chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fair amount of bleeding after the needle was removed/lot of bleeding at the injection site; This is a spontaneous report from a contactable physician.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history and concomitant medications were not reported. On an unknown date, it was reported that a resident at the hospital had a fair amount of bleeding after the needle was removed. It also mentioned that a lot of bleeding at the injection site. The reporter was unsure if the resident received the Pfizer of Moderna vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
2 days after administration, pt began experiencing sporadic waves of nausea (no vomiting) for 5 days. She recovered w/o treatment.
Vaccination site necrosis; fever; feverish chill; her arm ended up with erythema; red and tight and went up to the elbow; This spontaneous report was received from a consumer refers to a 59 year-old female patient concerning herself. The patient's concurrent conditions included lipoedema, asthma, hypertension, fibromyalgia and arthritis. The patient was allergic to codeine.      On 15-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and with influenza vaccine in the same arm (dose, route, lot number and expiration date were not reported). Concomitant therapies included ketorolac tromethamine (TORADOL), hydroxyzine hydrochloride, antibiotics and ketorolac tromethamine.     In September 2020, the patient experienced vaccine necrotic tissue (vaccination site necrosis). She was sick and got a "105 fever", feverish chill and her arm ended up with erythema where it got red and tight and went up to the elbow (injection site movement impairment). The patient received pain medications, antibiotics and wound care from 12-NOV-2020 to 04-JAN-2021, and she took seven trips there over a course of seven weeks. The patient had to take the "gunk" out and said it was trauma. At the end, she had a large patch of granulation, and it's sunken in. A laboratories from primary care physician and rheumatologist were performed, but the results were not reported.  The outcome of the events was reported as not recovered/not resolved.     The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).  Upon internal review, the event of vaccination site necrosis was considered to be medically significant.
Pt received HPV9 on 12/8. C/o fever, sore arm and head ache the next day. HA lasted 3 wks, daily, throbbing and self-limited. Some dizziness and nausea no vomiting seen in office on 12/17. Normal neuro exam. No hx of headache in the past. Unsure if to give more HPV vaccine.
Temp 100 degrees F on 5/17/04. Several erythematous macules and papules. Some clear fluid filled blisters on trunk, face, left majora, arms and legs.
7hrs p/vax acute onset of sneezing, wheezing, angioedema & itching of face & throat, hoarseness;responded slowly to ventolin inhaler & DPH
Patient was given MMR #2 for equivocal measles titer and was pregnant.
Migraine going on day 2 took ibuprofen.Left arm felt like it was going to explode for 24 hrs.Felt like throwing up  about 3 hrs. Cough for about 2 hrs. Sweaty/ cold chills for 24 hrs.
i have a quarter size red painful lump at injection site.  Did not appear until day 9 after injection and was not painful until roughly 8 hours after appearance.  No drainage
Fever on site of injection. Developed into Acute gastroenteritis. On day 2 had red rash at site of injection. Lasted 48 hrs. Mottled.
Large area of swelling, redness, warmth and pain around injection site; about 6" diameter; started 1-2 d after resolving some by 72 hrs.
Extreme fatigue, sore body & joints feel weak, nausea and temp if 100.6
Areas of mild arthritis (hands and feet) flared; Significant musculoskeletal pain in back; Location of injection for vaccine received same date Flu - right; Location of injection for vaccine received same date Flu - right; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 61 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 29Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: BNT162b2 (DOSE 3 (BOOTSER), SINGLE; Lot number: EK9893; Administration time: 09:00; Anatomical location: Right arm), administration date: 18Apr2022, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "Vaccination failure", "COVID-19"; BNT162b2 (DOSE 2, SINGLE; Lot number: EN8736; administration time: 09:00; anatomical location: right arm), administration date: 22Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Vaccination failure", "COVID-19"; BNT162b2 (DOSE 1, SINGLE; Lot number: EP7533; administration time: 09:00; anatomical location: right arm), administration date: 01Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Vaccination failure", "COVID-19". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 29Sep2022, outcome "unknown" and all described as "Location of injection for vaccine received same date Flu - right"; ARTHRITIS (non-serious) with onset 01Oct2022, outcome "recovered with sequelae", described as "Areas of mild arthritis (hands and feet) flared"; BACK PAIN (non-serious) with onset 01Oct2022, outcome "recovered with sequelae", described as "Significant musculoskeletal pain in back". Therapeutic measures were not taken as a result of arthritis, back pain.  Additional Information: It was reported that significant musculoskeletal pain in back. Areas of mild arthritis (hands and feet) flared for about 9 days following injection. The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19 and no other medical history.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253368 same product, patient, different adverse events and dose.;
Swollen left arm.  Large redness area with site pain.  Fever and chills at night.
