chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd Hep B vax in 1991;  A few day p/vax pt devel a pruritic rash across chest, upper back, neck & shoulders; pt presented to MD & placed on DPH & Seldane;
13 days after Smallpox vaccination, he presents with 3 days of fever/chills/malaise/poor appetite/slight spreading of red bumps across arms and chest. Also with decreasing in size but tender lymph nodes in chest/armpit and neck. Chest has bilateral supraclavicular LN; neck + right LAD. Right deltoid 5 X 5 erythematous patch surrounding inoculation site. Scattered multi-sized erythematous papulopustular lesions 2-8mm diameter; few scabbed lesions. Treated with Motrin 800mg, every 8 hours for fever/aches #21; Atarax 25mg 1 every 8 hours for itching #21, rest, contact isolation and follow-up in ED on 2/26/2003. Dx: Generalized vaccinia (mild).
c/o arm being sore x 2 wks 8FEB93) since last Td; arm aches when exposed to cold; arm did not hurt prior to Td; redness & swelling noted for a couple of days p/shot; main concern is arm is aching all over starting from TD site;
Initially severe pain in left shoulder (injection site), but over the course of many months, this evolved into left arm numbness, weakness, tingling, etc. and is not abating noticeably.
7 days after injection, large, red welt appeared at injection site and warm to touch. Temp 100.2 with fatigue, mild chills
may have had shingles after her first dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had Shingles.
Shot site is becoming swollen on day 8. It is itchy and hot to the touch. Did not have any symptoms prior when I first got the shot.
patient received an expired dose of tenivac, when he was suppose to receive a dose of Tdap with no reported adverse event; patient received an expired dose of tenivac, when he was suppose to receive a dose of Tdap with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 48 years old male patient who received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac], when he was supposed to receive a dose of Diphtheria, Tetanus And Acellular Pertussis Vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Sep-2023, the patient received a dose 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection lot U7092AA expiry date: 24-Jun-2023 via intramuscular route in the deltoid not specified for prophylactic vaccination (immunization) and patient received an expired dose of tenivac, when he was supposed to receive a dose of Diphtheria, Tetanus And Acellular Pertussis Vaccine with no reported adverse event (expired product administered) (wrong product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on an unknown date, the patients vaccinated with improperly stored doses of RECOMBIVAX HB (product lot#, expiry date not reported). No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
On 2/12 I woke up around 7:30am with body aches, chills, fever >101 F., heart palpitations, dull chest pain, fatigue, and arm pain at the injection site. I took Tylenol throughout the day to control fevers and rested. On 2/13 my fever broke around 9am, but continued to be low grade about 99-99.5. The same symptoms from 2/12 continued and I did not take Tylenol I took Advil for body aches. On 2/13 I was scheduled to work and I decided to go to urgent care in the morning to get checked out since the heart palpitations and shortness of breath continued. I ended up calling off that day and rested since exertion increases my symptoms and rest helps. On 2/15 I went to work because my chest pain and heart palpitations were under control with rest. So I went to work and experienced increased shortness of breath, heart palpitations, and chest pain. I was unable to preform at my job like I normally do and by the end of my shift I seriously considered going to the emergency room my heart was beating so hard and I was breathless. Today 2-16 I'm still having similar symptoms and I will be seeing a new doctor tomorrow.
Pharmacist stated that while administering Moderna COVID-19 Vaccine to a pateint, syringe blew off and vaccine leaked out on the floor; This spontaneous case was reported by a health care professional and describes the occurrence of OCCUPATIONAL EXPOSURE TO PRODUCT (Pharmacist stated that while administering Moderna COVID-19 Vaccine to a pateint, syringe blew off and vaccine leaked out on the floor) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced OCCUPATIONAL EXPOSURE TO PRODUCT (Pharmacist stated that while administering Moderna COVID-19 Vaccine to a pateint, syringe blew off and vaccine leaked out on the floor). At the time of the report, OCCUPATIONAL EXPOSURE TO PRODUCT (Pharmacist stated that while administering Moderna COVID-19 Vaccine to a pateint, syringe blew off and vaccine leaked out on the floor) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-035995 (E2B Linked Report).; Reporter's Comments: This case concerns a 31-year-old male who experienced NS events of unexpected occupational exposure to product.  Event onset occurred the same day as mRNA-1273 administration to a patient. The event, occupational exposure to product, is considered resolved.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-035995:same reporter, same events
10/12 Fourteen days after receiving vaccines began experiencing fatigue, achiness, headache, joint pain, muscle weakness, depression and shivering.  Denied fever at anytime after vaccination.
