chrisvoncsefalvay/vaers-outcomes huggingface dataset:
focal seizure; chest stabbing pain; grand mal seizure; second hive episode on both legs; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0173), via an unspecified route of administration, administered in the left arm on 09May2021 09:30 (at the age of 16 years old) as dose 2, single for COVID-19 immunisation. Medical history included asthma (prior to 2016, asthma free) and allergies (prior to 2016, underwent allergy shots for 4.5 years). The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously took amoxicillin and amoxicillin;clavulanic acid (AUGMENTIN) and experienced drug allergies to both then received the dose 1 of bnt162b2 (lot number: EW0162), via an unspecified route of administration, administered in the left leg on 18Apr2021 13:30 (at the age of 16 years old) for COVID-19 immunisation and experienced lump on left leg. It started the size of eraser. Within 2 hours, it was the size of an eraser, hives all over left leg, and vaccine administered at inappropriate site. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 15Jun2021, the patient experienced second hive episode on both legs. On 16Jun2021, she experienced first grand mal seizure. On 25Jul2021, she had another hives episode on both legs. On 07Aug2021, the patient had severe hive reaction all over both legs, lower torso. On 25Aug2021, she had another hive reaction on lower legs. On 08Sep2021, she experienced second grand mal seizure. On 15Sep2021, levetiracetam (KEPPRA) started. On 16Sep2021, the patient had her first focal seizure. On 27Sep2021, she had two grand mal and one focal seizure. On 29Sep2021, she had another focal seizure. On 01Oct2021, she had grand mal seizure. Chest stabbing pain was reported on 16Sep2021, 27Sep2021 and 02Oct2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
The patient reported that the nurse, administered the vaccine "really high on my arm but I didn't give it another thought. The next day and every day since I have such severe pain that I'm not able to raise my arm above my shoulder without shooting pain. Today (9/27/2023) the pain is so bad that even moving my arm backwards is not possible."
Information has been received from a nurse practitioner concerning a 24 year old female with a history of cerebrovascular accident perinatal and mental disorder who on 05-MAR-2008 was vaccinated intramuscularly with the first dose of GARDASIL. On 05-MAR-2008 evening, the patient experienced vomiting, blurred vision and near syncope. The nurse practitioner reported that they thought the patient might had a TIA (mini stroke). However, this has not been proven. The patient was referred to a neurologist for further evaluation. The patient was hospitalized, but the length of hospitalization was unspecified. The patient's last seizure happened in June 2008. The patient's outcome were unknown. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
We were under the impression we were giving the Pfizer Bivalent COVID booster but we gave the Pfizer Monovalent COVID vaccine in error. Patient made aware of mistake and given CDC guidance on how to proceed.
Received pfizer booster vaccine and experienced chills, myalgias, nausea, and headache 2-3 hours following vaccine administration. Twelve hours following vaccine, pt had a witnessed syncopal episode lasting seconds. She hit her left maxilla as a result of syncope.  She had resolution  of symptoms two days following vaccine.
The following day patient woke up with rash/swelling around the eyelids, maxilla face and some arms, hives present on right arm. Patient had the flu shot the previous day at the time of Shingrix, but has not had a reaction to previous flu shots. Also ate shrimp for dinner previous night, but never had a reaction to shellfish.  Patient took 1 dose of Benadryl prior to being evaluated for reaction.
Pt recvd vax & 1 wk later devel generalized joint & muscle pain, & fatigue;
I received both the flu shot and the pneumonia shot around 9:00am.  Around 4:00pm I started running a temperature of 100.6 degrees.  I took some ibuprofen and laid down.  Both shots were given in my left arm.  My arm was so sore that I could not touch it.  All through the night I continued to run a fever between 100 degrees to 102 degrees.  On 11-06-07 I woke up with a knot on my neck.  The knot was about the size of half of a baseball and located on my collar bone.  I continued to have a fever throughout the day.  My arm and the knot on my neck stayed very sore for two more days.  It is now 11-11-07 and the knot on my neck has gone down quit a bit but it is still visible.  I went to see my doctor on Thursday, 11-08-07.  He stated that I was having a reaction to the vaccinations but could not tell which one since they were both given in the same arm.  I was told to let him know if the knot did not go down and some tests would have to be run.
