chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Severe pain in arm pit with swelling in lymph nodes; Severe pain in arm pit with swelling in lymph nodes; Bruise; Swelling and heat from the injection site; Swelling and heat from the injection site; Tired; Joint pain; Dose 1: 29Jan2021; Dose 2: 01Sep2021; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 01Sep2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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-19 vaccine. Concomitant medications included levocetirizine dihydrochloride (XYZAL), bupropion hydrochloride (WELLBUTRIN), citalopram (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 29Jan2021 at 08:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 02Sep2021 at 08:00, the patient experienced fever, severe pain in arm pit with swelling in lymph nodes, bruise, swelling and heat from the injection site, joint pain and was tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, severe pain in arm pit with swelling in lymph nodes, bruise, swelling and heat from the injection site, tired and joint pain were resolving at the time of this report.
Information has been received from an unspecified reporter referring to a 6 week old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Pt complained of confusion, disorientation and aura-like symptoms following flu shot. Felt sick to stomach evening of vax. Increased anticonvulsant medication as needed.
Pt. states that after receiving the Influenza vaccine 10/07/2020, started experiencing symptoms 10/10/2020 of vomiting, passing out, loss hearing in the left ear, and balance issues. ER visit admitted for Observation overnight, steroid injections in eardrum treatments. Hearing loss is still noted and balance issues.
Difficulty breathing Fast heartbeat  Headache  Weakness  Chills  Fever  Eye heaviness
Patient was fine upon leaving  pharmacy on 10/01/19. Called on 10/03/19 and reported via telephone swelling at injection site and extreme shoulder pain.
Swelling, redness, soreness, itching, slight bumps - remaining and increasing in intensity to this time on 06/21/2012.
This case was reported by a physician via regulatory authority and described the occurrence of rotatory vertigo in a 63-year-old male patient who received INFLUSPLIT Tetra (batch number AFLBA083AA, expiry date 30th June 2016). Previously administered products included INFLUSPLIT Tetra (on 16th October 2014, well tolerated). On 15th October 2015, the patient received the 1st dose of INFLUSPLIT (intramuscular). On 15th October 2015, less than a day after receiving INFLUSPLIT, the patient experienced rotatory vertigo (serious criteria hospitalization) and nystagmus. On an unknown date, the outcome of the rotatory vertigo and nystagmus were not recovered/not resolved. It was unknown if the reporter considered the rotatory vertigo and nystagmus to be related to INFLUSPLIT Tetra. Additional details were provided as follows: The patient's concomitant medication was not reported. The patient experienced rotatory vertigo and nystagmus which lasted for more than 24 hours. On 16th October 2015, the patient was hospitalised for the events. At the time of reporting, the events were not resolved.
Information has been received from a physician reported that a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. After receiving PNEUMOVAX 23, the patient experienced hives. Physician also mentioned that the patient experienced hives after receiving TORADOL. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. This is an amended report. ONUM type was changed from MULTIPLE to MNSC. No further information is available.
her Vitamin D has been low; arm being red and sore; arm being red and sore; arm is swollen and red; started to itch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 11:15 (Lot number: FE3592) at the age of 65 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diagnosed 15 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot FC3182), administration date: 02Sep2021, for COVID-19 Immunization. The following information was reported: ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Sep2021, outcome "not recovered" and all described as "arm being red and sore"; PERIPHERAL SWELLING (non-serious) with onset 26Sep2021, outcome "not recovered", described as "arm is swollen and red"; PRURITUS (non-serious) with onset 26Sep2021, outcome "not recovered", described as "started to itch"; VITAMIN D DECREASED (non-serious), outcome "not recovered", described as "her Vitamin D has been low". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any Prior Vaccinations (within 4 weeks) of suspect vaccine. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.
expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Patient receive SHINGRIX on 11/24/18 patient called pharmacy on 11/29/2018  stating he is developing rash and itch around face and upper torso. Patient was advised to take some BENADRYL and talk with his PCP. Patient primary care doctor prescribed MEDROL DOSEPAK  thinking delayed adverse reaction. On 12/02/2018 patient rash was not gone and patient ended up going to urgent care where Dr. diagnose him with chicken pox and gave him VALTREX and KEFLEX. Patient also took 7 day off from work. In mean time we also called manufacture and report the adverse event. Patient had a follow up visit with PCP on 12/07/2018 where PCP also confirm the diagnosis of chicken pox.
Strong Metallic taste in mouth with mild nausea lasting  over 5 days.  The same thing happened with the first dose, but I wasn?t sure it was attributable to the vaccine.until it happened with the second dose.
On 3/23/15 mom noticed very loose diarrhea and vomiting at about 1 pm, then two hours later it happened again and diarrhea stopped 2 days after he was hospitalized. Was given IV fluids to hydrate after very bad dehydration. Was discharged 3/30/15.
