chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report obtained from a contactable pharmacist. This pharmacist reported similar event for two patients. This is the first of two reports. A 79-year-old female patient received, on 04Oct2018, PREVNAR 13 (Lot. W51924, Expiration date: Jul2020, NDC number: 0005-1971-02) at single dose, for immunization (prevention of Pneumonia). Relevant medical history included diabetes, thyroid disorder and blood pressure. Concomitant medications included oral atorvastatin 20 mg, daily (one tablet daily by mouth), from an unspecified date (ongoing); oral glipizide 5 mg, once daily (one tablet, once a day, by mouth), from an unspecified date (ongoing), for diabetes; oral levothyroxine 0.075 mg, once daily (one tablet, once a day, by mouth), from an unspecified date (ongoing), for thyroid disorder; oral losartan 25 mg, once daily (one tablet, once a day, by mouth), from 02Aug2018 (ongoing), for blood pressure; oral metformin, tablet, 1000 mg, twice daily, for diabetes and oral sitagliptin phosphate (JANUVIA) 100 mg, once daily (one tablet, once a day, by mouth), from an unspecified date (ongoing), for diabetes. After the vaccination, the patient experienced the following delayed reaction: on 05Oct2018, the patient's arm was blue and green. On 10Oct2018, the patient experienced little red bumps on arm and her arm was red and warm with a circle at the site. The adverse events were assessed as serious (Medically Significant). The events, vaccination site mass and vaccination site discoloration were considered related to pneumococcal 13-val conj vac (dipht crm197 protein). The patient did not recover from the adverse events at time of this report.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "vaccination site red/ warmth/discoloration and little red bumps" cannot be fully excluded considering the known adverse event profile of PREVNAR 13 and apparent time association.  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.,Linked Report(s) : US-PFIZER INC-2018421167 same reporter/drug, different patient/events.
01/02/23 presents to ED for "cough". PMHx of "asthma, migraines"
Following MMR #1 administered 8/9/02, child experienced 2 weeks later fever and swelling of left side of face. Lasted 4-5 days. Saw physician who diagnosed bacterial infection and gave course of amoxicillin. MMR #2 administered 10/10/02. Child complained of sore throat and 99.9 degree fever. Sought medical advice and told viral on 11/5. By 11/6 child experienced swelling of right side of face in cheek area, lower jaw and behind ear.
Chills, muscle aches, fever of 101.1, pain at injection site, nausea
This spontaneous report was received from a physician via company representatives from a support services director concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies were not provided. On 24-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number K010466, expiration date of 23-MAR-2016 (route of administration was not reported). The vaccine had two temperature excursions: one for 24 hours and another one for 32 hours. The lowest recorded temperature for the first excursion was 34 degrees Fahrenheit (1.111111111 Celsius) and the highest recorded temperature for the second excursion was 48 hours Fahrenheit (8.888888889 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
8 by 8 cm diameter area of erythema and edema with three clear vesicles at Left arm, starting a little over 24 hours after vaccination.
05/13/2003: DTAP administered in left deltoid -05/15/2003-erythma, warmth in left deltoid-fever to 101.8 degrees F.  Treatment: ice packs and Tylenol and Motrin for fever.
Raised rash that itches a lot, and burns every now and then. Rash has gotten bigger in diameter since day of vaccination.
Sudden onset vertigo; severe dizziness, impaired ability to walk straight or see clearly....came in waves. Was serious enough that it was disruptive to job functions, impaired motor functions. Ongoing.
A health care professional reported that a 7 year old female patient received a dose of Flumist nasal solution on 12/12/03. The reporter indicated that the patient is a well child. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 1 dose 1 time per day (IN). Patient was not taking concomitant therapy. On 12/12/03, the patient developed cough and a runny nose. On 12/14/03, the patient developed a fever of 101 degrees F to 102 degrees F. She was treated with Tylenol and Motrin. No additional information was available at the time of this report. Additional information was received on 13-Jan-2004 from the reporter which provided recovery status. On 13-Jan-2004, he recovered.
Patient became clammy and fainted after vaccine administration.  Episode lasted about 10-15 minutes.  Patient became alert and oriented and felt fine.
Miscarriage; melanoma; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4527037-00.  A 51-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Pregnant" (unspecified if ongoing); "Melanoma" (unspecified if ongoing), notes: She had Melanoma; "miscarriages" (unspecified if ongoing), notes: In past she had miscarriages. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: Unknown, Route of administration: Intra-muscular), administration date: 03Feb2021, when the patient was 51-year-old, for COVID-19 vaccination, reaction(s): "Panic attacks". The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "Miscarriage"; MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "melanoma". The pregnancy resulted in spontaneous abortion. The action taken for adalimumab was unknown. The fetus was exposed to maternal use of Humira in utero. The mother experienced melanoma and miscarriages.It was unknown if she was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful. Causality for Humira (Adalimumab), for the event Miscarriage Causality as per reporter was Not Reported and Causality as per manufacturer was No reasonable possibility and for the event Melanoma Causality as per reporter was Probable, reasonable possibility and Causality as per manufacturer was Not assessable.   The reporter's assessment of the causal relationship of "miscarriage" and "melanoma" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events  miscarriage", "melanoma"and the suspect drug BNT162B2 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
Initial unsolicited report received from a physician via other company (Novartis) (Reference number: PHEH2016US015660) on 16-Sep-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergies to tetanus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Patient received vaccination today. Is accompanied by Father . VIS explained and given.  Advised patient wait in clinic for 15 minutes to observe for any possible adverse or allergic reaction. Patient fainted about 1 minute after receiving last vaccine. Lost consciousness for approximately 10 seconds. Dr. was called into the exam room to assess patient. Pulse, oxygen and blood pressure taken about 2 minutes after incident. All within normal range - documented under vitals. Patient layed on exam table for ~ 10 minutes with legs elevated. Took blood pressure again- normal range. On Dr.'s direction patient sat on exam table for 10 minutes, retook vitals - normal limits. Had patient stand up for a few minutes, retook vitals - normal limits. Dr. reassessed patient and okayed to leave.
