chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. came to clinic with c/o of his left arm having edema and erythema from upper arm to wrist.  Area was red with some edema noted.  Pt. stated that area was better today than on yesterday.  Seen by Dr. and was advised to take Benadryl 25mg QH for the next 2 days.  PT. was advised to go to the local ER if he developed shortness of breath or wheezing.  01/25/2008 ADDENDUM Pt. received a pneumonia vaccine in this arm on 1-23-2008.  Symptoms: 1. Angioedema, 2. Skin Rash.  Treatment Drug #1 DIPHENHYDRAMINE Dose 25 Units MG Freq TID Route PO.
Pt vaccinated w/1st dose of vax same day developed tenderness @ inject site & arm became very sore; Following 2nd dose developed temp 99, tiredness, achiness, & nausea w/out emesis; W/in 24 hrs of 3rd dose fever, sore throat & body aches;
itching at the injection site; Area was swollen; Area was swollen and it hurts; muscle was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE SWELLING (Area was swollen), INJECTION SITE PAIN (Area was swollen and it hurts) and MYALGIA (muscle was sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B214-1 and 038B21A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN HCL), SPIRONOLACTONE, IRBESARTAN and VERAPAMIL HYDROCHLORIDE (VERAPAMIL [VERAPAMIL HYDROCHLORIDE]) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 20-May-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE SWELLING (Area was swollen), INJECTION SITE PAIN (Area was swollen and it hurts) and MYALGIA (muscle was sore). At the time of the report, INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE SWELLING (Area was swollen), INJECTION SITE PAIN (Area was swollen and it hurts) and MYALGIA (muscle was sore) outcome was unknown.            Treatment details included cold and hot water to the area.
BODY ACHE; DIZZINESS; TEMPERATURE; LIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced body ache, dizziness, temperature, and light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature, light headache, body ache and dizziness was not reported. This report was non-serious.
soreness at the injection site / upper left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th February 2021, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 11th February 2021, 6 hrs after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was patient's mother. The patient had soreness at the injection site on the upper left arm. The soreness at the injection site started approximately 6 hours after receiving the injection of Bexsero. Reporter did not consented to follow-up.
7 days after the shot, my right arm started getting itchy, swollen, sore and red.
all body skeletal muscle contractions lasting overnight, 01/21/2022-01/22/2022, shortness of breath, fever, pain in the site of injection lasting 1 day, muscle weakness lasting 3 days, total body weakness, headache, general feeling unwell, loss of appetite, change in urination pattern, dark urine, total change in health pattern from being a healthy person prior to a booster shot to turning into a seak person, took ~ 5 days to recover
Body turned red, became hot, rapid heart rate, increase in blood pressure, throat started swelling, itching, swelling around face and tongue, shortness of breath-was given EPI pen-taken to hospital by ambulance.
This spontaneous report was received from a 74 year old male patient regarding himself. The medical history, concurrent conditions and concomitant medications were none. On 19-OCT-2016 at 2:30pm, the patient was re-vaccinated with PNEUMOVAX 23. The patient explained that he had first dose of PNEUMOVAX 23 at an unspecified time 3 or 4 years ago. The first time the patient received PNEUMOVAX 23 he stated that his arm was really sore. After the re-vaccination with PNEUMOVAX 23, the patient experienced the chills and fever. On 19-OCT-2016 at 7:30pm, the patient experienced chills. At an unspecified time after the chills began, the patient's temperature went to 101.5 F. The chills and fever lasted 24 hours and then they resolved. By 20-OCT-2016 evening the patient was feeling fine. There was no treatment rendered for the event. No lab tests were performed. The outcome of the events were reported as recovered/resolved. The patient sought medical attention. Additional information has been requested.
