chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel pain at the inject site/muscle pain in injection site; body pain/body aches; flu like symptoms; headaches like a migraine; fever of 101.4 F/updated fever of 101.9; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (feel pain at the inject site/muscle pain in injection site), MYALGIA (body pain/body aches), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headaches like a migraine) and PYREXIA (fever of 101.4 F/updated fever of 101.9) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Epilepsy. Concomitant products included OXCARBAZEPINE, CITALOPRAM, LAMOTRIGINE, GABAPENTIN and LORATADINE (CLARITINE) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (feel pain at the inject site/muscle pain in injection site), MYALGIA (body pain/body aches), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headaches like a migraine) and PYREXIA (fever of 101.4 F/updated fever of 101.9). At the time of the report, VACCINATION SITE PAIN (feel pain at the inject site/muscle pain in injection site), MYALGIA (body pain/body aches), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headaches like a migraine) and PYREXIA (fever of 101.4 F/updated fever of 101.9) outcome was unknown. Not Provided      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.   Other concomitant medications include Prenatal vitamins. No treatment reported
Localized reaction at injection site (R arm) from shoulder to elbow, pink slightly nodular rash, pain, itchiness. Treatment - supportive care and antibiotics PRN worsening.
Right upper extremity swelling, redness, tenderness, swelling at injection site. Consistent with cellulitis.
Seizure occurred 12-18 hours after he received the vaccine. Previous seizures on KEPPRA. Neurologist feels seizure not from vaccine, but due to the seizure happening within 72 hours of vaccine it is being reported.
Patient did not have adverse event, but we are reporting that patient received the pediatric dose vs the adult dose.  We have communicated with the manufacturer, per their guidelines according to disease control, we are to revaccinate with the correct dose and continue with the series where patient left off.  We were told to not count the subdosing injection as part of their series.  Discovered error on 4/24/23 and communicated with patient on 4/24/23.
This spontaneous report was received from a Medical Certified Assistance referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date in 2017, the patient was vaccinated with an expired dose of VAQTA lot # L048460, expiration date on 14-JAN-2017 (strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse event reported. Additional information has been requested.
pt recv vax; immed became very sleepy & lethargic, was able to arouse pt but only momentarily;eyes did not seem to focus & rolled back; stimulated pt for 10 min w/ no chance; to MD;
exposure to someone positive to the COVID virus; She was exposed to COVID a week ago and has tested positive; She was exposed to COVID a week ago and has tested positive; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 23Dec2020 at a single dose as she doesn't want COVID.  Medical history included occasional mild hypertension since Mar2019 and ongoing anxiety depression.  Concomitant medication included sertraline hydrochloride (ZOLOFT) since Aug2020 for anxiety depression. The patient reported that she is supposed to get the second dose of the vaccine today (13Jan2021). She was exposed to COVID a week ago and has tested positive on 06Jan2021. She does not have any symptoms.  She tested negative on 08Jan2021. She will be tested again today. She is asking if it is still ok to get the second vaccine after having exposure to someone positive to the COVID virus. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Mom reports p/immun pt lt leg (site of DTP) was red, swollen to knee 2-3 days p/inject & "drug leg for 3 months;" had fever but did not take temp; Did not take pt to MD;
Loss of greater than 50 percent of hearing loss in right ear; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Feb2021 12:00 (Lot number: E13248) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies : Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: EK4231, Route: Intramuscular, Dose administration time: 12:00 PM at left arm), administration date: 14Jan2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 22Mar2021, outcome "not recovered", described as "Loss of greater than 50 percent of hearing loss in right ear". The event "loss of greater than 50 percent of hearing loss in right ear" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of deafness unilateral.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. The patient was not tested for COVID-19, Since the vaccination. Device Date: 21Feb2022
The same night of vaccine Pt had severe neck pain. Could not move due to pain, went to Doctor and was advised to see Physical Therapy. Chronic pain. Had 3 months of neck pain before seeing a doctor.
heart attack; This is a spontaneous report from a contactable consumer. A 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE  (at age of 84 years old) for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced heart attack on an unspecified date within 15 minutes after taking the Pfizer COVID-19 vaccine. Outcome of the event heart attack was unknown.
ringing in both her ears started a couple days after first vaccine.   She still has ringing in her ears. It has been three months.
Painful to touch, red, raised, hard rash at the injection site that didn't appear until 1 week after the vaccination. Similar to reports of 'covid arm' in adults, but not as large. The main thing is the delayed reaction.
Information has been received from a 70 year old female consumer with a history of shingles in 1988 and 2002 and no known allergies who in approximately June 2007, was vaccinated IM with a dose of ZOSTAVAX.  There was no concomitant medication.  "One and a half weeks ago", on approximately 08-DEC-2007 the patient developed shingles.  The patient indicated that the case she has now is not as bad as her previous cases.  Unspecified medical attention was sought.  There were no lab studies performed.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  No further information is available.