PATIENT FELL LATER ON WHEN HE ARRIVED HOME.  HIT HIS FACE AND HURT HIS HIP.  IN HOSPITAL FOR SEVERAL DAYS.
Left arm pain, nausea, dizziness, upset stomach, disorientation, headache. Lasting three days. Still lightly dizzy - to date 4/9/2021
PAIN CHEST, NECK PAIN, INFLAMMATION OVERALL, ANXIETY, HEART PALPITATIONS. TREATMENT :TYLENOL. SYMPTOMS LASTED ABOUT TWO WEEKS
Had to walk bent over; Hands felt tingly; Migraine; Vomiting; Dizziness; Muscles in her back became stiff; stiffness progressed to her whole body; Muscles in her back became tight; Muscles are still very sore; This is a spontaneous report from a contactable consumer (patient who is a medical assistant). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 13Jan2021 at 08:30, at a single dose, for COVID-19 immunization. The patient's medical history included anxiety. The patient's concomitant medication included escitalopram oxalate (LEXAPRO) from 2018 and ongoing (for two-and-a-half years) for anxiety. The patient previously took the first dose of BNT162B2 (Lot Number: EK5730) on 22Dec2020 at 09:00 AM (in the right arm) for COVID-19 immunization. The patient was calling to report side effects. After the second dose on 13Jan2021, the patient noticed around 18:00 that the muscles in her back became stiff and tight. It got worse overnight and, in the morning (14Jan2021), she had to walk bent over. This stiffness progressed to her whole body. That morning she also noticed her hands felt tingly (like when they fall asleep) and she had a migraine with vomiting and dizziness. All of these effects started to resolve but now her muscles are still very sore (Jan2021). The migraine went away this morning as did the vomiting and dizziness. The patient recovered from "Hands felt tingly", "Migraine", "Vomiting", and "Dizziness" on 15Jan2021. The patient had not recovered from "Muscles are still very sore". The outcome of "Had to walk bent over" was unknown. The patient was recovering from the remaining events.
heard from others they had side effects after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (heard from others they had side effects after vaccination) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (heard from others they had side effects after vaccination). At the time of the report, ADVERSE REACTION (heard from others they had side effects after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. No treatment of events was reported.
Patient received a ZOSTAVAX immunization on 5/27/10 and complained within 2 days of redness and swelling at injection site. Pt visited an urgent care office and received a course of antibiotics.
round red rash, below injection sight, the size of the donut; Itchy; round red circle, about the size of the donut; This spontaneous case was reported by a consumer and describes the occurrence of RASH (round red rash, below injection sight, the size of the donut), PRURITUS (Itchy) and ERYTHEMA (round red circle, about the size of the donut) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ERYTHEMA (round red circle, about the size of the donut). On 03-Feb-2021, the patient experienced RASH (round red rash, below injection sight, the size of the donut) and PRURITUS (Itchy). At the time of the report, RASH (round red rash, below injection sight, the size of the donut), PRURITUS (Itchy) and ERYTHEMA (round red circle, about the size of the donut) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
1) Sensitive to touch, per pt 2) pt c/o extreme soreness (R) arm 3) Edema noted (R) arm.
