chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the shot quite high on my upper rt arm. By bedtime, I had swelling and redness on the area. The next day I noticed red bumps like measles on the inner and top side of my lft. arm behind my lft. bicep, across my chest above my breasts and across my upper back from shoulder blade and up. The bumps started to get water on the heads and the itching was unbearable. I tried using cortisone but to no avail and my husband felt we should go to urgent care to see Dr. My husband and I talked about anything different or new I had eaten or put on my skin and came up with nothing. The Dr. asked about the injection checked all the areas and came to the conclusion I was having an allergic reaction to the flu shot I had received. I was also vomiting. Was running a slight to high fever, fatigued and falling asleep constantly.  I was given a prescription for triamcinolone acetonide ointment USP. 0.1% with directions to use up to 3/4 x's daily. It took almost two months for it to heal. I have a few scars left on my inner and outer left arm. It was one of the worse reactions I have had. I have had flu shots given to me yearly due to my health and never had a reaction to it. I believe she never checked my date of birth and gave me wrong shot.
I had the second dose on 04/20/2021. Within a couple of days, I had strong tight chest pain, swelling of left ankle, and sharp chest pain. It gradually increased over six weeks and never really settled. During the booster shot, I had the same pains (chest pain, swollen ankle, and body pain). It settled slightly after 2 weeks. I thought I was better after the chest pain went away. On 12/17/2021, I started showing skin symptoms of shingles and it was confirmed by a dermatologist that it was shingles. I was showing respiratory symptoms the Sunday before; I had a stuffy nose, sore throat, and swollen lymph nodes on both sides of my neck. I had fatigue and notice a skin irritation on my face and went to see the dermatologist. I had seen many healthcare providers and spoke to a nurse practitioner that Monday for an e-visit on the 12/20/2021 and was given Valtrex, an anti-viral which helped ease the respiratory symptoms like my sore throat, chest pain, and swollen lymph nodes. I started taking antibiotic ointment prescribed by a nurse practitioner from urgent care that Tuesday, 12/21/2021. I had visited the emergency room the following day, 12/22/2021, after recommended to do so by urgent care due to a possible staph infection and was told it was shingles as well. It was confirmed after seeking medical attention from many healthcare providers on 12/22/2021 that I had shingles. The shingles has started from my cheek to the nerve in the eye.
TESTED + FOR COVID ON       2-9-22  AT MED CENTER        AND DECEASED ON 2-12-22.
FELT TIRED; ACHINESS; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, non alcoholic, allergic reaction, anaphylaxis, sulfa allergy, and asthma, and other pre-existing medical conditions included: The Patient did not have history of drug abuse/illicit drug use. The patient experienced drug allergy when treated with erythromycin, sulfamethoxazole/trimethoprim, and tetracycline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for an unspecified indication. No concomitant medications were reported.  On 11-MAR-2021, the patient experienced achiness. On 12-MAR-2021, the patient experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, and felt tired. This report was non-serious. This case, involving the same patient is linked to 20211106318.
Pt received vaccine on 4/21/21 at 10:10 am. States she felt fine all day. When she woke on 4/22/21 at 05:00 am, she noticed that her face and hands were swollen. Noted swelling around bilateral orbital region and swelling to lips. Pt was evaluated at 1500 on 4/22 and reported that swelling was improving. Was treated with oral antihistamine and responded well to this treatment.
initial symptoms of rotator cuff pain was followed by axillary and suprascapular nerve pain and numbness resulting with significant loss of function of the left arm. The treatment consists of nonsteroidal anti inflammatory medication and physical therapy. As of 03/26/2022 the treatment continues with partial improvement.
patient had an anxiety attack related to vaccine administration (needles) and  potential side effects after administration. vitals : hr 50, r 30, BP 140/100,m o2 sat 88%. EMS was called due to dropping o2 sat and HR. vitals reached normal range after EMS arrived. final vitals upon leaving facility: HR 56, R 25, BP 138/90, O2SAT 99%. EMS took patient to mt sinai west in NYC for further observation.
Vaccine was received Wednesday afternoon which resulted in mild arm discomfort which began to get better through Friday. On Saturday Morning, I woke up and there was a bright red mark at the sight of injection and then extended below it by about 3 inches, and was about 4 inches wide. It was painful and hot to the touch. I consulted a Nurse at my PCP by phone who advised me to go to medical Care since all the regular clinics were closed. I went to medical Care and the Dr diagnosed me with Cellulitis, likely staph infection from the Tetanus shot. I started Cephalexin antibiotic treatment on Saturday. So far, the infection has reacted well to the treatment and the mark has mostly disappeared. I still have two more days of antibiotics to take.
