chrisvoncsefalvay/vaers-outcomes huggingface dataset:
each of them feeling sick; aching all over for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "aching all over for a day or two". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "each of them feeling sick"; PAIN (non-serious), outcome "recovered", described as "aching all over for a day or two".  Additional information: Caller reported receiving 6 Pfizer COVID-19 vaccine injections in the past (dates and formulations not provided) and after each of them feeling sick and aching all over for a day or two. Caller's last Pfizer COVID-19 injection was in May.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312955 Same patient/vaccine/event, different dose;
Pt devel hives 45-60 minutes p/receiving immun; Given Tavist & now doing fine;
within 24 hours of receiving my 2nd dose, I first experienced common side effects: fever, chills, headache, muscle pain, nerve pain, severe fatigue, etc. However, around 8:00 PM 27 hours after vaccination, I began experiencing strange and severe pain/pressure around my eyes - especially above my eye below the brow bone. It has now been three days since vaccination and the pain has not subsided. It has possibly increased. It hurts to look side to side and up and down. My eyes refuse to water naturally and seem to be swollen. Lubricant drops provide little relief. This side effect is in both eyes but slightly worse in the left eye.
Severe headaches for the last 6 days since getting the vaccine, and my menstrual cycle began earlier than normal
Elian was given the wrong vaccine. He was given the 5 -11 years covid vaccine when he was only 4 years old.
Metallic taste within minutes of injection; Severe headache; Nausea; Dizziness; Fatigue; Slight swelling in face and eyes; Slight swelling in face and eyes; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 05May2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL); for an unknown indication from an unknown date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN), TRIPTANS (unspecified), sulfamethoxazole/ trimethoprim (BACTRIM), sumatriptan (IMITREX) and experienced drug allergy.  On 05May2021, the patient experienced metallic taste within minutes of injection, severe headache, nausea, dizziness, fatigue, slight swelling in face and eyes. The events did not result in doctor or other health care professional office/clinic visit, and 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 metallic taste within minutes of injection, severe headache, nausea, dizziness, fatigue, slight swelling in face and eyes was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Red, swollen, hot 4" band across width of arm (right) above elbow. Approximately 3" below hwere Pneumovax was given. 1 week later, it is gone.
C/o itching 30 min later, swelling of body, redness of skin, problems breathing. Seen in ER, was given BENADRYL and EPI - kept in ER x4 hr. Sent home with Rx for steroids.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; ZETIA. Past drug history included: Actonel, reaction(s): "known aleergies: Actonel". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid..  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
severe stomach cramps; Upon standing up, fell over; diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach cramps), FALL (Upon standing up, fell over) and DIARRHOEA (diarrhea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach cramps), FALL (Upon standing up, fell over) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (severe stomach cramps), FALL (Upon standing up, fell over) and DIARRHOEA (diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Electrocardiogram: normal (normal) normal. On 04-Apr-2021, Vital signs measurement: normal (normal) bloodwork normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment medications provided by the reporter.
1/12 Sat soreness left side of neck, felt nodule middle and above left collar bone, size of an M&M, firm feels the same from Sat to today Tuesday muscle aches went away after 24 hours
Fatigue, headache, body ache, chills, nausea Started in the morning, faded in the evening
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-364572 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up contains no new information.
I82.401 ACUTE POSTPROCEDURAL DVT OF RIGHT LEG, UNSPECIFIED VEIN 3/15/2023 ACUTE EMBOLISM & THROMBOSIS OF RIGHT ILIAC VEIN
I started to have blisters that seamed like a burn at my upper back. But I ignored them because I thought that with time it will go away. Then the blisters begin to spread to my chest. Months later I had in my under arm, upper and lower back, belly and head. Sometimes it would get itchy and a burning feeling.  After approximately 6 months and after numerous biopsies doctors diagnosed me with an autoinmune diasease and it all began after my third covid-19 dose. All my live I've been healthy and never been hospilatized. Finally a blood test and a inmunofluoesent biopsy was enough to get my diagnosis. I got no family history of autoinmune diasease.
Pt reported pretty severe headache, diarrhea, and nausea - lasted for about 1 and 1/2 - 2 days.
I had a rash all over my arms, my legs, my crotch, my nose, my eyes, my ears, and my scalp. It continued to get worse. I will call back to provide LOT number for vaccine. My eyes were starting to get really red and I saw the doctor for the skin rash.
