chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose of FLUZONE HD vaccine was administered with no reported adverse event; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and consumer or other nonprofessional via Media information (under the reference 00829581).  This case involves a 92-year-old female patient receiving expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Frequency: once, strength: fluzone high dose, lot UJ515AA, expiry date: 30-Jun-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine use (latency same day)  The reporter reported "Nurse Practitioner reported that the FLUZONE High Dose vaccine from last year, which expired on 30-Jun-2021, was given to 8 patients."  At the time of report, no adverse event reported.  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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9261), on 05Mar2021 as dose 2, single (Lot number: EL6199) and on 09Oct2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 41 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results; (10May2022) Negative, notes: I tested negative by the 4th day of taking it; (21May2022) Positive, notes: Had a rebound infection on 21May2022; (23May2022) Positive, notes: Still positive and symptomatic today on 23May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 07May2022 to 11May2022. Clinical course: The paxlovid seemed to work and patient tested negative by the 4th day (10May2022) of taking it. Had a rebound infection on 21May2022. Still positive and symptomatic today on 23May2022. No other medication were received in 2weeks. No known allergies.  No follow-up attempts are possible. No further information is expected.
Symptoms of Vertigo began 09/12/2021 and lasted 5 days.  Vertigo symptoms returned again, each time lasting longer and more frequently with symptoms not clearing up.  Feelings of off balance and falling continued for hours to more than a day.  Vertigo symptoms occurred on the following dates after never having had any of these symptoms previously:  9/12/2021 thru 9/17/2021 2/21/2022 thru 2/24/2022 3/15/2022 3/23/2022 thru 4/08/2022 5/17/2022 5/19/2022 thru 5/25/2022 I visited an urgent care clinic for the first event, and followed up with my PCP as the events continued.  My PCP referred me to Dr., Otolaryngology.  Dr. put in orders for Physical Therapy, Balanace Test VNG, MRI and a consult with a Neurolo The earliest appointments are in July, so there is no outcome as of yet.
extreme body aches and fatigue, particularly back and sciatica pain, @ 36 hours
Symptom free from Chronic Idiopathic Urticaria; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Symptom free from Chronic Idiopathic Urticaria) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Drug allergy.   On 15-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Symptom free from Chronic Idiopathic Urticaria). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Symptom free from Chronic Idiopathic Urticaria) outcome was unknown.            The patient treatment data was not provided.
Hives every day for over 6 months. Often 50+ hives on various areas of the body.  Allergy testing showed nothing causing it.  One year later, still getting hives, but less frequently.  Hives do not lessen with allergy medication. Only had hives once in my life before this & it was over 10 years ago.
At 16:00, mother of the pt called stating that the pt had swollen and blue lips and increased fluids. Pt sent to ER.
She wakes up like she's drunk and feels like she's going to fall; severe muscle aches, very bad; vertigo; very dizzy; sleepy all the time; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (very dizzy), SOMNOLENCE (sleepy all the time), BALANCE DISORDER (She wakes up like she's drunk and feels like she's going to fall) and MYALGIA (severe muscle aches, very bad) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (very dizzy), SOMNOLENCE (sleepy all the time) and MYALGIA (severe muscle aches, very bad). On an unknown date, the patient experienced BALANCE DISORDER (She wakes up like she's drunk and feels like she's going to fall). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo) outcome was unknown and DIZZINESS (very dizzy), SOMNOLENCE (sleepy all the time), BALANCE DISORDER (She wakes up like she's drunk and feels like she's going to fall) and MYALGIA (severe muscle aches, very bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant FU- AE Outcome was updated
I developed a sore throat and headache on August 3.   I tested positive for Covid-19 on August 4. I had a fever on August 4 for about 2 hours I was very tired for several days I developed a cough that is still lingering In general, symptoms remained mild
Got heaviness in chest and ring finger turned white and numb around 8:30 a.m.   Got heaviness in chest again around 6:00 p.m. and it would not subside so I went to the ER and they gave me 3 nitroglycerin and did several tests to check my heart but could not find anything wrong.  I am scheduled for a stress test April  20. The person in the bed next to me had similar symptoms and received he Janssen vaccine the same day I did but about 10 minutes earlier.
Severe headaches for past 2 ½ months. Inflammation in the head (on left-side). Inflammation in the left eye. This started all after the first vaccine.
Onset was simple cold sore on lower lip, few days later sore inside left nostril, week later sore inside right nostril. Three days fatigue as of yesterday. None have healed at this point.  Bloody and oozy.  Ouch.  No fever.
PE tender L deltoid and erythema AC jt shoulder edematous and pain (patient rated 8/10), redness.
Kinrix ws given instead of Dtap and hib was not administered.  A puncture wound was given to left thigh with already spent vaccine from right thigh; unknown which one.  Child  later developed a large local reaction for which she was seen in ER and dx with cellulitis and started on clindamycin.
POSITIONAL VERTIGO; LIGHTHEADED AND DIZZINESS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient reported for unknown allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced positional vertigo. On 23-MAR-2021, the subject experienced lightheaded and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the positional vertigo and lightheaded and dizziness was not reported. This report was non-serious.