The day after my vaccination, on 2/4/21, I started having headache followed by fever and chills in the afternoon and throughout the night till the early morning on 2/5/21 when the fever, chills and the headache are all gone.  However, the site of the injection on my left arm has turned red. I would say it is a red circle with a radius of 1.5-inch around the injection location. It is painful when pressed on. Also my left armpit (lymph nod) is swollen and is painful. Hopefully I won't die :/
Client complained of shortness of breath and chest pain. ALS was called, MD and Paramedics on site assessed client.  Symptoms self resolved.  Client left medical facility did not want to go to the hospital.
pt became very irritable shortly p/vax, given APAP & then became very limp for approx 1hr p/which was irritable & then recovered;
Severe body aches, chills, fever, diarrhea about 10 hours after vaccine
-sore arm at shot location, lasted about a week -mild cramps (in uterine/lower abdomen area), lasted 4 days -bloated feeling in lower abdomen, lasted a week so far -diarrhea (mild) lasted a week so far [Note: lower abdomen means below belly button area]
This is a spontaneous report from a contactable physician. A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced platelet count of 1, petechia on trunk and extremities, and epistaxis. Outcome of the events was unknown.  Information on the batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case.  Company cannot completely exclude a causal relationship between the reported event and administration of vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), considering temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
05may90 pt vax heptaB. following a needle stick.  w/i several hrs pt devel urticaria.
rapidly increasing swelling and redness at injection sites and generalized papular urticaria; treated with oral prednisolone and diphenhydramine
Fever, chills, malaise beginning about 12-18 hours after injection. Severe arm soreness began within hours and lasted for about 36 hours. Fatigue, headache began about 24 hours after and lasted for 3-4 days.
Information has been received from a physician concerning a 5 year old female with no medical history and no known allergies who on 04-JAN-2000 and on 17-SEP-2004 was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella  virus vaccine live respectively.  Concomitant therapy on 04-JAN-2000 included a dose of varicella virus vaccine live.  There was no other  concomitant medication.  On 11-AUG-2005 a titer was drawn.  The child seroconverted to rubella, rubeola, but not to mumps.  Unspecified medical attention was sought.  No product quality complaint involved.  Additional information has been requested.
Severe fatique, chronic pain,  headache, swollen lymphnodes, memory and other cognitive symptoms mainly with speech. This remains ongoing.  Treatment: CuraPro, ProOmega, LDN
FLUZONE HD QIV was administered to a 9 year old patient with no reported AE; Initial information received on 31-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 9-years-old male patient who was administered 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) and family history were not provided. Concomitant: no other vaccines  On 25-Oct-2023, the 9-years-old patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine (unknown strength, formulation) (Batch number: UT8072DA; expiry date: 30-Jun-2024) via intramuscular route in the right deltoid for Immunization 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.
Really blurry eyes; she could not see anything; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6200, NDC number, expiry date was not reported) via an unspecified route of administration on 18Feb2021 in left arm as dose 1, single for covid-19 immunisation. The patient's medical history, concurrent conditions were reported as none and concomitant medications were not reported. On 21Feb2021, the patient experienced really blurry eyes; she could not see anything. Event was improving a little bit, but she still was not able to see well. She was not able to see herself in the mirror. She asked if really blurry eyes were a common side effect with Pfizer covid-19 vaccine. The outcome of both the events was resolving.  No follow-up attempts are needed. No further information is expected.
Pt. states that after receiving the 3rd Booster of Moderna 11/03/2021, started experiencing symptoms 11/04/2021 of fainting after awaking and vomiting. Fatigued throughout the day lasting 24hrs. 11/05/2021 still fatigued but symptoms have subsided. No noted Primary visit/communications.
Headache, Myalgia & Fever Narrative: 3/26 #1 dose covid vaccine, had covid infection 8/25/2021. On 3/27/21 developed T 104 and persist today 3/29 to 100, stayed home from work today. Recommend to hydrate, take ibuprofen otc use as directed. Will retest for covid rapidly and continue to monitor
Herpes zoster; Administered Zostavax at age 36; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In December 2015, at age 36, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the events is unknown.  Additional information has been requested.
