chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Fatigue; headaches; BP was quite low, as low at 80/57; increased heart rate between 101bpm and 158bpm while stagnant working a desk job and as high as 133 bmp at 12:50 am; didn't sleep for 48 hours; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 48-years-old), dose 1 via an unspecified route of administration, administered in arm left in Mar2021 (17:30) (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included lacosamide (VIMPAT); diphenhydramine hydrochloride (BENADRYL); and melatonin. The patient previously took NORTON and experienced drug hypersensitivity. The patient was not pregnant. The patient had no other vaccine in four weeks prior to COVID-19 vaccine. She had no covid prior vaccination; she had not been tested for covid post vaccination. The patient experienced adverse events of nausea, fatigue, but didn't sleep for 48 hours (started in Mar2021), headaches and most importantly an increased heart rate between 101 bpm and 158 bpm while stagnant working at a desk job and as high as 133 bmp at 12:50 am which the patient should have been sleeping. Her BP was quite low, as low at 80/57 at one point. The event "didn't sleep for 48 hours" started on an unspecified date in Mar2021,  heart rate increased was on 30Mar2021 00:50; while the other events started on 30Mar2021 12:00 PM (as reported). The outcome of "didn't sleep for 48 hours" was unknown other events were recovered in 2021. The patient had not received treatment for the events.   No follow up attempts are needed; no further information expected.
Patient reported feeling itchy all over. She reported no hives or rash and no difficulty breathing. Patient was given 2 tablets of Diphenhydramine 25mg. The patient remained in the pharmacy for 30 minutes following the injection.  She reported feeling better and no further itching before leaving the pharmacy.  I called to follow up with the patient the same evening and she reported she was doing better and had no additional itching after leaving the pharmacy.
PT CAME FOR 1ST COVID VACCINE DOSE ON 5/7/21.  DEVELOPED PAIN / NERVE TINGLING AND HAD SEIZURE LIKE ACTIVITY THAT NIGHT.  LEFT SIDE WAS NUMB AND COULD NOT HEAR FROM LEFT EAR.  RINGING IN EAR, EYE TWITCHING.  ARTHRITIC-LIKE PAIN IN LEFT HANDS (NEVER ON RIGHT SIDE).    HAS NOT BEEN TO ER BUT STILL AS EFFECTS ON 5/27/21.  NEVER ANY PROBLEMS W OTHER VACCINES
Moderna COVID-19 Vaccine EUA Swelling, redness, tenderness, heat hot and itching of left arm (injection site arm) that did not appear until the 8th day after the shot.  This condition lasted about 48 hours and arm is now back to normal size and no other symptoms.
PATIENT CAME IN WITH VERY RED AND SWOLLEN ARM, WARM TO THE TOUCH. IT WAS SWOLLEN FROM THE ELBOW BACK AROUND TO THE SHOULDER BLADE.
Moderna Covid vaccine for 6 mo - 5 years of age was given to this patient who is 6 years, 1 month of age, resulting in a lower than recommended dose.  No adverse event occurred, we are just reporting the administration error.  PA was notified and we will follow with their recommendation for dose 2.
Swelling and redness at the site L deltoid. Local reaction at the site. No difficulty breathing, no fever.
Developed a couple of hives, rash, and itching 40 minutes after vaccination. Relieved with one dose of oral benadryl. Employee reports symptoms have mostly resolved as of 12/16/20 with some intermittent itching that is relieved with benadryl oral.
On May 6, 2021, patients were relatively normal. On June 4th he started complaining of right sided abdominal pain along with increasing generalized weakness/fatigue. On June 10th CT Abdomen/Pelvis ordered by PCP, it was completed on 6/16/21. On 6/17/21 patient started c/o of right flank pain as well as ongoing right abdominal pain, U/A collected, normal results. On 6/22/21 patient contact PCP office c/o acute shortness of breath, chest pain and increased weakness. He was advised to call 9-1-1 and go to the ER. He was transported to local Medical Center and found to have extremely elevated platelet count as well as elevated liver enzymes. He was admitted to the ICU he ultimately succumbed to this acute illness on 6/25/21
Unable to move arm & muscles on left side of body, where shot was given, are beyond extemely sore, even at rest.
