chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received from a healthcare professional on 20 September 2012. A 67-years-old female patient whose medical history included restless leg syndrome and concomitant medications were not reported had received a dose of FLUZONE HD vaccine (Batch Lot number: U4499AA, route of administration not reported) in left deltoid on 19 September 2012. The reporter stated that, the patient experienced "Charley horses" in both legs on 19 September 2012 (the day of vaccination) and also on the next day of vaccination. Laboratory details were none and corrective treatment was not reported. As of 20 September 2012, the patient had not recovered from the event. Documents held by sender: none.
VARIVAX was ordered by MD/ZOSTAVAX given by error.  Both meds side by side on freezer shelf/Merck contacted/observe child/child was without any side effects after 24 hours.
Foster mom reports red, raised rash on face 1/7/10-extended across cheeks, now to both temples-also c/o being fussy and "stuffy"-states on 1/9 rash progressed to arms and legs-no rash to torso-on 1/10 spoke with pharmacist-applied OTC hydrocortisone cream and states as of 1/11 rash "some better". Stated baby also on antibiotic at time of injections but d/c now-bottle discarded-does not know name of antibiotic.
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
jerked back & forth x 2mins; eyes rolled back in head-not coherent x20mins; slept 1 1/2hr p/event-occurred 7JUL95-vax 5JUL95;
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of discomfort (1st dose received on an unknown date-refer case US2018GSK152830). On 20th July 2018, the patient received the 2nd dose of SHINGRIX. On 20th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: After receiving 2nd dose of SHINGRIX, the patient came back into the clinic later that day and complained of extreme arm pain. The patient followed up at clinic on 26th July 2018 and she still had arm pain but was subsiding. This case has been linked with case US2018GSK152830, reported by same reporter for same patient.
Over 24 hours after shot developed rash on left arm BELOW not at the injection site. Similar rash 7 days after first shot. This one came sooner, was more intense. Itching, burning, very red, about 3 inches wide and 4 inches log starting about two inches below the injection site.
Fatigue, diarrhea (02/04/2021 - 02/06/2021)
Large 8 inch by 5 inch red, swollen, area from 3 inches above the injection site to the elbow, hard lump under injection site, Itching, hot,  then progressed to blisters, area about 2 inches square, fluid filled.
8-12hr post vax pt devel t103, inconsolable crying w/local swelling x 3hr;
Increasing erythema and temp circumference around and down arm to elbow and approximately 2 inches into the forearm.
Developed pericarditis Jan 2022. Sick for over 2 weeks. Confirmed by Ct scan. Neg tb test. Was given azithromycin  and depomedtol. Symptoms relieved in 3 weeks. Extreme fatigue, high fever for several days 103.5.   Insurance refused several follow up test for heart check up. Have had same pain in chest a few times and have now started to have bilateral ankle swelling  that I have never had.
Myalgias / arthralgias / HA (L) shoulder pain with t ROM-->Bursitis Rx CALEBREX/NORCO/ROM exercises
Patient was given dose 1 Pfizer 5/19/21, given Moderna for dose 2 on 6/9/21 mistaknely; no AEs reported at this time
It was reported that a 41 year old female received a Fluzone WV '99-'00 vaccination on 11/5/99. Reportedly, that same day, the pt developed hives on trunk and arms; also experienced itching of her face and scalp. The pt was treated with oral Benadryl and was given oral Benadryl to take home. Correspondence received on 12/1/99, provided additional pt demographic data.
fatigue; headache; chills; fever; swelling at injection site; swelling on body and limbs; swelling on body and limbs; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 11:30 as dose 1, single (Lot number: HF9275) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, start date: 19Sep2023, stop date: 19Sep2023. Vaccination history included: Covid-19 vaccine (Dose 4 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1, 2 Manufacturer unknown, Primary immunization completed), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering"; FATIGUE (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering"; PYREXIA (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering"; INJECTION SITE SWELLING (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering", described as "swelling at injection site"; SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 03Oct2023 at 21:30, outcome "recovering" and all described as "swelling on body and limbs"; VOMITING (non-serious) with onset 03Oct2023 at 21:30, outcome "recovering". Therapeutic measures were not taken as a result of fatigue, headache, chills, pyrexia, injection site swelling, swelling, peripheral swelling, vomiting. Additional information: The patient did not diagnose covid prior vaccination and was not tested for covid post vaccination. The patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a lawyer regarding a case in litigation concerning an adult male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On or about 31-OCT-2008, the patient was inoculated with a dose of ZOSTAVAX in a Clinic as recommended for routine adult health maintenance and for the long-term prevention of shingles (strength, route, anatomical location, dose number, lot/batch # and expiration date were not reported). On or about 31-AUG-2016, the patient was treated in a Clinic by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The vaccine did not prevent shingles as intended, and subsequently contracted a persistent strain of herpes zoster or shingles (vaccination failure). The patient was prescribed VALTREX for management of his painful symptoms and chronic pain (post herpetic neuralgia). As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages (injury), and required extensive medical care and treatment. As a further proximate result, he had suffered and would continue to suffer significant medical expenses, and pain and suffering (emotional distress), and other damages (injury). At the time of reporting, the outcome of vaccination failure, herpes zoster, emotional distress, injury, pain and post herpetic neuralgia was unknown. The reporter considered the events to be related to ZOSTAVAX.
