chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives everywhere; eyes swollen; malaise; fatigue; Lips swollen; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09May2021 at 11:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known drug allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any medication within two weeks of vaccination. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) in the left arm on unknown date as a single dose for COVID-19 immunisation.  On 10May2021 at 09:00 the patient experienced hives everywhere, lips and eyes swollen, malaise and fatigue. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event hives everywhere, lips and eyes swollen, malaise and fatigue were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was in office to receive Tdap, Menveo, and HPV vaccine.  The Tdap vaccine that was administered was expired.  Expiration date  was 6/21/22.  There were no reactions at the time.  After calling CDC and GlaxoSmithKline Manafacturer recommendation was to administer correct Tdap in opposite arm that expired Tdap was initially given.  Pt will come in to the clinic and have this repeated.
Patient had the anthrax vaccine on 4/10/2017 and experiencing itchiness and soreness on left arm 4/12/2017.
pt recvd vax & had a splotchy like rash on trunk of body; rt ear canal was very inflamed & rt eardrum protruded some; taken to MD; MD said it was urticaria from vax;
Patient reported severe adverse effects that she did not experience with first shot. Severe left arm swelling, pain and redness. On her left side from her neck to her ear was painful, couldn't turn neck, had headache, upper back pain and chills (flu -like sx) Received shot Monday evening and woke up Tues morning with symptoms that lasted 24 hours.
pt recvd vax;devel a little red raised knot, & a warm area near inject site in the thigh;
Before going to bed began having intense body pain all over. Cold and hot episodes followed by sweating and shivering. Next day felt very bad pain in my abdomen and when using the restroom noticed a significant amount of blood in my stool and around the bowl of the toilet. It was very painful to use the restroom and continued for days. Stomach pain worsened to the point where waist bands from shorts or underwear were excruciating and I couldn't wear anything anymore. Body pain remained and I also noticed I could no longer get erections which was very concerning.
Patient has a 3 inch red spot that is sensitive to touch but not at injection site.  The spot is 3 inches down from injection site and inside arm area.  Patient has had the spot for 6 days and gets very red after hot shower.
patient presented to pharmacy checking on redness slightly under injection site. she was advised to use a cold compress and watch redness. she was advised to seek medical attention if redness worsens or spreads further, and let us know the outcome. We attempted to reach patient on 7/18/19 to see how she was doing.
This is a spontaneous report received from a field representative who received a report from a physician regarding a 65-year-old female consumer who received a dose of ZOSTAVAX injection subcutaneously for prevention of shingles (lot # and expiration not reported). The physician reported that about 4 weeks ago on an unspecified date, a female consumer came into the office to receive her ZOSTAVAX injection. The physician stated that the consumer came back to their office about 2 weeks later on an unspecified date with complaints of a 'rash' at the injection site and on their other arm (did not specify which arm was the injection site arm). The physician stated that it was concluded that the consumer 'developed chicken pox' as a result of the ZOSTAVAX injection. The physician stated they instructed the consumer to take diphenhydramine (BENADRYL) and use calamine lotion. The outcome of the event was not reported. Additional information has been requested.
Expired dose given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HBV (Engerix B) (batch number 5397F, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th December 2021, the patient received Engerix B (intramuscular) and Engerix B Pre-Filled Syringe Device. On 9th December 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient inadvertently given an expired dose of Engerix-B, which led to expired vaccine used. It was unknown at the time of this call which dose of the series this was. No further details provided. The reporter consented to follow-up.
Information has been received from a physician concerning a 10 year old female who on 11/21/2000 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot 635449/1141K). The physician reported that on 6/29/2005, the patient developed a breakthrough case of varicella characterized by about 50 lesions. Unspecified medical attention was sought. The patient was noted to be afebrile and no treatment was given. At the time of this report, the outcome was unknown. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 14-JUN-2016 the patient received a dose of improperly stored VARIVAX (lot # L041206, expiration date 20-OCT-2017). No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Left shoulder pain shortly after injection.  Her left shoulder pain started suddenly in October of 2018 after getting a flu shot. She denies any injury to the shoulder immediately prior to her pain starting in October 2018. She has continued to have persistent left shoulder pain for the past year. She has pain with overhead activity, lifting and reaching. She points to the lateral upper arm as the main location of her pain. Her shoulder feels weak and becomes fatigued easily. She has pain at night that interferes with sleep. Her shoulder pain is affecting her daily life and limiting her activities. She completed a course of physical therapy which made her shoulder pain worse. She did two courses of oral steroids which only provided temporary improvement. She has had two CORTISONE injections performed by PCP. The first injection in January 2019 provided good relief of her symptoms for about eight months, but the second injection performed in August 2019 was not as effective. She gets some relief of her pain with ice and IBUPROFEN. Her shoulder pain has not improved despite conservative treatment. Assessment findings: Rotator cuff syndrome of left shoulder, Arthritis of left acromioclavicular joint, Nontraumatic incomplete tear of left rotator cuff, Superior glenoid labrum lesion of left shoulder.  Patient with persistent chronic left shoulder pain with an MRI and clinical exam consistent with high-grade bursal sided rotator cuff tear, subacromial impingement/bursitis, AC joint arthrosis and possible SLAP tear refractory to multiple injections and physical therapy directed program without improvement. Ultimately resulting in Left shoulder arthroscopy, arthroscopic rotator cuff repair, transosseous equivalent with dual row fixation, arthroscopic subacromial decompression with anterior acromioplasty, arthroscopic debridement degenerative labral tearing with biceps tenotomy, arthroscopic distal clavicle excision, open subpectoral biceps tenodesis. In discussion with surgeon, the vaccine injection could have caused the bursitis that led to the need for procedure.
