chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headaches; sore arm in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and VACCINATION SITE PAIN (sore arm in the arm of the injection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (headaches) and VACCINATION SITE PAIN (sore arm in the arm of the injection). At the time of the report, HEADACHE (headaches) and VACCINATION SITE PAIN (sore arm in the arm of the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid hormones test: high (High) little high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-398519, MOD-2021-398543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Significant follow-up event added
JANSSEN COVID-19 Vaccine  High fever, chills and nausea started 6 hours after the injection and after tempra was taken.
Fever around 101 degrees F, general lethargy, loss of appetite.  Fever onset about 20 hours after injection. Treated with 2 tsp of Children's Motrin, administerd 2 tinesd at 6 hour interval. Fever broke and other symptoms abated about 12 hours after onset.
A difficult time breathing; Welts all over his body; A full blown rash / rash kind of resolving; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (A difficult time breathing), URTICARIA (Welts all over his body) and RASH (A full blown rash / rash kind of resolving) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced DYSPNOEA (A difficult time breathing), URTICARIA (Welts all over his body) and RASH (A full blown rash / rash kind of resolving). At the time of the report, DYSPNOEA (A difficult time breathing) and URTICARIA (Welts all over his body) had resolved and RASH (A full blown rash / rash kind of resolving) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist recommended Benadryl to the patient.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, very limited information regarding these events has been provided at this time. Case downgraded to non-serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint, given that medical intervention was not needed. Further information is not expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, very limited information regarding these events has been provided at this time. Case downgraded to non-serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint, given that medical intervention was not needed. Further information is not expected.
Pt had prolonged continuous crying for >3 hrs, & t102 which lasted several days;
Local reaction- warmth and erythema. Pt not given any tx on clinic 11/16 visit. Pt done c/u with Dr on 11/17/14. Unknown if PCP complete form.
Pt has had vomiting from date of vaccine admin. increased freq of vomiting (projectile), increased fussiness, refuses to eat. Vomiting episode lasted 2 days.
At the injection site,  a red raised welt the size of a tennis ball; swelling subsided in 3 days; on 03/08/2021 it started to itch and I became aware of a hard knot approx 2 inches wide by 2 inches long.
Peds Pfizer vaccine 0.2 mL administered in right deltoid. Upon withdrawal of the 25g 5/8" needle, bleeding occurred. Bleeding was stopped without issue. Patient endorsed nausea, dizziness and developed minimal emesis.   Patient placed in supine position with legs elevated under pillow. Ice pack placed on head and neck for comfort. Felt better within 10 minutes. Able to tolerate fluids and snack without issue. Ambulating and engaging as appropriate.   Patient was evaluated by doc of the day. Family advised of when to call CNS if symptoms resumed. After care instruction given.
drug administered at inappropriate site; injection site hot to touch; Two-inch red circle at injection site; A spontaneous report was received from a Consumer concerning a 58 -Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site erythema and injection site warmth.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On 13 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 02TJ20A) in the deltoid for prophylaxis of COVID-19 infection.    On 13 Feb 2021, The patient was concerned now whether they gave her the shot in the deltoid muscle and concerned if it was still effective? Also about eight days later she developed a 2 inch red circle that was hot to the touch.   Laboratory details not provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.    In Feb-2021, the outcome of the injection site erythema and injection site warmth resolved. On 13 Feb 2021, the event was product administered at inappropriate site was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site erythema and vaccination site warmth, a causal relationship cannot be excluded.  The causality for vaccine administered at inappropriate site is not applicable.
but the pain is gone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: ER8733) as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild osteoarthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Mar2021, for Covid-19 immunization, reaction(s): "After my first shot, the next mornng, no pain". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "but the pain is gone". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional Information: There was no other vaccine in four weeks. Patient have a mild case of osteo-arthritis, so, in the morning, he usually wake up with a little joint pain which takes about 1/2 to 1 hour to go away. After the second dose, and it still has not come back. The joints are still old and stiff, but the pain is gone. He hope this side effect continues. He wanted to know if he was the only one who has reported this result. No treatment for AE. No covid prior vaccination. Did not tested covid  post vaccination. There was no known allergies.  No follow-up attempts are possible. No further information is expected.
First 3 days there was swelling, pain and fever followed by weakness in the left arm, intense pain at night, intense pain upon putting on clothes, pain during daily living activities. I'm currently starting physical therapy. I had an arm xray and an ultrasound. Neither showed anything negative, as communicated to me by the Dr.'s nurse.
