chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was inadvertently given the fluzone hd, with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 62 year old male patient who was inadvertently given the Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect Influenza Quadrival A-B High Dose HV Vaccine at a dose of 0.7 ml (lot UJ918AD, expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for immunization.  On an unknown date the patient was inadvertently given the fluzone hd, with no reported adverse event (product administered to patient of inappropriate age) (same day latency).   Action taken: Not applicable.  Outcome: Unknown.   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.
positive covid test the second week of March; positive covid test the second week of March; This is a spontaneous report received from a  contactable physician reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had a positive covid test the second week of March and has been hospitalized and on a ventilator for 3 weeks. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Large 8 in wide swollen blotch. Rapid pulse - 130 BPM. Short of breath. High fever -103. BP 175/135 within 6 hrs.
This spontaneous report as received from a pharmacist refers to a 15 year old male patient with asthma. There was no drug reactions/allergies. On 11-NOV-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# as reported J007060, expiration date not reported, 0.5 ml, Intramuscularly). Concomitant therapies included albuterol as needed. On 12-NOV-2013, the patient developed a 6 inch diameter area of redness, slight swelling, and pain at the injection site. On 14-NOV-2013, the patient developed a fever of 104.5F. He was initially evaluated at a local urgent care facility and then admitted to hospital. The patient was then transferred to the hospital. The patient was receiving intravenous hydration and was undergoing unspecified testing. The outcome of the events was reported as not recovered. Additional information has been requested.
Nausea, Lethargic, Feeling Hot, Dizziness, and Insomnia.
A non-serious spontaneous report of ringing in ears has been received from a consumer concerning himself, a 41-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 12-Oct-2009. On 14-Oct-2009, the patient developed ringing in the ears. Treatment for the event was not provided. The outcome of the event is not resolved.
body rash; Diaper rash; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-healthcare professional via Global Medical Information (GMI) (Reference number- 00546075) and transmitted to Sanofi on 02-Apr-2021.  This case involves an 18-month-old female patient who had body rash (rash) and diaper rash (dermatitis diaper) after receiving HIB (PRP/T) VACCINE [ACT-HIB].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 16-Dec-2020, the patient received a dose of suspect HIB (PRP/T) VACCINE Injection (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious body rash (rash) and diaper rash (dermatitis diaper) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  The details of laboratory data were not reported.  The patient was treated with CALAMINE, ZINC OXIDE (CALADRYL) nd cool bath.  At time of reporting, the outcome was unknown for the events.   There will be no information available on the batch number for this case.
Initial report received from a health care professional on 16 November 2010.  A 55-year-old male patient, with a history of chronic idiopathic urticaria and food allergies, received on 10 November 2010 a left deltoid intramuscular injection of FLUZONE No Preservative 2010-2011, lot number U3777BA.  The patient had no concomitant medications and denied any illness at the time of vaccination.  On 15 November 2010, 5 days after the vaccine, the patient reported that he had an area the size of a 25 cent piece at the injection site which was ulcerated and painful.  The patient was evaluated by an infectious disease specialist.  The outcome was unknown.  Documents held by sender: None.
I had my first injection on 01/19/21 had just normal reaction injection site tenderness mild headache and fatigue.  Then I noticed Tuesday evening 01/26/21 a week later that my right arm the same one looked a little red and it was pretty sore and by Wednesday morning I woke to to very painful, swollen, red, very hot to the touch. I had the provider I work for look at and we marked around it, and by Thursday morning my muscle was  very red, swollen and very hot to the tough. I do have pictures. By today 02/01/21 it has pretty much subsided I went to my PCP she stated that she could still see that it still had a knot at the injection site and was still warm to the touch and she could see some redness.  She did not treat with anything at this time. She advised me to report delayed reaction and to ask about getting my second dose which I am due for it on 02/16/21. Is this something that you have been seeing?  Should I receive my second dose?
Narrative:  FIve minutes after receiving 1st moderna vaccine she developed blurry vision that lasted over an hour. VSS were stable and no other symptoms. I walked her to the ER to be checked out and was later sent home and vision cleared.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history, concomitant medications were not reported. On 07-FEB-2018, the patient was vaccinated with expired dose of VARIVAX (lot # M002061 and expiration date 12-JAN-2018) (dose, units and frequency unknown) via subcutaneous route for prophylaxis. No adverse effects were reported. No product quality compliant reported.