Received Smallpox Vaccination 14 FEB 03.  On 2 MAR, pt developed non-productive cough, fatigue.  Denies chest pain, fevers, n/v or rash.  Robust take on left arm at site of vaccination. Pt seen 4 MAR thought to be dehydrated, given fluids (2L NS).  Next day (5 MAR) patient's SOB worsened with pronounced fatigue.  CXR with bilat infiltrates--thought to be CHF.  Echocardiogram wnl.  Pt. eventually diagnosed with bilat viral pneumonia.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 11Jul2022 to 16Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
muscle aches throughout my body and hip and ankle joints; Injection site was also painful; severe headache; stuffy nose; mild fever; tinnitus; chills; Daily living activity impaired; This case was reported by a consumer and described the occurrence of headache in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 3N7F2, expiry date unknown) and (batch number 4Z432, expiry date unknown) for prophylaxis.   On 25th February 2020 09:30, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. In February 2020, less than a day after receiving Shingrix, the patient experienced activities of daily living impaired. On 25th February 2020, the patient experienced fever, tinnitus and chills. On 25th February 2020 12:00, the patient experienced headache and nasal stuffiness. On 25th February 2020 18:00, the patient experienced muscle pain and injection site pain. The patient was treated with ibuprofen and atorvastatin. On 26th February 2020, the outcome of the headache, fever and chills were recovered/resolved and the outcome of the muscle pain and injection site pain were not recovered/not resolved. On an unknown date, the outcome of the nasal stuffiness was not recovered/not resolved and the outcome of the tinnitus was recovering/resolving and the outcome of the activities of daily living impaired was unknown.   The reporter considered the headache, nasal stuffiness, muscle pain, injection site pain, fever, tinnitus, chills and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received the intramuscular injection of the vaccine on 25th February 2020 at 9:30am. By 12pm, the patient had severe a headache and stuffy nose. By 6pm, the patient had muscle aches throughout the body and hip and ankle joints. The Injection site was also painful (but not swollen), the night following the injection the symptoms persisted and patient had mild fever and tinnitus. The symptoms were severe enough to prevent him from going to work on next day of vaccination. On 26th February 2020 morning, headache resolved. The muscle aches, injection site pain, plus chills & mild fever persist. Tinnitus has reduced in intensity but not resolved as of this time. Symptoms were managed using Ibuprofen 400 to 600mg, q 6 to 8 hours. The patient was not taking any other medication except for Atorvastatin 10mg daily. The reporter consented to follow up.
Patient was admitted to hospital 1 day after receiving 3rd covid shot. Patient passed away 53 days after receiving 3rd covid shot.
Patient was under the FDA EUA age of 12, as patient was 11 years old and 11 months at the time and was administered the Pfizer vaccination. No adverse events noted at this time.
onset of window shade expression or morbilliform rash yesterday assoc w/subjective fever & fussiness;
I did not have any trouble or adverse reaction to the Covid 19 vaccine but I did contract Covid 19 and was positive on April 22. I tested multiply times afterwards and it showed positive. On April 26, I received the Monoclonal Antibody Therapy bebtelovimab.
Patient is suffering from weakness and numbness on her arm (left) to index finger which she had vaccine being administered on 8-28-11. Pt stopped on 9-16-11 evening time.
onset of fever few hrs p/vax w/erythema 4x3 devel sometime afterwards;
Itchy Rash and sweating.  Treated with one Benadryl. BP at time of initial symptoms elevated 150/85.  After one hour and a 25 mg oral Benadryl rash regressed and BP 135/80.
Patient received one dose of Moderna Bivalent in the left arm. Vaccinator incorrectly documented vaccine site as left bicep instead of left deltoid. Medical record on state reporting system was fixed and correct documentation was added stating patient received vaccine in the left deltoid.
shortness of breath, dizziness nausea vomiting, migraine for just over 3 weeks, fine motor function in both hands affected, tremors in both arms, vice like pressure across top of chest through to the upper back.
numbness and tingling in her upper thigh; numbness and tingling in her upper thigh; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) 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: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 2021, outcome "unknown" and all described as "numbness and tingling in her upper thigh".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Information has been received from a physician concerning a 19 year old female with a history of type I diabetes mellitus who on 17-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included insulin. On 19-MAY-2007 the patient experienced vomiting. It was reported that the patient sought unspecified medical attention. Subsequently, the patient recovered from vomiting. No further details were provided. Additional information has been requested.
DTaP and polio given 2/20/02, Site where DTaP given erythematous and swollen w/in hrs. By day 3, generalized rash concentrated in the groin area-bright red. Day 4 groin area began to peel like sunburn and remained red X 1 wk. During next 4-6 wks palms of hands and soles of feet peeled. Pt seen by pediatrician, dermatologist and allergist. No treatment given. No fever or mucosal involvement.
Patient had no immediate reaction, she said her symptoms started in the evening. Her upper arm felt swollen and hard all the way down to her elbow. She went to the dr who thinks its an infection so she was prescribed Keflex 500mg 1 capsule tid for 10 days. I did see her arm dec 1 at 1pm and it was red and swollen - but clearly not at the injection site but lowed and moving towards her elbow.
Red, swollen, sore arm around injection site. Hive-like appearance. Soreness through arm and  neck and lat
About 5 minutes following injection, patient noted numbness to right side of throat. Eventually extended across back of throat and down left side of throat No angioedema on exam. No respiratory distress.  Given 50 mg of diphenhydramine po and symptoms resolved after about 40 minutes of monitoring
forgetfulness; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (forgetfulness), CHILLS (Chills) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Mar-2021, the patient experienced MEMORY IMPAIRMENT (forgetfulness), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MEMORY IMPAIRMENT (forgetfulness), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.