1 day p/inject a large 10-12cm area of erythema assoc w/fever >101, chills & nausea; 3 days into reaction the inject site devel a 7-6cm eccymosis which progressed to eschar & 2-3 cm scar;
Grogginess; No desire to eat; Tiredness; Arm pain; Mental distress/ worsening morning loopiness; This spontaneous case was reported by a physician and describes the occurrence of SOMNOLENCE (Grogginess), EMOTIONAL DISTRESS (Mental distress/ worsening morning loopiness), PAIN IN EXTREMITY (Arm pain), DECREASED APPETITE (No desire to eat) and FATIGUE (Tiredness) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis.    The patient's past medical history included Back injury in 2007, Tobacco user (One pack per day.), Cigarette smoker and Cochlear implant. Previously administered products included for Product used for unknown indication: Hydrocodone. Family history included Deafness (Family history of Deafness) since an unknown date. Concurrent medical conditions included Type II diabetes mellitus since 2007 and Drug allergy (Hydrocodone allergy manifested by agitated).   On 30-Apr-2020, the patient started RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) 150 mg. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 07-Apr-2021, the patient experienced SOMNOLENCE (Grogginess), DECREASED APPETITE (No desire to eat) and FATIGUE (Tiredness). In April 2021, the patient experienced EMOTIONAL DISTRESS (Mental distress/ worsening morning loopiness). On 09-Apr-2021, PAIN IN EXTREMITY (Arm pain) had resolved. In April 2021, SOMNOLENCE (Grogginess), DECREASED APPETITE (No desire to eat) and FATIGUE (Tiredness) had resolved. At the time of the report, EMOTIONAL DISTRESS (Mental distress/ worsening morning loopiness) 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 product use was not provided.No treatment information was provided
This spontaneous report was received from a registered nurse concerning an approximately 65 years old female patient with calexa allergies. On 09-NOV-2012, at 2:00 pm. the patient was vaccinated with one dose of PNEUMOVAX23 intramuscularly (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. On 10-NOV-2012, she was sleeping and at 2:00 am, the patient woke up because she experienced body aches and she felt cold. She had not fever. She was treated with TYLENOL and ibuprofen. The patient recovered 24 hours after onset of symptoms. There were not diagnostic tests performed. Additional information has been requested.
RIGHT LEG BRUISING ON HAMSTRING; SWOLLEN AREA ABOVE THE ANKLE; TENDER TO TOUCH; RIGHT LEG PAIN IN HAMSTRING; ACHEYNESS/MUSCULAR TYPE ACHEYNESS IN HIS ONE LEG OR ARM; MILD FATIGUE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 140 pounds, and height was 70 inches. The patient's concurrent conditions included alcohol use, non-smoker, and penicillin (hives) allergy, and other pre-existing medical conditions included the patient had no medical history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced swollen area above the ankle. On JUL-2021, the subject experienced tender to touch. On JUL-2021, the subject experienced right leg pain in hamstring. On JUL-2021, the subject experienced acheyness/muscular type acheyness in his one leg or arm. On JUL-2021, the subject experienced mild fatigue. On 21-JUL-2021, the subject experienced right leg bruising on hamstring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acheyness/muscular type acheyness in his one leg or arm, and mild fatigue on JUL-2021, and had not recovered from right leg pain in hamstring, right leg bruising on hamstring, swollen area above the ankle, and tender to touch. This report was non-serious.
mom indicated p/vax when pt got home temp of 104.5;mom reported to MD later;MD is questioning poss rxn to vax since it was the first time pt received it;
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL 9 lot # K026246 expiration date 28-JAN-2017, Lot K026247 expiration date 29-JAN-2017, Lot L007560 expiration date 15-JUN-2017 (dose and route were not reported). The vaccines underwent supported temperature excursions. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
at time of injection, my face immediately became red and flushed. did not get more severe during 20 minute observation period so facility allowed me to leave. 5 minutes after leaving, (25 min after injection) i could not swallow and was light headed and had trouble breathing. I forced a sip of water down that seemed to resolve the not swallowing issue. I was closer to an Urgent Care than the vaccine location at that point so i went to urgent care. I was able to walk, talk and was monitored for about 2 hours. Had red blotches on my neck and arms. Airway was clear. The swallowing issue subsided. Blood pressure was 150/110 for first hour. Was 110/80 when they let me go. Blotches were gone when i was released
LARGE AREA OF SWELLING WITH CELLUITIS ON BACK OF ARM. WAS PLACED ON A COURSE OF ANTIBOTICS. HAD CELLUITIS FOR A TOTAL OF 6 DAYS. totally RESOLVED WITH NO MORE REDNESS. EDEMA OR DISCOMFORT.
Entire body aches terribly.  extreme nausea and a headache not relieved by OTC medication.  Full blown malaise.
Missed menstrual period ongoing, last cycle 3/24/21 with multiple negative urine pregnancy tests. Dizziness and blurred vision also experienced shortly after administration.
Approximately 2 to 3 weeks after my second Moderna injection, I experienced a burning sensation in my thumbs and noticed a large lump on my left thumb along with a small wart. Rubbing the painful thumbs for several minutes reduced the burning sensation and shortly after stopped hurting. The burning sensation reoccurred a few more times during the week or two following the initial occurrence. Subsequently, the large lump has reduced in size but the small wart is still present.