I had a headache for about 3 months. I contacted my doctor and informed him on it who scheduled me for an appointment. I had to wait a month before being able to get scheduled for When my appointment came, my doctor performed an MRI on 02/20/2023 where they discovered an ischemic stroke. I was then sent to a neurologist where they performed an MRA and bloodwork for additional tests on 03/20/2023. They think I have blood flow between two chambers in my heart, but that hasn't been verified yet. They're referring me to a cardiologist for additional tests for confirmation. Until my cardiologist appointment, I'm currently on a heart monitor since 02/22/2023. I had an echocardiogram on 03/29/2023 and doppler of my cathartic arteries in my neck.
Pt. reported swelling, pain in left arm 4-5 days after PNEUMOVAX injection on 5/18/12. Resolved spontaneously without treatment. Pt states he forgot to mention to PCP that he had previously received PNEUMOVAX vac on 4/14/2008.
2 days after receiving the Moderna vaccine, patient woke up with a "rash all over her body". She states that the rash moves location her body and its itchy, hot, painful and at times forms welts. Since the start of this reaction, which again started two days after receiving the COVID vaccine, they have continued up to the reporting of this reaction which was 2/23/22
Patient states 4 hours after receiving vaccine he started having hallucinations, throat itching, loss of sleep, and nose clogged. Symptoms lasted for 3 days. Patient denied receiving any treatment. Patient reported symptoms when came in for 2nd dose of GARDASIL. Pt did not receive second dose of GARDASIL.
2 days after Td administration, local area became red and tender. Patient went to ER on 7/19/06 and saw a doctor- local reaction approximately 2 inches in diameter, indurated, red and tender, no abscess. ER doctor diagnosed local cellulitis. Patient was prescribed Bactrim twice a day. Patient returned on 07/20/06 to ER and showed signs of improvement. ER doctor said that patient will recover. Follow up: On 07/26/06 ER doctor had no additional information in the patient and suggested contacting patient's primary doctor. On 07/26/06 and 08/04/06 patient's primary care physician was contacted and was unable to locate patient's medical record. No further attempts to obtain follow up information will be made, as neither of the doctors have any additional information on the patient.
PATIENT HAS A SWELLING  CLOSE TO THE INJECTION SITE,  IN THE UPPER RIGHT ARM CLOSE TO THE ARMPIT. NO FEVER, RASH, PAIN OR ITCHING. PATIENT IS CURRENTLY USING COLD PACKS TO REDUCE THE SWELLING. THE SIZE OF THE SWOLLEN PART IS DECREASING.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration not provided). No concomitant therapy was reported. On an unknown date the patient experienced malaise/fatigue and the patient was sleeping for 22 hours per day for 3 weeks. The patient went to unspecified physician on 09-DEC-2015 and it was noted that patient seemed irritated. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Within 10 seconds of vaccine, pt sat back on bench and started going limp, breathing rapidly, and shortly after lost consciousness for about 10-20 seconds. After fainting the patient was shaking/twitching in her extremities which she could not control for about 1 minute. Her blood pressure was 115/71, 10 minutes later 115/73, 10 minutes later 121/73. She was given ice water. She felt fine within 10 minutes and left pharmacy after about 30 minutes.
Initial and follow-up information has been received from a medical assistant and a physician concerning a female who on unspecified date was vaccinated with the first dose of GARDASIL SQ in the buttocks. On an unspecified date, the patient was vaccinated with the second dose of GARDASIL. It was reported the route of dose 2 was correct but it was learned that the vaccine had been frozen and thawed previously. Post the first vaccination, the patient's buttocks were bruised for 1 month time. Unspecified medical attention was sought. At the time of the report, the patient recovered. Additional information has been requested.
My OB recommenced that I receive the vaccine to ensure I protect myself and my child from the covid virus. At the time of vaccination, I was 10 weeks pregnant. Shortly after receiving the shot, I felt a numbness in my mouth and a heaviness in my throat. I immediately took a few sips of water which didn?t go down very easily then notified the nurse who called the ER staff. I was brought to the ER for observation. The numbness lasted for about an hour. I believe I was discharged an hour and a half after I had received the vaccine. Thankfully, we are feeling better after much needed rest.
TINGLING, NUMBNESS IN THE LEFT HAND AFTER A FLU SHOT.
30 minutes after flu vaccine (Aventis) 0.25 injected, child developed spreading, red, fine rash to chest and torso. VS 144 pulse 36-> Benadryl 12.5 mg IM, 15 mins after injection pulse 136 .
