chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red swollen arm at injection site; red swollen arm at injection site; red swollen arm at injection site, became itchy lasted 1 week.; elevated temperature; body weakness; severe headache for 3 days; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3246), via an unspecified route of administration at site of left arm at 11:00 on 09Jan2021 at single dose for covid-19 immunization. Medical history included lung cancer, chronic obstructive pulmonary disease (COPD), atrial Fib, hypertension and COVID. The patient's concomitant medications were not reported. The patient experienced red swollen arm at injection site, became itchy lasted 1 week. elevated temperature, body weakness, severe headache for 3 days, all occurred at 05:00 on 10Jan2021. Facility type vaccine was Doctor's office/urgent care. No other vaccine received in four weeks. Other medications received in two weeks. Adverse reactions did not result any serious consequences. No treatment received for adverse event. No COVID tested post vaccination. No known allergies. The outcome of events was recovered in Jan2021.
Pt tested positive for COVID-19 on 2/10/2021, and was deceased on 2/16/2021 at.
got both shots, still got it twice in one month/Suspected vaccination failure; got both shots, still got it twice in one month; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 22-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles twice in one month. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Immediately following injection of Pfizer vaccine patient had a panic attack due to emotional response. No allergic reaction was noted. Patient was sweaty, light headed, dizzy and felt faint. Patient never lost consciousness. Patient asked for ambulance to go to hospital to be examined. Patient left in the care of emergency personel.
Pt rec. the above vaccines and PCV on 9/14/17. 5 min after administration of vaccines, (L) leg swelling and redness measuring 4 in was noted at injection site. PRELONE and ATARAX and Ice pack to site was advised. Pt returned to clinic on 9/18/17 for follow up. No redness or swelling seen at site. She was advised (mom) to return to clinic prn if return of symptoms occur.
No known adverse effects; a patient received an expired dose of M-M-R II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N013868 with expiration date 04-MAY-2019, subcutaneously, albumin status recombinant Human albumin (rHA) (exact dose, dose number, site and route of administration was not reported). There was no known adverse effects.
Warmth and erythema and swelling nearly the entire left thigh-not tender to touch.
CHILLS BODY ACHES ABDOMINAL PAIN HEADACHE NAUSEA FEVER
Pt received a series of vaccine. /P the 2nd dose, pt c/o of abdominal pain. /P 3rd dose, pt c/o dizziness. No treatment was administered. Pt seems all right. Pt is a physician
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who experienced only received the dtap/ipv portion of the vaccine, powdered acthib portion inadvertently not mixed in or given, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PREVENAR 13 for Immunisation. On 19-Oct-2018, the patient received a  only received the second 0.5 ml dtap/ipv portion of the vaccine, powdered acthib portion inadvertently not mixed in or given from suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5447AB, expiry date- 15-NOV-2019 via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. The patient outcome is reported as Not Applicable for only received the dtap/ipv portion of the vaccine, powdered acthib portion inadvertently not mixed in or given. 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.
Elevated temperature 102.1 and chills. on 1/15/21 vomited.
This spontaneous report as received from a 63 year old female consumer with high cholesterol and contrast media allergy (reported as allergic to IVP dye) referring to herself. The reporter also stated that she is extremely sensitive to sound and that she has had physical therapy because her doctor thought she had crystals in the inner ear. The patient reported she has 90% hearing loss in the left ear. The patient reported that the inner ear problem started before receiving ZOSTAVAX. On 29-DEC-2013 the patient was vaccinated with ZOSTAVAX, (Dose, route, anatomical location, lot number and expiration date not reported). Concomitant therapies included ZETIA (10 mg, once daily, oral tablets) (duration unspecified), TRICOR (145 mg, once daily) (duration unspecified), aspirin (81 mg, once daily) (duration unspecified), calcium (unspecified), Multi-vitamins (manufacturer unknown), loratadine (manufacturer unknown) and OMEGA-3 MARINE TRIGLYCERIDES (900 mg once daily,oral) (duration and frequency unspecified). On an unknown date the patient have been dizzy and developed chills after receiving the ZOSTAVAX. The patient sought medical attention saw the doctor. The outcome of the events was reported as not recovered/not resolved. Additional information is not expected.
Lack Of response-  information has been received from a registered nurse concerning a female foreign student who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  Sebsequently, it was reported that titer levels were not detactable for rubella.  Unspecified medical attention was sought.  Additional information had been requested.