Information has been received from a physician concerning a 16 month old female patient with no allergy to eggs who on 02-SEP-2009 was vaccinated with the first dose of MMR II (lot number, route and site not reported). 10 minutes after vaccination, the patient developed a rash locally at the injection site that was 10 centimeters. The patient had sought unspecified medical attention. At the time of the report, the patient had recovered. No further information is available.
About 12 hours after shot and during sleep, I woke up feeling faint and light-headed. I then vomited several times and started shaking. My temperature was 101.4 and I had the chills. I had extreme body aches and the tips of my toes felt on fire/frost bit. I took a normal dose of ibuprofen and these symptoms subsided within 30 minutes. I then had the sweats and my fever was in the 100s the rest of the night. I felt pains throughout my body in places where I had surgery years ago, and in the place of my epidurals from having kids more than 5 years ago. About 20 hours after my shot, my temp was down to 99.7 and the rest of the day mild chills and sweats occurred throughout the day.
This initial spontaneous case was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to a 15th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
After 2 vaccines were given to pt. she started to pass out (faint).  Mom shouted pt was having a seizure.  Pt. was shaking, rigid & eyes were rolling back for very short time 4-5 seconds.
01/20/22 presents to EC ED for "chills/shaking". PMHx of "GERD, HLD, MI, PVD"
Injuries due to the COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: INJURY (non-serious), outcome "unknown", described as "Injuries due to the COVID vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
itching on her left leg; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching on her left leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis (anaphylaxis reactions in the past to other substances).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (itching on her left leg). At the time of the report, PRURITUS (itching on her left leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included dphenhydramine
This case was reported by a nurse and described the occurrence of expired vaccine used in a adult female patient who received FLUARIX (batch number unknown, expiry date June 2014). On 26th September 2014, the patient received the 1st dose of FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to FLUARIX. Additional information received on 26 September 2014. The nurse had no other information at time of reporting.
hives, racing pulse, chest tightness, low grade fever  irregular pulse persistent for 2 weeks now
This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-SEP-2018, the patient was vaccinated with and expired dose of RECOMBIVAX HB injection, lot # L016959, expiration date 12-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
Pt. claimed itching and burning of skin was give 25 mg Diphenhydramine (at pt's request).
(4/10/21)Day of shot: small headache and tired 4/13/21: had tingling/numb  feeling in my lower half of my right leg and right arm and a bit on my left leg as well, lasted all day until i woke up the next day and the symptoms were no longer there 4/28/21: those tingling/ numb feeling came back but this time my right leg around my calf area would hurt when i would walk down/up the stairs( wouldn't hurt if i walked around the room unless i angled or moved my foot up) 4/29/21: still feel a bit of the tingling feeling a bit on my right hand but not as much s the day before
Fever to 103 w/in 24 hrs of inject; 3hrs of screaming;
redness, pain and tenderness at the injection site; redness, pain and tenderness at the injection site; redness, pain and tenderness at the injection site; This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. This nurse reported similar events for three patients (nurse's mother and two patients in the office). This is the second of three reports.  A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness, pain and tenderness at the injection site. The patient also experienced flare on unspecified date. The patient was given antibiotics and steroids for symptoms. Outcome of the events was unknown.   Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019296477 different patient, same drug and event
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 05-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Developed high blood pressure, started on Losartan twice a day plus diuretic. Now on Losartan 50 once a day. Developed tinnitus, went to ENT, gave me ears drops but still persist.
