chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of chills in a 75-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX with an associated reaction of headache (experienced severe probable reaction as headache after receiving 10 years before the time of reporting). Concomitant products included PNEUMOVAX. On 31st January 2018 15:00, the patient received SHINGRIX. On 31st January 2018 17:00, 2 hrs after receiving SHINGRIX, the patient experienced chills. On an unknown date, the patient experienced cold sweat and dry heaves. The patient was treated with ZOFRAN. On an unknown date, the outcome of the chills, cold sweat and dry heaves were recovering/resolving. The reporter considered the chills, cold sweat and dry heaves to be probably related to SHINGRIX. Additional details were provided as follows: The reporting healthcare professional was the patient. The patient received SHINGRIX on the left arm and PNEUMOVAX on the right arm concomitantly on the same day. The reporter did not have lot number or expiry date for the SHINGRIX or PNEUMOVAX. The patient experienced shaking chills, dry heaves and cold sweats on standing, hours after receiving a SHINGRIX administration. The patient received ZOFRAN after developing dry heaves in the middle of the night and the symptoms were alleviated the little.
Shot was given on 02-24-2021 around 12 noon.  On the next day 02-25-2021 around noon driving home from a meeting I started to feel very tired and body aching.  By the time I got home I felt drained and hurting all over.  Did not ever have a fever but did have a slight headache several times with the 24 hour period of my reaction.  Upon arrival to my home, I laid down on my couch - needed to rest.  I stayed asleep off and on, on the couch until 10 p.m. that evening.  I felt that every bone in my body ached and I was so tired.  I didn't want to eat or drink anything - just rest.  I went to bed and again slept all through the night until 10 a.m. the next morning - Friday, February 26, 2021.  When I woke up I felt better but still not up to par.  I mostly relaxed all that day - just didn't have the strength to do anything.  Gradually over the weekend I felt my strength coming back and by Monday, I was much better.
Soreness in my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness in my shoulder) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced ARTHRALGIA (Soreness in my shoulder). At the time of the report, ARTHRALGIA (Soreness in my shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
I experienced mild tingling and numbness in my lips, which lasted for several hours.  I had taken an Allegra 24 the evening of 3/8/2021, no treatment was necessary.
This is a spontaneous report from a non-contactable consumer. A male patient (age unknown) received a dose of PREVNAR 13 on 29Oct2011. Relevant medical history and concomitant medications were unknown. On 29Oct2011, during vaccination, the patient moved and the needle of the vaccine scratched his finger. Relevant laboratory data were unknown. Therapeutic measures taken as a result of the event were unknown. The clinical outcome of the event was unknown at the time of report.
Patient developed chest pain and shortness of breath a day after vaccine Admitted to the hospital, troponin were elevated, Echo showed mildly reduced EF treated with colchicine and NSAIDs
Injection site:  8 inch  long by 8 inch wide , bright red, hard, hot, swollen, very painful.  Woke me up in the middle of the night. Can?t lift my left arm.  Two large painful lymph nodes under my left armpit
Patient reports sharp frontal lobe pain on right side initially, then progressed to pain on left temple and left eye and left shoulder pain . She also reporst abdominal upset and high blood pressure reading  177/111
Tenderness at injection site, chills, fever of 100.3 by the morning (June 1), strong body aches, nausea on the morning of June 1, headache on the morning of June 1. On June 1 took a total of 4 Tylenols (500 mg). One at 6AM, one at 11AM and one at 3PM and lastly one at 7PM. By June 2nd I felt much better.
Lg. amt pain erythema, heat at injection site . - (~ 3 cm).  10 days later still with lump no pain no erythema.
The pt had 5-10 lesions and a low temperature X 1-2 days.
migraine headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (migraine headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, ISOSORBIDE, OMEPRAZOLE, HYDRALAZINE, SERTRALINE, VALSARTAN, DILTIAZEM, CARVEDILOL, MESALAZINE (PENTASA), DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), GLYCERYL TRINITRATE (NITROGLYCERINE), CLOPIDOGREL, LORAZEPAM and CYCLOBENZAPRINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-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 MIGRAINE (migraine headaches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Stomach pain; nausea; vomitting; diarrhea; fever; chills; aching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6204, expiration date was not reported) via an unspecified route of administration, in left arm, on 04Mar2021 (at the age of 79-years-old), at dose 1, single for covid-19 immunization from doctor's office/urgent care. Medical history included htn (hypertension) and covid-19. The patient had known allergies to morphine and statins. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient experienced stomach pain, nausea, vomiting, diarrhea, fever, chills and aching on 05Mar2021. No treatment was administered for the events. The outcome of the events was recovering.    No follow-up attempts are needed. No further information is expected.