Per father, the patient recieved the vaccine at 1:15, the patient got dizzy and passed out, the nurse used ammonia to wake him up then they left the facility.  About 10 minutes after the vaccine while they were in the car, the patient grabbed his left arm injection site, began coughing, passed out, and had a seizure.  The father states that the child "stiffened up".  When I called the nurse to get the vaccine info, she states that the child wanted to keep his eyes closed before and after the vaccines and that he did not respond to verbal stimuli after the vaccines, so they used ammonia, to which the patient replied, "why did you do that?"  The nurse states they gave the child a cool, moist cloth and fanned the child.  He and his family left about 15 minutes after the shots.  Father states that the child has not had ADE's to other vaccines and no family member has had reactions to vaccines.  The child states he has had chicken pox as a child.  Has not had any vaccinations in the last month, nor is he currently ill or suffering from a fever.
The patient called the medical provider 9 months after the date of vaccination to report persistent pain at the Td injection site. The patient did not specify at what point the pain started (i.e. at time of vaccination or after several months). Patient was asked to present to office for an evaluation, but he has not returned. All attempts to obtain additional information have been unsuccessful.
Arthralgia, Fever, Diarrhea, NauseaVomiting,fatigue; shortness of breath Narrative:
One week after my shot, I noticed itchiness and a rash at the inoculation site. The rash is 2-3" in diameter and has lasted for 2 days so far.
I have had lymph node swelling in both of legs ever since I got the second booster. The swelling comes and goes. Is very painful can also cause a lot of numbness in my feet.
Soon after MCV4 injected, felt dizzy and gradually became pale, slumped on the chair - responded to name on/off. Pale lips, HR decreased 40-60, BP palpable, weak. Given intranasal O2 supported & called for EMS - on arrival still w/ bradycardia/hypotension but more aware/conscious.
Within one min of receiving flu shot, pt reported burning in muscle and arm feeling stiff. BP 120/80 pt warm to touch ice pack applied to site. No redness at site. Not hot to touch. Swelling approximately 1 inch in diameter. Returned to work. No problems when called 7:30 pm.
3/17/03 Started having palpitations and chest pain.  Client is taking B/P meds.  Needed echocardiogram on 3/19 the ultrasound during week of the 24th.  4/3 and 4/5 had another episode of palpitations and chest pain.  Stress test done 4/7. Changed meds., wore Holter monitor for 1 week. 5/27 had thyroid storm.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drug reported. No Treatment drug reported.   This case was linked to (Patient Link).
Covid + twice: late 2020 and 02/2022. I did not have an adverse reaction to the vaccination. I had the following symptoms: fever, chills, mouth ulcers and burning mouth syndrome. I drank buttermilk to try to soothe my mouth. I tried several different over-the-counter protects to relieve the pain. I had a breakout for the ulcers for two months. One out break, clear and break out again. As of today, I don't have an outbreak.
BOOSTRIX given at 2:45 pm. After 10 to 15 min. pt c/o nausea. I check O2, pulse (99%) P 80. Unable to get BP reading. I asked for nurse to assist. Pt started coughing at that time. Nurse couldn't get BP due to coughing. Provider evaluated pt and ordered oxygen, BENADRYL and EPI PEN and called 911. Pt fell out of chair, face first. Ambulance took pt to hospital.
On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms.
This case was reported by a pharmacist and described the occurrence of migraine in a 29-year-old female subject (a pharmacy technician) who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included paroxetine. On 8 October 2008 at 11:30 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 8 October 2008, approximately 40 to 60 minutes after vaccination with FLULAVAL, the subject experienced migraine, nausea and vomiting. The subject was hospitalized and the pharmacist considered the events were disabling. The subject was treated with ADVIL for migraine. At the time of reporting the outcome of the events was unspecified.
Itchy swollen sore arm 2 days later. I went to minute clinic after 7 days of itching and swelling and was given triamcinolone and told to take benedryl twice a day
Case number PHEH2013US007866 is an initial spontaneous report received from a health care professional on 03 Apr 2013. This report refers to an 11-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12009, expiry date: Feb 2014) at a dose of 0.5 ml intramuscularly on 28 Mar 2013. It was reported that the MENVEO she had received had been at 34 F for 12 hours and the vaccine was reported as not frozen. No adverse events were reported.
Left Thigh Swelling Localized Swelling, Probably reaction to immunization.
Breakthrough case of COVID, running nose, congested nose, loss of taste, little bit of coughing, chills.