Noted that night on irritation on chest-tender-not itchy and noted slight pinkness. In AM noted red round rash-and 3 other nickel size, slightly raised tender areas. Treated with Claritin and took Benadryl MS for 2 nights. Gradually symptoms subsided.
In June 2000, the vaccinee experienced arm pain for one week and pain in his elbow. The vaccinee used a brace from a previous sports injury and the pain resolved. Additionally, he had some warmth in the right elbow which resolved. He was dx with lateral epicondylitis. He was evaluated by an orthopedist who advised him that his symptoms were probably related to his age and golfing.  Follow up on 02/02/2001: "On 07/13/2000, the vaccinee received his third IM-right arm dose of Lymerix.  On approximately 08/06/2000, pain appeared in his right elbow.  He was diagnosed with possible lateral epicodylitis/tendonitis left and right elbow.  The vaccinee felt that this diagnosis was not related to Lymerix.  The responsible physician (allergist) stated that the possible epicodylitis/tendonitis right and left elbow was mild in intensity and possibly related to Lymerix.  As of 10/16/2000, the outcome of the event is ongoing.  The adverse events of 'possible lateral epicondylitis, possible endonitis, bilateral elbow pain, and elbow warmth' do not meet ICM serious criteria, but are being submitted as an expedited report by special request per the 06/28/2000 letter."
Facial swelling, urticarial rash about 8 hrs after receiving varicella. Treated with Benadryl.
Tinnitus and diminished hearing  in the left ear only 5 minutes post injection. Pain at injection site lasting 1 week. Anxiety prior to receiving vaccine and post lasting 1 hour. Fatigue, body aches starting 5 hours post injection. Chills starting 12 hours post injection and lasting 2 hours. Headache lasting 24-36 hours. Elevated temp at 98.4, normally 97.4
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic to establish care several months after immunization. Reports symptoms consistent with a severe allergic reaction almost immediately after receiving vaccine: dyspnea and stridor. Patient was hospitalized, received intravenous fluids, epinephrine, and was discharged to home. Since then patient continues to experience dyspnea on exertion and activity level has not returned to pre-vaccination status.
Hives that comes & goes, treatment 1/2 tsp ZYRTEC daily until no longer symptomatic.
Patient reports feeling flushed and having increased chest redness 5 minutes after taking her first dose of the Moderna COVID-19 vaccine.  She denies swelling, itchiness, shortness of breath, or chest pain.  Her vital signs were stable (BP 122/89, HR 71, RR 16, SaO2 99%RA).  She self administered her own hydroxyzine 50mg and symptoms resolved. She was monitored for a total of 49 minutes.  She was educated on angioedema and anaphylaxis symptoms. She was also given go to ER precautions if symptoms return or worsen.
Fatigue, muscle aches, nausea temp 99.0. Soreness at inj site x 2 days so far.