Seven to ten days after vaccine administration, the pt started developing musculoskeletal problems (legs and arms). Less movement = increased pain. He has started using pain meds and muscle relaxers to relieve the pain.
injection site has rash like hives that is red but raised; injection site has rash like hives that is red but raised; tired; could not eat; woke up twice soak and wet last night; nauseated; fever of 102.4; slight headache; later intensified and it felt like her head was going to explode; chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night), VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised), VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) and HEADACHE (slight headache; later intensified and it felt like her head was going to explode) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HEADACHE (slight headache; later intensified and it felt like her head was going to explode), CHILLS (chills), MYALGIA (Body aches) and PYREXIA (fever of 102.4). On 14-Mar-2021, the patient experienced DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night) and NAUSEA (nauseated). On 15-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised), VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) and FATIGUE (tired). At the time of the report, DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night), HEADACHE (slight headache; later intensified and it felt like her head was going to explode), CHILLS (chills), MYALGIA (Body aches), NAUSEA (nauseated), PYREXIA (fever of 102.4) and FATIGUE (tired) was resolving and VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised) and VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 102.4 (High) high.         Concomitant medications were not provided by the reporter.  On 14MAR2021 the patient took an acetaminophen to alleviate the symptoms, but it did not really work. The following day, she took acetaminophen every 4 hours.
Shortness of breath, almost heart attack, passed out, vomiting, chill from head to toe, both feet and hands were numb, exhausted, dizzy. Took Ibuprofen. Follow-up: I do not want to release my medical record.
Had a fever, then started having numbness in her leg and just not feeling right.  Started following day when she reported it.  She didn't want to go to ER or Urgent Care, it was late in the evening when she called.  No redness or swelling on leg.  I called in the morning and it felt better. As of 6/9, she still says she doesn't feel right.  Sleeping 10-12 hours a night, which she never has, and she can't concentrate when she is working.
Watery diarrhea within 8 hours of administration of flu shots, lasting 2 hours persistently, aches, nausea, fatigue, malaise lasting 1 week
Information has been received from a physicians assistant concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine 650453/0791P. Subsequently the pt developed cellulitis with a fever, and injection site swelling, pain and redness. The pt went to the ER. Subsequently, the pt recovered. The reporter expressed a concern about the lot number. No product quality complaint was involved. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control Quarantine rejection system revealed that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
Patient presented to Hospital with inferior ST segment elevations on EKG and troponin elevation concerning for STEMI. He underwent cardiac catheterization and diagnosed with myocarditis. Echocardiogram showed moderately reduced LV systolic function with ejection fraction 40-45%
Patient in clinic to receive meningococcal and tdap immunizations. Patient stated he was nervous, but tolerated injections well. Upon exiting to the clinic waiting room, patient became dizzy and sat down. After sitting down, patient passed out in the chair. Patient's mother called for help. RN responded and observed patient had lost consciousness. RN laid patient down, put his feet up, and attempted to arouse him. Patient regained consciousness immediately but was still very pale with blue tinged lips. RN instructed clerk to call 911. RN took patient BP and found it to be WNL at 116/74. RN continued to talk with patient. Patient admitted to not having anything to eat since breakfast. Patient stated he was feeling better but was not ready to sit up yet. Within a few minutes, patient no longer had blue tinged lips, and normal color began to return. Patient sat up, and RN gave him water and a snack. Patient tolerated water and snack well. Paramedics arrived on the scene. Paramedic assessed patient, found patient's vitals to be BP of 120/80, pulse in the 80s, and pulse oxygenation to be 96-97%. Paramedic had patient stand up and walk around, patient tolerated activity well. Paramedic gave recommendation that patient should be allowed to return home, but could be taken to the hospital if patient's mother felt it was necessary. Patient and mother returned home.
Patient was given the Menveo Vial 2 ONLY; Patient was given the Menveo Vial 2 ONLY; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 38-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA687A, expiry date 31st October 2022) for prophylaxis.   On 7th April 2022, the patient received Menveo (intramuscular). On 7th April 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-APR-2022  Reporter's Comments: The pharmacist reported that the patient was given the Menveo vial 2 only in the left deltoid. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo vial 2 only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
DTAP administered Thursday afternoon. 5th dose. Upon waking Friday morning, I noticed redness and swelling at the injection site. He complained that it hurt. I gave him ibuprofen and put an ice pack on the injection site. By Saturday morning, it had worsened. The red area was about 4 inches in diameter, was hard to the touch and very hot. I called the doctor and was advised to put warm compresses on the area 5-6 times throughout the day and take him to the ER if it got worse. I applied warm compresses. By Sunday morning it had improved slightly. By Monday morning it was looking much better - heat, swelling and color had reduced and he no longer complained that it was painful.
I tested positive for COVID-19 on 5/24/22. I started having symptoms on 5/11/22.  I had congestion, cough, headache, and sore throat. On the second day I just had the headache and cough. I am still dealing with this at this time.