Started to experience shortness of breath and chest pain on 4Oct15. Was induced into a coma on 8Oct18 due to coughing up blood tinged fluid and having fluid build up around my heart. Was intubated for 4 days and kept in observation for several days after that.
5 minutes after receiving vaccine I started feeling ?heavy ?. This progressed until I was diagnosed with Covid pneumonia and hospitalized on 1/17/21. I must have had asymptomatic case of Covid that was escalated by vaccine.
Patient devloped cellulitis at site of smallpox vaccination on vaccine day 9 which required her to miss a day of work.
Adult dose of 0.5ml given to patient under 3yr of age. Health Department contacted as well as patients parents. No symptoms.
Pt. woke up during night with painful arm. This a.m. 10/24/08 arm very sore decreased R.O.M. Red/swollen area 11 cm wide x 16 1/2 cm in length
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient experienced syncopal episode within 10 minutes after immunization.  He was standing at the time, and fell into the floor.  He was not injured.  911 was called out of precation.  His vital signs were good.  Patient left store on his own accord after being checked by EMT.
Red area, warm to touch. Pt went to walk in clinic and was treated with Cephalexin. Infection is healing well.
Left arm pain, weakness, onset with injection; worse that night. Steroid injection, physical therapy, arthroscopy on 5/11/17.
PT COMPLAINED OF SLEEPING FOR 36 HOURS. THEN DIZZINESS AFTER AWAKENING. THEN  SYNCOPE ON 2/12/22. 911 WAS CALLED. PT HAS RECOVERED
This case was reported by a consumer (the company owner) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the event was unspecified. The consumer reported that 5 employees at one company and one employee at another company all reported extreme redness at the injection site after receiving FLULAVAL. This is case 5 of 6 (see case IDs A0952647A, A0952653A-A0952655A, A0952657A for details of the other reports).
Headache; Chills; Muscle ache; Fever; Vomiting; Fatigue, feeling uncomfortable; feeling fairly uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle ache), PYREXIA (Fever) and VOMITING (Vomiting) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Apr-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle ache), PYREXIA (Fever), VOMITING (Vomiting), FATIGUE (Fatigue, feeling uncomfortable) and DISCOMFORT (feeling fairly uncomfortable). At the time of the report, HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle ache), PYREXIA (Fever), VOMITING (Vomiting), FATIGUE (Fatigue, feeling uncomfortable) and DISCOMFORT (feeling fairly uncomfortable) outcome was unknown.        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.   no concomitant medications are provided. treatment to the events not provided.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 21-OCT-2015 the patient was vaccinated with one improperly stored dose of ZOSTAVAX (lot # was reported as L0274322, expiration date 21-OCT-2016, dose and route unspecified). No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-DEC-2014 the patient was vaccinated with a dose of M-M-R II (subcutaneous, dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
After 30 mins walking to my car profusely coughing, able to drink however couldn't clear my throat. I thought about getting Benadryl and going home. I went back in the facility to get observed for 2 hours and I was given Benadryl then I was fine.
Pain at injection site. No other side effects.; Maternal exposure during pregnancy; This is a spontaneous report from a contactable Nurse (patient). This nurse reported information for both mother and fetus/baby. This is the maternal report. A 32-year-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 05Feb2021 14:00 pm (age at vaccination was 32-year-old) at a single dose for COVID-19 immunization. Medical history included hypothyroidism, PCOS and Raynaud's. The patient had no known allergies. The other medications the patient received within 2 weeks of vaccination included levothyroxine sodium (LEVOTHYROXINE SODIUM) and ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]). The patient was pregnant at the time of vaccination. Gestational period was 14 weeks. The patient's delivery due date was reported as 07Aug2021. On 05Feb2021 at 14:00 pm, the patient experienced maternal exposure during pregnancy. On 05Feb2021 at 18:00 pm, the patient experienced pain at injection site. No other side effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event vaccination site pain was recovered on an unknown date and outcome of event maternal exposure during pregnancy was unknown.  Follow up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021239924 mother/fetus
Patient given shingrix vaccination Tuesday around 11:30 am. He returned late Thursday night with slight redness/warm at injection site as well as red, circular rash down right arm from injection site to wrist. patient stated some off/on itching. Stated that around 1 am he experienced shivering/shaking and feeling cold but that it went away by Thursday night. I followed-up with Glaxo Smith Klien and the patient Friday morning.  Patient stated rash appears to have "almost went away now".  Patient primary care physician was unavailable to discuss/ inform of the side effects but will follow-up Monday.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.0 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, and headache. This report was non-serious.