Headache for 2 weeks, shingles like symptoms, felt like her immunity compromised.
Fever, chills, body aches, dizziness, lump at injection sight; ibuprofen and rest
This case was reported by a pharmacist and described the occurrence of Hepatitis A infection in a currently 58-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline). The subject's medical history included foreign travel. The subject recently traveled. The pharmacist stated that the subject reported "eating frozen berries that have recently been recalled from [retailer] due to Hepatitis A contamination." In 2006 the subject received 1st dose and 2nd dose of HAVRIX (unknown details). On 4 June 2013, 7 years after vaccination with HAVRIX, the subject experienced Hepatitis A infection and vaccination failure. The pharmacist stated that the subject was "not usually a customer of that [retailer] and the vaccine was not administered here." The pharmacist also stated that the subject reported "eating frozen berries that have recently been recalled from [retailer] due to Hepatitis A contamination." The subject's wife, who was a doctor, stated that the subject had "all the signs and symptoms of Hepatitis A." Relevant laboratory results: The pharmacist reported that the subject stated that in 2013 (described as "now"), the subject had "now tested positive for active Hepatitis A infection." This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
Sudden onset of muscle spasms approximately 16 hours after 2nd Moderna Vaccine for COVID-19 followed by: ?Low-Midgrade fever,Dizziness, Dry Mouth,  Muscle Pain, Injection Site Pain, Difficulty Swallowing, Chills, Skin Sensitivity, Teeth Grinding,  Loss of Appetite,  Loss of Sense of Time,  Feral Hallucinations,  Feelings of Regret.
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a 24-month-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Discharged. This is a 73 y.o. year old patient who was admitted on 1/24/2022 with PMH of recently diagnosed AML on treatment with cycle 1 of Vidaza/venetoclax, COPD, HTN, HLD, and hypothyroidism who presented to the ED after discovering low oxygen saturation at her office appointment.  Patient was known to be positive for COVID, having tested positive on 1/21.  She had also noted weight gain of 11 pounds with swelling in bilateral legs. Patient was placed on oxygen and started of a 10-day course of dexamethasone and 5-day course of remdesivir.  BNP was elevated at 1659 with negative troponins and bilateral LE dopplers negative for DVT.  Patient was started on PRN lasix with good urine output.  Patient was noted on telemetry to have a bundle branch block, which was confirmed on EKG.  Cardiology was consulted and started patient on lasix 20mg BID with plans for outpatient stress test.  Limited echo on 1/26 showed an EF of 65% with mild-moderate mitral regurgitation.  On 1/28, patient was noted to have an asymptomatic 5-beat run of non-sustained V-tach. Cardiology was notified and started patient on metoprolol with plans for a 14-day ziopatch at discharge.   Patient experienced good diuresis with above lasix and was able to be weaned down to 1-2L per NC.  Patient was still desaturating to the 80s without oxygen, and thus home oxygen arranged per respiratory. PT/OT followed during stay, and home services were recommended. Patient accepted to organization.   Prior to discharge today, patient doing well on 1L NC and has completed 5 days of remdesivir. Care discussed with doctor and patient deemed stable for discharge. Patient and daughter are agreeable - she is feeling overall improved with no new or worsening ROS. Home oxygen and services arranged. Ziopatch to be placed at discharge and cardiology follow-up arranged. Daily weights and diet/fluid restrictions discussed.  All new medications discussed in detail with patient and her daughter.  Patient will plan to follow up in our office as below.  Patient's discharge medication plan were discussed as per below and new prescriptions were sent to patient's requested pharmacy prior to discharge as per generated list below.  Patient is aware to call our office should further questions or concerns arise following this discharge.
Breakthrough COVID infection during admission. Tested for placement to SNF. Does not appear to be symptomatic. Positive test collected 09/07/2022.
7-10 days, post vax, child experienced red, vesicular rash on his torso. No SOB, no hives and no allergic reaction.
Evening of shot back hurt. Patient took a pain pill and went to bed. Patient woke at 4am and needed to urinate. Legs felt wobbly patient needed to grab on doors to walk. Patient went back to bed and awoke at 9am. Legs were very rubbery. Patient tried not to walk. This lasted for 24 hours. Gradually got better.
She got the vaccine, had no side effects.  Woke up in the middle of the night last night a little bit of achiness, and some coldness last night and a temperature of 101.2, and 100, normal is 98.6.  Does not feel that good.  Was going to go to the beach, but did not go due to the chills.  She has tenderness in the glands by her TMJ.  She is thirsty which she normally is not.   She is a biochemist, and uses all COVID protocol with masking and hand washing.  She has not taken anything for the symptoms and prefers not to.  She has not taken any of her medications due to feel of interference with the reactions.
Arm pain, redness, swelling, severe headache, fatigue, muscle soreness, chills.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves Elderly male patient who experienced severe allergic reaction, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE HIGH DOSE lot UJ000AA. On an unspecified date, post vaccination patient developed a non-serious severe allergic reaction throat and lip swelling, throat and lip swelling, non-serious blood shot eyes. Patient went to local emergency room. Lab data not reported. Final diagnosis was severe allergic reaction. An unknown corrective treatment was received. The patient outcome was reported as Unknown for severe allergic reaction, as Unknown for throat and lip swelling, as Unknown for throat and lip swelling and as Unknown for blood shot eyes.
wheezing starting 4 hours after vaccine, did not take anything, came to urgent care the day after when symptoms subsided, prescribed albuterol inhaler with improvement
Tinnitus has increased both frequency and loudness. It also now pulsates at times.