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (pregnant) received BNT162b2 (BNT162B2 NOS), on 22Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11May2023 to 15May2023.  The information on the batch/lot number for [BNT162B2 NOS], has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300198915 Same patient, different drug/ events;US-PFIZER INC-202300199883 Same patient/product, different dose/events;
could not sit down; She could not sit down and sleep before; muscle pain in right leg, from right foot and traveled up to knee/It came on and off/the pain was unbearable/The muscle pain at first was on the right leg only and last night it was both legs.; Right arm soreness; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 63 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534) via intramuscular, administered in arm right on 25Mar2021 14:30 as single dose for covid-19 immunisation.  Medical history included high cholesterol. She is pretty healthy. No vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Concomitant medications included pravastatin (40 mg tablet) for high cholesterol taking for 2 years and stopped since Friday (unspecified date); Vitamin D. After having the first injection at a hospital, patient did not feel anything, just a little right arm soreness (25Mar2021 14:30).  But exactly a week after, on Thursday (30Mar2021), she started to feel muscle pain in her right leg, from right foot and traveled up to knee. It came on and off.  She did not take any medication. But Friday (02Apr2021) it got worse, she took only one paracetamol (TYLENOL Arthritis PAIN 650 mg, Count size 24 caplet, Lot: SLA055, Expiration: Jul2023) and felt okay.  On Saturday (03Apr2021) happened again, she also took one in the morning and at night. On Sunday (04Apr2021), she felt again in morning took 1 paracetamol and at night she took another one, the pain was unbearable. Next Monday (05Apr2021), she almost called 911 at 7pm but she didn't do it, her neighbor is a nurse for 46 years and she told her to take two paracetamol. Last night (05Apr2021), she took two.  She could not sit down and sleep before (Apr2021).  She was able to sleep.  This morning she felt it again (06Apr2021), her neighbor told her to take 2 for 3 times or every 6 hours.  She took 2 this morning.  She is scared.  She called her doctor. She was going to call 911 last night because the pain was bad and she was scared.  The muscle pain at first was on the right leg only and last night (05Apr2021), it was both legs. She needs the right medicine.  The doctor said she should call Pfizer and discuss. She wondered if it is okay to take second dose and what the right medication is to take to help with the pain. Patient did not visit emergency room. The patient assessed the report as serious. Outcome of muscle pain in legs was not recovered, outcome of other events was recovering.   No follow-up attempts are needed. No further information is expected.
This case was reported by a physician via call center representative and described the occurrence of palpitation in a male patient who received TWINRIX (batch number 3EX72, expiry date 22nd March 2016). On an unknown date, the patient received TWINRIX (unknown). On an unknown date, an unknown time after receiving TWINRIX, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown. It was unknown if the reporter considered the palpitation to be related to TWINRIX. Additional information was provided as follow: The patient experienced hourly palpitations to his heart lasting about a second. The physician did not wish to provide any information for adverse event report at the time of report.
itching on the skin of both her arms and hands which comes and goes; ittle bit of a rash" on her arms and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on the skin of both her arms and hands which comes and goes) and RASH (ittle bit of a rash" on her arms and hands) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRURITUS (itching on the skin of both her arms and hands which comes and goes) and RASH (ittle bit of a rash" on her arms and hands). At the time of the report, PRURITUS (itching on the skin of both her arms and hands which comes and goes) and RASH (ittle bit of a rash" on her arms and hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient said she was scheduled for 2nd dose on 21Apr2021. The concomitant medications information was not reported. Treatment information was not provided.
190 patients (9 different lot numbers) received a vaccine past the beyond use by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date).    No concomitant medications were reported. No treatment medications were reported.  This case included information of patient 184th out of 190 reported patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Ablation procedure for pericarditis occurred on 3/5/21. Received 1st dose of Moderna on 3/10. That night experienced fevers (101.7F) and fever like symptoms (sweats, chills, body aches). Continued to "not feel well". 3/15/21, presented to ED with chest pains and dx with pericarditis again.  Treated with IV Vanco x1 and IV Zosyn x2 until blood work came back and cultures were negative. Due to no infection and negative for an MI, Dr. determined pericarditis was a rxn to the vaccine.   Other tests results include: Elevated BNP, BUN, and CRP.  CT of chest, abdomen, and pelvis is clear. 5 covid tests since admission, all negative. IgG antibodies for COVID negative.   PT currently is stable and bloodwork somewhat improved. On O2, fluids and Morphine for chest pain. An acute Hepatitis panel is currently pending.
On 3/4/21, @ 2:pm, I had a very severe pain between  my shoulder blades that took my breath away, that radiating to the front of my check. I put an aspirin under my tongue, walked around and had some water. Pain kept getting worse. My husband drove me to the ED got there at 4pm. They took blood, did chest x-ray, ekgs. Blood work showed my Troponin level @ .11 and later elevated to 2.1. My blood pressure was 215/99, temp 97.  I started having pain in my right shoulder & right wrist.  I was diagnosed with a slight heart attack. On Friday, 3/5/21, facility did an angiogram, which showed my arteries were clear, no blockage or plaque, no heart damage. Did show it appeared the arteries had gone into a spasm which may have caused the heart attack.  I saw my primary Dr on Monday, 3/8/21, and she said I have no history of heart problems, no high cholesterol, etc. I asked her if this could be a side effect of my vaccine. Dr. said it was a good question & she didn't know the answer, since not all the research has been done. She suggested I submit my question to VAERS!  I'm now taking  Aspirin 81 mg, daily, Bisoprolol 5 mg Tab, Losartan 25 mg Tab, DOK 100 mg Cap.