Went on 8-30-14 to get the shingle vaccination. The girl never explain about the adverse till after she gave the shot and I would never got the shot. My arm is hurting still today. 10-2-14 I went to the store. 2 x then my doctor. I'm on pain pills can't work.
The morning following the vaccine, she had a fever, chills, felt really sick.  Also had a headache, a lot of muscle and joint pain.  She was nauseous, no appetite, and abdominal pain.  Very tired as well.  She did not take anything for it, just slept and by the morning of 2/6/21 was still tired, but not sick anymore and able to eat some, was not able to prior to this.
Getting worst at injection site; it is hot to the touch; Big red circle at injection site; It is really itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Getting worst at injection site), VACCINATION SITE WARMTH (it is hot to the touch), VACCINATION SITE ERYTHEMA (Big red circle at injection site) and VACCINATION SITE PRURITUS (It is really itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included CELECOXIB for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE REACTION (Getting worst at injection site), VACCINATION SITE WARMTH (it is hot to the touch), VACCINATION SITE ERYTHEMA (Big red circle at injection site) and VACCINATION SITE PRURITUS (It is really itchy). At the time of the report, VACCINATION SITE REACTION (Getting worst at injection site), VACCINATION SITE WARMTH (it is hot to the touch), VACCINATION SITE ERYTHEMA (Big red circle at injection site) and VACCINATION SITE PRURITUS (It is really itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Tylenol
Headache, Arthralgia, Fever, FATICUE, CHILLS, PAIN/SWELLING INJ SITE, Narrative:
Sore sholder and upper arm with impaired range of motion 3-20-13 PC from her to lodge a complaint about high dose flu vaccine. She said her arm was sore the next day and just keeps getting more and more sore. Now it is impairing her snow shoveling ability and she wanted to report it. Said it was her first dose of High Dose flu however our records indicate it was her third. She said she mentioned this to her doctor during her regular appointment and was diagnosed with possible tendonitis and physical therapy was recommended. She complained she has no transportation and decided not to go. I strongly recommended she see her doctor and do the PT.
The night after my second vaccine,  I started experiencing burning pain in my left hip area. I had a total left hip replacement on June 1st and had no pain in that hip prior to the second vaccine.
Had immun @ 1130AM; @ 930PM eyes were dilates, poor color, stopped breathing & turned blue; mom gave CPR called paramedics who transported to ER;
This medically confirmed spontaneous report (initial receipt 22-Jul-2015) concerns a patient (demography not reported). On an unspecified date, the patient received unspecified flu vaccination (batch number not reported) and ZOSTAVAX (batch number not reported) concomitantly. On an unspecified date, the patient experienced local itching. No further information was provided. The outcome was not reported.
A consumer report has been received. The report concerns a 10 year old, Male consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 28-Oct-2013. The patient experienced patient has been having harder time with focusing at school and at home. The outcome of the event of patient has been having harder time with focusing at school and at home is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune on 09-Jan-2014 from consumer: Patients initials, date of birth added. Reporters tab updated.
VACCINE SYRINGE REMOVED FROM FRIDGE AT 08:11 AND ADMINISTERED AT 11:53 TODAY(OUT OF SPECIFICATION PRODUCT USE); VACCINE KEPT FOR OUT OF FRIDGE FROM 8:11 TO 11:53(INCORRECT PRODUCT STORAGE); This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 18-JUN-2021 11:53 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-JUN-2021, the subject experienced vaccine syringe removed from fridge at 08:11 h and administered at 11:53 h today (out of specification product use). On 18-JUN-2021, the subject experienced vaccine kept for out of fridge from 8:11 to 11:53 (incorrect product storage). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine syringe removed from fridge at 08:11 h and administered at 11:53 h today(out of specification product use) and vaccine kept for out of fridge from 8:11 to 11:53(incorrect product storage) was not reported. This report was non-serious.
Pt received DTaP #4 R th. and IPV #3 L th. on 10/31/02. Presented in office 11/1/02 with redness and swelling on R thigh.
0830 c/o dizziness, bp 139/78 hr 86. given water and laid flat.  0833 physician asked pt to sit up bp 141/80 hr 90 0850 bp 132/96, hr 95. pt able sit, stand, walk without difficulty. pt discharged from site.
Pt came back to pharmacy on 9/26/14 after receiving shots on 9/22 to report fever of 102 degrees and arm is red from shoulder to elbow and hot to touch.
Patient started with upset stomach and shaky around 1:45 pm. When pt got home from school had diarrhea and upset stomach. The shaking did stop at home. She rested and drank fluids. Sx improved the next day 9/16/16.
BAD CHILLS; MAJOR HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced bad chills, and major headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from bad chills, and major headache. This report was non-serious.
woke up in the middle of the night with a fever of 101, remained with fever and fussiness all day; that evening had a seizure and at ER temperature was 104