chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bladder felt full, like they could not empty it; limited bowel function; vomiting that day; limited appetite; dry mouth; felt very dizzy; extreme tiredness for 3 weeks; A spontaneous report was received from a healthcare professional concerning a 65-year-old, female patient, who experienced urinary retention, dizziness, vomiting, fatigue, decreased appetite, dry mouth  and limited bowel function.  The patient's medical history, as provided by the reporter, included two time cancer survivor . Concomitant medications reported included Carvedilol for high blood pressure, acetamide for cholesterol, potassium, multivitamins, zinc, calcium, Vitamin D.  On 05 Feb,  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) in the left arm for prophylaxis of COVID-19 infection.   Patient was ok at midnight, but when they woke up, they felt very dizzy, were vomiting that day, and experienced extreme tiredness for 3 weeks, now they feel relatively recovered, like 90%, but still somewhat tired, probably related to not been able to eat on account of having very limited appetite. They mentioned they had limited bowel function, and their bladder felt full, like they could not empty it. Patient states they had a dry mouth from  the beginning of the symptoms.  After a week of these symptoms, on Saturday, the patient went to a clinic and they did some bloodwork and found that the liver enzymes were elevated and 5 more values were not normal and that their kidney function was not normal.  They consulted with their oncologist and they believed these could be an extreme immune response to the vaccine, since the lab work conducted on the 23Dec2020 was normal.  Last Friday they have some blood tests and the values were back to normal.  Treatment for the events included paracetamol and ibuprofen alternating; and  Prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The events, dizziness, vomiting, fatigue, dry mouth were relatively recovered, like 90%, but still somewhat tired.  The outcome events,  urinary retention,  decreased appetite,   and limited bowel function are unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
patient stated that the vaccine burned/tingled as i gave the vaccine.  she waited the 15 minutes for observation, then stated on her way home her face felt numb around her nasal passages above her top lip and slightly between her eyes.  it lasted for just a couple minutes and then went away
Doctor said that she was experiencing a hypersensitivity reaction; rash in her entire body except for the face and hands; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in her entire body except for the face and hands) and HYPERSENSITIVITY (Doctor said that she was experiencing a hypersensitivity reaction) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency common variable.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced RASH (rash in her entire body except for the face and hands). On an unknown date, the patient experienced HYPERSENSITIVITY (Doctor said that she was experiencing a hypersensitivity reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, RASH (rash in her entire body except for the face and hands) and HYPERSENSITIVITY (Doctor said that she was experiencing a hypersensitivity reaction) outcome was unknown.            No concomitant medications were provided. Treatment drugs also included unspecified antibiotics and steroids.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07MAY2021, updated Reporter details, treatment medications and first dose information updated.
fatigue Narrative: patient reported increased fatigue, body aches, joint pain and headache evening of vaccination. Patient with history of migraine headaches controlled with duloxetine 40 mg qhs and topiramate 50 mg BID. Pt took duloxetine at around 7pm the night of vaccination with food and headache "got a little better." Had nausea with vomiting x1 and photosensitivity. The day after vaccination patient seen in clinic and denied any chest pain/pressure no shortness of breath, no fevers or chills, no lightheadedness/dizziness, no diarrhea, no loss of taste or smell, no coughing, no chest congestion. Patient was able to speak in full complete sentences without break. No audible wheezing or gasping for breaths. Injection site: no discoloration, no inflammation, not warm to touch no open wounds or rash- appears WNL
Passed out for 15 seconds. Says he was dehydrated from PT from the (place of work), had not eaten and felt dizzy prior to passing out.