Extremely sore arm; 102 degree fever for 36 hours; ringing in ears for about two weeks.
Several patients were administered PROQUAD during this temperature excursion; This spontaneous report was received from a nurse referring to  a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 11-DEC-2020, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA)(PROQUAD) lot # T021302 (also reported with lot # T011302), expiration date 19- DEC-2020, 0.5 milliliter, subcutaneous for immunisation (vaccination scheme frequency and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of -5 degree Celsius (°C) for 10 hours (also reported with timeframe 20 hours) as recorded by a data logger. There was no previous temperature excursion reported.  Lot # T011302 has been verified to be an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot number T011302 is a valid lot number for sitagliptin phosphate (XELEVIA).
Fever, Redness and swollen thigh. Dr. give Rx Amoxicillin 250 1tsp tid only for increased redness, pain and fever. Warm soaks / compresses 15 min qid. No swollen or redness per mom. 5/3/04 at 5:28 PM.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age (the pharmacist's mother). On an unknown date (reported as many years ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided) in the arm. On an unknown date, the patient experienced redness and swelling on her arm at the injection site after receiving ZOSTAVAX. The outcome of redness and swelling at the injection site was unknown. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. This is one of several report from the same source. Additional information is not expected because the pharmacist did not want to provide any additional information.
The first day nothing  every day it has a red spot that  keeps getting bigger.  It is red and hot and itchy and very painful
Swelling injection site after first shot; Tenderness  injection site after first shot; Redness on the injection site after first shot; Tired after first shot; Headache after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, FATIGUE, and HEADACHE in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, FATIGUE, and HEADACHE. At the time of the report, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, FATIGUE, and HEADACHE had resolved.            No concomitant medications were mentioned. No treatment details were reported. Patient stated that she was not sure if all that was caused by the vaccine or it was caused by her Anxiety of getting the vaccine. Patient was thinking about getting the booster.  Consent declined for safety to follow up.
Swollen eyes and face, whole head filled with fluid, sneezing, watery eyes, difficulty breathing and sleeping, stuffed up nose/ears, red and itchy eyes.
I was notified that patient passed away at Hospital 10:37 am today. Per message to medical office from Coroner, it was reported that patient collapsed this morning while walking his dog. Patient was brought in by ALS complaint of FULL ARREST to Hospital 10:10 am and pronounced at 10:37 am 4/24/2021  by Dr. at Hospital.
10pm after taking the vaccine started getting headaches and nausea he was in alot of pain from the headaches. 911 was called  After the he experienced diarrhea and swollen lymph nodes in his neck
Narrative: Per 05/07/2022 note "Pt has reaction to Shingles Vaccine and her right arm is swollen, red, and itching. Sleeve is very tight on her arm." Provider administered a methylprednisolone shot IM in office and prescribed patient antihistamine and prednisone for short term use.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 66-year-old female patient who received SHINGRIX (batch number 957J3, expiry date unknown) for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th August 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and skin warm to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist calling on behalf of a patient. The patient experienced redness at the injection site following the injection and also the injection site was warm to the touch, after approximately 1 day, the redness and warm to touch moved further down her arm below the injection site. This is 1 of the 3 linked cases reported by the same reporter.
Granuloma (hardened swelling) at injection site in one thigh for at least one or two months after the shot, loss of eye contact, blank, vacant look in the face; slower to respond to mother and father's voice.
Weakness with numbness to both hands and legs. Severe headache the next morning after the vaccine. 1st visit 2/10/2022, bloodwork; EKG; CT head done. Given solumedrol, Zofran, Pepcid, and Demerol for the severe headache. Next day, continued severe headache with progressive numbness to left arm hand, leg, and foot. 2/12/2022 2nd visit. Symptoms: Complete immobility of the left arm and left leg. Numbness to the left-side of the face. Continued severe headache. Blurred vision. Bloodwork, EKG, CT head and spine obtained. Lumbar puncture attempted. No significant finding. Informed to follow-up with PCP Monday. By Monday continued immobility with numbness to left-side of the body.
Fainted twice 4 days following the first dose of the vaccine, then hospitalized for 6 days.  At the hospital they conducted an EKG, blood tests, electrocardiogram, an MRI of the brain, and a CAT scan.  All came back normal.  Was released from hospital after 6 days with no diagnosis and experiencing, both light headed and heavy headedness, brain fog, fatigue, difficulty concentrating, and difficulty sleeping.  Vertigo was ruled out after two weeks.  Heart condition was ruled out.  Currently on Clonazepam, Gabapentin, and Amitryptiline for pain and sleep with not much improvement (also on famotidine for stomach). Fainting has not reoccurred.