11/16/21 presents to triage "with c/o contractions" "G2P1001 at 38w1d" "No past medical history on file".
her period is here and it has been the whole month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 (Lot number: EW0185, Expiration Date: 31Aug2021) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, lot number: EW0175   , Anatomical Location: left arm, Expiry date: 31Aug2021, NDC number: Unknown), administration date: 26Apr2021, for COVID-19 immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 02Jun2021 03:00, outcome "not recovered", described as "her period is here and it has been the whole month".  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No Family Medical History Relevant to AE. No AE(s) following prior vaccinations. Patient was calling about the covid vaccine.  She took her first shot then after the second one. It had been 3 months and her period is here and it had been the whole month. On 02Jun2021 was the first day it came and it was still here today.  She called her doctor and they said to wait it out and they could not  do anything because it was currently on her so she just has to wait. Time of event onset: (24-hour clock): around 3 o'clock on 02Jun2021. No additional vaccines administered on same date of the pfizer suspect. No other products received. She works in a hospital, she works in covid vaccination. No Emergency Room visit. No Physician Office visit. She just had a Teladoc visit over the phone. Relevant  tests conducted was reported as none. Information on Lot/Batch number was available. Additional information has been requested  Follow-Up 21Jul2021: Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 09Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid from 18Sep2023 to 22Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was vaccinated for Covid in left deltoid.  See immunization record.  She immediately became pale and started breathing heavy.  I had her remove her mask and breathe deeply, she also drank an apple juice and water. She started to feel better. She still c/o "waves" of dizziness and lightheadedness. Transferred patient to WC and placed in recliner with feet elevated.  Patient did not lose consciousness or experience a fall.
Dose given may have been 1 hour and 45 minutes outside the 6 hour limit on use of an open Moderna vaccine vial.
3APR99 stated had a large area of redness around DTAP inj site instructed w/DPH & cool compresses & could need to be seen if worsens;
Injecton site reaction, swollen and red area of about 3 inches. Flu-like symptoms, chills and malaise.
Pt called on 1/24/12 with symptoms of swollen upper arm on same arm as injection site. Pt was told to use MOTRIN to reduce swelling and use cold packs to relieve inflammation.
was diagnosed with leukemia in January of 2020; This case was reported by a consumer via call center representative and described the occurrence of leukemia in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In January 2020, between 1 and 3 months after receiving Shingrix, the patient experienced leukemia (serious criteria GSK medically significant). On an unknown date, the outcome of the leukemia was unknown.   It was unknown if the reporter considered the leukemia to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left deltoid. The patient was diagnosed with leukemia. The reporter did not consent to follow-up. This case has been linked with case US2020065624, reported by the same reporter.
Information has been received from a consumer concerning his 10 year old daughter with no known allergies and no reported medical history who in OCT-2007 was vaccinated with her first dose of Gardasil via injection. There was no concomitant medication. Per the father, the patient experienced a mild seizure and then passed out a few minutes after receiving the second dose of Gardasil. The father did not specify the exact date when his daughter received the second dose. The first dose was administered sometime in OCT-2007. There was no adverse event reported after the patient received her first dose. Lot number was not available. The father also reported that the patient fell on the floor, face down, and bruised her lips badly and moved her teeth backwards. The patient had braces prior to  receiving the second dose of Gardasil. The father mentioned that it took 10 to 15 minutes for the patient to recover after passing out. The patient was brought to the hospital for some blood work but was not admitted to the hospital. No results were given. The patient was brought to the orthodontist and an x-ray was done to her. Per the father, the orthodontist mentioned that "if the patient did not have the braces when she passed out, the patient might have lost some teeth because of the fall". No further information was provided. Upon internal review, mild seizure was considered an other important medical event. Additional information has been requested.
COVID positive; COVID positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "unknown" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: COVID test type post vaccination: Nasal swab. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Imodium and Ibuprofen.  Clinical Course: The patient did not received other vaccine within four weeks. Patient tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events "COVID-19', 'drug ineffective' and the suspect drug BNT162B2 cannot be excluded.
Moderna Arm-large red itchy spot around injections site appearing a week after the vaccination.