24 hours: (L) arm pain and swelling axilla to elbow 48 hours: 102.8F temp, throbbing headache, (L) upper deltoid hot to the touch, lethargy, weakness-started on Avelox-WBC 26.4 with left shift. Day 6: URTI with Bronchitis
migraine; nausea; nausea followed by vommiting; mild headache; This is a spontaneous report from a contactable consumer (Patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9262) via unspecified route of administration on 11Feb2021 10:00 AM at single dose for covid-19 immunization. Medical history included Psoriasis - Take Stelara every 12 weeks for it. The patient had no known allergies. 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 included multivitamins in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on 22Jan2021 10:00 AM at left arm single dose for Covid-19 immunization (Lot number: EN6201). It was stated on 13Feb2021 at 06:00 PM, 50-60 hours after injection- migraine that lasted for about 6 hours , nausea followed by vomiting, no fever even after 3-4 days still mild headache. No therapeutic measures were received for all the events. The outcome of the events were recovering.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. No concurrent conditions, medical history and concomitant medications were reported. The excursion occurred on 26-SEP-2016 and the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes and a maximum temperature of 6.2 F for 20 minutes. On 27-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA012216:
Started with fever up to 105.6. Very irritable, inconsolable. Crying. Continued Fever for several days. On 05/31/2007, a rash developed all over his body. Doctor examination concluded he had measles induced by MMR vaccine. Rash and fever gone with 10 days. Chronic constipation followed, and developemental regression.
recurrent fever tmax 100.5, myalgias and chills, usually occuring at night in a cyclic fashion every 3 weeks.
Possible Breakthrough Case Per H & P:   Assessment/Plan  Active Diagnoses  COVID   dc steroids dc home  atypical chest pain-per my discussion with daughter med mgt only does not want extensive workup even if it could lead to death  htn-norvasc  hypothyroid-synthroid Chief Complaint  e/m covid, htn, hypothyroid History of Present Illness  This is a 95-year-old female who was vaccinated against COVID-19.  She has a past history of hypertension and hypothyroidism and breast cancer she was diagnosed with Covid 2 weeks ago.  At that time she had medical antibody infusion.  She described chest pressure.  She said is worse when she would take breaths.
URI symptoms, prior to vaccination ? has faint, diffuse rash on body and feet - pruritic viral exanthem?
Fever 104 with febrile seizure. Lab work was done for sepsis work up all negative. Fever resolved in 48 hours. 2 seizures less than 1 min duration.
Pt received BOOSTRIX on 5/12/14. Called on 5/14/14 with complaints of swelling of face/hands, itching and rash. Rec pt take BENADRYL and contact PCP.
Case number PHEH2017US006056, is an initial spontaneous report received from a nurse on 24 Feb 2017. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1418501, Expiry date: Apr 2017) at a dose of 0.5 ml intradermally into right arm on 24 Feb 2017 at 9:30 AM. It was reported that, the patient received FLUVIRIN vaccine which might have been inadvertently administered as a PPD (purified protein derivative) and was given intradermally in the lower portion of the inside of arm where the tuberculin test is usually given. The patient experienced local site reaction of swelling to inner aspect of right forearm. It was resolved in 7 to days. The case was assessed as non serious by the nurse. Causality of the events was not reported. Follow up information was received from a nurse on 23 Mar 2017. Event swelling of arm, Batch number, anatomical site of vaccination was added. Updated narrative accordingly.
Awoke with temp 105 sore throat no congestion no cough no mylagia Mild pharyngeal hyperemia. Lungs clear no evidence of dehydration.
On 7/12/21 went to er for stomach pain and they found a blood clot in the iliac vein, no injury, no birth control, don't smoke. They couldn't find a reason for it. Hospitalization and put on blood thinners.   Got pfizer booster 2/10/22 . About died 2/15/22 got a massive blood clot  from my groin to my knee  hospitalized.  Had covid 1x on 12/31/21   No history of any blood clots before getting vaccinated.  I get these shots and now I'm getting them.