pt devel vesicular lesions on abd, back, face, head & thighs about 10-15 in number;
accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     It was unknown that patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On an unknown date, the patient received 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 WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series).    No concomitant medications details were reported. It was reported that, a nurse accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series.  No treatment medications details were reported.   Reporter did not allow further contact
left arm, at the injection site, has not stopped itching; left arm, at the injection site, has not stopped itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 16:00 (Batch/Lot number: unknown) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Raw egg" (unspecified if ongoing), notes: Known allergies: Raw egg. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, Single, Previous dose details:, Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot unknown: True, Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose administration date: 05Apr2021, Prev dose administration time: 06:00 PM, Prev dose dose number: 2, Prev dose vaccine location: Left arm), administration date: 05Apr2021, when the patient was 69 years old, for Covid-19 Immunization, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (DOSE 1, Single, Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot unknown: True, Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose administration date: 06Apr2021, Prev dose administration time: 06:00 PM, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 06Apr2021, when the patient was 69 years old, for Covid-19 Immunization.  The following information was reported: VACCINATION SITE REACTION (non-serious), PRURITUS (non-serious), outcome "not recovered" and all described as "left arm, at the injection site, has not stopped itching". Therapeutic measures were not taken as a result of vaccination site reaction, pruritus.  Additional information: No other vaccine in four weeks. Patient reported that left arm, at the injection site, has not stopped itching. This is now 4 months post vaccination with no relief. No covid prior vaccination. Post vaccination, the patient was not tested for covid. No other medical history reported. The patient reported that he had reaction to the Covid booster and his family physician was confused with him and was not sure.  Follow-up attempts are completed. No further information is expected.
Narrative: The patient received the J&J vaccine at an outside facility and 4 weeks later presented to the ED with a DVT
Symptoms: fatigue, following day armpit of vaccinated arm has localized pain and soreness.
I get small, red circular bumps that are extremely itchy; I get small, red circular bumps that are extremely itchy; hives; At first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 07May2021 at 16:15 (04:15 PM) (at the age of 33-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included rheumatoid arthritis, COVID-19 (if COVID prior vaccination Yes). The patient received concomitant medication in two weeks which included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was COVID tested post vaccination. The patient previously took ibuprofen (was not previously but now ibuprofen) and experienced drug allergy; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 16Apr2021 at 03:45 PM as dose 1, single for COVID-19 immunization. On 01Jul2021 at 20:00 (08:00 PM), the patient experienced I get small, red circular bumps that are extremely itchy, hives, at first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine. Adverse event: Developed an allergy to ibuprofen. Everytime I take ibuprofen I develop hives. I get small, red circular bumps that are extremely itchy. At first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine (and he takes a different brand of ibuprofen). The patient underwent lab tests and procedures which included SARS-COV-2 test was negative (nasal swab) on 19Jul2021. The patient received Benadryl (just self-medicated with Benadryl each time) as treatment medication for all the events. Outcome of all the events was recovered with sequelae (recovered with lasting effects).  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
102F Fever; Chills; Body ache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM0164) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received azithromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 17:00, 26 hours after vaccination, the patient experienced 102F(Fahrenheit) fever, chills, body ache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fatigue was resolved on 23Apr2021, within 4 hours while that of the events 102F fever, chills and body ache was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Vaccine administered on 8/02/21 and was expired on 7/31/21
ROTATEQ was improperly stored and administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 01-JUN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number 1707408, has been verified to be a valid lot number, expiration date reported and validated as 07-JAN-2022) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature of 13.5 degrees Celsius (C) for 1 hour and 50 minutes, as recorded by a data logger. There was no previous temperature excursion reported.
11/09/09 RASH, ITCHING,WHEEZING; TOOK BENEDRYL 11/10/09 REPORTED TO EMPLOYEE HEALTH; NO HIVES AT THAT TIME, NO DYSPNEA, DR ON CALL CONSULTED: CONT WITH BENADRYL 11/11/09 REPORTED TO EMPLOYEE HEALTH WITH ONE SPOT ON FOREHEAD, 2 ON ABDOMEN 11/12/09 REPORTED TO EMPLOYEE HEALTH VERY ANXIOUS, HAD CLINIC APPT TO SEE DR: DEPOMEDROL IM GIVEN;  AT NOON PRESENTED TO ER WITH SAME EPISODE:  NO FURTHER CARE  12/04/09 ED notes received for DOS 11/12/09. DX: Allergic reaction Pt c/o wheezing, hives, rash on arms. On examination no evidence of hives or pruritus. Tx: Benadryl, Depo Medrol, Decadron.  Pt discharged in good condition.  12/08/09 Urgent Care notes for DOS 11/12/09 DX: Allergic reaction, exanthema. After being seen in ED, Pt presented to Urgent Care with c/o wheezing, hives, itching, tight throat, dizziness, palpitations. Pt prescribed Epipen. On examination Pt was feeling better.
This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of RECOMBIVAX HB, lot # L044917, expiry date 05-OCT-2018; lot # L044707, expiry 06-OCT-2018 (dose and route were not reported), that had been exposed to 34.4 F during 2 hours and then back in range, were given to multiple unspecified patients on unspecified dates. It was unknown if the patients sought medical attention. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Lot number L044917 and L044707 have been verified to be valid lot numbers for RECOMBIVAX HB. Additional information has been requested.
5 year old received the adult dose vaccine.  Her father was told to monitor her for pain, malaise and fever this evening and tomorrow