4/9/2021 10:30 am After shot I was fine just a headache  4/9/2021 10:14 pm I noticed that the injection site had a hard knot and it was red, tender to touch and movement  4/10/2021 7:46 am Knot was still present and red spot was larger, tender to touch and movement  4/10/2021  6:14 pm Knot was larger and so was redness was spreading , now has heat behind it and still tender to touch and movement  4/11/2021 10:20 am knot is still present with redness still spreading larger, still had heat behind it and still tender to touch and movement  4/12/2021 8:26 am Called into work because the knot was still present and the redness has spread more, still had heat and tender to touch and movement  4/12/2021 9:30 am Went to urgent care clinic to get it looked at, doctor looked at it and measured the red area it was 5in across and 3 1/2 in long.  4/12/2021 11:00 am Started antibiotics 4/12/2021 2:12 pm redness has disappeared , still have pain with touch and movement  4/13/2021 All day I have had pain with movement or touch and it is very itchy  I have also been taking pictures if you would like those.
About 20 minutes after the patient received her dose, she became extremely nauseated and dry heaved.  The patient did take a Zofran ODT to alleviate the nausea and in about 10 minutes, was feeling much better.
chronic tendonitis on my whole left arm and left hand to intensify, from my shoulder to my fingers; The pain was so bad I had to go to the emergency room. The pain lasted for months, my left hand still hurts.; my left hand still hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (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; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: TENDONITIS (non-serious), outcome "not recovered", described as "chronic tendonitis on my whole left arm and left hand to intensify, from my shoulder to my fingers"; PAIN (non-serious), outcome "not recovered", described as "The pain was so bad I had to go to the emergency room. The pain lasted for months, my left hand still hurts."; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my left hand still hurts". The event "the pain was so bad i had to go to the emergency room. the pain lasted for months, my left hand still hurts." required emergency room visit.   Additional information: the fifth dose on 14Nov2022 caused all of patient's chronic tendonitis on the whole left arm and left hand to intensify, from  shoulder to fingers. The pain was so bad patient had to go to the emergency room. The pain lasted for months, left hand still hurts. Patient was afraid to get the new booster, can't use the right arm, because had chronic tendonitis in that shoulder and hand also.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a 6 month old patient who on approximately 28-JAN-2008 last week, was vaccinated with the first dose of ROTATEQ.  No adverse events were reported.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/14/2008. Follow-up information has been received from the reporting registered nurse concerning a 6 month old female who on 29-JAN-2008 was vaccinated PO with her first dose of ROTATEQ vaccine (lot# 655317/0980F). No medical attention was sought. Additional information has been requested.
Patient reports dry lips and sore throat a few days after taking the flushot. He states that he has not started any new meds and was wondering if it was from the flu shot.
Noticed right arm was red, swollen and warm at an area of upper arm, 11cm X 13cm. Dx: Cellulitis. Plan: Keflex 250mg tid X 10 days; Benadryl 1 tsp prn for itching.
Bumps over Arm; Nerve pain; Tickling sensation in nerve; Stabing sensation; Electrocuted sensation; Radiating pain in Arm; itching; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), FURUNCLE (Bumps over Arm), NEURALGIA (Nerve pain), PARAESTHESIA (Tickling sensation in nerve) and NEURALGIA (Stabing sensation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TOPIRAMATE (TOPAMAX), ALPRAZOLAM (XANAX) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Migraine). On 19-Mar-2021, the patient experienced FURUNCLE (Bumps over Arm), NEURALGIA (Nerve pain), PARAESTHESIA (Tickling sensation in nerve), NEURALGIA (Stabing sensation), ELECTRIC SHOCK SENSATION (Electrocuted sensation), PAIN (Radiating pain in Arm) and PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Mar-2021, MIGRAINE (Migraine) had resolved. At the time of the report, FURUNCLE (Bumps over Arm), NEURALGIA (Nerve pain), PARAESTHESIA (Tickling sensation in nerve), NEURALGIA (Stabing sensation), ELECTRIC SHOCK SENSATION (Electrocuted sensation), PAIN (Radiating pain in Arm) and PRURITUS (itching) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.
