chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (Sep2022) Negative, notes: after testing negative; (Sep2022) Positive, notes: Rebound about 2 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid HR9 from 19Sep2022 to 23Sep2022 for COVID-19. Patient had no known allergy. Patient has received Other medication in 2weeks was yes.
area of inj inflamed & painful to touch;onset of measles like rash of leg & chest area then spread to rest of body;pt c/o tired dx 12APR97 a cutaneous hive like rxn to vax;DPH prescribed course of rash 5 days;
diffuse rash on extremities, trunk, no drainage;no resp distress;no fever;
2nd dose administered/Boostrix + Administration in less than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3GX9E, expiry date 18-MAR-2024) for prophylaxis.   Previously administered products included Boostrix (received 1 dose of boostrix on 31st Mar 2022).   On 06-JUL-2022, the patient received Boostrix. On 06-JUL-2022, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: 2nd dose administered/Boostrix + Administration in less than recommended interval). The outcome of the extra dose administered was 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 21-Mar-2023 The pharmacist reported that multiple patients received Boostrix in less than the recommended interval. The reporter could  only provide information for one of the patients who received one dose of boostrix on 31st March 2022 and the second dose was administered on 6th July 2022. It was mentioned that the reason of the 2nd dose was that the patient forgot about having the first dose. The Vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received boostrix on 31st March 2022 and the second dose was administered on 6th July 2022 which led to extra dose administered.; Sender's Comments:  US-GSK-US2023AMR043739:Same reporter
Pfizer-BioN Tech COVID-19 Vaccine EUA Headache - less than 1 hour Diarrhea - 4 days
HIGHER LEVEL OF PAIN (EXTREME PAIN) IN THE SHOULDER AND IN UPPER ARM; LACK OF MOBILITY IN THE SHOULDER AND THE UPPER ARM OF THE INJECTED SITE; FROZEN SHOULDER; HIGHER LEVEL OF PAIN (EXTREME PAIN)  AT THE LOCATION OF INJECTION; SORE ARM; LITTLE FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immune thrombocytopenic purpura, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced little fatigue. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) in the shoulder and in upper arm. On 24-APR-2021, the subject experienced lack of mobility in the shoulder and the upper arm of the injected site. On 24-APR-2021, the subject experienced frozen shoulder. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) at the location of injection. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Platelet count before the vaccination was 40. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fatigue on 03-APR-2021, and had not recovered from sore arm, higher level of pain (extreme pain) at the location of injection, lack of mobility in the shoulder and the upper arm of the injected site, higher level of pain (extreme pain) in the shoulder and in upper arm, and frozen shoulder. This report was non-serious.
Patient came out of the room and fainted. The doctor and nurses took care of her. When she got home, she ran a fever, vomited and was very sick. The doctor's office kept on calling to check on her. He advised never to get these shots again.
I did not have an adverse reaction to the vaccine. On 03/01/2023, about 04:30AM ET I felt a fluttering feeling in my chest. I contacted my doctor and was referred to a cardiologist. I went to the emergency room for observation. I was diagnosed with AFIB. I take a beta blocker and blood thinner and that has helped with my symptoms. I have a follow-up appointment in May 2023.
Extreme brain fog similar to dementia for two weeks, fever daily for 3 days, sudden menstruation and heavy bright red blood lasting for 10 days, eyes strained by any light, hearing intensified, taste in mouth is that of metal or spoiled milk, sense of smell intensified to the point that I can smell everything beyond anything I have ever experienced, hearing intensified, ringing in the ears for two days, shaking, vibrating and then heart palpitations nonstop causing me to be awake every 45 minutes, unable to walk upstairs, extremely dizzy, cannot work or drive or walk anywhere, Im an artist and lost all ability to control hand eye coordination, and no sensation of other body parts, suddenly warm nonstop when I am usually freezing, skin rash on face and chest and arms thickening skin, loss of hair on head, aches and pains in all joints within 3 days of the vaccine. Finally had to go to hospital and be seen with high blood pressure, EKG, ECHOCARDIOGRAM and blood tests. Blood tests show a TSH of 11.45 and TPO of 307. I have not had numbers that have been close to this since 2002. This is a response to the vaccine, the vaccine purged my body of all thyroxine. Nothing could remove the thyroxine that quickly after taking 150 -175 of Thyroid replacement hormone for 20 years!!!
10 inch radius of rash/hives around and beneath injection site - I suggested she take 2 BENADRYL to start and to notify her doctor.
after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling numb and tingly, was taken to ER as it was part of the same building in a wheel chair,  was also anxious, nauseated and had dry heaves and blood pressure was elevated.  Received IV solumedrol, ativan and zofran and then later oral benadryl.  I was told to contact my PCP to see if I should get the second vaccine and he indicated no.
Agency completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/26/21 Lot#ER8733 2nd dose04/16/21 ,lot#EW0162 Diagnosed covid positive:08/11/21 Symptom onset:08/09/21 Exposure:Home Symptoms:SOB, COUGH,FATIGUE,MUSCLE ACHES, SORE THROAT, CHILLS, HEADACHE.
