chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right at time of vaccination being administered, intense pain radiated from the injection site down through the wrist. Soreness throughout the first day, followed by intense soreness for 3-4 days afterward. Painful enough that arm hurt to use, and woke during sleep at night. Pain seemed to lessen after 6-7 days, but on 4/1 woke up unable to lift arm and in intense pain. Saw PCP 4/1 and was diagnosed with capsulitis in L arm based on visual exam, and practitioner seeing this in other vaccine patients. Discussed with practitioner and it is believed that person giving vaccine administered it too high on the arm.
Several hours after vaccines administered, patient transported to ER by parents. "Unable to wake the patient."
He came in close contact with someone who tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "He came in close contact with someone who tested positive for Covid-19".  Additional information: Pharmacist said patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine (orange cap) 3 weeks ago, came in close contact with someone who was positive for COVID about 5 days after he had the vaccine. HCP said the patient was scheduled to receive the 2nd dose tomorrow, 04Dec2021. She also wants to know if the patient needs to hold off with the 2nd dose even if he was asymptomatic, and tests negative. She also mentioned that it was still too early for the patient to get tested so they do not know whether he has contracted the virus of not. HCP also wants to know how long the quarantine period should be. According to the CDC, people in the community or in outpatient settings who have had a known COVID-19 exposure should not seek vaccination until their quarantine period has ended to avoid potentially exposing healthcare personnel and others during the vaccination visit. This also avoids causing diagnostic confusion between possible adverse effects of vaccination and symptoms of a new COVID-19 diagnosis. This recommendation also applies to people with a known COVID-19 exposure before receipt of the second mRNA vaccine dose. Investigation Assessment: No.  Description of Product Complaint: Description of complaint: pharmacist, reporting on behalf of a patient mentioned that he came in close contact with someone who is positive for COVID about 5 days after he had the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
P.T. Presented Feeling lightheaded about 5 min. after vaccine. P.T. was moved to private observation area. P.T. was A/ox4 with normal vital signs. PT. started to Feel better after about 10 min of observation. Pt was Discharged home after 30 min oF observation. PT. stated that she has had vasovagal Reactions to injections
Tinnitus is both ears.  Feeling of blocked ears and pressure in ears, and loss of balance.  Left ear worse than right ear.  Hearing loss.
Pt stated arm was sore for 3-4 days post-injection.  After 3rd day she looked at her arm and noticed redness, 2 days later she called pharmacy since it was still red, then she came back to rx the following day.
"shingles" type rash on left leg, inner thigh.  Have never had any type of rash issue like this before.  Painful and tender on Sunday 8/15, swollen by the next day, then became red with bumps, which were at times mostly painful and sometimes itchy.  The bumps are now sores that are red and dark.  It is only on the one side of my body.  Left leg.  Inner thigh.  I have self treated with ibuprofen, anti inflammatory and anti itch OTC creams.
He experienced some adverse events affecting his hearing/ My apparatus; it's very thin; I could bare my hearing is not great; one or two occasions, it's extremely bright; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "He experienced some adverse events affecting his hearing/ My apparatus; it's very thin; I could bare my hearing is not great; one or two occasions, it's extremely bright". Therapeutic measures were taken as a result of hypoacusis.   Additional information: The caller received the Pfizer Covid Vaccines, two Covid Vaccines and two Boosters and he mentioned and he experienced some adverse events affecting his hearing. Patient apparatus was very, he just got apparatus in, it was very thin. Patient could barely see it. Patient could bare hearing was not great but he liked, He did not know if it was the bandwidth issue or about two Boosters and two Vaccines and then two Boosters, He did not know if it was the bandwidth issue. Patient did not know what the 'deal' was but it was very thin, patient was seeing, as he spoke, but sometimes it was there, sometimes it was not, hardly visible and in one or two occasions, it was extremely bright. He had been told that he had the very best available, patient was looking to get clarity of the audio and video to begin with.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT. PASSED OUT AFTER RECIEVING THE VACCINE. WHEN  HE CAME AROUND HE WAS SWEATY AND CLAMY. EMT WAS CALLED. HE ORIGINALLY HAD LOW BLOOD PRESSURE. WEHN THE EMT SHOWED UP ALL VITALS CAME BACK GOOD.