It was recognized upon adding dose given in the registry that it was expired, family was still in waiting room, no adverse events seen and pt. was playing with his siblings in the waiting room so no s/s of adverse events at this time.  Advised mom to let me know if any seen in upcoming hours/days.
This case was reported by a healthcare professional and described the occurrence of crankiness in a 3-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix GlaxoSmithKline) for prophylaxis. There were no concurrent medications. The subject had no relevant medical history. The subject had no adverse events following the receipt with any prior immunizations. On 2 November 2007 the subject received unspecicifed dose of Fluarix (unknown, left thigh). As a result of vaccination with Fluarix, the subject experienced vaccination error, decried as "adult" by the healthcare professional. On 2 November 2007, less than one day after vaccination with Fluarix, the subject experienced crankiness. The healthcare professional reported on 7 November 2007 that the subject was unusually cranky since receiving the Fluarix on Friday (2 November 2007) and that the crankiness had improved but the subject was still cranky.
Cellulitis right arm Hot, red, swollen 8 cm x 9 cm
Rapid heart beat; fever; aches; body pains; sore arm. Swollen lymph node in neck by injection site. Fatigue.
Narrative: 09/07/2020 COVID swab, result; NOT detected COVID infection following COVID vaccine series 01/31, Pfizer, dose #1 02/03, Pfizer, dose #2 08/05 pt cc: chils, cough, fatigue, headache, myalgias, nausea, rhinorrhea, sore throat exposure: unknown 08/06 COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE result: B.1.617.2
On 4/26/18 at 1400 this client appeared at clinic with concerns following a vaccine she received at this location, on 4/23/18 at 0940. She said that she discovered a blistered area at site of injection on 4/24/18 at approximately 1400. Observed the area on the left deltoid to have an intact clear fluid filled blister present. It was measured to be 10 mm long by 5mm wide. There was no erythema and no swelling noted. Client denied any pain but said that the area was scratchy. Client was instructed to NOT puncture/pop the blister, to allow the area to heal without intervention. She was instructed on s/s of infection and to seek medical attention if she felt it be necessary. She verbalized understanding of information presented.
Two months after my 4th dose of the Moderna Covid vaccine,  on 06/28/2022 I started feeling a tickling in my chest. Then, 2 days later on 06/30/2022 I had a high fever and took a home COVID-19 test and tested positive. Thursday morning I had a fever. I took a home test and then went to Urgent Care. They tested me and I was positive. Was prescribed Paxlovid, but only took for 2 days because I started feeling bad. Still recovering now on 7/7/2022. Breakthrough case.
I did BOTH shingrix shots and both times I had 48 hours of illness including aches, pains, sleeplessness, nausea. The first time I had a fever. The second time I had no fever, but I took tylenol every 6 hours.
Felt dizzy; Tired; Pale; Felt exhausted; Hives all over the back of neck and back; This is a spontaneous report from a contactable consumer. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm right on 18Apr2021 at 11:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included eczema and egg allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of receiving the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Apr2021 at 11:10, within 10 minutes after the vaccine, the patient felt dizzy and tired and was pale. A few hours after the vaccine, the patient felt exhausted and had hives all over the back of her neck and back. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 reported events. The clinical outcomes of the events felt dizzy, tired, pale, felt exhausted and hives all over the back of her neck and back were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
- palms and wrists extremely itchy about an hour after getting the vaccine - overall body itchiness for the next week - 6 days after getting the vaccine, hives on face,  chest, arms
This spontaneous case was initially received on 03-FEB-2016. The case report was received from a Health Professional and concerns a male patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): On an unspecified date, the patient received AFLURIA (batch number: "U54004"). Indication not reported. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced a reaction after receiving AFLURIA (non serious, outcome: Unknown). Event treatment: The patient received prednisone for treatment. Follow up received 09-FEB-2016 from pharmacist: Reporter's Assessment: The reporter's pharmacy facility  carry FLUZONE and ALFURIA and stated that it was possible there was mix up in the brand of vaccine documented, but cannot confirm this. The probability of this happening is low.