chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 7:00 pm I started to get sick and my body started to hurt. Joints hurt. Tried to take Tylenol - it didn't take it away -  maybe slowed it down but then it came back. Thursday morning - I woke up really sick - joints hurt, hot and feverish and I called ambulance. My temp was over 100 degrees. They took me to ER. They took my temp there and it was 101.6. The Dr. requested morphine and I was given that for the pain. They observed me for awhile and sent me home with Tylenol with Codeine (300 mg). The morphine helped and I came home and I went to sleep and the next day my pain was not as bad as it was the day before. I was able to start moving around even though I was still achy. By third day I was feeling better. By fourth day, I was doing a lot better and the pain had gone back down. Felt shortness of breath when I first got symptoms and was using my inhaler. My shortness of breath lasted a little longer - for about a week. Had a Telehealth visit with doctor to refill meds if I needed it.
Patient states as soon as the needle went in her arm she felt paint and numbness go into her neck, shoulder and down her arm and into her fingers. She states she did not have any of this pain before. The medical assistant checked the arm and there was no redness and swelling at the time. The patient waited her 15 minutes and she states she had no relief in the issue. We offered her a ice pack but she declined. The Doctor talked to the patient and advised that the muscle may be sore and that she should experience less pain over the next 24 hours. He advised she could take Tylenol and use ice if the arm became red, swollen and to reduce pain. Her arm did not have any swollen or redness when The Doctor examined it. Patient was informed to contact her PCP to advise of the reaction and to keep in touch with him. We also advised the patient to call The Doctor Saturday morning at the office if she was having any further issues or not feeling better.
I experienced  low back pain, body aches, chest tightness and chills. I also experienced a low grade fever, extreme fatigue, severe body pains which lasted two days. I saw my PCP who put me on a muscle relaxer with Benadryl.  Today I continue having chest pain with congestion and I am not able to move around due to the body aches and pain.
24 year old female with last menstrual period 3/26/21, received Pfizer mRNA COVID vaccine on 4/20/21. she had yet to take a pregnancy test. She received her 2nd vaccine on 5/18/21. Ultrasound was done on 5/21 when patient was expected to be 8 weeks pregnant, showing pregnancy loss.
On or about 04-26-2021  (around six weeks) of receiving the J&J vaccine I developed a lump to the back of my neck. I went to the doctor who performed an ultrasound. The ultrasound demonstrated a lymph node and that it was of normal balance.   To this day I still have the lymph node on my neck, unchanged in size.  I do not have my lot# to provide today.
Both knees feel locked; Burning pain coming from the inside from both knees down both legs; Burning pain coming from the inside from both knees down both legs; Burning pain coming from the inside from both knees down both legs/Burning from inside from knees down to her feet; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in left arm on 10Mar2021 13:30 (at the age of 81 years) as dose 2, single for COVID-19 immunisation. The patients medical history included diabetes, obesity and allergies to aspirin. The patients concomitant medications included metformin (METFORMIN); losartan potassium (LOSARTIN); gabapentin (GABAPENTIN); ibuprofen (IBUPROFEN); simvastatin (SIMVASTATIN). The Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 16Feb2021 11:00 (at the age of 81 years) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. 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. On 22Mar2021 12:00 the patient stated both knees felt locked, burning pain coming from the inside from both knees down both legs. Sitting, standing walking with a walker was awful pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. The outcome of all the events was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Pt experienced fever related seizure. Fever was 102.3 and also experienced a macular rash lasting for 7 days and diarrhea for 5 days.
Nausea within 30 minutes, sleepiness within 1 hour, after 3 hour nap woke up with scratchy throat and eyes & muscle weakness. Chills, sweats, fatigue, nausea, muscle weakness, loss of appetite, and irritability lasted 2 days. Day 3 woke up with swollen toes on my left foot still irritable but less fatigued. Took Aleve, drank lots of fluids. No formal treatment sought at this time.