When I close my eyes at night, I saw like vague faces, and it would turn more gruesome; headache; chills; dizziness; allergic reactions; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced when she close her eyes at night, she saw like vague faces, and it would turn more gruesome, headache, chills, dizziness and allergic reactions. It was further reported that when the patient close her eyes at night, she saw like vague faces, and it would turn more gruesome, she would open her eyes and close them and it would happen again, vaguely for a couple of days and a short time. The patient mentioned that she didn't think it was a side effect, her friend who had the vaccine said, she had a hallucination, I looked on line, and found there are some hallucinations after vaccine, One person said after vaccine, not sure if Pfizer vaccine, think it was, had a bad hallucinations like taking mushrooms or something. Patient would like to know if it's safe for her to get the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Started experiencing chills at 2200 on date of vaccination (01/13). Progressed to severe chills about half an hour later. By 0300 on 01/14, I developed a fever of 105.0 degrees. I was experiencing severe chills, sweating, and an extremely painful headache. By 0600, the fever went down to 103 degrees. By 0800, my temperature was about 99 degrees, but I was still experiencing a severe headache, like an incessant throbbing. By 0930, the head pain had subsided. Throughout the day, minor chills have come and gone, and a minor headache remains.
lingering fatigue issues; spent two days in bed with fever; chills; body aches; nausea; depression; This is a spontaneous report from a contactable other HCP (patient) reported for herself that:  A 38-years-old female patient (Non pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EJI686), via an unspecified route of administration, administered in Arm Right on 20Jan2021 (At the age of 38 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ELI284), via an unspecified route of administration, administered in Arm Right on 30Dec2020, 07:00 (At the age of 38 years) as DOSE 1, SINGLE for covid-19 immunisation. and experienced after first dose I believe the vaccine may have impacted my hormones as well as my menstrual cycle. My FSH levels were taken on 07Jan2021 (one week after dose one) and were 9.1 (high end of normal prompting retest in three cycles). Upon retest on 22Feb2021 (one month after dose two) it was 17.4 (very high prompting referral to fertility). On 22Mar2021 my AMH was down to .54 (low) but on that same day my follicle count was 11 (pretty good). My period which previously was 27 days consistently and light flow. Since December my period has been very heavy and also my cycle has been 23-25 days in length. Medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing. Patient was allergies to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Advil taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient had stated that I also had significant fatigue following second dose and spent two days in bed with fever, chills, body aches, and nausea. I also had some depression in the weeks following the second dose and lingering fatigue issues until two months later. The patient had nasal Swab test on sars-cov-2 and resulted as negative on 17Dec2020. Treatment was received for adverse event. At the time of reporting the outcome of the events were unknown.  No follow-up attempts are required. No further information is expected.
Hives occured 9 days after administration of HPV, HepA and Varicella vaccines
sore throat, nasal congestion, nonproductive cough, body aches, loss of taste, loss of smell, sneezing. starting 11/27/2021
pt presented with erythema & swelling of face & periorbital regions    C/O feeling fullness in tongue & throat & some difficulty swallowing approx 30 - 45 min following vaccine    Had also eaten a english muffin with plain cream cheese just prior to symptom onset      She was noted to have mild swelling of her tongue & very sl lower lip   She was administered 50 mg of diphenhydramine, 20 mg famotidine & 60 mg Prednisone & cold compress to face   Was able to take all orally with water & had no difficulty -- after approx 30 minutes her s/s had much improved & her facial erythema & swelling had reduced no resp distress and O2 sat was 99%
rash, fever, serum sickness, colitus, rash, fever, colitis & serum sickness are reported in an pt who recvd fluogen on 12OCT92; exp rash & fever;
This spontaneous, non-valid report was received from a medical assistant and refers to unspecified patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date, reported as "in the past, unable to clarify further", the patient was vaccinated with PEDVAXHIB for prophylaxis. On 04-OCT-2017, the patient was vaccinated with PEDVAXHIB lot # N007751, expiration date: 13-NOV-2019, intramuscularly (dosage was unknown) instead of influenza virus vaccine inactivated (unspecified) (lot#, expiration date, dosage, route of administration were unknown), reported as "flu shot". No adverse effects were reported.
5-10 mins after injection of fluzone and pneumovax. Pt complained of throat being on fire with stiffness in sinus area after BP taken complained of arm itching and burning between fingers. 8mg chlorpheneramine give 134-86. After 20 mins symptoms resolved.
These symptoms apply to both me and my husband who got the injection at the same time.  Around 3:30  - 4 PM, I began to feel flushed, light-headed and VERY shaky, weak with some thirst and fatigue and a headache at the back of my head (I never get headaches).   NO FEVER.   At 4AM, 9/13/22, I began to  have severe body aches and stabling pains especially neck and shoulders at site of injection along with rapid heartbeat and mental fuzziness.  At 9:20 AM on 9/13/22, the same symptoms were there only stronger and a very strong all-over body sickness; so ill that both of us laid on the sofa with some nausea and increased leg pain and body aches, but there was also some pain at back of throat--no appetite and NO FEVER .  Late 9/13/22 the all-over sickness abated and felt fairly normal on Wednesday 9/14 and Thursday 9/15; however, today 9/16/22, the all-over body sickness, mild headache and body aches plus some stomach and GI upset have occurred.  The weakness is such that we not be active today.