth symptoms with salt water rinse. As of this report, muscular and joint pain are subsiding.  Fever and chills no longer present. Mouth bleeding and weals are subsiding but still present.
Pt reported shortness of breath and fast heart rate.  Pt received vaccine at approx. 1410, about 2 minutes later pt reported SOB and fast heart rate. Pt then took 2 puffs of albuterol inhaler and reported it was not helping. Pt reported faster heart rate and difficulty breathing. Pt was given 1 dose of auto-injector epi 0.3 in left thigh. Pt was taken and guided to ground from car seat with assistance and place on shaded concrete. EMS was notified and en route. Pt was monitored with CNO at bedside. Pt was tachy 118 with 96% pulse ox on RA. Maintained own airway which was patent without obstruction.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received ROTATEQ oral (doses, lot # and expiration dates were not reported) stored at 33F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
site where they got the vaccine itched; site where they got the vaccine swelled up; site where they got the vaccine turned red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (site where they got the vaccine itched), VACCINATION SITE SWELLING (site where they got the vaccine swelled up) and VACCINATION SITE ERYTHEMA (site where they got the vaccine turned red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A2114) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Stroke and Arthritis.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (site where they got the vaccine itched), VACCINATION SITE SWELLING (site where they got the vaccine swelled up) and VACCINATION SITE ERYTHEMA (site where they got the vaccine turned red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (site where they got the vaccine itched), VACCINATION SITE SWELLING (site where they got the vaccine swelled up) and VACCINATION SITE ERYTHEMA (site where they got the vaccine turned red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include medicines for asthma, blood thinner because had stroke and arthritis.
Paranoia - yelling at people talking to her on shoulder  - gave night meds early - helped Unsteady walking - had sit down then to bed  Passed out twice - blood pressure down to 70/40 when paramedics took to hospital - IV fluids
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient received first dose of pfizer vaccine with in 2 minutes passed out parents then told me later he has Aspergers and is very much afraid of needles has had reactions before after getting shots but none quite this severe patient was sitting and when he passed out he did not hit his head mother was beside him and helped him down called ems patient did not want to be transported to hospital left rx 20 minutes later
SEVERE RASH - ARMS AND CHEST, ITCHY EARS AND PUBIC AREA
Normal reaction with first dose; 16 year old male who received first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old male who received first dose) and NONSPECIFIC REACTION (Normal reaction with first dose) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old male who received first dose). On an unknown date, the patient experienced NONSPECIFIC REACTION (Normal reaction with first dose). On 27-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old male who received first dose) had resolved. At the time of the report, NONSPECIFIC REACTION (Normal reaction with first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient was 17 year old and discussed with moderna person, the patient was scheduled for second dose.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Adverse event, normal reaction with the first shot updated. On 14-Apr-2021: Second dose information with events updated. On 14-Apr-2021: MOD21-077328 email added (narrative updated)
Approximately 20 minutes after vaccine injection, patient complained of tingling in tongue. Patient then noticed a strange taste in her mouth and tongue began feeling "thick" at that time. Approximately 10 minutes later, patient noticed that lips and mouth began feeling numb and tingly.  Our regional MD was called and advised nurses to have epinephrine on standby and to notify EMS. Ambulance arrived approximately 15 minutes after patient alerted staff of reaction. No medications were administered by Health Department staff, however patient did take one Benadryl that she had in her pocket. Upon arrival, EMS advised patient to take second Benadryl pill that she had in her pocket. EMS transported patient to local hospital. Called to check on patient 4 hours later, patient has made a full recovery and is resting at home. Patient states that she was given a steroid at the hospital and monitored for several hours before being sent home.
Moderna COVID-19 Vaccine EUA  Reactions:  Fatigue the day after the shot, followed by extreme itchiness on legs, torso, arms, neck, chest and back. Large oozing sore on left leg by the ankle with red splotches and bumps all over the body. Used anti-itch cream (Histamine - over the counter) to no affect, covered sore with gauze or large band aid.  Discharge was always noticed on the pad or through the gauze and onto socks.  Tried  calamine lotion.  Did calm the itchiness a little bit.
DTaP vaccine received on last Friday.  My son started getting a "cold" on Saturday with runny nose, cough. I have had to give him over the counter cough syrup each night for the last 8 days so he can sleep.  The cough has gotten worse and the medicine doesn't seem to help prevent the cough, just lessen it.  As of yesterday my son has a decrease in appetite, increase in fatigue and the cough remains.
Headache, muscle aches, rise in temperature (not fever) for a little of 12 hours, treated with ibuprofen, cold compresses, and limited mobility through the day.
pt reported arm is still sore to the touch & it is worse @ noc it lay on it;denies s/s of infect;21NOV pt states arm is getting better;pt states can put on coat & sleep @ noc w/o OTC pain med;
a Pediatric vaccine, Engerix B was given to an adult; a Pediatric vaccine, Engerix B was given to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: a Pediatric vaccine, Engerix B was given to an adult) and adult use of a child product (Verbatim: a Pediatric vaccine, Engerix B was given to an adult).  The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-Aug-2023 Nurse stated that the call was dropped and no further information was available. Above information was all the reporter was able to obtain. Did not consent to follow-up. An adult patient received a dose of Engerix-B pediatric, which led to underdose and adult use of a child product.
N/A - patient given dose of bivalent Pfizer 5 days beyond use date. No adverse outcomes.
Immediately upon administration, pt claimed a sharp shooting pain that continued/lasted after administration. Pt claimed a "nerve pain" from middle of arm to her neck on left side. (Additional info: dizziness).