Narrative: 79yo male patient in home health contacted facility to inform pt had died at outside facility on 1/8/22. See info below about pt's death from provider's chart noted dated 1/10/22 which came from non-facility medical record: "Date of Service: 12/26/2021-1/8/2022 Name of Facility: Inpatient reason for hospitalization pleural effusion, septic shock, hospital acquired pneumonia, pleux catherer placed 12/28/2021, continued antibiotics withotu improvement, not much drainage from catheter, persistent hypotension treated albumin, midrodrine, phenylephrine drip for days, could not eat or tolerate tube feeds egd/peg exchanee 1/3/2022 unfortunately multisystem organ failure, despite maximal resuscitative efforts began bradycardia arrhythmias, family elected to make him dnr comfort care, passed peacefully with family and several hospital staff, cause of death refractory cardiogenic shock 1/8/2022 8:46am "Pt had received covid vaccines from non-facility site on 2/9/21 & 3/10/21. Likely pt's death is not related to covid vaccines given pt's advanced age, information about pt's death provided, and long length of time between death & date of vaccine administrations.
Customer came into the pharmacy at around 4:30on 03/29/2021 stating that when she went home this morning after her shot that her throat was dry. Her breathing was fine, but she had redness around her neck and chest area when she was here at 4:30pm and her breathing was still fine.  She went to her provider's office around 4:00pm before coming to the pharmacy and her provider was gone , but the personnel that was left told her to come back in the morning or to seek medical attention if her symptoms got any worse. I instructed her to take some benadryl, but she said that she could not take it. We told her that we could call EMS for her, but she refused saying that she was fine and would take the advice of her
Narrative:  Patient was admitted to the medical COVID unit on 10/9/2021. He required treatment for COVID-19 on 10/15/2021. He completed remdesivir therapy on 10/19/2021 and dexamethasone therapy on 10/24/2021. He was discharged home on 10/29/2021.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with M-M-R II (lot number: K002816 with unspecified date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with M-M-R II was not reported. product quality issue was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Informaton received from a pharmacist on behalf of a physician on 03NOV2015 who inquired whether BioThrax was known to cause cholesterol xanthoma. In approximately 1999-2000, 1-2 weeks after receiving BioThrax (Lot FAV036), a male consumer reported that he experienced cholesterol xanthoma around the eyes. Subsequently, every time the individual received BioThrax the condition worsened. No further information was provided. Sender's Comments: Not assessable.
Few minutes after vaccine administered client was standing ready to leave, and client later reported felt extremities getting numb.  Client sat down in chair behind her, and appears to have fainted. Noted by Mom and Rn that client in chair and not responding to verbal commands.  Eyes open, but rolled back, extremities lax, color pale.  Skin warm and dry.  RN gently shook clients arm and client returned to alertness within two to three minutes. Clients sibling fainted within about 1 minute of patient fainting as well.  Mother and RN and HD staff all at both clients side.  After incident client reported she could hear Mom and RN calling her name.  Gave client Orange drink to sip and ice pack to neck.  Client remained under staff observation for 15 more minutes after above incident. Mom instructed to feed client when arrives home.  No other treatment administered.
No adverse event; Medical Tech calls to report vaccine given during an excursion.; This spontaneous report was received from other health professional referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.    On 16-AUG-2023, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA) (lot # W038815 which was determined to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date not reported, but upon internal validation established as 04-JUN-2024; strength, dose and route were not reported; one time) was given during an excursion to the patient (product storage error).
Very bitter taste in my mouth within 30 minutes of taking medicine.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Very bitter taste in my mouth within 30 minutes of taking medicine.) in a 38-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Graves' disease. Concurrent medical conditions included Penicillin allergy. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and METHIMAZOLE for an unknown indication.   On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2022 at 11:00 PM, the patient experienced DYSGEUSIA (Very bitter taste in my mouth within 30 minutes of taking medicine.). At the time of the report, DYSGEUSIA (Very bitter taste in my mouth within 30 minutes of taking medicine.) outcome was unknown.  The patient took other medications/products within 2 weeks of starting COVID-19 treatment No treatment medication was reported.
Patient completed pre-vaccine questionaire citing had not been  diagnosed with covid within the past 2 weeks and was given the vaccine (2nd dose) after being covid positive
1500:  pt received 2nd dose of Moderna vaccine.  1505:  pt in car with caregiver in onsite observation lot, starts to feel "tightness in throat".  1515:  caregiver notifies RN's in observation lot and pt assessed with worsening tightness in throat.  911 called by RN .  RN's  retrieve medical kit directly inside front door of building and bring to car side.  Pt assessed again and continues to have increasing tightness in throat.  1518:  0.5mg Epinephrine given IM in right deltoid by RN. per written standing order for, medical director.
Arm sore, swollen, Temp 2-28-14 101.8. HA, nausea Bad GERD. Pt treated with Prednisone and NORCO as needed.
Heart palpitations, was given a home monitor, mild heart issue, stomach pain and acid reflux, hard to swallow.