Information has been received from a registered nurse concerning an 86 year old female who was in the hospital at the time of being vaccinated because she was recovering from pneumonia. She has a history of allergy to codeine. On 12-SEP-2007, the patient was vaccinated with PNEUMOVAX 23 0.5 ml subcutaneously in the deltoid. Concomitant medication was reported as none. On 13-SEP-2007, the patient developed an injection site reaction. The patient reported to the nurse that her arm hurt (arm unspecified). The injection site was reddened and swollen to the size of a grapefruit. Ice was applied to her arm and the arm was elevated. The physician ordered BENADRYL. No other symptoms or treatment were reported. At the time of reporting, the patient had not recovered. Additional information has been requested.
I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; This is a spontaneous report from a contactable consumer. A 50-year-old female received BNT162B2 (COMIRNATY, Formulation: Solution for injection) dose 2 via unspecified route of administration in Right arm (Lot number: EM9809, Expiry date: Unknown) on 17Feb2021 at 10:00AM as a single dose for COVID-19 immunisation. The patient was not pregnant. The patient medical history included Lichen Sclerosis and hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was allergies to Environmental allergies & blue dye. Concomitant medications included liothyronine, unithroid, clobetasol and estradiol for unknown indication. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccines in four weeks. Patient previously received first dose of COVID vaccine. On 18Feb2021, the patient experienced a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches. Obviously some type of allergic reaction. Patient had zero side effects from first dose not even sore injection site. Since the vaccination, patient was not tested for COVID-19. Therapeutic measures were not taken as a result of events. The outcome of the event was not recovered.
numbness + tingling in both fingertips. No redness, swelling, rash, hives noted. No CP, SOB, dyspnea, blurry vision, HA. A&O x 4, able to speak in full sentences. Refused transport. VS: 100 HR, 97% RA, 177/87 (noncompliant with HTN meds), BS: 96. Observed for 30 mins.
I had the 2nd vaccine on Thursday April 8th with no real adverse effects -- some fatigue .  Went to the gym Monday evening 4/12 -- while running the track and doing some exercising I became seriously short of breath and this lasted the entire 1 hour workout depending on what I was doing.  It took most of the night for the  tightness and burning  in my lungs to subside.  I dont feel out of breath now, but it still isn't quite right.  I did not have this issue after the 1st shot.  I have to admit tho that I have a pulmonary exam scheduled for April 22 because of being a former smoker, etc.  So, I dont know if the vaccine caused the problem or some underlying lung issue.
he tested positive for COVID-19 between the 1st and 2nd dose of the vaccination schedule; he tested positive for COVID-19 between the 1st and 2nd dose of the vaccination schedule; Fever; This is a spontaneous report from a contactable consumer (patient's wife). A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), intramuscular on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 between the first and second dose of the vaccination schedule. The reporter asked if it would be safe for him to receive the second dose (COVID-19 vaccine) on an unspecified date (reported as tomorrow). He has been fever-free for 5 days. Outcome of the event fever was recovered on an unspecified date in Jan2021 and of the other events was unknown.  Information on the lot/ batch number has been requested.
Patient become pale after receiving vaccination.  RN also reports that patient became unresponsive a brief moment.  Also reported some mild shaking which subsided quickly
(L) arm pain at site of injection within couple of hours 10/23, same night biceps became red and tender and has worsened. Biceps erythema size 6 inches x 4 inches. Cellulitis and allergic reaction to pneumococcal vaccine 23.
Brain fog; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog".  Additional information: Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. I had a patient who experienced brain fog with the adult dose and she had concerned about the possibility of that type of side effect for pediatrics before she makes a decision to vaccinate her child.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer, with an allergy to "phenergan" and no pertinent medical history, who was recently exposed to her husband who was vaccinated on 27-Jan-2008 with a dose of ZOSTAVAX (Oka/Merck). The consumer is currently taking alendronate sodium (MSD). In the "middle of January", also reported as "a couple of weeks" after her husband was vaccinated, the patient recognized symptoms of shingles. She sought medical attention at the dermatologist who told her that she had a mild case of shingles on her left buttock. The patient reported that "it feels like a cactus thorn in my left buttock when I lean back and sit." There were no laboratory or diagnostic studies performed. The outcome was reported as recovering. No product quality complaint was involved. Additional information is not expected.