After administering Pfizer COVID-19 vaccine on 12/29/2021, it was discovered that 1.8mL of diluent was added to the 5-11 year dose vial instead of 1.3mL as required. Per CDC guidelines and pharmacy, it was recommended that this dose be administered again with the proper amount of diluent added. Patient came back to office and was given correct dosage. Monitored for 15 minutes continuously with no reaction and was discharged.
Vaccinated with Pfizer 2/1/21 and 2/22/221.  Symptom onset 6/8/21 - cough, runny nose and nasal congestion. - mild cold symptoms.  Sample sent for genomic sequencing
Increased and intense stimming (exessive hand flapping, body cringing/tightening) and vocal stimming followed by long periods of staring in space with episodes of eyes rolling towards back of head, increased aggitation and excessive head sweating. Not typical behavior for child.
The patient experienced syncope seconds after the vaccination. He was supported by his father and myself and no injury occurred due to fainting. He was monitored for at least 25 minutes after the event. He ended up looking at the needle which I believe triggered the response. He turned pale and had minor muscle twitches for a couple seconds after. He was supported physically and emotionally until his symptoms resolved.
pt was given havrix 1st on 1/31/20 and 2nd dose 3/9/20. 2nd dose given too early. no adverse reaction for pt on either dose. recommendation by GSK to give Havrix vaccination 6 months from last dose therefore on or after 9/9/20
Was walking to car when she felt her throat become stratchy, sore, and a lump in it. She came back in to be evaluated. Was escorted to ED for further evaluation.
This is a spontaneous case, initially received from a pharmacist on 29-Nov-2018, concerns a 50-year-old, adult male patient. It was reported that as the vial was being held upside down to withdraw doses, the vial leaked as the needle was removed. On 08-Oct-2018, the patient was administered FLUAD (TIV) from the leaking vial [dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: not reported] for unknown indication. 25-gauge needle and 3 mL size syringe were used. The user added air to the vial from the syringe. The leak was observed at the exit point of the needle. No adverse reactions reported after administration of the vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034039. Based on the QA investigation, the Investigation of the Batch Production Records and Manufacturing Systems involved in Batch 252234, found it to be unlikely that the Leaking Vial defect identified in this complaint was the result of the manufacturing process at the facility. It was concluded that, the complaints were reported after the vials had been punctured; during and after usage. FLUCELVAX was manufactured for multi-dose usage. Facility did not manufacture or supply the devices used for administration activities. Additionally, the technique used to administer the preceding doses from the complaint vial(s) could not be determined. No factors from within facility processing were found to have contributed to the reported complaints. This case is linked to case: 201806030 (same reporter). The reporter assessed this case as non-serious. Follow-up received from pharmacist on 21-Jan-2019: The patient's date of birth and other details (address, city, county, state, postal code and phone number) were added in the patient tab. Added reference number (Med info number: SEQ19-00381) in the additional information tab. No changes were done in the narrative. Reporter's Comments: A 50-year-old male patient was administered dose from the leaking multi-dose vial of FLUAD TIV. The company assessed the events as not related to the suspect vaccine due to the accidental nature of the event product leakage and incidental nature of the event drug administration error.
Sore arm for a day after; This is a spontaneous report from a Contactable Consumer (patient's wife). A 50-year-old male patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 27Jan2021 at single dose for covid-19 immunization. Her husband takes no medications. He has no medical history or conditions. He has no allergies at all. It was reported that She thought she would report some side effects after one shot of the Pfizer COVID19 Vaccine. It is strange. She didn't read the symptoms until seven days out. Then she saw some have reported a lot less. After the shot, that night she had swelling in her upper chest. She thinks it was lymph nodes in the breast and chest area on the side she got the shot. The next day her arm that she got the vaccine in got very large. Then, she doesn't know if it was related, two days later she had itching on both of her feet. It was the tops of her feet and only for a couple of days. She is not counting that. Day five after the shot has been the main problem. Her arm pits started itching like crazy. It was severe itching and swelling in her arm pits. The itching lasted for three to four days. The lymph nodes in her arm are still swollen. It was five days after the shot. It is both arm pits. The night of the shot she had a lot of neck pain and she thinks it was probably the lymph nodes in the back of her neck. That has lasted and is slowly diminishing. Height six-foot one inch or six foot two inches. Weight 225 to 230 pounds. He is not obese, but a big guy. There was an agency for assisted living for people that need help. They were giving it and had extra doses. This guy in charge at the assisted living house offered it to caller and caller's husband because her and her husband run a behavior health counseling. He offered it to them as healthcare professionals. Her husband got it at the same time and didn't even have a sore arm. Caller clarified that he did have a sore arm for a day after. It didn't swell up. The outcome of the event was "Unknown".  Information on the lot/ batch number has been requested.