Pfizer-BioNTech COVID-19 Vaccine EUA: seven minutes after receiving  vaccine patient reported severe left lower quadrant pain. Transferred to emergency department, administered analgesics, observed, admitted for observation, symptoms improved, and patient discharged to home medically stable.  On follow-up visit no residual symptoms documented. Pregnancy history: estimated 12 weeks pregnant.
Dizziness, faint, swelling of throat, pain at injection site, fever, cold sweat.
Flu shot received 1100am on 9/22/17 and diarrhea one hour thereafter (toast and banana eaten 830am). Diarrhea each day for five days and left arm pain and left thigh pain 5 days. September 29-30 irritating itch in both ears. October 2, headache and runny nose. October 3, sneezing, coughing, runny nose, scratchy throat.
Events: itching over the entire body, a rash, not raised, shingles came out after 2-3 days. Vision is blurring Treatment : went to PCP, could not take anything because she has had reactions to vaccines in the past, did take antihistamine for itching, which helped. She still has some itching, but it does not seem to be getting worst.
Area of erythema with small mobile nodules. Area measures 2 1/2cm x 1 1/2cm. Area was at site of immunization injection.
Patient received a booster dose of Pfizer vaccine per guidelines.  Patient stated that she had not had much water to drink that morning, complained of "not feeling well."  Patient stated that she was a diabetic.  Patient was monitored:  b/p 185/65, pulse 71, and pulse ox. was 97%.  Patient was given water to hydrate and offered something to eat.  Cold pack applied to back of neck and patient was monitored for 20 minutes.   Patient was re-evaluated prior to being released to go with her daughter.
Information has been received from a consumer concerning a female relative of hers who on an unspecified date, was vaccinated with ZOSTAVAX (Merck) (lot# not reported). The consumer stated that the patient was inadvertently given the ZOSTAVAX (Merck) twice within 6 months and since she had developed ulcers in her throat on an unspecified date. At the time of reporting, the outcome of the events was not reported. It was unspecified if the patient sought medical attention. No further information is available.
Patient was administered a dose of Covid Pfizer marron cap vaccine that was under a temperature excursion, which was unknown at that time. Once we became aware of the temperature excursion, reports were filled to Pfizer and Pfizer determined that the stability data does not support the use of this vaccine, and the patient needs to be revaccinated.
This spontaneous report was received from a patient's mother, who was referring to her child of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a fourth dose of GARDASIL 9 in injection for prophylaxis (lot number and expiration date were not reported). No adverse event was reported. No product quality complaint was involved.
On Apr. 17, I had a sore arm at the injection site and a slight headache. On Apr. 20, I began to be very tired and the headache became more intense.  Apr. 20 I has a mild night sweat. By mid day on Apr. 21, I have severe back pain, body aches and extreme fatigue, in addition to a continuous headache impacting my vision. Apr. 21 I had an extreme night sweat, requiring me to change in the middle night and constant chill. These symptoms persisted through Apr. 22. I was not able to work on Apr. 21 and 22. The symptoms continued but were mild on Apr. 23rd. The back pain, chills, fatigue and headache continued Apr. 24.
arm is itching at the site of injection and it is real hot; arm is itching at the site of injection and it is real hot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm is itching at the site of injection and it is real hot) and VACCINATION SITE PRURITUS (arm is itching at the site of injection and it is real hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 022M20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, DIGOXIN, POTASSIUM, FUROSEMIDE and LOPERAMIDE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm is itching at the site of injection and it is real hot) and VACCINATION SITE PRURITUS (arm is itching at the site of injection and it is real hot). At the time of the report, VACCINATION SITE WARMTH (arm is itching at the site of injection and it is real hot) and VACCINATION SITE PRURITUS (arm is itching at the site of injection and it is real hot) outcome was unknown.            No treatment medications were reported.
5 pox on chest; 5 pox on back;  No temperature; no discomfort; Did not require medical attention.
