chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a dose of Shingrix on 26Sep2023 that was exposed to a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 3J972, expiry date 20-AUG-2024) for prophylaxis.   On 26-SEP-2023, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: received a dose of Shingrix on 26Sep2023 that was exposed to a temperature excursion).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 28-Sept-2023 No symptoms were reported. The reporter consented to follow-up via email. This is 2 of 3 linked cases reported by the same reporter. The patient received a dose of Shingrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023133818:same reporter different patient US-GSK-US2023133821:same reporter different patient
Pt had a swollen arm.  was seen a ER & followed up with us 5 days after initial shot 3 days after ER vistis.
T 5am on 8/25 I woke up with severe chest pain. My husband drove me to the emergency room. I was admitted to the hospital. Diagnosed with cardio myocarditis in mostly my ventricles
started from 12/28/20 soreness, then swelling and more intense redness and itching, 1/4/21 more intense itching, swelling and warmth of RUE
This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-AUG-2022, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection. This report was non-serious.
Patient stated her lungs felt "bubbly" starting on day 3 after the vaccination. Then on day 4 her airways closed. She used her inhaler and took Benadryl and then went to the ER. She was told her lungs were inflamed and she was given 7 days of IV steroids.
Patient had shortness of breath, nausea, dizziness, and their tongue tingled soon after receiving the Pfizer vaccine. EMT onsite evaluated patient and called 911. Ambulance Service arrived, evaluated the patient, and transported the patient to the hospital.
See attached form ID 2766CX Vaccine Administration Record. Standard Form 600 Health Record Chronological Record of Medical Care
LEFT ARM REDNESS @ INJECTION SITE, 3CM HEMATOMA UNDER INJECTION SITE AND LOWER PART OF BICEP AREA WARM TO TOUCH AND IN BACK OF UPPER ARM AS WELL - SWOLLEN - LIMITED MOTOR
Information regarding PREVANR 13 was received from a healthcare professional regarding a patient who experienced injection site reaction and high fever. The patient received a dose on an unspecified date. The patient experienced injection site reactions and high fever on an unspecified date. The Physician commented that these events didn't seem to happen with PREVANR 7. The patient's outcome was not reported.
I am not feeling well today; Light-headed / dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EN6205) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "Light-headed / dizzy"; MALAISE (non-serious) with onset 03Mar2021, outcome "unknown", described as "I am not feeling well today".  Additional information: The patient was inquiring if it was okay that side effects were experienced a couple of days later; patient thought it (side effects) would show up within the same day.  No follow-up attempts are possible. No further information is expected.
Patient scheduled to have a 2nd dose of Pfizer vaccine on 4/16. Unfortunately patient received a Moderna dose in place of the Pfizer 2nd dose by mistake. Patient made aware. No reports of any adverse reaction and an incident report was made with the provider.
Seizures seen at hospital and at home then transfered to another Hospital.  8/7/07 Received hospital medical records which reveal patient experienced seizure activity of head & arms jerking, eyes rolling back, pallor, limpness & post ictal staring w/o fever or s/s of infection day after vaccines.  Seen at outlying ER & d/c to home s/p labs & CT all WNL.  Had second seizure & taken back to outlying ER.  Transferred to higher level of care & admitted 7/25-7/26/07 for tonic-clonic seizures.  Neuro consult done.  No further seizure activity in hospital.  D/C to home on antiseizure meds & precautions w/follow up in neuro clinic. FINAL DX: Seizure.
Moderate lethargy. Injection site reaction, redness, swelling, pain/tenderness, and itching. Site size on injection date 1x1cm. On 1/25/21, site 4x4cm. Treated with ice/heat, Benadryl, Ibuprofen, and rest.
Pt had an irritation. scratch in his throat about an hour and a half after vaccination , felt like he was having difficulty swallow, no shortness of breath , was able to speak clearly when he alled the clinic for advise for an extended period of time. Did not have Benadryl on hand, EMS was called, pt was given epinepherine, Benadryl and 2 steroid IM shots in the ambulance, observed in ER x 3 hours with no further medication, sent home with Epi Pen Rx and advise not to get second dose.