After getting the second shot of Pzifer vaccine on Jan 14, 2021, I developed a drop in platelet count. I have no pre existing conditions before taking the vaccine . Last year my platelet count was 166.  After 1 week of taking the second shot of vaccine my platelet count dropped to 129.  After 5 days later I had reexamined the cbc and the platelet dropped to  121. I believe it is a reaction to the vaccine.
Reaction starting the day after my 2 nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction starting the day after my 2 nd dose) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00721A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction starting the day after my 2 nd dose). At the time of the report, VACCINATION COMPLICATION (Reaction starting the day after my 2nd dose) outcome was unknown. Not Provided.          No concomitant medication was provided.  No treatment medication was provided.
Felt worse than when I actually had COVID-19. Full body pain. Fever. Large rash developed at injection site. Fatigue.
I received my second dose of Shingrix shingles vaccine on Monday, January 17. I have been wearing a smart watch for the last month which displays pulse on main dial. I noticed after the vaccine my pulse is running 90-105 bps, vs normal baseline of 70s. I checked my BP and found my diastolic BP was elevated about 20 pts. I checked the PI and found mention of rare tachycardia. I suspect I would not have noticed this reaction if not wearing a smartwatch, and that this reaction may be less "rare" than published.
Patient stated that since receiving vaccine in September she has experienced pain shooting down arm and wrist, over her collarbone and up her neck.
Patient was in office for well child exam.  Administered Menactra & Adacel to Patient and as recommended patient was being monitored for 15 minutes after vacciens. Prior to getting vaccines patient was very nervous about receiving vaccines . Mom was given VIS and both provider and MA discussed vaccines and potential for reaction as well as the recommendation to stay for 15 minutes after vaccines given.  Mom agreed with plan for patient to be monitored for 15 minutes after vaccines given.  Patient was alert but crying after vaccines.  Mom was left in the room with patient for monitoring. Ten minutes in to the 15 minute monitoring time mom began to yell for help.  Provider and other clinical staff entered exam room.   Mom stated that  patient fainted for a few seconds. No injury.    Patient was alert in room but was breathing heavy and crying. She then started to have a panic attack.   After reassurance  and some time lying down the patient began to calm. Mom stated patient had not eaten for sometime and so patient was given apple juice. Patient rechecked/monitored for 20 minutes and symptoms completely resolved.  Vitals rechecked  and stable just before leaving office .  Patient left office with mom on her own and mom made aware to call office with any concerns.
Injection site pain started a few hours after 1st dose COVID vaccine and hasn't fully resolved five weeks later. Range of motion is fine. Second dose was given slightly lower and with deltoid pulled out slightly by the vaccinator and wasn't painful. I saw my sports medicine doc yesterday (2/12/21) for routine follow-up to a right rotator cuff tear and had her examine my left shoulder as well. She says her exam of the L shoulder is consistent with bursitis and the history and exam suggest the 1st dose of the COVID vaccine was a bit too deep and at least some of the vaccine got into the bursa. I'm a physician working in public health with occupational exposures to COVID, so I'm concerned whether or not the vaccine will be effective if the first dose was injected deep to the deltoid.
Headache in back of head, dizziness on rising, vomited once,  soreness and tender in backs of mouth and tongue, sore throat
pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 (Lot number: EL9269) as dose 1, single and administered in arm left, administration date 04Mar2021 12:05 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Back pain", start date: 2014 (ongoing), notes: Regenerative therapy 21Sep2021; "Leg pain" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL (500 mg) taken for back pain, pain in extremity (ongoing). The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain".   No follow-up attempts are possible. No further information is expected.
Enormous headache, Nausea, Dizzy, Rapid heart beat, facial swelling and beet red Massive joint ache Gone in 24 hours!
Flu-Like Symptoms; Initial Report Received on 26-Mar-2021, 29-Mar-2021, 30-Mar-2021, and 11-May-2021.  A nurse practitioner reported that a 54 year-old patient (gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced flu-like symptoms.   No relevant medical history was reported.   No relevant concomitant medications were reported.  On an unspecified date in Dec-2020, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, site not reported).  On an unspecified date, after the first dose of HEPLISAV-B, the patient experienced flu-like symptoms for 10 days and had a full recovery. Laboratory tests for COVID-19 and Streptococcus were negative.  Four weeks after the first dose of HEPLISAV-B vaccine, Hepatitis B surface antibody was greater than 600 mIU.  The patient was reported to have completed the series of HEPLISAV-B vaccine.   Additional information was requested.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a company representative regarding six patients who experienced cysts in their lungs. The patient received a dose on an unspecified date. Relevant medical history was not provided. The indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. The physician reported that six patients developed cysts in their lungs following administration of Prevnar. No additional information was available at the time of this report.