At midnight 12/28/2021 I started getting cold and my arm hurt. The next day I was nauseas, and I didn't feel like eating and drinking. I called up the doctor because I thought something was wrong. They told me it was probably just the third dose, and they gave me something for my Nausea. I ate bland diet of broth, toast, and sprite for the next few days. I just felt so nauseous and cold. They did give me a COVID test and it was Negative.
Swelling started in left wrist on the day after the vaccine. The swelling extended to his entire left arm then to his left arm and shoulder and neck. Later that day the swelling continued to right neck then arm then wrist. It then receded back over several days the way it came. Swelling in left wrist lasted a week.
Approx 52 hrs p/vax, pt got up from watching TV to go to table to eat; when pt reached table stared off & did not respond to name being called; then began to tremble; parents felt seemed to stop breathing a few seconds; pt taken to ER;
lump at injection site.  Now has turned into an itcy painful and red swollen area very large on arm.  progressively getting larger as time goes on
Basically I started having issues in August. I had pain in the lower part of a old scar. It developed infection. I was tired and fatigue. Sinus tracts formed in the scar. I needed surgery in September. The surgical site was left as a open wound. I believe the vaccine weakened my immune system I am now in rehab recovering.
3/31 I visited my ENT and my BP was elevated.  On 4/26 I went to see my PCP and my BP was still elevated at that time so I was started on Lisinopril.  I have never had any BP issues in the past.  A few days after starting the meds I  had a real fast dizzy spell that came and went really fast and my BP was taken at that time and was in 190/80's range so I was advised by my PCP to go to the ER.  I went to emergency room and an EKG and Chest X-ray was performed.  I was monitored and advised to take another lisinopril while in the ER and to see my PCP at the end of the week.  I was advised to continue the Lisinopril and so far everything has been ok since.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients were administered M-M-R II (Lot# L036851, expiration date: 23-SEP-2017, dose, frequency and route were not reported) that were improperly stored at 31.3 Fahrenheit for 124 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
At approximately 12pm the day after the vaccine I experienced severe body aches, chills, lack of appetite, sweats, nausea, dizziness, headaches. The symptoms have persisted since that day .
After admin of Tdap, patient sat well for PPD test. 5 seconds aftger admin of ppd, patient said "Whoa", fell to her R side  and seized. Lasted ~7 seconds. Pt. said she has "passed out" in the pat, felt similar to this, but with no witnesses.
delayed local reaction at injection site. erythema and swelling occurring 5 days after vaccination. treated with antihistamine and topical steroid. outcome unknown.
Four days post third dose, the pt developed a rash, fever of 99.3, irritability, cough and vomiting. No further information is available at this time.
Pt recvd Engerix-B & approx 2 wks p/1st dose had macula-papula lesion on face; not pruritic & no indication of superinfection;
Hand swelling; Pain worsened; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Hand swelling) and PAIN (Pain worsened) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 029A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Alcohol use (A glass of beer, occasionally) from 1960 to 2020 and Tobacco user (pack and a half of cigarettes a day) from 1960 to 1991. Previously administered products included for Rheumatoid arthritis: Enbrel. Past adverse reactions to the above products included No adverse reaction with Enbrel. Concurrent medical conditions included Rheumatoid arthritis (Could not make a fist), Tiredness (easily gets tired), Impaired driving ability (uncomfortable driving due to wrist pain), Wrist pain (uncomfortable driving due to wrist pain), Drug allergy (allergy with unspecified prescription pill to stop smoking manifestated by sweating and fingers swell), Blood pressure high and Diabetes. Concomitant products included VALSARTAN for Blood pressure high, INSULIN DEGLUDEC (TRESIBA) for Diabetes, PREDNISONE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Pain worsened). On 25-May-2021, the patient experienced PERIPHERAL SWELLING (Hand swelling). The patient was treated with DICLOFENAC SODIUM at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Hand swelling) and PAIN (Pain worsened) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERIPHERAL SWELLING (Hand swelling) and PAIN (Pain worsened) to be not related.    It was reported that, in Apr-2021 (date unspecified), the patient experienced worsened soreness/more pain on palms, each finger of both hands and on 25-May-2021, the patient experienced recurrent right hand swelling.   This case was linked to MOD-2021-198372 (Patient Link).
Covid-19 vaccine given at 8:20 PM. Vaccine expired at 8:13 PM. Patient refused to stay 15 minutes for observation.  Patient declined multiple requests to do so.  Instructed patient  to go to the emergency room should he have any signs or symptoms of severe allergic reaction or if develops any severe symptoms. Patient verbalized understanding and agreed with plan.
This spontaneous report has been received from a physician via a company representative, referring to a 1 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with the first dose of VAQTA, 0.5 ml (strength, route of administration, lot# and expiration date were not provided) for prophylaxis by mistake. The reporter stated that the mistake was due to an human error and not due to product confusion. No adverse events were reported.
Reportedly is having "cardiac issues" for approximately 7 days and ongoing. Has required hospitalization and follow-up from PCP. Have not been able to get concrete details or specific symptoms.
right arm went numb,shortness of breath, diiness, felt faint, wheezing
COVID test (+); symptomatic: HA, cough, nasal congestion Narrative:
6 days after injection, injection site is red, swollen, itchy, rough textured, thick-skinned, about 2? in diameter. Day 7 no improvement even after topical and oral Benadryl.
Itchy-burning at injection site with raised red swelling that was slightly bumpy measuring 2" x 1 1/2". Lasted 3 days before resolving after applying cortisone cream and ice packs.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 24Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Sep2000; FOLIC ACID, start date: Aug2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient received treatment of Paxlovid from 13Nov2022 to 18Nov2022 (lot number: GE9774).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
20OCT95 c/o rash all over body, resp easy, in ER had started IV & given Solumedrol, DPH given & Zantac