suddenly started sneezing; This spontaneous case was reported by a patient and describes the occurrence of SNEEZING (suddenly started sneezing) in a  patient of an unknown age and 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 15-Nov-2022, 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. In November 2022, the patient experienced SNEEZING (suddenly started sneezing). At the time of the report, SNEEZING (suddenly started sneezing) outcome was unknown.            No concomitant medications were reported. Patient received  Moderna booster and suddenly started sneezing. The patient wanted to know if it was a side effect of vaccine or if the patient had a cold. No treatment information was reported.   Reporter did not allow further contact
Large, red, hard, itchy bump on the arm of the insertion site that spread across down the arm and hand
In Nov of 21 I had my third covid vaccine, Moderna for all 3.  In December of 21 I started to have an occasional heart flutter.  I went to a cardiologist and did a stress test and echo, both show ok, and the occasional flutter was attributed to stress.  They occasionally continued .  They were showing up as PVC's.  Went back to the cardiologist for a follow up in June of 23.  Did another stress test and echo and again it was ok.  Shortly after (a couple days) in June of 23, the arrythemias intensified.  I called the cardiologist and they put me on a halter monitor.  in the middle of that, I was experiencing extreme arrythmias at home and went to the ER.  I was having PVC's, bi and tri gemini, and unsustained vtac and was admitted.  Was given a variety of medications and a battery of tests, to include an Echo that shoed my EF went from a normal 55 about 2 weeks prior to 37.  Went home the next day and saw the cardiologist and was put on a variety of other meds.  The next day the arrythmias got unbearable and I returned to the ER, and was again admitted for a night.  I was sent home that afternoon with a life vest.  3 hours later, the life vest went off trying to shock me, and I again returned to the ER.  I was admitted in heart failure and was diagnosed with myocarditis.  I had an angiogram and a cardiac echo, both were clean.  I was scheduled for an EP study but then sent home on strong medication.  I am now awaiting an ablation, just under 3 months later.  No other cause could be found other than viral.  As a note, I had covid shortly before the events increased dramatically.  I can only attribute the events to the vaccine and covid
Arm pain started on Tuesday evening. Light headache on Tuesday. Wednesday after 12 pm, headache, chills, body ache, and fever of 100.4-100.8 for the whole evening. Took Tylenol.  Morning of 4/14 no fever, just headache and slight soreness in the left arm. Feel tired. As well.
Unconscious; Fainted; head was rapidly spinning then developed severe vertigo; broke her 3 ribs on her left side; hurt her left leg; She thought "i was dying"; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Unconscious) and SYNCOPE (Fainted) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic and Environmental allergy. Concomitant products included LIRAGLUTIDE (VICTOZA) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion medically significant), SYNCOPE (Fainted) (seriousness criterion medically significant), VERTIGO (head was rapidly spinning then developed severe vertigo), RIB FRACTURE (broke her 3 ribs on her left side), PAIN IN EXTREMITY (hurt her left leg) and FEELING ABNORMAL (She thought "i was dying"). The patient was treated with IBUPROFEN at a dose of for the first couple of weeks; ASPIRIN [ACETYLSALICYLIC ACID] at a dose of for the first couple of weeks and PARACETAMOL (TYLENOL) at a dose of for the first couple of weeks. At the time of the report, LOSS OF CONSCIOUSNESS (Unconscious), SYNCOPE (Fainted), VERTIGO (head was rapidly spinning then developed severe vertigo), RIB FRACTURE (broke her 3 ribs on her left side), PAIN IN EXTREMITY (hurt her left leg) and FEELING ABNORMAL (She thought "i was dying") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was unconscious on the bathroom floor but  unaware of how many minutes she was unconscious. It was reported that overall her pain scale was 8. The patient did not go to the hospital, just stayed at home and laid in bed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
She initially experienced a bruise at the injection.  The following day, she had an 8-10 cm reddened area around the injection site.  These symptoms resolved with an antihistamine a topical hydrocortisone.  On Day 8 following injection she developed a large inflammation on the outer aspect of her left arm that ran from her shoulder to her elbow.  It was itchy, achy, and sensitive to the touch.  She was treated with additional antihistamines, acetaminophen, and topical triamcinolone.  The reaction is currently resolving.
pt recv vax 24FEB97 & immed p/vax pt exp stomach pain;lips became blue;diaphoresis;pallor;blood pressure was 88/48;eyes crossed & closed & became disoriented;pt was described as being verbal but confused;pt given 02 & epi & recovered;
This spontaneous report has been received from a 61 year old male patient with asthma and hypothyroidism refers to himself. The patient's medical history included acid reflux, breath arrest at 2 years old after receiving penicillin, irritated nerve in his neck after receiving aminoglycosides and his skin turned red after receiving vancomycin. On 10-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported, lot# was not reported). Concomitant therapies included ADVAIR, PROAIR HFA, PREVACID, domperidone, FLOMAX, PAXIL and levothyroxine sodium. On 11-JAN-2015 the patient experienced exacerbation of his asthma. The patient visited the office to seek medical attention. None lab was performed. The patient received prednisone to treat the events. The outcome of the exacerbation of his asthma was reported as not recovered/not resolved. Additional information has been requested.