VERY stiff arm.  After 72 hours, the arm could finally be raised above my head. 48 hours post shot, a lymph node in the armpit of the shot arm was swollen.  This went away 72 hours.
Patient incorrectly received the plain pfizer vaccine and NOT the Pfizer-Bivalent vaccine. Intended vaccine-supposed to be Pfizer Bivalent!!
Myalgia, Arthralgia, Fever, NauseaVomiting, chills, sweating, sleeplessness Narrative:  Vomiting, chills, no sleep, sweating, fever 102, myalgia, arthralgia; taking ibuprofen.  Other Relevant History:
Pt recvd 3 doses of Engerix-B vax 30OCT90, 6DEC90, & 29APR91 & 23SEp91 it was determined that pts titer was neg p/3 doses of Engerix-B; recvd booster, titer pos;
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 02-SEP-2015, the patient was vaccinated with an expired dose of MMR II lot # J003004, expiration date: 14-MAR-2015) (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse experiences were reported. Additional information has been requested.
Patient with topical reaction in the area of the arms, abdomen and neck. VS 140/80, P 125, Sat 99%. Paramedic did not have an Antihistamine. Doctor recommended BENADRYL 25mg, then reaction decreased.
Patient developed a fever that eventually spiked to 102.9 degrees Fahrenheit and was lethargic and fussed inconsolably upon waking in the morning.  Patient was treated with infants' ibuprofen with some alleviation of symptoms.  Fever lasted intermittently for 12 hours.  Lethargy lasted concurrently with fever.
sharp pain across left chest, left armpit, left chest. Hours later, swollen tongue, pins & needles sensation in tongue & throat. I took one tab Benadryl at 10pm, then one tab at 11pm, then 2 tablets at 3:30am. Today, at 12pm I took one tablet benadryl and my tongue is not as swollen as last night, but still puffy with Pins & needles sensation. I called my Doctor and she ordered an epipen, also instructed me to continue Benadryl tabs for a few days, If no improvement or worse, go to Urgent Care
Loose stool (2/3/times a day in the morning hours), bloating in the abdomen, 'quizzyness', fatigue which started in the same day of the 1st dose of 4 capsules; seemed to feel better after the 3rd dose.
Patient was given an Adacel at the age of 8, no adverse event; Initial information regarding an unsolicited non-valid non-serious case was from a pharmacist via Global Medical Information (GMI) (Reference number- 00517032) and transmitted to Sanofi on 12-Mar-2021.  This case involves a 8 years old female patient who was given 0.5 ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number- U5472AA, expiration date- 15-Oct-2018) via unknown route in unknown administration site for prophylactic vaccination on an unknown date at the minute clinic (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to the patient.   It was an actual medication error due to inappropriate age at vaccine administration (same day latency).  Also stated that she was 12 now but she got the dose when she was 8 years old and reporter was asking if it was safe for her daughter to get an Adacel injection at age 12.   No laboratory data was reported  It was not reported whether the patient had any adverse event.  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 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.
19 month old received an adult dose; 19 month old received an adult dose; received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-month-old female patient who received HAV (Havrix 1440 adult) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose, adult product administered to child and expired vaccine used. On an unknown date, the outcome of the overdose, adult product administered to child and expired vaccine used were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The reporter stated that the patient received an expired dose of adult Hep A (Havrix) vaccine and it was given in a thigh, not sure what side.  The reporter did not consent to follow-up. Additional Supportive Information: On the day of reporting, a 19th month old patient received an expired dose of adult Hepatitis A (HAVRIX) vaccine, which led to overdose, adult product administered to child and expired vaccine used.
