chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complains of redness, itching, swollen, and hot to the touch at the injection site. Instructed patient to take Benadryl, and put ice on the injection site. If patient develops fever, then they are to seek medical attention. Patient said the inject site started bothering her the day after the injection was given, and has gotten worse every day since.
Covid 19; Covid 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 43 years 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (22Feb2023) positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 14Feb2023 to 18Feb2023.  No follow-up attempts are possible. No further information is expected.
VAR form was reviewed with patient prior to vaccinating. It was noted that he has a history of syncopal episodes with vaccines. Patient was advised to sit for 15 minutes after receiving the vaccine so we could observe him. After receiving the vaccine, patient was escorted to observation chair. Immunizer advised registration technician that patient had a history of fainting, so to keep a watchful eye on him. Patient said I need to get some ice and stood up before we were able to advise him to sit and we would assist him. Upon standing, patient had syncopal episode. Patient did not has loss of consciousness an denied any injury from the fall. Patient was assisted back to the observation chair and monitored for the next 15 minutes.
Pt recvd vax in 1983 & 1984 SEP1984 was found to be anti-HBs pos; In 1991 was found to be pos for core antibody; In 92 was found to neg for both anti-HBs & core antibody; No further details were reported;
SHE FELT TINGLING SENSATION IN HER MOUTH AND HOT FLASH AROUND HER JAW AND FELT WEAK.
Vaccination adverse reaction; Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose.) 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)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose.). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Mother stated that she noted swelling and redness on the child right arm the day after the vaccine received. And then noted it has gotten bigger in size( about 5 inches length and 2 inches width) . Seen by Dr.at the clinic on 08/18/17 and advised to put ice to the area, Benadryl and Motrin to give according to the instruction on the label.
This 42 year old medically discharged male reservist reported receipt of two ANTHRAX vaccinations in 2003 as part of pre-deployment readiness. AVA #1 was administered 28 Jan 2003 with no reported or remembered adverse events. On 01 Feb 2003 he received his primary smallpox, typhoid, yellow fever, meningococcal and hepatitis B #1 vaccinations. On 14 Feb 2003 he received  AVA #2, again with no reported adverse events to any of the above vaccinations. April 2003, injured his right knee running. Records note evaluation completed (records requested) documenting bone bruise of the medial tibial plateau. By November he was complaining of chronic popping and locking with pain about patella and tingling to right knee. He was treated with MOTRIN, use of brace and cane prn. On 2/6/04 providers document mild degenerative joint changes per MRI right knee R>L (see below paragraphs). Counseling was also initiated for complaints of hopelessness, feeling down, depressed, being on guard around others, watchful and super alert. Approximately 6 months (July 2003) post vaccination he reported sleeping prob (snored then stopped breathing, then gasped and snored again) and he was restless. He would awaken tired and exhausted after 3-8 hours of sleep. A sleep study evaluation diagnosed with sleep apnea and placed on CPAP (per patient - records requested). In 2005 he complained of new onset hypertension with mood changes, increased irritability (snaps at people for no reason), and problems with CPAP (not helping sleep, increased fatigue). In May 2007 he moved from one place to another being off CPAP for six months. He advised his moods were initially fine but gradually worsened with increased fatigue, irritability, low energy, low concentration and depression. He concurrently stopped his ATENOLOL as it made his sleep apnea worse. He presented to medical where his CPAP was reinstated and he was started on WELLBUTRIN and ATIVAN and BP meds changed to ADALAT. He was given a diagnosis of adjustment disorder with mixed anxiety and depressed mood. He admitted to improvement of all symptoms over next 2 months but stopped meds after sleep problems appeared to resolve (with CPAP). Sleep apnea.
Initial unsolicited report received from a physician (consumer) on 21 September 2015. This case involves a 65 years old male patient who was vaccinated with a dose FLUZONE HD (batch number, dose, site of administration was not reported) on an unspecified date. It was reported that the patient has been taking the flu vaccine for 40 some odd years. Concomitant medications were not reported. On an unspecified date, following the vaccination, patient reported that the vaccine almost killed him. Lab data and corrective treatments were not reported. The outcome of event was unknown. Upon internal review, the company decided to consider the event serious because of important medical event (FLUZONE HD vaccine that almost killed him). List of documents held by sender: none.