migraine; shooting pain from the top of the head to the injection site any time there was head move.; body ache; headache; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6206), via an unspecified route of administration in the right arm on 10Mar2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medication included lialda (MANUFUCTURER UNKNOWN), mercaptopurine (MANUFUCTURER UNKNOWN), sulfasalazine (MANUFUCTURER UNKNOWN), singular (MANUFUCTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6200), via an unspecified route of administration in the right arm on 15Feb2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to tree nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 (first day), the patient underwent tab test and procedure which included body temperature and result was shown as 102 (unspecified units). On 11Mar2021, on the first day, the patient experienced fever, chills, body aches and headache. On 12Mar2021 on second day, the patient experienced migraine on the right side of the body, shooting pain from the top of the head to the injection site any time there was head movement. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the events. The clinical outcome of the events fever, chills, pain, headache, migraine and shooting pain was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient stated after receiving her booster shot around 15 to 20 mins after patient c/c of painful to swallow. Mild itchiness. No edema. Denies any rash, no edema of tongue,  breathing difficulty or SOB, chest pain, dizziness or any other medical symptoms.  Px was evaluated Vitals : BP: 101/66, RR 20 HR 97 Pulse ox (* at RA.)  px was anxious, but alert, oriented by 3, no acute distress.  lungs clear, HEENT:  no edema, no rash. clear.  heart : normal s1,s2, RRR. no murmur.  EMS was called. evaluated patient was in stable condition and refused to go to ED. px went home with mother. in stable condition.
Narrative: 87 yo male with hx of htn, dm, gerd, aortic valve stenosis, rheumatic heart dx, oa, hld & hernia had a fall at home. While residing in rehab at hospital pt died on 6/20/2021. Pt had received one covid19 vaccine of moderna series on 2/12/2021. Appears death is not related to vaccination.
shaking / uncontrotably shaking / continued to shake; lightheaded; fell asleep; Left arm  pain from  injections; This spontaneous report was received from a registered nurse, via the Agency (HA # 857596), referring to a 16-year-old male patient. The patient's pertinent medical history and concomitant medications were not reported. The patient had not known drug allergies. His concurrent conditions included attention deficit disorder (ADD).     On 20-JAN-2020 at 16:30, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly in the right deltoid, lot # 1637641 (expiration date not reported, but upon internal validation established as 16-FEB-2022), for prophylaxis (strength and dose were not reported). Additionally, the patient was vaccinated with the first dose of meningococcal vaccine b rfhbp/nada/nhba omv(BEXSERO) intramuscularly in the left deltoid, lot # ABXA77A; and the second dose of meningococcal vaccine a/c/y/w conj (dip tox)(MENACTRA) intramuscularly in the left deltoid, lot # V6575AA (strength, dose, expiration date and indication were not reported for both suspect vaccines). The patient did not receive any other vaccine within one month prior and did not ever have any adverse event following any previous vaccination).      On 21-JAN-2020 at 05:30, while on toilet, he started shaking, he started to shower and felt lightheaded (dizziness) in tub; his mom witnessed him uncontrollably shaking for 1 hour. He did not present loss of consciousness (LOC) and was taken to bed and continued to shake (tremor), fell asleep (somnolence), had not fever. The patient was taken to the physician 's office, on the same date. He also had left arm pain from injections (vaccination site pain). He was able to walk out from physician's office. On an unspecified date, the patient recovered from the events.       The causality assessment between the events and the suspect vaccines was not provided.  Follow-up information has been received from the reporter's office, indicating that the correspondence physician was no longer available at their  practice.
claimant alleges after getting a covid 10 moderna vaccine shot at the pharmacy he stood up and fell backwards, striking his head on the floor resulting in a laceration to the back of the head. He became conscious within 1 to 2 minutes