Early in the morning on 4/10/2023, I noticed that I had abdominal pain and sensations that weren't consistent with those that accompany bowel movements (or the need to make them). The pain was still present, but not unbearable, on 4/11/2023. On 4/12/2023, the pain was still present, and I thought that I should be seen by a doctor. On that afternoon, I saw a NP. Based on the area of where the pain was concentrated, the NP thought that I could either have an ovarian cyst or diverticulitis. She then ordered a clear diet and some bloodwork. Bloodwork results indicated that my white blood cell count was high, so I was prescribed amoxicillin-clavulanic acid on 4/14/2023. I was instructed to keep the antibiotic as a standby, as the clinic would be closed for a holiday the following Monday. Overnight, from 4/14/2023 to 4/15/2023, I had abdominal pains that I would compare to those of childbirth. On 4/15/2023, I began taking the amoxicillin-clavulanic acid. By 4/16/2023, I felt much better. I continued the course of antibiotics and ate a bland diet to give my gut a chance to heal. I finished the complete course of seven days, and everything is great now.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-DEC-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a county health department, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-MAR-2016, the patient was treated at an urgent care center for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
REDNESS AND HEAT AROUND INJECTION SITE, ABOUT THE SIZE OF A SAND DOLLAR, IN A CIRCLE
This spontaneous report as received from a pharmacist refers to a 7 year old patient (gender unknown). Pertinent medical history and drug reactions/allergies were not reported. On 8-OCT-2013, the patient was vaccinated with RECOMBIVAX HB, 1.0 ml (adult dose), intramuscular. Other suspect therapies included VAQTA 1.0 ml (adult dose). Concomitant therapy was not reported. No adverse effect was reported. This is one of two reports from the same reporter. Additional information has been requested.
My staff pharmacist gave Pfizer adult Covid-19 vaccine to twins with age of 10 Years 11 months 25 days while the vaccine was supposed Pediatric Pfizer (PEDS) 5-11 years old. I called the mom and they told me the twins are doing well. I apologized and disclosed what happened.
The day after he received the booster shot, (Fri, 4/8/22) my husband complained of a bad headache and he sounded awful.  I saw my husband on Sat (4/9/22) afternoon, two days after the vaccination and he was unsteady on his feet and he seemed out of it/not himself -- I?m not sure he even muttered a word.  That afternoon he went to the infirmary and he told me they gave him a Tylenol and sent him back to his bunk.  The following morning, Sunday (4/10/22), they found him on the floor of the shower room and sent him to the hospital.  The hospital staff thought he?d had a stroke and did a CT scan but there were no signs of a stroke.  They did note that his platelets were extremely low at 9,000.  I found out on Monday (4/11/22) around noon that my husband was sent to the hospital, and by that time my husband was already in a coma and on a ventilator.  They showed me the scans where he?d suffered a massive brain hemorrhage and said there was nothing that they could do.  I?d told the Dr that my husband had just received the booster on Thurs but he said they never gave him that information.   I?d asked the Dr. to please run a test for Vaccine-Induced Thrombotic Thrombocytopenia (VITT) to see if my husband?s extremely low platelet count was related to the booster, but he did not/would not run the test.  They did run additional tests to confirm he was brain dead and we took him off the ventilator on Thurs (4/14/22).   My husband was sent for an autopsy where they determined his cause of death: Hypertensive Intracerebral Hemorrhage.  I?d also asked the Medical Examiner?s Office (ME) to test for VITT and was told it was outside what they were able to test for, but that they stored specimen for a year in case I wanted an outside lab to do the VITT test.  Unfortunately, the ME office requires a court order to release the specimen which I imagine is costly.  If that is something that you are able to do, please let me know and I?d be more than happy to work with you so my family and I have some resolution.
Left shoulder pain, reduced range of motion. Bursa pain extreme.  Left arm pain, numbness, tingling, weakness in deltoid, tricep.  Left hand numbness, weakness Causing inability to lift, sleep, do yoga All symptoms continue currently & have worsened in severity since May 2021
Patient received the wrong vaccination resulting in her having 2 Moderna bivalent vaccinations 10 days apart.  Patient said she is feeling fine and actually felt better than when she had the first dose.  I have been checking in with the patient every couple days, and she is doing fine.
Several large bruises on left arm, swollen face and neck, aches and pains everywhere.