The client developed blisters on toes ( Right foot 3rd toe, Left foot 3rd and 4th toe)of her bilateral feet and Achilles tendons she also had a  rash on bilateral feet that was very itchy. The rash and blisters appeared two days after being vaccinated.   The client also reports having a head ache but is not sure if it is related to the vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that the patient took other medications within 2 weeks of covid-19 treatment was reported as Yes. The patient previously received a COVID-19 Vaccine. She had diarrhea vomiting bad taste in her mouth. She was not able to complete her regiment. She only took the first dose and could not continue.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12 cm induration with lymphangites and tender axillary LN and left arm site of his 1st vaccinia  vaccination cellulitis treated with 5 days of levaquin
Pt presented with flu form filled out in front and back - As new employee. I asked her to sign the back of the form in the wright place which she did. I gave her the flu shot and recalled Admin had not given me a vaccine record to fill out for her so I called the front desk requesting it. This took longer than expected & I went with Pt to the front and was handed the form which I signed. The Pt then told me she was here for Hepatitis - Not flu which she had gotten last month. The Pharmacist was asked to see if there could be adverse reaction to 2 flu shots. But I still fill out an incident report. Pt mistakenly given a flu dose rather than a Hepatitis B #2 dose. Pt filled out front and back page of flu form; didn't say anything about Hep B dose until after shot record handed to her. Shot received not included in until after flu shot given. Pt didn't get flu shot #1 at MD - so this was not on record. I gave Hepatitis B vaccine after this mistake noted and apologized to Pt. Not sure why she would fill out Flu form in the 1st place and not say something.
I woke up with an unexplained lump on my left hand, the back of my left hand. It was a burst vein under the skin that created an inch and a half high lump of blood. This was in July. There was no known cause for it to happen, I just woke up with it and it got progressively fatter as I moved about that morning. When I went to my chiropractor he suggested I went to the ER and so I went to urgent care, they said nothing was broken and they iced it and wrapped it in gauze. They also had me keep it elevated above my head. I have recovered now but it lasted about 4 weeks. The lump reduced in a few days, but bruising lasted for weeks.
Hep B #3 outdated on 1/11/04 given on 3/3/04 to be regiven.
Rash; Swelling in hands; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06Apr2021 as a single dose for COVID-19 immunization. Medical history included undifferentiated connective tissue disease from an unknown date and unknown if ongoing UCTD. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no concomitant medications. On an unknown date in Apr2021, the patient experienced rash and swelling in the hands. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received treatment for the rash and swelling in the hands including Steroids (methylprednisolone) and antihistamine. The clinical outcome of the event rash and swelling in hands was Recovering. Therapeutic measures were taken as a result of rash (rash), swelling in hands (peripheral swelling).No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Angioedema and eyes were red and watery. Diphenhydramine 50 mg once, diphenhydramine 25 mg HS.
Night following vaccinations patient states 50-cent piece sized red/itchy/slightly raised bump formed. They have had a similar reaction with the flu shot last year but it was only a small red/itchy area but with no swelling.
Pneumonia; This is a spontaneous report based on information from a contactable consumer received by Pfizer manufacturer, [manufacturer control number 4365306].    A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 03Jun2021 via an unknown route at 56-year-old for Covid-19 immunization. Patient's concurrent condition included relapsing remitting multiple sclerosis, increased falls, broken foot, anxiety worse, lymphatic colitis, allergy to aspirin, allergy to penicillin, allergy to sulfa drugs, allergy to tecfidera, emphysema, Von Willebrand's disease, depression, acid reflux, high blood pressure, dizziness, and nausea. Patient's concomitant medication included ocrelizumab, diazepam (VALIUM), duloxetine hydrochloride (CYMBALTA), omeprazole (PROTONIX), diltiazem, vitamin D3, vitamin B complex, meclizine, hydrocodone bitartrate, paracetamol (NORCO), ondansetron hydrochloride (ZOFRAN), loperamide, budesonide (ENTOCORT), and salbutamol sulfate (ALBUTEROL). On an unknown date (reported as Jul2020), patient experienced pneumonia. The outcome of the reported event was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician and a consumer concerning her 15 month old daughter with no pertinent medical history or drug allergies who on 19-OCT-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. On that same day (also reported as 26-OCT-2007) the patient's mother felt a pea-sized mass in the groin. The pediatrician examined the mass and stated that the mass was an enlarged lymph gland. No labs or diagnostic studies were performed. No treatment was rendered, although the enlarged lymph gland could be biopsied in in two months if it still persisted. There was no product quality complaint. The reporter felt that enlarged lymph gland was not related to therapy with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) injection of 19-OCT2007. No further information is available.