Pt recv vax on 10/29/98; on same day pt exp nausea, cramping, vomiting, hot flashes, headache, shooting pains/ spasms in hands, eye pain; pt seen by specialists
03/03/2021 temperature, could not stop urination, high glucose level, did not eat, could not get up, the entire day at least 12- 24 hours. Let it run it course and unable to function. Very bad day.
CHEST PAIN RADIATING TO JAW WITH ELEVATED BP BEGAN MORNING AFTER VACCINE AND UPPER LIP SWELLING BEGAN 4 DAYS AFTER VACCINE LASTING A WEEK
She stated that a few seconds after receiving the first dose of the vaccine, the patient blacked out; chills; This is a spontaneous report from a Pfizer sponsored program, via a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She stated that a few seconds after receiving the first dose of the vaccine, the patient blacked out and when they went home, she experienced chills. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event loss of consciousness and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a medical assistant referring to a 14 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 06-JUL-2017, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M036059, expiration date 03-JUN-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012777: US-009507513-1709USA012776:
Pt was immunized on 05/27/2005 with DTaP, IPV, Hib, and PCV-7. Hib vaccine was given to right upper thigh. Mom states pt developed a fever up to 104.0F 24 hours after receiving vaccines. 48 hours fever 103 F on 05/30 fever 99-100 F. Redness and swelling to RUT. 05/31/2005-low grade fever, 99F .
Sore arm; Mild stomach upset; Dizziness; Little sleepy; Shivering; Intense body aches; Extremely fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (Mild stomach upset), DIZZINESS (Dizziness), SOMNOLENCE (Little sleepy) and CHILLS (Shivering) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Depression in 1987. Concurrent medical conditions included Seasonal allergy since 1985, Allergy to antibiotic (Azithromycin), Allergy to antibiotic (Bactrim), Allergy to antibiotic (Flagyl) and Drug allergy (Vicodin). Concomitant products included LORATADINE for Allergy, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, LANSOPRAZOLE (PREVACID) for Heartburn, ALLOPURINOL (ELAVIL [ALLOPURINOL]) for Nerve pain.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, 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 experienced PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (Mild stomach upset), DIZZINESS (Dizziness), SOMNOLENCE (Little sleepy), CHILLS (Shivering), MYALGIA (Intense body aches) and FATIGUE (Extremely fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (Mild stomach upset), DIZZINESS (Dizziness), CHILLS (Shivering), MYALGIA (Intense body aches) and FATIGUE (Extremely fatigue) was resolving and SOMNOLENCE (Little sleepy) had not resolved.            No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Rashes / skin reactions on the left side of body (chest and back); This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 07Apr2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) of 20mg from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CN6208) via an unspecified route of administration in the left arm on 16Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 08Apr2021, the patient experienced rashes/skin reactions on the left side of body on chest and back. It had been 14 days and the patient still had rashes. Since the vaccination, the patient had not been tested for COVID-19. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of reported event. The clinical outcome of event rashes/skin reactions on the left side of body on chest and back was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Redness and swelling in arm within 24 hrs - Seen by MD - given prednisone, BENADRYL, ZANTAC. Redness worsened by 4th hrs, seen in ER - given KEFLEX (abx). Seen 10/19 and sxs resolving.
Patient reported severe dizziness at 2:00 am when going to bathroom. Then at 4:00 am while going to bathroom again he fell. He has been in bed all day with vertigo. He does not report any fever, illness, blood pressure problems or anything else to note in the report.
Patient began experiencing numbness in entire right arm, especially in right hand since morning after first dose (4/7/21) until now (4/27/21). Symptoms have not improved. Patient will follow-up with MD.
