chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild chest pain starting day after shot (w fever, swollen lymph nodes, muscle pains).  Went to ER, told she was ok, then phone call next day telling us her ekg had abnormalities (borderline high  qtc and other non-specific findings).  Told to follow up w cardiologist.  Went to cardiologist on 6/30,  qtc had normalized but other non-specific ekg findings remained.   Echo normal except for occasional extra heart beat. Told to avoid exercise, was given 24 hr heart monitor (we are still waiting on results), and come back for new ekg on 7/7/2021.
VACCINE WAS ADMINISTERED 1 DAY AFTER THE 30 DAY WINDOW OF THE VACCINE BEING STORED IN A FRIDGE ( NOT A FREEZER)
A round red rash appeared over injection area.  The rash is itchy and came about 5-6 days after receiving vaccine.  No other symptoms or reactions noted.
pt recvd vax & exp muscle soreness & stiffness @ inject site; 3-4 hrs p/dose 2 exp nausea & abdo cramping;
vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; This spontaneous report was received from a registered nurse referring to an unspecified number of unknown patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, an unspecified number of unknown patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot#W030849, expiry date: 26-MAR-2024 and lot#; X004371, expiry date: 07-AUG-2024 (recombinant Human albumin (rHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#W018829, expiry date: 14-JUN-2024 as prophylaxis (dose and route of administration for both vaccines were not provided) that were exposed to temperature excursion of -11.8 Celsius degree, for 29 minutes that occurred on 01-AUG-2023. There were no previous temperature excursions. No additional Adverse events reported.  This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from the registered nurse regarding the 4-year-old female patient.  The patient historical vaccines included varicella virus vaccine live (VARIVAX). The patient's current conditions included functional heart murmur.  She had no known drug allergies (NKDA). Concomitant therapies included cetirizine.   On 29-AUG-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (administered subcutaneously in the left upper arm, lot number W030849, expiration date 26-MAR-2024) and with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (administered intramuscularly at the right deltoid, lot number U7908AB, expiration date 03-OCT-2025). Both vaccines experienced a previous temperature excursion.    Furthermore, the nurse reported that there were ongoing issues with the freezer and auto-defrost. On 01-AUG-2023, the temperatures on state supplied data blogger reached -11.8 degree Celsius for 29 minutes.  She was unaware of temperature excursion until temporarily moving the vaccines to another office for temporary storage to manually defrost and had unit serviced on 16-AUG-2023.  The patient received immunization impacted by excursion prior to notification.  There were no known adverse events.   This case was previously considered non-valid, but upon receipt of follow-up patient identifiers were received and it was determined that the case is now valid.  This is one of three cases from the same reporter (2309USA002333 and 2311USA005370).
This case was reported by a nurse via sales rep and described the occurrence of shingles in a 52-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced sickness. On 3rd October 2018, the patient experienced shingles. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the shingles and sickness were unknown and the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the shingles, rash and sickness to be related to SHINGRIX. Additional details were reported as follows: The reporter agreed to follow up from GlaxoSmithKline. The patient received 1st dose at the end of July and till the time of reporting, had not received 2nd dose. The patient got shingles on approximately 3rd October 2018. The location was upper thigh of right leg and rash resolved after 1 week. The case was fairly mild according to the patient. The patient felt very sick within 4 hours of 1st dose and was in bed for the 2 days but was fine after those two days.
Patient did not experience a medical reaction to the vaccination. The wrong route was administered. Per the consent form the parent requested flu mist instead of an intramuscular injection. The parent was contacted and advised of the route change. She stated that she only selected the flu mist because she was unsure of the child's ability to allow the nurse to give him  shot.
Itchiness all over her body; This spontaneous case was reported by an other health professional and describes the occurrence of PRURITUS (Itchiness all over her body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013C20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PRURITUS (Itchiness all over her body). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness all over her body) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient inadvertently received the old booster (primary series) instead of the updated bivalent booster
From telephone call received at AP on 12/27/2002, it was reported that a 50 year old female patient received Imogam HT (Lot # U07062 expiration date 06/26/2003) and Imovax Rabies (Lot # U0815) vaccine administered on 12/24/2002.  Within 24 hours of vaccination, the patient complained of general body aches and a 100.6 degree F fever.  These symptoms were treated symptomatically.  It was not reported whether the patient recovered from the event.
Patient diagnosed with Covid at Health center on 3/2/2021.  Admitted to hospital on 3/19/2021 after being found hypoxic, fever 104 and AMS. She was diagnosed with COPD exacerbation, Pneumonia and Pulmonary HTN. She was discharged 3/29/2021. She was evaluated on 4/1 2021 and appeared alert and oriented on oxygen 24/7. She was evaluated in the office on 4/5/2021 again with hypoxia, altered mental status, parkinsons type features and subsequently readmitted to the hospital. She was again dxd with COPD exacerbation, pneumonia, pulm HTN, afib with RVR. Patient discharged to rehab.