Onset of mild cough before giving to bed. Increase in cough, ? wheezing, restless asleep low grade fever early a.m. received Rocephin IM and Z-pak.
Pt c/o sx 5DCE91 & 1130AM numbness of tongue; pt called clinic 6DEC91 c/o hives under rt breast, abdomen & groin area; also, c/o swollen lips; pt seen 6DEC91 w/edema of lips, hives & chest pain;
Left side of neck, site of injection, elbow, joints and muscles down left side; Left side headache continuing to spread; Left jaw, cheek, nasal area swelling; left eye sagging/ occasional eye droop; Tired; general aches mostly on left side; wobbly; hives; skin itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534 and expiration date not provided) via an unspecified route of administration, administered in left arm on 15Mar2021 15:45 as a single dose for COVID-19 immunisation. Medical history included hypertension, chronic dry eye, Bells Palsy, arthritis, allergies to penicillin, injected iodine and food sensitivities. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan, multivitamin and ciclosporin (CEQUA). On 15Mar2021 15: 45, the patient experienced left side headache continuing to spread. Left jaw, cheek, nasal area swelling and left eye sagging (previous site of Bells Palsy attack)-Left side of neck, site of injection, elbow, joints and muscles down left side. She was tired and progressed to general aches mostly on left side and was somewhat "wobbly" on 15Mar2021 15:45. She later had hives and skin itching on an unspecified date in Mar2021 which lasted a couple of days. Tiredness continues and swelling in face and occasional eye droop at 4 days out. No treatment was given in response to the events. The outcome of the event fatigue was not recovered while the outcome of the rest of the events was recovered on an unspecified date in Mar2021. The patient has not been tested for COVID-19 post vaccination.
Numbness and tingling in left side of face. Pt reports onset about 45min to 1 hour after injection.
Patient Vomited after receiving the booster dose of  Pediatric Pfizer Covid Vaccine (5-11 Y)
pain on the arm where she got vaccine; Movement in arm is limited; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the arm where she got vaccine) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Movement in arm is limited) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain on the arm where she got vaccine) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Movement in arm is limited). At the time of the report, PAIN IN EXTREMITY (pain on the arm where she got vaccine) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Movement in arm is limited) outcome was unknown.            Concomitant medication was not reported. Treatment medication was not reported.
Information has been received from a physician concerning a male with hypertension who in December 2007, was vaccinated SC with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine concomitantly with a dose of influenza virus vaccine (unspecified). Other concomitant therapy included ECOTRIN, MONOPRIL and simvastatin (MSD). Subsequently, the patient developed swelling, redness and pain at the injection site. Medical attention was sought at the physician's office. The patient was treated with over the counter BENDADRYL. Subsequently, the patient recovered.  Additional information has been requested.
Neck hurts; Arm hurts really bad; Chills; Fever; Body ache; This spontaneous case was reported by a nurse and describes the occurrence of NECK PAIN (Neck hurts), VACCINATION SITE PAIN (Arm hurts really bad), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced NECK PAIN (Neck hurts), VACCINATION SITE PAIN (Arm hurts really bad), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache). The patient was treated with IBUPROFEN for Ache, at a dose of 800 mg. At the time of the report, NECK PAIN (Neck hurts), VACCINATION SITE PAIN (Arm hurts really bad), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
6/24 8:00 p.m. was very/unusually tired and went to bed early.  6/25 4:45 a.m. woke up and told mother his legs hurt (like muscles were tight).  Said he felt like he was going to faint...started to fall down, mother caught him and carried him back to his bed.  Temperature was 100.9 F.  Said his upper arms also felt tight, like the circulation was being cut off.  Took 650 mg acetaminophen then went back to sleep.  Mother called pediatrician on call due to the weakness/almost fainting episode.  Pediatrician advised he should be ok with the acetaminophen/water and that it should not happen again.  About 9:00 a.m. felt better, but still has two reddish/pink bumps at injection sites on left arm.
Fever started approximately 12-14 hours after the vaccine. Ranged from 100.4-101.8 x 12 hours. Also chills and body aches.