PATIENT NOTICED A TENDER, RED, SLIGHTY PUFFY AREA AT THE SITE OF INJECTION MEASURING APPROXIMATELY 1" X 3". PATIENT WAS NOT SURE WHEN IT BEGAN BUT FIRST NOTICED IT AND CAME TO US ON 07.18.17. AT THIS TIME PATIENT HAD NOT DONE ANYTHING TO TREAT THE AREA.
Fever; Chills; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at the age of 51-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included Blood pressure high, Thyroid, Water retention. Concomitant medications included amlodipine, levothyroxine, atenolol, Montelukast, losartan, potassium, salbutamol sulfate (PROAIR HFA), budesonide, formoterol fumarate (SYM-BICORT), fluticasone all taken for unspecified indication and Furosemide for Water retention. The patient experienced fever, chills, diarrhea on unknown date in 2021. Patient received treatment for the event fever with Ibuprofen and not received treatment for the other events. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Following day after vaccine given, pt states to have body aches and swollen lip; went to hospital after taking Bayer Back and Body. After two weeks after taking allergy med's she went back to ER due to a rash.
Rec'd first set of age appropr vaccines within 5 min after admin of Imm. develop migratory urticaria & wheezing in lungs - SpO2 100% - nebulized Albuterol treatment - pt to ED 1930 - exam unremarkable.
Cellulitis to the whole left arm, 3 days post Anthrax vaccine.  Pt #5 of 6 series.  Physician recommended Ceftriaxom IgM IM now, then Keflex 500 every 6 hours for 10 days for treatment.  Immobilized left arm.
The pt reported warmth, redness and swelling at the site of the injection onset 10/6/22.  The pt also reported fever and itchy red sores on chest, back, legs and face onset 10/6/22.  Symptoms were reported on 10/7/22 at 5:30 pm.  Dr. was notified of the reaction via email.  The pt was going to go to see his PCP the following day.  The pt was seen by his PCP on 10/8/22 and was diagnosed with the Chicken Pox.  He was sent home without treatment just symptom management.  He reports feeling much better and that most of the sores are either completely gone or much smaller and dried.
Moderate tenderness at injection site; Malaise; Headache; This is a spontaneous report from a contactable nurse, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: en5318) via unknown route on 28Jan2021 09:30 AM as a single dose at left arm for COVID-19 immunisation. The patients medical history was not reported. No drug allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ej1686) via unknown route on 07Jan2021 09:45 AM as a single dose on left arm for Covid-19 immunization. After second dose on 28Jan2021 03:00 PM, the patient experienced moderate tenderness at injection site starting at 6 hours posts vaccine. Next day general malaise and headache for several days. The outcome of the events were recovered on an unknown date in 2021.
Caller received vaccine 1/31/21. Called today and stated he has a temp of 100.9  and feels achy like he has the flu. He stated he had a sore arm right after the vaccine but that it is gone now.  He denies SOB, chest pain, or any other symptoms. RN reviewed taking Tylenol or Advil, which ever he takes when he has pain, drinking plenty of fluids and rest. RN reviewed red flags to call 911. RN stated will follo up with him tomorrow.
1/3/10 approx 1245pm Bilateral neck pain, headache, lightheaded. Approx 125pm still present but better. 205pm feeling better. 1/5/10 pt is fine.
8/25/2021, I tested positive for Covid-19 via home test via nasal swab. There have been 2 students with prior positive covid 19 case. I still have fatigue and loss of taste and smell.
Patient develops, vesicle rash at injection site and right side of neck. Used Benadryl and hydrocortisone cream, resolved in 3 days.
Patient is a 4 y.o. male. He presents with his family to the office today with complaints of rendess, swelling in thighs that have been ongoing since his vaccinations.  There is mild itch in both thighs, some pain in Lt thigh.  No fevers.  He was "tired" for a few days, mother denies fevers.  Pt with hyperemic rash on both thighs, Lt > Rt; Pt with indurated, red and tender area on Lt thigh within the hives rash.  Both thighs were ink-marked and dated. Vaccine reaction, initial encounter Vaccine reaction, initial encounter [T50.Z95A] Comment: Pt has notable history of vaccine reaction as an infant, and again now as a toddler; will only vaccinate ONE AT A TIME with predosing of Claritin
Info has been received from a consumer concerning his 57 day old son w/no past medical history and no allergies who on 6/12/02 was vax'd with Haemophilus B conjugate vax (0.5 ml). There was no concomitant medication. The reporter stated that the PT received two accidental doses of Haemophilus B conjugate vax and the PT became sleepy. The reporter stated that the MD stated that "there will not be any complications from the accidental dose of haemophilus B conjugate vax". The PT did seek medical attention. Add'l info. has been requested.