Developed a chest rash approximately 36 hours after the injection. The rash extended slightly up my neck. Within 24 hours it was nearly gone. I had no other allergy symptoms. I did NOT take antihistamines to resolve the rash.   I did feel mild flu like symptoms beginning about 24 hours after the injection, lasting for about another 24 hours.   A consult with my doctor did not yield any significant findings or suggestions,
No additional AE; HCP called to report inadvertent administration of expired VAQTA and MMR-II to a patient. VAQTA expired on 07/13/2023 and MMR-II expired on 07/15/2023 and were both administered on 07/21/2023. No additional AE/PQC.; This spontaneous report was received from a medical assistant referring to a 14-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 21-JUL-2023, the patient was vaccinated with an expired doses of hepatitis a vaccine, inactivated(VAQTA) expiration date reported as 13-JUL-2023 (dose, route of administration and lot number not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with an expiration date reported as 15-JUL-2023 (dose, route of administration and lot number not reported) both for prophylaxis (expired product administered). No adverse event was reported.
Breakthrough case admission after three vaccines ; Pfizer 2/24/21 Lot# EN6200;  Pfizer 3/17/21 Lot# EN6207;  Moderna 11/29/21 Lot# 051F21A
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 26th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm and injection site muscle pain. On an unknown date, the outcome of the pain in arm and injection site muscle pain were recovering/resolving. It was unknown if the reporter considered the pain in arm and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced arm pain. The patient reported that the arm where vaccine was given still hurts at the time of reporting. It was improving everyday but it was still hurting. The patient clarified that the pain was in the muscle where he received the vaccine. It was not just pain at the injection site. At the beginning the patient could not lift his arm straight out or up without pain. Day by day it was getting better.   This case has been linked with the case US2018182666 (patient's wife), reported by same reporter.
Swollen and tender Lymph nodes causing difficulty sleeping on the same side as the injection; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Swollen and tender Lymph nodes causing difficulty sleeping on the same side as the injection) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007Bz1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), AZITHROMYCIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), OMEGA-3-ACID ETHYL ESTER, IBUPROFEN, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA HANDIHALER), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT FORTE TURBUHALER) and TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (Swollen and tender Lymph nodes causing difficulty sleeping on the same side as the injection). At the time of the report, LYMPH NODE PAIN (Swollen and tender Lymph nodes causing difficulty sleeping on the same side as the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Moderna COVID-19 Vaccine EUA Localized red rash surrounding the site of the injection. It was red, raised, and warm to the touch for about 1 day. The redness slowly started dissipating over the course of several days. Went away after about 5 days. Also had a headache on Friday, Jan 8 2021 that lasted for a few hours.
Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm. Patient is asking if she can get symptoms on second dose. The outcome of the event was unknown.   Follow-up attempts are completed. Information about lot/batch number cannot be obtained.
About 5 hours, post vax, pt developed an "all over rash". The next AM, pt had hives and the whites of her eyes were red. She saw MD that day, twice the following day and again the 3rd day. Symptoms are resolved and she is completely recovered.
Dizziness, itching, hives, lips and eyes swollen, and hoarseness.
This case was reported by a nurse and described the occurrence of tight feeling in arm in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. There were no concurrent medications. On unspecified date on or before 24 April 2006, the subject received a dose of Infanrix in an unspecified arm (dose number not provided). The nurse reported that lot number of Infanrix was "either lot AC14A007BA or lot AC14A008AA." At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24 April 2006, the subject experienced "tightness in the arm," injection site redness and swelling injection site. The subject was seen at physician's office. The outcome of the events was not reported. The nurse considered the events to possibly be related to vaccination with Infanrix.
CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, a couple hours after taking the vaccine, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
fatigue; body aches; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0202) via an unspecified route of administration in the left arm on 06Aug2021 at 19:30 (at the age of 13-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. 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. On 07Aug2021 at 15:00, the patient experienced fatigue and body aches. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events fatigue and body aches was unknown at the time of reporting.
I had cough, tickle in my throat, pressure in my head, and congestive in my nose. My eye was red and itchy. I had a headache as well. Most of the symptoms lasted about 6 days and the cough is still ongoing. On Jan 5th, I did a home Covid-19 test, negative results. Then I did another Covid-19 test on Jan 6th, positive result.
Shortly after administering immunizations, pt started scratching at left deltoid where shot administered, I checked the site and noticed a reddened splotchy area and both arms, immediately got the doctor, about 2 inches in diameter. No change in status, vital signs stable; lungs/throat continued to be clear. Pt. playful.