Headache, chills, bodyache, joint pain, sore arm, fatigue for 30 hours. Headache, chills and joint pain subsided after 30 hours
Patient fainted after injection and was unconscious for 15 seconds. No signs of allergic reaction. Breathing was normal and patient was able to be reoriented to time and place within 1 minute of awakening. She waited in the pharmacy lobby for 30 minutes with no other symptoms/signs. No fall due to patient being seated at time of fainting.
No adverse effects; patient was  vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 25-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
p/vax pt devel full blown varicella;pt sought unspecified medical attention;
This vaccination was intended for patients over the age 18 and the patient was 13 years old.
Reported started to feel warm with rash aprox 10 minutes after receiving vaccine.  Rash noted on left arm .  Given Pepcid 40 mg PO, Benadryl 50 mg, Monitored for 35 minutes with no progression of rash.  No respiratory issues noted.
DIARRHEA; SICK; FEVER; COULD NOT BREATH DEEPLY; LOSS OF TASTE; LOSS OF SMELL; SALIVA LIKE FOAM; DRY COUGH WITH NO SECRETIONS; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 60 year old male. 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced loss of taste. On 27-JUN-2021, the subject experienced loss of smell. On 27-JUN-2021, the subject experienced saliva like foam. On 27-JUN-2021, the subject experienced dry cough with no secretions. On 27-JUN-2021, the subject experienced could not breath deeply. On 28-JUN-2021, the subject experienced sick. On 28-JUN-2021, the subject experienced fever. On 29-JUN-2021, the subject experienced diarrhea. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Twice Negative. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste, loss of smell, saliva like foam, dry cough with no secretions, and fever, and the outcome of sick, could not breath deeply, loss of appetite and diarrhea was not reported. This report was non-serious.
Patient initially seen at this clinic 8/16, 2 days after vaccine with local swelling and discomfort, which would not be reported.  Phone call 8/21 from Dr. who was seeing patient in his office for rash, described to me as maculopapular, on the arms and legs, without vesicles or pustules. Patient told Dr. the rash had started about 4 days after the vaccine.  No fever or lymphadenopathy.  No treatment was recommended by the physician other than observation.
Acute angioedema and systemic pruritis. No respirtory symptoms . Onset 15 minutes after innoculation. 25 mg on Bennadryl, 60 mg solu medrol given IM immediatedly.
Exactly 8 days after receiving the shot (in my left arm) it was swollen, red, sore and itchy.  Benedryl  helped relieve the itch and swelling.  Since then, my arm continues to ache, noticeably, and I still have a faint redness.  I?m concerned about the aching as today it is the 21st day after my first shot,
Severe reaction to hair dye 30 days after receiving second COVID-19 vaccine.  Significant swelling of scalp, face and eyes.  Started around 9:00 PM Thursday night and into Friday at 5:00 PM as I write this.  I visited an urgent care facility and a round of steroids and antihistamines was prescribed.  I understand no research has been done and I am not sure how often salons or individuals will report this reaction as a possible COVID-Vaccine reaction.  I think a caution to salons to recommend a patch test prior to coloring hair of clients who have had a recent case of COVID-19 or a vaccine is appropriate.
3 days of intractable headache beginning 4/11. Right sided facial symptoms beginning 4/14 - diagnosis of Bell?s palsy. Later diagnosis of cluster headaches.   Treatment: prescribed 7 days of Prednisone (60mg) and Valtrex. Currently acupuncture 2x weekly, oral B12 (2500mcg), TCM herbal supplements. Prescribed Sumatriptan for h/a but not used as they have subsided.   Headaches currently subsided to jaw only. 15 days after diagnosis, Bell?s palsy symptoms show very minor improvement (R eyelid more  functional now).