Patient began to feel light headed and asked her mom for water.  Patient then fell to the side and hit her head as she fell to the floor, then had a seizure lasting 30 sec.  patient was Alert and oriented x4 when we got to her.  Patient stated she felt like she was falling asleep and dreaming then remembers everyone standing over her.  Patient has small bump on upper left of head.  Patient was taken to medical center for treatment and observation.
Initial misuse report received from a healthcare professional (nurse) ion 18 October 2013 and the case was received on 20 March 2014 at GPV. It was reported that 4 adult patients (information regarding the patient ws not provided) had received a dose of 0.25 ml of FLUZONE (batch number, dose in series and site of administration was not reported) on an unspecified date. No adverse event was reported. List of documents held by sender: none.
milk supply decreased to nearly zero.; breastfeeding mother; breastfeeding mother; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on an unspecified date (lot Number: FC3180) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient is not pregnant at the time of vaccination. There were no concomitant medications. Historical vaccine includes dose 1 of BNT162B2, lot number: FA6780. The patient did not have COVID-19 prior vaccination. The patient is a breastfeeding mother and had her son on 30Jun2021. After I received the second dose of the vaccine, her milk supply decreased to nearly zero. The onset of the events was reported as 09Aug2021. The events involved physician office visit. The event her milk supply decreased to nearly zero was assessed as serious, disabling. The patient has not been tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101051671 same reporter/drug, different patient/event (son case)
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 2013-005251 to 2013-005263, 2013-05268, 2013-05269, 2011-03827, 2006-03086, 1995-00668, 2006-03230, 1995-00224 and 2003-02926. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. Regarding this case which involved a 28-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and one day later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
3-11-21 5:11PM 'FEELS LIKE PASSING OUT'. PALE, SLIGHTLY DIAPHORETIC.  5:14PM MOVED TO COT IN SUPINE POSITION- FEELING BETTER. A/O, PINK, W/D. 5:21PM 'FEELS 100% BETTER NOW'. NO PAIN NO SOB. 5:35PM HUSBAND HERE TO DRIVE PT HOME - PT AMBU TO EXIT- GAIT BRI SK AND STEADY. NO ACUTE/OBVIOUS DISTRESS NOTED. 3-12-21 9:45AM TC:  PT STATES SHE 'FEELS BETTER - FULL RECOVERY'.
Approximately two minutes after I received the vaccine I had a strange feeling in my right arm (where I received the injection) that went away after about 30 seconds. About two minutes after that, I developed a bitter taste on my tongue that later spread to the rest of my mouth. Several minutes later, my lips began to tingle and swell, then my mouth (i.e. my soft palette) began to swell as well. About forty minutes after I received the vaccine, I began developing shortness of breath and spiked a fever.  The on-site doctor administered an Epipen and I was transported to the ER. While at the hospital I had a blood drawn, a COVID test, a chest X-ray, and multiple EKGs performed. I was discharged about 2.5 hours later.
2 days p/vax pt became very dizzy & c/o severe vomiting; adm for severe dehydration; sub normal temp & cold sweats; pt was treated w/IV fluids & discharged on 6NOV94 w/instructions not to receive Hep B #2;
PATIENT REPORTED INFLAMMATION OF THE ARM SHE HAD THE INJECTION BUT THE ISSUES DID NOT BEGIN UNTIL OVER A WEEK AFTER INJECTION SO UNSURE IF RELATED OR NOT. PATIENT BELEIVES SO.
Initial report received from a health care professional on 03 August 2007. A 37-year-old female patient with non relevant medical history, had received an intramuscular left deltoid injection of Menactra, lot number U2377BA on 01 August 2007 and one day later, she developed minimal redness at the injection site, pain in her left upper extremity and left axilla. The reporter noted the patient's temperature was 99.3 degrees Fahrenheit. The patient had no illness at the time of vaccination. At the time of the report, the patient had not recovered. No additional information had been provided.
Woke up, body was covered 90% with hives, red and inflammed.  Fever and itching. She had Benadryl, Tylenol and oatmeal baths...Sunday 11/29/2010 hives covering only a small portion of her legs to feet.
Patient received VARIVAX vaccine on 12/19/97 and 6/27/08. Exposed to chicken pox vaccine 2 weeks ago. Developed chicken pox rash on 5/10/09.
Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse reported for herself. This 63-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Et1685) intramuscular on 11Jan2021 13:15 at single dose for an COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included atenolol Atenolol, Losartan, Calcium, plantago ovata (METAMUCIL), bifidobacterium lactis (PROBIOTIC). Patient received the first dose of BNT162B2 intramuscular in left arm on 21Dec2020 03:30 PM. No other vaccine in four weeks. On 12Jan2021, the patient experienced Arm pain at site, Fatigue, Nausea, Body aches. No treatment received. The outcome of events was not recovered.