This spontaneous report as received from a nurse refers to three unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. From 03-AUG-2017 to 17-AUG-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose and route of administration were not reported) lot # M029681, expiration date 22-JAN-2018, for prophylaxis. The vaccine was exposed to 32 Fahrenheit degree to 35 Fahrenheit degree for 39 hours. There was no previous temperature excursion. No digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved.
Employee began to develop pruritus without rash.  Began feeling weak and sweaty.  She started shaking and was reported to become extremely pale.  Felt she was going to pass out.  Was assisted in lying down.  Rested for about one hour and was driven home where she went to bed for the remainder of the night.  Feels her usual self this morning except for a new area of erythema distal to the injection site.  Area not indurated or excessively tender or warm to touch.  Warm pack applied and advised to see MD if area worsens.  Possible cellulitis.
Day after booster on 11/16/21 my right leg was aching.  7 days later on 11/23/21 my sole of my right foot was very painful upon walking.  This resolved 2 days later by 11/25/21.  On day 11 (11/26/21) my ankle was slightly swollen and painful to touch.  These symptoms continued to migrate up my leg to my inner thigh.  On 12/13/21 I was seen by my primary care Doctor and was sent for a d-dimer blood test which was 1.77.  I was seen in vascular dept and ultrasound indicated multiple DVT from my groin to my ankle.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, drug reactions/allergies and concomitant medication. On 09-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported), following this on 11-OCT-2018, the patient received another dose of PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects have been reported in the patient.
Approximately 24 hours after vaccine administration, I developed a fever, chills and body aches. Approximately 48 hours after vaccine administration (7/17), vaginal irritation and pain noted while I was at work. Upon examination, several open lesions noted inside my vagina. These were painful and caused emotional distress as well as physical discomfort. I was evaluated by my midwife on 7/19 and the visit notes are included below. A pelvic exam was performed and a viral swab testing for HSV was collected.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patient of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) lot # L011080, expiration date 01-OCT-2016 and lot # L031602, expiration date 18-FEB-2017 which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Starting Saturday, 6/15 (one day after his second vaccination) the patient experienced severe flu-like symptoms and couldn't get out of bed for 48 hours. He has residual muscle cramps in his back that also started on Saturday.
his throat felt like it was going to close; nauseous; Legs Aching; ankle swelling; sore arm/experienced leg aching like he has never felt before; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FA6780), via an unspecified route of administration in deltoid right on 25Jul2021 at 17:30 (at the age of 41-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient was reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) were reported as none. On 25Jul2021, the patient experienced sore arm/experienced leg aching like he has never felt before, on 26Jul2021, the patient experienced ankle swelling and patient experienced his throat felt like it was going to close, nauseous, legs aching on an unspecified date. The patient reported after first dose of Pfizer covid vaccine 25Jul2021 in which he experienced a sore arm, ankle swelling after 4-5 days he experienced leg aching like he has never felt before, his throat felt like it was going to close. He went to the emergency department and they found nothing wrong with him. He wanted to know if these are common side effects after the first dose and if it is safe for him to receive the second dose of Pfizer covid vaccine. He stated he had an EKG and all kinds of stuff, and blood work for blood clotting. He doesn't know if he should take the second one. He clarified that his legs still ache a little bit, but it could be his allergies or from his lower back now, but it wasn't from his lower back that week. His right arm was sore after the vaccine that day and was recovered by the next day. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, weight: 157-158lbs all on unspecified date. Therapeutic measures were taken as a result of events that included taking Ibuprofen and Tylenol. The patient recovered from the nauseous and his throat felt like it was going to close on an unspecified date, recovered from sore arm/experienced leg aching like he has never felt before on 26Jul2021, recovered from joint swelling on 27Jul2021, the outcome of the event legs aching was reported as resolving.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on concurrent conditions, pertinent medical history and drug allergies of the patient were not reported. On 11-MAR-2016, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025765, expiry date 08-JUN-2016 (dose, frequency, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concern (PQC) involved. Temperature at which the administered product was stored was 9.3 Fahrenheit, there were no previous temperature excursions performed. This is one of several reports received from same reporter. Additional information has been requested.