86-year-old male presented with hypoxic respiratory failure.  Initial O2 saturation was around 70% on 5 L nasal cannula.  He was placed on 15 L nonrebreather and O2 saturation corrected to just above 90.  He met signs/symptoms of septic shock with viral sepsis.  He was started on Levophed therapy and found to have a PO2 of 38 on arterial blood gas.  Nasal swab was obtained and positive for COVID-19.  Chest x-ray revealed multifocal opacities/infiltrates.  He was started on dexamethasone, broad-spectrum antibiotics, and breathing treatments.  Initial admission was to intensive care unit. Admitted started on broad-spectrum antibiotics including vancomycin and cefepime.  Cultures were obtained as well as procalcitonin and antibiotics were de-escalated.  Confirmed COVID-19 infection required aggressive steroid therapy.  His acute renal failure on presentation was prohibitive of remdesivir therapy.  Echocardiogram was obtained on 12 7 with preserved ejection fraction noted.  He was noted to have right ventricular enlargement and right atrial enlargement with moderate pulmonary hypertension.  A CTA was obtained and negative for pulmonary embolism.  Initially he was treated with heparin infusion pending rule out of pulmonary embolism.  A left femoral central venous line was removed following 3 of 4 blood cultures positive for gram-positive cocci.  Vancomycin was continued throughout his inpatient stay based on this.  He was adequately fluid resuscitated with improvement in his lactic acidosis and his AKI.  Because of his leukocytosis and bacteremia he was not an appropriate candidate for baricitinib therapy.  Ultimately he has failed to respond to aggressive broad-spectrum antibiotics with O2 support and Decadron therapy.  Nebulizer therapies have been provided scheduled and as needed throughout his stay without significant provement in his pulmonary function.  He has been followed by pulmonary service.   Discharge diagnosis Acute respiratory failure with hypoxia Viral sepsis Septic shock ARDS COVID-19 pneumonia Possible superimposed bacterial pneumonia Acute toxic metabolic encephalopathy due to sepsis and hypoxia Pulmonary Edema on exam Blood culture contamination Pulmonary hypertension Acute Hypernatremia AKI Lactic acidosis Hypokalemia Thrush Hematuria Hyperglycemia Severe protein calorie malnutrition History of prostate cancer Normocytic anemia
Injection site pain; Injection site pain which is swelling, red, and hot; Injection site pain which is swelling, red, and hot; Injection site pain which is swelling, red, and hot; They both don't have energy to cook or anything and are sleeping a lot.; They both don't have energy to cook or anything and are sleeping a lot.; They are in a fog and can't think/Feel like they've been run over by a car; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical Information team. An 84-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FA7484; Expiration Date: 30Sep2021, NDC 59267-1000-02), dose 2 via an unspecified route of administration, administered in right arm on 02Aug2021 (at the age of 84-year-old) as 0.3 mL single for covid-19 immunisation. Medical history included pacemaker, fall from 13Feb2021. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0181, expiration date 30Aug2021, NDC number: 59267-1000-02) dose 1 via an unspecified route of administration on 12Jul2021 (at the age of 84-year-old) as 0.3 mL single for covid-19 immunisation. The patient had nothing with the first one, she was just tired and sluggish and worn out all a week. This started the day of the vaccine and lasted a week or so, she didn't even want to cook or eat. This improved then she got second dose. Since receiving second doses, patient have been experiencing "injection site pain which was swelling, red, and hot" on 02Aug2021. Her mother's site "was really hot" and "looks like the size of a baseball". Duration of pain at the injection site after Dose 2 was 2.5 days. They want to know if these reactions are normal and how to treat. Asked what if the reaction last longer than 2 days. The patient's looks like a baseball on her arm. The patient's arm is so hot she could fry an egg on her arm. The patient's arm did not bleed when she took the Band-Aid off. In Aug2021, she felt she had been run over by a car. She does not have energy to cook or anything and sleeping a lot. The patient feels like she was in a fog and can't think in Aug2021. The patient's arm was red and very very hot. The redness started right away. Outcome of the events injection site pain which was swelling, red, and hot was not recovered; for other events was unknown.  Follow up information completed.no further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100999212 Same reporter/product, similar event, different patient
Day 6 I noticed raised red rash on my arm by the injection site. Day 9 it is 4 inches long by 2 1/2 inches wide.
Short episodes a fib; increased PVCs; This is a spontaneous report from a contactable physician (patient).  This 69-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm on 30Jan2021 at 16:00 PM at patient age of 69-year-old (Lot number EL9265 and EN6203) as single dose for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. No other vaccine in four weeks and no other medications in two weeks. The patient experienced short episodes A fib, increased premature ventricular contractions (PVCs) on 01Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment.  COVID was not tested post vaccination. The outcome of the event was resolved in 2021.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of atrial fibrillation and increased premature ventricular contractions cannot be excluded. 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.
I developed a red, itchy rash about 12 hours after the injection.  The rash is painful and burning.  It is hot to the touch.  Today is 5 days after the injection and the rash is continuing to get larger each day.  It now covers my entire upper left arm, down to my elbow.  I had the same reaction to the first injection.
Chills, low grade fever starting day after injection , pain at injection site and injection site hot to touch and swollen starting day of injection in evening, fatigue starting day after injection, As of today only symptoms are still swollen injection site, pain in arm and injection hot to touch and red and inflamed looking.
This case was reported by a other health professional via sales rep and described the occurrence of pain in thigh in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in thigh. On an unknown date, the outcome of the pain in thigh was recovered/resolved. It was unknown if the reporter considered the pain in thigh to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter informed that, the patient was hesitant to get her second dose of shingrix because the patient relayed to the reporter that, the day after the patient received her SHINGRIX vaccination, which was administered in her arm as indicated, the patient experienced significant pain in her thighs, that lasted a long time, could not remember how many days, and still on occasion would have some pain in her thighs but once she moves in the am, she was then fine. This was all the information reporter could obtain at this time from the reporter. The reporter agreed to follow up from GlaxoSmithKline.