The day after the Tdap I got a bad migraine. Then I started having 2 or 3 severe migraines every week after that. I went to several doctor appointments for it and it was so bad I went to the hospital and had a CT scan which didn't show any reason for the migraines. I also started having frequent illnesses and infections at the same time.
he just felt like crap; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received second Dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 29Aug2020 (age at vaccination 70-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) on 08Aug2020 (age at vaccination 70-year-old) via an unspecified route of administration at single dose for COVID-19 Immunization. It has been 290 days since he got the second dose of the vaccine and he has just tested negative for antibodies and he had the same test 6 months ago at the doctor and tested positive for antibodies. Caller was calling about the COVID vaccine. He said he was a trial participant, and it has been 290 days since he got the vaccine, he clarified since he got the second dose, he said he was 10 months out and he has just tested negative for antibodies. He only knew his first vaccine was on 08Aug2020 and the second one was on 29Aug2020 and they notified him when they broke the blind that he did get the vaccine which he already knew then because he got sick. He clarifies he did not get sick, he just felt like crap. There was no medications medical conditions or lab results, it was all the same medications as it was when he had the initial blood test 6 months ago when he was positive for the antibodies. No further information provided. The patient underwent lab tests and procedures which included Antibody test which showed positive test 6 months ago and negative after 290 days since he got the second dose of the vaccine. The outcome of event was unknown.  Information about lot/batch number has been requested.
Brachial plexus neuritis, rt shoulder; muscular weakness in rt shoulder w/pain/soreness; sx are gradually resolving;
Pt called pharmacy to report possible adverse event after the first Shingles vaccination. per pt's son, pt woke up around 8:30 AM with angioedema of face, mostly eye lids, no breathing difficulties. Pt took Claritin 10 mg and experienced  symptoms improvement within an hour. Pharmacist advised to visit local ER to be seen by MD.
I had what appeared to be a swollen lymph node near my collarbone by my PCP. It is no longer tender and seems to be getting smaller.  It is located on the same side as the vaccine was administered.
This is a spontaneous report from a contactable consumer reporting for herself. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration in the arm, on 13Oct2016, at single dose, for immunisation and INFLUENZA, via an unspecified route of administration in the arm, on 13Oct2016, at unspecified posology, for immunisation. Relevant medical history included spina bifida from 1943 and ongoing (born with spina bifida), back problems (related to spina bifida), allergy multiple (allergic to all antibiotics and a lot of stuff), gallbladder disorder in Sep2016 (she was in the emergency room overnight and was already scheduled for surgery on 25Oct2016), bladder disorder and soreness. Concomitant medications were not reported. The patient previously received an unspecified number of flu shots and pneumonia shots for immunisation and they have caused arm soreness for a day or so. The patient's arms get sore after shots in Oct2016 with outcome of recovered on 15Nov2016.
Bad Rash at the injection site; Red at the injection site; Itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Bad Rash at the injection site), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE RASH (Bad Rash at the injection site), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site). At the time of the report, VACCINATION SITE RASH (Bad Rash at the injection site), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.
Tested positive for COVID-19 in July 2021; Tested positive for COVID-19 in Jul2021; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Dec2020 (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no other vaccine in four weeks. He had no covid prior vaccination. It was reported that the patient tested positive for COVID-19 in July 2021. He had nasal swab and PCR tests on Jul2021 with positive result. He did not receive any treatment for the event. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Jul2021 nasal Swab and PCR.  Information about lot/batch number has been requested.
Starting 11/08/2022, I tested myself for COVID-19 at home and it was positive. I only tested myself due to known exposure the Saturday prior (11/05/2022). I normally have allergy symptoms like sneezing which is the only thing I was experiencing. I called the doctor when I tested positive and I was told to treat symptoms unless it gets worse. I had the same symptoms on the 9th except slightly more sinus drainage and it felt more like a cold. I had some coughing but likely due to post nasal drip. I felt better by the 10th with breathing but not 100%. I felt slight brain fog but was still able to work. By Friday and Saturday, I was feeling much better so I tested myself again, but was still COVID-19 positive. Despite some slight fatigue and nasal congestion, I am feeling okay as of today.