5/9/21- started with headache, bad chills, aches, pains and fatigue 5/10/21- left heel pain & swelling,  Hard to walk and put weight on foot., started to limp. 5/11/21- left foot swelled so bad, couldn't fit a shoe on. weakness in left hip, no weight on left foot. left hip felt like it would give out. 5/12/21- no weight on left foot, left foot & ankle really swollen. left hip pain & weakness. swelling left about 8 weeks later- pain & weakness in left hip lasted until about the end of Oct. 2021.
Rash on bridge of nose, swollen nasal passage below eyes, crusty discharge from right nasal cavity, itching around waistline on back, unable to have full range of motion on neck from side to side on 11/15/13. 11/16/13 nasal passages under both eyes swollen pink, eye lids swollen pink, nose sore, discharge from both nasal passages, neck continues to be sore.
arm is still Red and swollen; arm is still Red and swollen; Low grade fever 100 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is still Red and swollen), ERYTHEMA (arm is still Red and swollen) and PYREXIA (Low grade fever 100 degrees F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is still Red and swollen), ERYTHEMA (arm is still Red and swollen) and PYREXIA (Low grade fever 100 degrees F). At the time of the report, PERIPHERAL SWELLING (arm is still Red and swollen), ERYTHEMA (arm is still Red and swollen) and PYREXIA (Low grade fever 100 degrees F) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Information has been received from a registered nurse concerning a 8 year old female student with a history of chronic otitis media who on 7/30/02 in the PM was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 640821/1438L). Illness at the time of vaccination included left otitis externa treated with hydrocortisone (+) neomycin sulfate (+) polymyxin B sulfate. On 4/26/04, the patient presented with her mother to the office with over 150 vesicular lesions, which were diagnosed as chicken pox by the physician. An onset time of 15:50 on 4/26/04 was noted. The lesions were confined mostly to the upper torso. The patient had a fever of 99 to 100 degrees F. The physician recommended Aveno, diphenhydramine hydrochloride and calamine lotion, but no aspirin. The physician also stated that patient should be isolated. Laboratory tests were not performed. On 5/6/04, the patient recovered and returned to school. A product quality complaint was not involved. Additional information is not expected.
1 of 4 pts exp an inject site react which began 1 wk following vax; no other clinical info available;
Pt reported that he sometimes passes out when he gives blood, but thought that he should be fine with a flu shot. I administered vaccine and the pt said he felt fine. He and his wife were walking around the store. Pt started to feel lightheaded and they came back to the pharmacy. He tried to sit on the floor and just before reaching the seated position he fell and passed out briefly. When he fell he cut his lip on his braces. Within 30 seconds he was awake and instructed not to call 911. I raised his feet and rested them on a chair as he was laying on the ground. After he was feeling better, he sat in a chair for a few minutes. I checked his blood pressure and it was 128/78. He drank a Gatorade and when he was feeling ok I walked he and his wife out to their car and his wife drove him home.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 03-MAR-2015, the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
2 days after ZOSTAVAX burning, itching, tingling sensation and waist. Within 1 week numbness, burning tingling from waist to toes.
Chills; Fever; Headache; Body aches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0170) via an unspecified route of administration in the left arm on 17Apr2021 at 08:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and high blood pressure. 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 vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) started on an unknown date for thyroid disorder and unknown if ongoing. The patient previously took metoprolol (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 15:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 20:30, about 12 hours after injection, the patient experienced chills, fever, headache, body aches and nausea. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever, headache, body aches and nausea were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
sacral pain got worse after first Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Sacral pain" (ongoing). The patient took concomitant medications. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "sacral pain got worse after first Covid vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
having tiny sore arm; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (having tiny sore arm) and FATIGUE (feeling tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LZOA) for COVID-19 vaccination.     Concomitant products included L-THYROXINE [LEVOTHYROXINE], NALTREXONE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (having tiny sore arm) and FATIGUE (feeling tired). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (having tiny sore arm) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-281132 (Patient Link).
15 y/o female had fainting spells and syncope 5 seconds after administration of vaccines. Client was very pale, diaphoretic, hypotensive BP 93/ pale, thready pulse responsive to verbal commands.
pt recvd vax; fever of 100.5; pruritic rash at forehead hairline to neck, shoulders & upper back; occasional intermittant sore throat & sneeze;seen at hosp;
Immediate headache; Increased tinnitus after 4 hours; 48 hours later developed intense redness, swelling and pain both knees with documented NEW elevation in both CCCP antibodies and Rheumatoid Factor Abs. (there is no known RA in family). The rheumatology symptoms lasted about one week, and the antibodies resolved to normal within a few weeks.
On 5/10/21, during a trip,  I woke up with neck and left rib cage pain. Breathing was painful so I was talking and breathing softly. On 05/11/21 I went to my doctor's who did different tests (EKG, Xray, D-Dimer). The D-Dimer came back slightly high so I did a Cat-scan which determined a small blood clot in my left lung. I was put under Eliquis for 6 months.
16 year-old received first dose of Moderna; first dose was 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old received first dose of Moderna) and UNDERDOSE (first dose was 0.25 ml) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old received first dose of Moderna) and UNDERDOSE (first dose was 0.25 ml). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old received first dose of Moderna) and UNDERDOSE (first dose was 0.25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment drugs were provided.