This spontaneous report was received from a certified medical Assistant refers to a patient of unknown age and gender. On an unknown date, the PROQUAD (Merck) was improperly stored and was inadvertently administered to a patient on 09-JUL-2014 (dose and lot # were not reported). The outcome of improperly stored PROQUAD (Merck) was inadvertently administered to a patient was unknown. Additional information has been requested.
Not feeling well/feeling bad; fever of 103.5/started out last night at 100.8/101.5, this morning it was a 103.5/he's burning up/feeling very warm last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received pf-06928316 (ABRYSVO), on 21Sep2023 at 22:30 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 21Sep2023, outcome "unknown", described as "Not feeling well/feeling bad"; PYREXIA (non-serious) with onset 21Sep2023, outcome "unknown", described as "fever of 103.5/started out last night at 100.8/101.5, this morning it was a 103.5/he's burning up/feeling very warm last night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, pyrexia.  Additional information: Reporter's husband is currently in the bed. She said that he received the Abrysvo at 10:30 yesterday started feeling bad and started feeling very warm last night. His temperature was 100.8 and then about an hour later his temperature was 101.8. He had a terrible night last night and this morning and his temperature was 103.5. He had a terrible night and was treated with Tylenol last night.   The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
Patient describes onset of joint pain in October 2001, during first semester of RN program, 2 months after received MMR vaccination. Barely able to complete the one semester, she then dropped out due to diagnosis of rhematoid arthritis. Just now returning to RN program with permission of her rheumatologist as her arthritis symptoms waning.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified patients were vaccinated with doses of VARIVAX (Merck), (strength, dose, frequency, route and anatomical location were not reported), (lot# L007225 with expiration date: 03-MAR-2017, and lot# reported as K018960 with expiration date: 15-OCT-2016), which were improperly storage. Other suspect and concomitant therapies were not reported. No adverse events were reported. Additional information has been requested.
Sunburn-like rash on face, neck, chest, back and arms. It also burns like a sunburn and my skin feels tight. This started at 7pm tonight and is continuing now, 40 minutes later.
AFTER INJECTION - ABOUT 10 MINS- SWELLING DOWN THE FOREARM AND WRIST. AT 6:30PM, CHILLS, TEMP 99.1. BY 10PM, TEMP CHILLS ALONG WITH FATIGUE. TOOK ADVIL.
pt came into store 7/26/21 complaining of sore arm with numbess and tingling down the arm also. told pt to contact md
Day after injection my tinnitus shot up to higher level of noise in my head.   It now continues at a louder noise and I?m having second thoughts about getting the 2nd dose since it could make the tinnitus even worse.
Headache, Myalgia, Arthralgia, Fever, Rash, NauseaVomiting,  INJECTION SITE PAIN, SWOLLEN GLANDS  Narrative:   Other Relevant History:
This spontaneous report was received from a 78 year old female patient with an allergy to sulfur. No other information about concomitant medications or past medical history was reported. On an unknown date (reported as "over a year ago"), the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously. After the patient received the ZOSTAVAX, she had to go to the medical center because she developed a rash and small red bumps all over her body (onset date unknown). The patient received unspecified treatment. There were no diagnostic studies or laboratory tests performed. It has been over a year, and the patient has not recovered from the rash or the red bumps all over her body. Additional information is not expected.
Was given 0.25ML MODERNA BIVALENT BOOSTER.  No apparent injury.
w/in hour, arm sore; 5pm-fatigued, some body/muscle aches; 8:30pm-slight headache; 9:30-more body/muscle aches, very tired; 10:30pm-cold; 11pm-started shivering; 11:30-temp of 99°, coughing; by 1am-temp up to 101.7°, continuous coughing, headache, body aches, chills, shivering, some nausea. Continued throughout night. But by 8:30am, temp lowering, now 100.8°, no more chills/shivering, not cold, but actually hot, body/muscle aches & cough had started to subside, headache& nausea gone. By 10:30 - all symptoms gone except very tired. 11:30 until late afternoon-exhausted, slept. Next day, I was fine, not one symptom.
Shoulder surgery; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER OPERATION (Shoulder surgery) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SHOULDER OPERATION (Shoulder surgery). At the time of the report, SHOULDER OPERATION (Shoulder surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. The patient wants to know will the shoulder surgery effect the second Moderna vaccine he is scheduled for on 5-28-2021. No treatment information was provided.