Pt. presented with a rash approx. 8 inches wide on and around injection site. It is warm to the touch. Counseled to use cool compresses and if anything worsens, contact MD. RPh will follow-up 9/28/12 in the AM. Pt. improved overnight.
Narrative:  COVID infection following COVID vaccine 03/31, Pfizer, dose #1 04/21, Pfizer, dose #2 12/28 COVID swab, result: detected 12/26 pt cc: cough, fever, congestion and body aches for 2 days exposure: unknown 12/28 pt admit ED CC: cough, fever, congestion and body aches DX: Covid infection LOS:1 day
INJECTED TOO LOW. PATIENT GOT INFECTION AT INJECTION SITE: REDNESS, SWOLLEN.
This was the PFIZER Booster. I had no allergic reaction to the first two doses.  A day later, I began to feel itchy on my lips and my tounge felt ichy.  I began to feel itchy everywhere, and then I broke out in hives.  The reaction lasted for (I believe) a couple of hours.  I went to the ER and was given an IV steroid and IV benadryl drip. I did begin to clear up prior to the administering of the medication.  I did also have a panic attack prior to the meds.
Approximately 3 days after receiving the 2nd COVID-19 dose, the patient experienced tinnitus which did not resolve. The patient consulted with her physician who determined that she did not have a case of otitis media. The patient contacted us about 7 days after receiving the dose to report this event, and was still suffering from the effects at the time of reporting.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, a pharmacist administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (onset date unknown), and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the event was unknown. Causality assessments were related.
Viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna; Viral condition fully went away; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (Viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna) and THERAPEUTIC RESPONSE UNEXPECTED (Viral condition fully went away) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Foot infection (viral problem in the foot for 13 years.).   On 17-Nov-2021, the patient received third 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRE-EXISTING CONDITION IMPROVED (Viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna) and THERAPEUTIC RESPONSE UNEXPECTED (Viral condition fully went away). At the time of the report, PRE-EXISTING CONDITION IMPROVED (Viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna) and THERAPEUTIC RESPONSE UNEXPECTED (Viral condition fully went away) had resolved.            No Concomitant and Treatment medication were reported.   This case was linked to MOD-2021-410453 (Patient Link).
pt recv vax FEB94 & pt gave blood, tested positive for hep B core antibody;
nausea/vomiting, inc temp called in rx for Phenergan suppos & APAP suppos;
Hospitalized 11/3/00 for 12 days. Discharged on 11/15/00 and re-admitted on 11/19/00 with the flu. Returned home on 11/28/00. Admitted on 11/3/00 with severe respiratory distress.  Diagnosed with exacerbation of COPD, Anxiety, Depression, Chest Pain
2 1/2inch indurated area over inj site, warm to touch & firm, pt denies fever or itching;inj site lt deltoid;
Fatigue/Tiredness; Headache; Nausea; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the medical information team for a Pfizer-sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 02Mar2021, outcome "not recovered", described as "Fatigue/Tiredness"; HEADACHE (non-serious) with onset 02Mar2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 02Mar2021, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 02Mar2021, outcome "not recovered", described as "Not feeling well". Additional information: The patient's age was reported 28 (unit not specified) who stated that it has been a week from the report and the symptoms were still going on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
administered 3rd dose of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 99E53, expiry date 9th April 2023) for prophylaxis.   Previously administered products included Shingrix (First dose was administered on 14th June 2021) and Shingrix (Second dose was administered on 22nd September 2021).   On 15th November 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 15th November 2021, an unknown time after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The reporter administered 3rd dose of Shingrix to the patient, which led to extra dose administered. Consent to follow up was granted. VAERS details updated.
Swelling and redness at injection site on right upper arm. Fever noted on 04/20/2002 and none on 04/21/2002. Itching, gave Benadryl, no prior reaction. Cephalexin for 7 days. Mom stopped antibiotic due to child vomiting and diarrhea.
Fever, headache, very bad body aches, chest pressure, dizziness and missed two days of work