Reaction was immediate. Intense chills, severe backache extending up to neck. Dull headache, muscle aches. The rest of day: occasional chills, continued backache, low grade fever, muscle aches (101.1). Overnight: headache and backache intense enough to interfere with sleep, even with acetaminophen. Ongoing backache after 24 hours (time of this reporting).
flu like symptoms; left arm very sore; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and pain in arm. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the influenza-like symptoms and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient had received the 1st dose of Shingrix this past Tuesday, before reporting date. Less than a week after receiving Shingrix, the patient experienced flu like symptoms and left arm very was sore. The patient was taking Advil for the events and inquiring if anything else could be taken to help with the symptoms.
Patient in process of passing out was laid to the floor at 12:00pm.  Patient turned pale, eyes rolled back into head and stopped breathing, code blue was called.  Patient resumed breathing within a few seconds, code blue was cancelled.  Patient administered oxygen and vital signs were taken BP 150/76, HR 52, Res 22.  Code team showed up and patient was talking.  At 12:02pm, vitals were BP 140/76, HR 53, Res 20. 12:04pm patient transported to ER via gurney.
patients receiving Flublok Quadrivalent at age 16 and 17 years of age; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA304586, 2019SA304587, 2019SA304588, 2019SA304589, 2019SA304590, 2019SA304580 and 2019SA304592.  This case involves Adult patient for whom receiving flublok quadrivalent at age 16 and 17 years of age (product administered to patient of inappropriate age) was reported, while he/she received vaccine influenza quadrivalent recombinant vaccine [Flublok Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose  dose of suspect influenza quadrivalent recombinant vaccine lot QFAA1938 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age.   It was unknown if 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.
11/11 Acute onset progressive ascending weakness; neuro eval/imaging for cva/TIA unremarkable. 11/13 LP with elevated Protein. 11/14 started on IgG for findings consistent with Guillan Barre Syndrome
Pt recvd 1st dose of Hep B vax & devel flu-like sx; 1 wk p/vax devel a pimple on forearm which festered almost to the point of cellulitis;
On the 24th, I had bruising around my eyes and swelling. I was also having body pains. I had reactions to topical things. I went to see an eye doctor and dermatologist. I was given a shampoo from my dermatologist because I was diagnosed with psoriasis on my scalp which is something I was not aware of. I saw the eye doctor, and it kept up for the entire next week. I had continuing eye and body pain. I had a rash on my face and reacted to everything the dermatologist gave me. I tried 3 different products that I reacted to. I was given cortisone and used it on one side of my face just to see what would happen. I reacted to this as well. All this time, I am also having acute body pains and extreme fatigue. I ended up going to my doctor on 9/13, where she thought I might have psoriatic arthritis. I was given medication but was told not to take it until after a scheduled colonoscopy I has. My eye sensitivity remains currently, and I still have body aches and fatigue that I seem to be getting over. I can barely read with my eyes but my eye doctor said my eyes seemed fine to him.
unknown if it was moderna or pfizer.  Vaccine administered elsewhere so details are not known to me.  Pt received vaccine on Friday and was admitted to hospital Sunday 1/17 with CVA, right sided weakness.
COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Lanolin " (unspecified if ongoing); "afib" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "high blood pressure " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 30Oct2023, outcome "unknown". Therapeutic measures were taken as a result of covid-19. Additional information: paxlovid treatment 30Oct2023-03Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Subject received initial Anthrax immunization on June 5, 2007. Approximately 4 days later the subject was admitted to hospital with shortness of breath and weakness. He was kept in ICU overnight. He did not require ventilatory support. The subject's primary complaints are wheezing, pain in hips and back, and weakness in lower extremities. A summary of events, written on June 15, 2007, described the subject as improving slowly with oral steroids and physical therapy but he remains hospitalized. The summary states that on June 14, 2007 his doctor came to the conclusion that this probably was an event related to Anthrax vaccine and has reported the information to VAERS.
Information has been received from a physician concerning a 4 year old male (chart # 1160) who on 05-FEB-2007 was vaccinated with a dose of hepatitis A virus vaccine inactivated (lot#656495/1209F). There was no concomitant medication. In February 2007, the patient experienced skin was raised 10" x 10" around the injection site. The patient received hepatitis A virus vaccine inactivated in the right leg. The right leg measured 34 cm in length compared to 26 cm for the left. Unspecified medical attention was sought, the adverse event improved, "on therapy". Subsequently, the patient recovered from the injection site reaction on an unknown date. No Product Quality complaint. Additional information has been requested.
tinnitus; Loss of taste; Loss of smell; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "Loss of taste", "Loss of smell", "tinnitus". The following information was reported: TINNITUS (non-serious), outcome "unknown"; AGEUSIA (non-serious), outcome "unknown", described as "Loss of taste"; ANOSMIA (non-serious), outcome "unknown", described as "Loss of smell".  Additional information: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201065129 Same patient/drug/AE, different dose;