His hemoglobin was low; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-2021263886 (Pfizer).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMOGLOBIN DECREASED (non-serious), outcome "unknown", described as "His hemoglobin was low". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of haemoglobin decreased. Additional information: The events started after 15 days of second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
started with Tinnitis with facial numbness - also all fingers in left hand went numb and she developed pettechiai in both upper thighs the next day and that lasted 7 days-
This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. Nurse reported that unknown number of doses of improperly stored GARDASIL (lot # not reported), had been administered to the patients. No adverse effects reported. This is one of several reports from the same reporter source. Additional information has been requested.
Pt had a hospitalization on 11/1/21 after a positive COVID test; COVID Pneumonia; treated; had increasing O2 needs; 11/25/21 dx with bacterial pneumonia and interstitial fibrosis; 12/10/21 comfort care due to dyspnea, chest pressure, full body pain; pt terminal due to respiratory failure secondary to COVID 19; pt transferred to hospice where she passed away
presented with SOB, cough, fever x3 days; admitted with Covid PNA; tx with merrem, steroid, zinc,  He was ambulated and was able to maintain oxygenation during ambulation even on room air. At this point he was advised to continue treatment at home as no additional hospital treatment was necessary.
Pt. reports got shots on Fri, Dec 4 and on Sat, Dec 5th arm very sore, decreased ROM. On 12/7/09 - "hurts so bad can barley lift it".
Positive test for COVID on noted date.  Took Paxlovid.  Minor cough, runny nose.  Isolated from wife (she's negative).  Two tests since Paxlovid end have been negative - two days apart.
patient stated that her arm was red and slightly swollen and she took benadryl and that the injection site swelling has come down in size after about 1 week
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 1st dose of SHINGRIX. On 24th October 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved. It was unknown if the reporter considered the pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she experienced arm soreness right away and had problems sleeping that night because of her soreness in her arm. The day after of the vaccine it was almost gone. Within a couple of days, it was gone completely. She also felt tiredness but she said that it also went away quickly. The reporter consented to follow up.
Patient was pale, blood pressure was high, coldness of hands, weak, headache, couldn't keep her eyes open, shaking
Pt had crying @ 7:30 PM for just over 3 hr., has been well since
Patient complains of frequent headaches since getting the vaccine almost 3 weeks ago. Headaches interfere with activities of daily life.
Received my second dose of Covid vaccine 1/26/21 at 1320. No immediate adverse reaction occurred. I started experiencing injection arm soreness around 2100. By midnight I was experiencing chills and body aches. The morning of 1/27 my Temp was 100.0 and I was still having body aches and chills/feeling feverish. This continued throughout the day. I took one dose of Tylenol 1g and later ibuprofen 600mg. The morning of 1/28 I still had a mild headache and temp of 100.00 but overall was feeling much better - no more chills or body aches. My temp prior to going to work that night was 98.6 and my headache had resolved.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: redness large from injection area spreading to insid of arm down to elbow. pt advised over the phone to seek medical care to determine if cellulitis or just a localized reaction
Patient reported redness, raised bump, and extreme soreness for several days after immunization that only started to subside on 10/08/2016.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and current conditions were reported. On 25-MAR-2015 the patient was vaccinated with PROQUAD (Merck) (dose and lot number was unknown), which was improperly stored. The outcome of the event was unknown. This case is linked to MARRS# 1504USA001857 with the same patient link. Additional information has been requested.
Shivering began at 10:45 pm and lasted until 12 midnight.  Treatment = Advil Day 2 - No longer shivering, but feel colder than normal.
Not hydrated enough; tired/fatigue; Headaches; Overheated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Overheated), DEHYDRATION (Not hydrated enough), FATIGUE (tired/fatigue) and HEADACHE (Headaches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FEELING HOT (Overheated), FATIGUE (tired/fatigue) and HEADACHE (Headaches). On an unknown date, the patient experienced DEHYDRATION (Not hydrated enough). On 29-Mar-2021, FEELING HOT (Overheated) had resolved. On 31-Mar-2021, FATIGUE (tired/fatigue) and HEADACHE (Headaches) had resolved. At the time of the report, DEHYDRATION (Not hydrated enough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       2nd dose scheduled for 16Apr2021.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Non Significant - DOB add.
Patient was 11 years and 9 months years old at time of vaccination. Must be 12+ for Pfizer
covid in middle aug 2021. It started head cold, congestion and  101 fever, home test on 17Aug2021, Teledoc with Doctor, Following Monday on 23rd I went to the hospital because I had shortness of breath. Got prednisone and antibiotic . I still have shortness of breath, I am still very tired.