Arm pain Narrative: 1 week after vaccine, so 2/20,developed itching for 3/4 days Since then, sensitive muscle to touch. when sleeps or moves muscle, feels "dead" or sensitive, pain runs down arm, no rash no fever no improvement over time but no worsening no swelling --- He relates concerns of continued arm pain s/p initial vaccination. At this time, most of his hesitancy related to receiving the 2nd dose are related to unknown potential of continued adverse effects. He mostly feels annoyance at the lingering occasional arm pain - which is not inhibiting him from being able to do his daily activities. Of note, he continues to drum and also notes being annoyed that he can sometimes feel the pain with maneuvering on the drum kit. Exam was benign.
Pt developed a red, swollen, warm area around the injection site the size of a quarter. Arm is extremely sore.
PATIENT WAS HOSPITALIZED FOR COVID19 PNEUMONIA. PT WAS SEEN WITH INCREASING SHORTNESS OF BREATH. REQUIRED 3-5L OF OXYGEN VIA NASAL CANNULA FOR 5 DAYS, AND RECEIVED PREVIOUSLY MONOCLONAL ANTIBODIES AND THEN REQUIRED REDESIVIR AND DECADRON FOR 5 DAYS. PT'S SYMPTOMS AND OXYGEN REQUIREMENTS IMPROVED TO 2L NASAL CANNULA AND PT WAS DEEMED SAFE FOR DISCHARGE AFTER THE 6TH DAY.
Lump in armpit, it was hard and around the size of a large lima bean; Soreness in left armpit; Discomfort; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration on 17Apr2021 at 10:15 (at the age of 31-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Apr2021 at 00:00 hours, the day after the first vaccination, the patient experienced soreness in her left armpit. On 23Apr2021, six days out of the first dose, the patient had a lump in her armpit. It was hard and around the size of a large lima bean. After reading reports and side effect information of swollen lymph nodes she waited several days. The lump was gone by day 9 and the discomfort faded by 12 days after the first vaccine shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events of soreness in left armpit was recovered on an unknown date in 2021, the event of lump in armpit was recovered on 26Apr2021 for a duration of 3 days and for the event of discomfort was recovered on 29Apr2021 for a duration of 12 days.  No follow-up attempts are needed. No further information is expected.
PERIPHERAL NEUROPATHY 4/10/2022 NONTRAUMATIC INTRACRANIAL HEMORRHAGE, UNSPECIFIED
Dry throat; Cough; Cold like symptoms; Headaches; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 15Sep2021 at 09:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin b nos (VITAMIN B), ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), zinc (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all were taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 15Sep2021 at 12:15, the patient experienced dry throat, cough, cold like symptoms, headaches and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events with dextromethorphan, hydrobromide, guaifenesin, paracetamol, pseudoephedrine (DAYQUIL) and ibuprofen (ADVIL) on an unknown date and unknown if ongoing. The clinical outcome of the events dry throat, cough, cold like symptoms, headaches and body aches was resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Generalized rash upper extremities, torso, face. Swelling of face, pruritis, "throat feels weird". Seen in ER and tx with IV SOLUMEDROL, SQ epinephrine, IV ZANTAC, IV BENADRYL. Hives resolved, discharged with po BENADRYL and prednisone. Also had albuterol SVN tx in the ER.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt has a PMH significant for tobacco use, Diabetes, HTN, chronic obstructive lung disease, hypercholesterolemia, primary malignant neoplasm of lung. Pt was 76 years of age. Admitted on 4/13 for HYPERCAONEIC RESPIRATORY FALIURE. Per note on 4/13 ". Patient is a 76-year-old gentleman with chronic respiratory failure on home oxygen, severe COPD (FEV1 0.6 L), history of lung cancer status post right middle and lower lobe lobectomies in 2008, history of pulmonary embolism in July 2015, diabetes, newly detected enlarging right upper lobe nodule concerning for bronchogenic carcinoma who presents with increasing cough, dyspnea and fatigue. He was noted to be hypoxic/hypercapnic in the ED, placed on BiPAP and transferred to the MICU." Discharged 4/15 under the care of his son.