Swelling and a red rash on left thigh (flu shot side) Pain spasms in right thigh (RSV side) which continued about twice a minute throughout the day till about 10 pm as reported by patient. Patient took Ibuprofen to help with pain.
Acute onset tinnitus which continues to this date. Treatment/Evaluation has been sought by 3 Physician Speacialists with audiomety evaluation.
Extreme dizziness, nausea and vomiting 2 weeks post booster. Lasted 7 hours followed by extreme fatigue and some unsteadiness.
Blisters on arm with shot, blisters on hip (same side), blisters on back; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 09:00 (at the age of 65-year-old), as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 65-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 15Mar2021 at 13:15, the patient experienced blisters on arm with shot, then blisters on the hip (same side), and then blisters on the back. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with corticoid cream (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blisters on arm with shot, blisters on hip (same side), blisters on back was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient has minimal deltoid muscle and because of lack of muscle obtained red inflammation reaction from IM injection.
having a reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (having a reaction) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (having a reaction). At the time of the report, ADVERSE EVENT (having a reaction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment medication was reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Persistent nosebleed started 1 day after and has persisted now on day 3. Also general malaise and fatigue on days 2&3
I got severe abdominal pain which turned out to be appendicitis. I've never had any pain or symptoms  before it. Pain started the next day after getting vaccine. Appendex was inflamed. Happened rapidly and with no prior pain before taking the vaccine.
Left leg had edema.  3x normal, whole leg hip to toe.  Treatment:  Tylenol, Benadryl, ice
INFLAMMATION OF BODY WENT DOWN FOR ONE MONTH AND WENT BACK; This spontaneous report received from a patient via a company representative concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis, and moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis, and moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced inflammation of body went down for one month and went back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation of body went down for one month and went back was not reported. This report was non-serious.
Inconsolable crying x 5 hours before visit, irritability, anorexia and continues with irritability anorexia
Per Client received Moderna vaccine on 3/4/2021 at 2:15 pm in left arm, waited at clinic site for twenty minutes and no reaction to vaccine. At 4:00 pm on 3/4/2021, Client reported standing at kitchen sink and started having sudden onset of sharp, lower right sided back pain, which intensified with positional changes from standing to sitting. Client also reported that along with the back pain experiencing his breath being taking away at that times. Client did see a Chiropractor on 3/8/2021 for back pain, taking Tylenol, using warm packs and Icy Hot ointment. Per Client the pain level has been at 2-10/10 and no complete resolve at this time. Per Client will be following up with PCP on 3/10/2021.
Information has been received from a licensed practical nurse concerning a 13 year old female who on 26-OCT-2007 was vaccinated with GARDASIL vaccine (yeast) (lot# 658488/1264U), 0.5ml intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified), "into other deltoid". The patient fainted about 5 minutes after receiving GARDASIL vaccine (yeast). The patient was observed and allowed to leave when fully recovered a short time later. Medical attention was required, in the office. No laboratory studies were performed. No other symptoms noted. Additional information has been requested. Information has been receivreed from a licensed practical nurse concerning a 13 year old female who on 26-OCT-2007 was vaccinated with HPV (lot # 658488/1264U), 0.5ml, intramuscularly. The patient fainted abotu 5-10 minutes after receiving HPV vaccine. The patient was observed and allowed to leave when fully recovered a short time later. Medical attention was required, in the office. No laboratory studies were performed. No other symptoms noted. Additional information has been requested.
Patient is four months pregnant.  She received the vaccine at an employee immunization clinic.   Ten minutes post-vaccination, she reported feeling lightheaded and dizzy, HR of 121.  She was provided an area to rest and given juice and peanut butter crackers. At 30 minutes post vaccination, she continued to feel lightheaded and dizzy. Vitals: BP 122/64, P 71. Continued rest, juice, and crackers provided. EMS and RN observation at bedside. 1 hour post vaccination, she reported feeling much better and feels safe to drive home. Discharge vitals: 120/66, HR 75.
I95.89 CHRONIC HYPOTENSION 4/20/2023 SKIN LESION I95.89 CHRONIC HYPOTENSION 4/20/2023 ANEMIA
9/8/21 history of atrial fibrillation, carotid artery stenosis, MI, CAD, diastolic CHF, and COPD; presents w/chief complaints of dizziness, fall, cough
Under age requirement for vaccine series. First not found. This is the second in the series that was given and through a clinic site
history of COVID-19 infection 5/29/22, lives at a nursing home and that his breathing is feeling more labored than usual.       Admin Location (Facility) Pharmacy Loc. "PRIVATE"
This is just to notify FYI. No medical treatment require. I believe in vaccines and am glad to have received the Pfizer vaccine. That said, I had a period until two days after my second dose. It was early by two weeks. I should have started 4/15. I started bleeding 4/2 and continued until 4/25. It was very very light. I usually have a normal period for 6 days once per month average bleeding. This was very light and for 23 days and two weeks early. I haven?t had a normal period since. getting my first dose. Just FYI.