I was vaccinated on 12/18/2021 in the afternoon on Dec 20th. On Monday morning, I woke up with a nose bleed. On Dec 29th, I noticed I had scratchy throat. On 1/1/22, I noticed I was congested and still experiencing nose bleeds 1-2 times a day. When the nose bleed increased to 2x a day, I went to urgent care who referred me to ER. ER gave me some Affirm nasal drops for the nose bleed and a Covid test. Later that evening I received a message stating I tested positive. I had headaches that started 1/2/22, my ears were clogged. This all lasted until this past Saturday 1/8/22. I am feeling better and was retested on Sunday 1/9/22 and it was negative.
felt a slight heavy feeling in that arm.; After the first dose he experienced a slight pain in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (felt a slight heavy feeling in that arm.) and VACCINATION SITE PAIN (After the first dose he experienced a slight pain in his left arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (felt a slight heavy feeling in that arm.) and VACCINATION SITE PAIN (After the first dose he experienced a slight pain in his left arm). On 14-Mar-2021, VACCINATION SITE DISCOMFORT (felt a slight heavy feeling in that arm.) and VACCINATION SITE PAIN (After the first dose he experienced a slight pain in his left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Antibiotics  Treatment information included Windmill exercises   This case was linked to MOD-2021-315705 (Patient Link).
Right upper leg became edematous with warmth,  erythema and temperature of 102.9.
Received Tdap on 2/13/2007.  Reports developing a rash on 2/14/2007 around 3pm that started on left side of neck and has extended around neck and to upper chest.  Patient reports some minor itching.  Took Benadryl due to previous reactions with medications before.   Took no Benadryl on 2/15/2007.  Rash has not resolved.
Left arm is very swollen & red a week from injection. No pain, some itching. Lymph node under armpit is also really tender.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient did not received other medication in 2 weeks. Anti viral details: Patient was taking Paxlovid product from 25Sep2022 to 29Sep2022 for Covid-19 treatment.  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.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Patient became flushed, bright red in the face, and perspiring.  Chest pain and tightness- described as an electrical feeling from her head down her spine.  We laid her down on the floor with head raised.  She was having labored breathing and asked for an emergency services call which was made.  EMS arrived and checked blood sugar and blood pressure and did a normal 4 and 12 lead EKG.  BP was slightly elevated (148/82) and sugar was 108.  All vitals within normal limits.  EMS offered transport and she refused.  Patient left with her husband, walking on her own, within 30 minutes of event.
During the injection, I felt a gushing of fluid into my shoulder. Removing the BandAid later that day, I noticed that the injection site was higher than normal. My shoulder pain and range of motion gradually worsened over the course of two weeks, to the point where I had difficulty moving my arm and completing basic tasks (showering, getting dressed, eating). I went to Occupational Health on 11/5/18, where a PA diagnosed me with "bursitis" but said that "it couldn't be from the flu shot" because she "never saw that before." The PA recommended ibuprofen 600 mg q6h for 5 days and ice packs. I went to my PCP's office later that same day. My PCP's NP agreed with the ibuprofen/ice and also recommended physical therapy.
right wrist is swollen and un-usable at this time...cannot use for cleaning after bowel movement///am on crutches and very difficult to use left hand left achilles tendon is so painful, i cant bear weight; throbbing having difficulty maintaining equilibrium...I believe I had the virus in march of 2020, though the antibody test i took in may was negative. there may be some question as to the efficacy of the test that was being used at that time
Pt had terrible headache that lasted 12 hours the next day, felt fatigue for 7 days, had a rash (blisters) around her mouth
sores in my mouth; This is a spontaneous report from a contactable physician. A 58-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient experienced sores in mouth on 08Jan2021 with outcome of unknown.  Information on the lot/batch number has been requested.
Shivering started at 8p and Tylenol helped with that.   At 2a I woke with horrible nausea and headache that lasted for 3-4 hours.  I still feel very tired and have a headache .
contracted COVID-19; contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient had 3 doses of the vaccine designed to lessen severe illness from a COVID-19 infection. The patient contracted COVID-19, likely 03Jul2022. The patient was vaccinated and boosted with Covid-19 vaccines and had contracted the virus.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200021017 Same reporter/vaccine/event, different patient.;
vaccine recipient experienced pruritus on her arms at approximately 1551 during her post-vaccine observation period; patient experience urticaria on her neck, c/o nausea; initial HR at 1555 was 84, BP 164/90; pt has a Hx of HTN; pt denied any difficulty with swallowing or itchy throat, no angioedema; pt has a Hx of reaction to IV dye contrast; EMS called d/t urticaria worsening;  pt speaks Portuguese and a Portuguese interpreter was available during the entire interaction.  EMS started IV and administered IV Benadryl 50 mg;  pt transported to Hospital. This nurse confirmed with Hospital Nursing Supervisor at 2030 that this pt was not admitted and was d/c at 1900.
This spontaneous report as received from a registered pharmacist refers to a 63 years old male patient with no pertinent medical history, drug reactions to allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) "7 days ago" on 03-DEC-2012. No other co-suspects were reported. There were no concomitant medications. The pharmacist reported that two days ago on 08-DEC-2012 the patient developed a rash on his arms and face after being administered ZOSTAVAX. The patient contacted the pharmacist. Hydrocortisone cream was given as treatment for the event. The outcome of rash on his arms and face after being administered ZOSTAVAX was reported as not recovered. The relatedness for the event was not provided for ZOSTAVAX. Additional information is not expected.