Patient had 2nd Pfizer vaccine at 14:30 (pre-medicated with Zyrtec and Solu-Medrol), but now having tingling sensation all over body, hoarse voice and cough.
This spontaneous report as received from a medical assistant refers to a 27 years old female patient. The patient was vaccinated (intramuscularly) with lot # (0101AE) (expiry date 10-OCT-2014) dose 1, 0.5 ml GARDASIL on 14-SEP-2012. No other co-suspects were reported. Concomitant medications included CYMBALTA, TRILEPTAL, gabapentin, ATIVAN and ZYRTEC. The patient was diagnosed with Lyme disease by another unspecified healthcare facility 2 weeks ago, 43 days after onset of therapy. The patient was treated with unspecified medications to treat Lyme disease. The lab diagnostic studies performed where unspecified by the reporter. The outcome of Lyme disease was reported as not recovered/not resolved. The relatedness for Lyme disease was unknown for GARDASIL. Additional information is not expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient received a treatment with Anti-viral Paxlovid, took Paxlovid for 5 days, at 9th day, felt runny nose. No other medical was taken by the patient within 2 weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 22-NOV-2017, the patient was inadvertently vaccinated with an expired ZOSTAVAX lot # M036297 with an expiration date 14-NOV-2017 for prophylaxis. There was no adverse effects reported.
COLD AND HOT FLASHES; NOT THINKING WELL; This spontaneous report received from a parent concerned a 31 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced cold and hot flashes. On 08-APR-2021, the subject experienced not thinking well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold and hot flashes, and not thinking well. This report was non-serious.
Swelling, redness, pain, itch, warm to touch, 6in x 4in patient noticed at 5am, saw Dr. same day 10/31. Given antihistamine and BENADRYL cream. Pt also has HA, so taking TYLENOL. (Upper left arm).
Client complained of feeling flushed, hot, heart racing and tight throat and difficulty breathing. Vitals taken and placed in supine position with feet elevated but complained of hard to breathe so sat up. Started yelling she couldn't breathe, encouraged her to calm down take deep breaths, able to take drinks of water, and talk. BP 144/80 Pulse: 119 No swelling noted and no blueness of lips or fingers. Calmed down after drank water but then started yelling again in about 2 minutes she couldn't breathe and she wanted EPI would I please give her EPI. Gave 0.5cc Epinephrine, this immediately helped she said still wanted 911 called noted no breathing issues or swallowing issues drinking water, also called 911 . Ambulance here at 1:45 and checked o2 sat reported 98% Vitals taken by ambulance but not reported to us. Called the patient this morning 01/13/2021, she reported she had another episode in the ambulance she felt she couldn't breathe and they gave her Benadryl 0.5cc and she said she never had another episode after she got to the hospital, she reported the ER DR. diagnosed her with anaphylactic reaction to the vaccine. She returned to work this morning no issues she reported.
At about 9:00 AM today (5/9/22) I noticed red splotchy areas developing on my bilateral distal legs above my ankles. The areas itched but did not have mounds; it was all the way around my right leg and partially around my left leg in the same area. As the day continued on, the redness and itchiness continued to move up both legs. At about 3:45PM (5/9/22) the redness had reached both upper calves and at 9:00PM (5/9/22) it had reached my inner right thigh. No treatments or other adverse effects at this time.
Parents took child across street to groc store.  She was crying when suddenly went limp + eyes rolled back in her head.  She had mild inflammation of R upper lip + erythematous macules on face.  Dad roused her & she recovered.  Brought into clinic + all S/S resolved.
Sore arm and moderate body aches and fatigue for a couple days after 2nd dose.  About 4 to 5 weeks later I started to notice the same muscle aches in both legs and both arms and some fatigue. Tingling and numbness in lower lip. Muscle pain seems to be more apparent when going from stationary to moving position and also weak, that abates somewhat once moving. Pain and stiffness in both hands and fingers that I have never had before.