Patient was taking daily CLARITIN for seasonal allergies when he received the vaccine. The KINRIX vaccine was given Monday at 4:00PM. Within 24 hours patient complained of general itchiness over his body and intense itching and discomfort at the injection site. The area around the injection site became red and swollen. By Wednesday evening the redness was 6" in diameter and swelling was from below his shoulder to just above his elbow. BENADRYL was given in addition to the CLARITIN to help relieve itching. Patient was scheduled for a food challenge at his allergist Monday so all antihistamines were discontinued Thursday evening. Symptoms remained stable Friday. Saturday morning patient work with hives covering his body. Hives were coalesced around the injections site and on the underside of his arm where he received the injection. Hives spread down his back and torso and onto his legs. A dose of BENADRYL was given to help, but the hives and arm swelling progressed. My family was traveling for the weekend so I called patient's allergist and discussed patient's symptoms and texted her numerous pictures of his reaction. Patient was prescribed ZYRTEC and 20 mg of Prednisone PO x 5 days. Symptoms started to improve within 24 hours of treatment, and significantly improved after 36 to 48 hours.
A non-serious spontaneous report of administered 17 doses of expired FLUMIST was received from a health professional concerning children. Neither relevant medical history nor concomitant medications have been reported for this patient. The two lots of the product expired on 08-Jan-2012 and 15-Jan-2012. On 31-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for this indicated population of 2 years to 59 months of age.
NEGATIVE REACTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced negative reaction, She was in the hospital and still undergoing some testing. Number of days hospitalized not reported The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative reaction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210741142-COVID-19 VACCINE AD26.COV2.S-Negative reaction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Red, swollen, hot skin by side of injection pain. Pt used TYLENOL, BENADRYL, and ice for a straight week after the vaccine and there was no improvement in symptoms.
Developed COVID-19 while on vacation in Ireland after receiving 3 doses of Pfizer Covid-19 Vaccine; Developed COVID-19 while on vacation after receiving 3 doses of Pfizer Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 29-year-old male patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Developed COVID-19 while on vacation after receiving 3 doses of Pfizer Covid-19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Negative; (Jun2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
her nose was running; sore throat; high fever; body aches; exhaustion; not appetite; cough; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PYREXIA (high fever), MYALGIA (body aches), FATIGUE (exhaustion) and DECREASED APPETITE (not appetite) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016320a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PYREXIA (high fever), MYALGIA (body aches), FATIGUE (exhaustion), DECREASED APPETITE (not appetite) and COUGH (cough). On an unknown date, the patient experienced RHINORRHOEA (her nose was running). At the time of the report, OROPHARYNGEAL PAIN (sore throat), PYREXIA (high fever), MYALGIA (body aches), FATIGUE (exhaustion), DECREASED APPETITE (not appetite), COUGH (cough) and RHINORRHOEA (her nose was running) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Blood pressure medication, Stomach medication. No treatment details was provided.
This spontaneous report as received from a medical assistant (also reported as "nurse") refers to an unspecified number of patients of unknown age. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot M039642, expiration 03-JUL-2019; lot M045653, expiration 03-JUL-2019. There was no adverse events. The doses of vaccines experienced temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. There was no previous temperature excursions. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA008739: US-009507513-1707USA008737:
None- vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-395985 (Patient Link).
01/14 Hearing in right ear seemed to change with buzzing sound. Went I went to ENT on 01/19 found I had about 80% hearing. (20% loss) The ENT tried 60mg of prednisone for 10 days. It seemed to improve while on it but went back to loss and buzzing. I went back on 1/31 follow-up. As a response to the issue was given an inner ear injection of dexamethasone. This did not help at all. On 03/03 follow up, determined that there was a need for a hearing aid. I can hear better with it but the tinnitus lingers.
With both Vaccines patient had sore arm that was hard and red and presented a rash that spreads. Also had neck and shoulder pain. the whole upper body was itching
they got a little ill for a couple of days, couldn't get out of bed; it was the first time other than arm being sore; tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (they got a little ill for a couple of days, couldn't get out of bed), PAIN IN EXTREMITY (it was the first time other than arm being sore) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049022A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (they got a little ill for a couple of days, couldn't get out of bed), PAIN IN EXTREMITY (it was the first time other than arm being sore) and FATIGUE (tired). At the time of the report, ILLNESS (they got a little ill for a couple of days, couldn't get out of bed), PAIN IN EXTREMITY (it was the first time other than arm being sore) and FATIGUE (tired) outcome was unknown.            Concomitant medication not reported.   The patient had all Moderna vaccines 1 st dose on 29 Jan 2021 with lot number 041L20A, 2nd dose on 27 Feb 2021 with lot number 023M20A, 3rd dose on 1 Nov 2021 with lot number 033F21A and 4th dose on 18 Jan 2022 with lot number 001M21A.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745579 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745579:Wife case (Master case)
Injection site was painful, tender. Injected arm muscles were very painful, hurt to move or use arm. Headache, fatigue, muscle and joint pains. no appetite, a little weak. (012M20A)
Painful redness, swelling and itching at site. Patient giver Bactrim ds 800 mg one bid x 7 days and advised to apply moist heat 4-6 times a day. Advised to follow up in 2 days.