Extreme pain in lower R leg, which had had a femoral bypass in May 2020. After a couple days I called my vascular team and they took me into surgery immediately. They did some kind of pharm treatment to break up the clot. Had procedure everyday for 3 days where they ultimately used some balloon device to open up the artery again. Still monitoring, am scheduled for another follow-up next week. I'm still vertical, but they had said the leg itself might be in jeopardy. Not happy with Pfizer, that's for sure.
Information has been received from a physician concerning a male who in approximately October 2008 was vaccinated with a dose of PNEUMOVAX 23. In approximately October 2008, the patient's arm swelled. It was reported that the patient did go to the emergency room (ER) but it was unspecified if the patient was admitted. Additional information has been requested. This is an amended report. The date of vaccination has been added as "approximately October 2008".
This spontaneous report was received from a registered nurse and refers to a patient of an unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 05-JAN-2017, the patient received improperly stored doses of M-M-R II injection, subcutaneously lot # reported as M029919, expiration date 13-JUN-2018 (also reported as 23-JUN-2018) (dose was not provided) and STERILE DILUENT (strength, dose, frequency, route of administration and indication were not reported), lot# reported as M024781, expiration date 21-FEB-2019. There was no adverse effects reported. Administered doses of vaccines and the diluent experienced the temperature excursion of -3 degrees Celsius for 6 hours. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007831.
Pt. called after leaving office pt. has paresthesias per Dr., no motor deficiency. Pt. mom was instructed to take pt. to hospital if symptoms worsen. Paresthesias occurred on (L) side of face.
Approximately 3 minutes after vaccination patient experienced a pre-syncopal/syncopal event. She was advised to stay seated and put her head between her knees. She was able to follow commands, had a normal pulse throughout. She stated she felt like vomiting. She was observed for an additional 10 minutes in which she was fully alert., cooperative, able to follow commands, and stated feeling better. She was able to stand and walk steadily and was escorted out of the clinic by her parent (father)
C/o redness, discomfort, swelling. Seen by Dr received antibiotic et antihistamine
MIGRAINE HEADACHE; BODY PAIN HEAD TO TOE; LOST APPETITE/COULDN'T EAT; STOMACH PAIN; RIB PAIN; CHILLS; WEAKNESS; FEVER; NAUSEA; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no past medical history of migraine disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 12/APR/2021) dose was not reported, administered on 12-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced couldn't sleep. On 12-APR-2021, the subject experienced migraine headache. On 12-APR-2021, the subject experienced body pain head to toe. On 12-APR-2021, the subject experienced lost appetite/couldn't eat. On 12-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced rib pain. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) No temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and nausea on APR-2021, had not recovered from migraine headache, body pain head to toe, lost appetite/couldn't eat, weakness, stomach pain, and rib pain, and the outcome of couldn't sleep was not reported. This report was non-serious.
In a letter, "Dear Sirs, I am a local Kaiser member and am 88 1/2 year old and have always been "healthy as a horse." but the injection I had at office in Escondido on Nov 27, 2006 has left me very ill after Friday, Dec 1st and I cannot seem to get out of bed and back into my busy life style. I haven't even been able to get over to the Kaiser plant about a mile an a half or two miles at the most. And worst of all my eyes a terribly effected and getting worse-I also had several days of 103 fever while normal temp is usually 97 to 97.6 and I'm excessively weak and getting weaker. It is my intention to get to my Dr.'s office in the next few days-when hopefully I get some strength and file a report of the re-action my body has been going thru. I'm sure you will be hearing from us and my lack of progress
Fever and irritability within hours, followed by regression into autism by 15 months of age or during the following 2.5 months. Per annual follw up: Neurological damage, seizures, autism.
itchiness on the body; rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: 9262), via an unspecified route of administration in right arm on 15Feb2021 at 12:00, age at vaccination was 69-year-old, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9262) via an unspecified route of administration in right arm on 24Jan2021 at 12:00 as dose 1, single for COVID-19 immunization. On 25Feb2021, the patient experienced itchiness on the body and rash. No therapeutic measures were taken as a result of the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.