Pain in the injected arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Pain in the injected arm).  The outcome of the pain in arm was resolved (duration 2 days).   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 27-Sept-2023 According to the pharmacist a few random patients (quantity unknown) had been in the pharmacy to report that pain in the injected arm after receiving Arexvy, that resolved after 2 days.  No identifiers provided or other information. The reporter consented to follow-up. The case was linked with the case US2023133480, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023133480:1st report
Moderna COVID-19 Vaccine EUA 10 minutes after receiving vaccine throat began tingling and I noticed my heart rate was 164 on my apple watch.  Notified nursed overseeing the monitoring.  Nurses began hooking my up to monitoring equipment. Heart rate came down to 120.  Nurses noticed flushing in face and blotchiness on arms. After an additional 15 minutes of monitoring, flushing was still present as well as throat tingling (just tingling, no swelling), so nurses sent me to the ER for further monitoring.  Upon arrival to ER temperature was 100.2 F. (Temperature before vaccine was 97 F, no fevers recorded after ER visit).  In ER fluids and zofran were given and was released after two hours of monitoring.  In the evening I experienced moderate pain in the left arm (very painful to lift arm above shoulder level) that lasted about 24 hours.  I also had a mild to moderate headache that lasted about 24 hours, beginning the evening of the vaccine.   I also experienced mild to moderate nausea that began the day of the vaccine (Saturday, 12/26) and was on and off through Wednesday, 12/30.
By day 6, there was a friction run upon acscultation of heart sounds; Felt to be most likely PVC's; irregular heartbeats; sub sternal burning sensation; had mild bronchial irritation; chest congestion symptoms; a sense of inflammation in the heart; This is a spontaneous report from a contactable other hcp. A 64-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6203) via an intramuscular route of administration in Arm Left on 03Mar2021 08:30 (Age at vaccination 64years old, Pregnant at Time of Vaccination no) as single dose for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive list of any other medications within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID. The patient experienced chest congestion symptoms, a sense of inflammation in the heart, sub sternal burning sensation, had mild bronchial irritation on 06Mar2021 12:00, irregular heartbeats, felt to be most likely pvc's on 07Mar2021 12:00, by day 6, there was a friction run upon acscultation of heart sounds on 09Mar2021 12:00. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
I am dealing with a blood clot in my left atrial appendage. I am also experiencing A. Fib. I was hospitalized from 4/5 to 4/11 2021. I have been exhausted since vaccination date.
6 months pregnant at the time of vaccine. Five minutes after receiving vaccine, had significant dizziness, sweating, and light headedness.
Case number PHEH2013US021531 is an initial spontaneous report received from a nurse on 14 Oct 2013 with a follow up information received from a nurse on 11 Nov 2013. This report refers to a 2-years-old female patient. Her medical history and concomitant medications were not reported. She was inadvertently vaccinated with an intramuscular dose of FLUVIRIN (batch number: 1308501) at a dose of 0.5 ml in the thigh on 10 Oct 2013. It was reported that the patient was administered 0.5 ml FLUVIRIN instead of 0.25 ml FLUZONE (other manufacturer, batch number: not reported). The physician was informed. No adverse event was reported following the maladministration. Follow up information received from a nurse on 11 Nov 2013: The event was recoded to wrong vaccine administered. FLUZONE was captured as suspect. Dose and site of administration of FLUVIRIN updated.
Pain, redness and swelling on left arm Treated with IV Fluids and Antibiotics
Fever uncontrolled by acetaminophen and ibuprofen rotations, nausea, weakness, muscle aches, joint pain, fatigue, cough, shortness of breath, seizure.
10/25/21 pt had a positive COVID test from nursing home where he stays, 10/28/21 pt to ED via EMS for AMS and O2 saturation 46% on RA; placed on NRB; DNR; pt had a second positive COVID test in ED; COVID pneumonia; Dexamethasone, Remdesivir; pt eventually succumbed to COVID PNA, became obtunded and hypotensive; he passed away in the hospital
headache; feeling nauseous; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer-sponsored program.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at an unspecified age for COVID-19 immunisation.  The patient medical history was and concomitant medications were not reported.  The patient experienced headache and feeling nauseous on an unspecified date. The events were considered non serious. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approximately 24 hours after getting Shingrix vaccine in my right arm I went to bed with chills and my whole body ached.  I was better the next day but my right deltoid area around the shot area is red and the skin is hard to the touch 3 days later.
Upset stomach; Cough; Headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and FAMOTIDINE (PEPCID AC) for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-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 ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough), HEADACHE (Headache) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough), HEADACHE (Headache) and ARTHRALGIA (Joint pain) outcome was unknown.             Treatment included cold compresses.
patient experienced flushing, and hand muscle cramps and rigity also experienced tightness in calf muscles. After patient sat down for about 15 minutes minutes and hydrated, the patient felt better and the muscle stiffness went away except for soreness.