This was a male patient presenting for second dose of Moderna vaccine to complete primary series, but was inadvertently given the booster dose (0.25mL instead of 0.5mL)
swollen face and hands rash on face and hands light-headed inability to walk at normal rate shortness of breath dryness in throat higher than normal blood pressure
No additional AE has been reported; she "made an error" and inadvertently administered PROQUAD and VARIVAX to a patient concomitantly.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 18-AUG-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, plus an sterile diluent, solution for injection/infusion and with varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneous injection concomitantly. All of the vaccines were administered at a dose of 0.5 milliliters (ml) as prophylaxis (strengths, routes of administration, anatomical sites of injection, lot numbers and expiration dates were not reported)(accidental overdose).   No additional adverse events were reported.
pt recvd vax 13JUN93 & suffered a sz & stroke on 2JUL93 following a resp illness w/high fever; pt w/mild residual neuro disability;
No additional AEs; 5 bad doses were given and 6 potential patients were involved; 5 bad doses were given and 6 potential patients were involved; back in April we had a delivery of GARDASIL 9 that did not arrive for more than 5 days; This spontaneous report was received from an office manager referring to a patient of unknown age and gender.  Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided.  On an unspecified date in April 2021, the reporter had a delivery of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days (product distribution issue), when the product was received it was supposed to be returned to the wholesaler, instead it was placed in the refrigerator. Information about the temperature storage or a time frame was unknown by the reporter. There wasn't a previous temperature excursion.  On 15-JUN-2021, the patient was vaccinated with a bad dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, 1 time dose as prophylaxis (with lot number T026168 and expiration date 04-DEC-2022, both verified as valid; vaccination scheme frequency, route and anatomical location of administration were not provided) (product storage error) (poor quality product administered). No additional adverse events occurred.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA005004: US-009507513-2106USA005001: US-009507513-2106USA005150: US-009507513-2106USA005081: US-009507513-2106USA005047:
Indication: "hsv"; I am one of the fortunate ones. I managed to get it. I will do it.; This spontaneous report was received from a consumer, referring to him/herself as a patient of unknown age and gender. The patient's current condition included herpes simplex virus (reported as "hsv"). The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  The patient stated that, zoster vaccine live (ZOSTAVAX) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) could be used as treatment for genital and oral HSV (product use in unapproved indication).   At the time of this report, the patient has not received the vaccine yet, he/her was one of the fortunate ones, he/her manage to got it, and he/her has scheduled the administration of zoster vaccine live (ZOSTAVAX) (circumstance or information capable of leading to medication error).  This is one of several reports received from the same reporter.
Patient presented with a chief complaint of chest discomfort, shortness of. breath.  The patient was diagnosed with COVID-19 infection 2 days prior to admission.  She presented as her chest pain/heaviness got worse with radiation to her left arm with which she was admitted as she was found to have elevated troponin. Cardiology was consulted.    COVID-19 infection:  Patient is not hypoxic.  Given comorbidities she was evaluated for monoclonal antibody and that was administered February 2, 2022 after discussion with the patient and she was monitored overnight and she did not have any adverse.   Elevated troponin/non ST-elevation myocardial infarction/type 2 MI:  Cardiology has evaluated.  She had a transthoracic echocardiogram that did not show any wall motion abnormalities.  Cardiology has cleared her for discharge
pt dev inc serum LDH following vax; SGOT & serum bilirubin were normal; No further details were provided;
patient came to the pharmacy today 10/18/22 complaining about swelling and pain in her left arm where she had gotten her flu shot in. She had received her flu shot on 10/03/22 in the morning. Patient developed swelling in the arm later that afternoon. She denied any numbness or rash on the body or trouble berating. She is mainly complaining of tenderness, swelling, and minor bruising. Patient was advised to consult with PCP for further evaluation, and utilize ice along with Tylenol to manage swelling and pain.