Fever - 12 hours - Recovered Headache - 24 hours - Recovered Body Aches - 24 hours - Recovered Pain and soreness at Injection Site - 24 hours - Recovered
Patient was observed for 30 minutes in the pharmacy due to her concerns. After she went home and had some lunch, she started feeling "jittery or "busy" inside." She was not visibly shaking and she took her BP and it was good.  She said she was not visibly shaky or trembling.  She took a Tylenol and went to bed and slept, then felt better later.  Patient just called in to pharmacy today ( May 27th) to voice concern about receiving 2nd vaccine.
Shortness of breath, chest pain, which got progressively worse, fatigue, pericardial swelling (diagnosed during inpatient admission following), treated with pain management, bronchodilators, NSAIDs.
This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingle from the Shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Afib; had a pace maker put in; Fever; terrible chills; Very weak; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included atrial fibrillation (occasional atrial fibrillation). Concurrent medical conditions included sulfonamide allergy. Concomitant products included metoprolol (Metoprolol Er), clonidine, dabigatran etexilate mesilate (Pradaxa) and flecainide.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Afib) (serious criteria GSK medically significant), cardiac pacemaker insertion (Verbatim: had a pace maker put in) (serious criteria clinically significant/intervention required), fever (Verbatim: Fever), chills (Verbatim: terrible chills) and weakness (Verbatim: Very weak). The outcome of the atrial fibrillation, cardiac pacemaker insertion, fever, chills and weakness were not reported.   It was unknown if the reporter considered the atrial fibrillation, cardiac pacemaker insertion, fever, chills and weakness to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation, cardiac pacemaker insertion, fever, chills and weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 9-NOV-2023 The patient had terrible chills, fever, was very weak so called an ambulance and went into atrial fibrillation and had a pace maker put in. The patient received metoprolol er, flecainide er, clonidine and Pradaxa as treatment. The patient had no prior vaccinations for those events. The patient had no current illness. Follow-up would not be possible, as no contact details were available.
p/vax pt exp chickenpox;the reporter noted child covered w/lesions, about 200 to 300 all over body;
Patient experienced headache, muscle aches in the neck and back, and a sore throat. Symptoms were moderate in severity. Patient self-treated with ibuprofen. Symptoms resolved approximately 24 hours after onset.
Patient received anthrax and typhoid vaccines, then moved to sign out. Patient lost consciousness, hit his face, recovered then LOC again. Doctor attended patient immediately. BP 118/67, Pulse 75, SPO2 98%. EMS was called.
Shingrix exposed at negative temperatures; This non-serious case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Shingrix exposed at negative temperatures). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2023 It was reported that Shingrix was exposed at negative temperatures minus 0.9 degree Celsius was the minimum in several occasions and probably administered to patients (no patients information provided) which led to incorrect storage of drug. The reporter did not consent to follow up. The vaccine administration facility is the same as primary reporter.
There was a bit of soreness at the injection site following the shot. Nothing major. The next day, I felt a little firmness in the area, and it was a bit more tender. With each passing day, the swelling got bigger. A firm swollen orb has been forming under the skin, growing bigger and more turgid each day.  It got to be the size of a marble, then the size of a gumball, and today, it's actually expanding in shape and is (pretty much exactly) the size and shape of a Cheeto Puff.  The area is warm to the touch. There is visible redness radiating around the area, and it is slightly itchy. There is discomfort and minimal soreness, but no pain.
Immediately after getting the vaccine I felt very weak, as if I was going to pass out. A person on site took my blood pressure which was higher than normal. I was advised to wait longer than 15mins, but after 30mins waiting I still was not okay to leave. I had to call family to come for me, at which point the people on site told me to eat food. I was given water and licorice by the facility, my mother brought me tacos but I still felt very weak. (Weakness was not food related). I was in the waiting area for 1 1/2hrs, advised not to drive myself home, my mother had to drive me home and stayed with me. I also had trouble walking, and was helped to the car. I did not go to a hospital for these adverse reactions as I did not get a fever at any point, and wasn't exactly sure what could be done for me.  Days following the vaccine I still felt very weak, slept a lot, and felt very out of it. It took 4-5 days to return to normal.
Left shoulder pain, weakness in legs severe aches and pain in joints in left side of arms chest and down to both legs. Feeling very cramped and severly aching with headache, lasting several days. Fatigued and tired for up to week. Still waiting for symptoms to alleviate no fever. General feeling of malaise lastng over a week about 5 days after vaccination.
Chills very early in the morning, however, I guess I'm feeling Ok now.  But I'm wearing warmer cloths now.
Fatigue, pain at injection site (left arm), spreading to head and down leg. 800 mg Ibuprofen at 7pm. 10/16: Tingling in scalp on left side, face, down to knee, increased soreness in shoulder and neck.
Pt awake on 7-9-12 with quarter sized raised reddened area on back of (R) A hot to touch, painful itching within 1 hour nausea & vomiting developed. Child was taken to hospital where she was given BENADRYL.
ight shoulder pain   two weeks ago - vaccines b/l shoulders 06/09/2022 at local Pharmacy  now right shoulder is pain following prevnar vaccine   initially some soreness  then more persistent discomfort  no swollen LN on right  no prior injuries  no bruising or swelling  no rash/hives.
Information has been received from a health professional concerning a 37 year old female 10-NOV-2007, received in her left arm a first dose of RECOMBIVAX HB (lot# 656680/0010). Concomitant therapy included tuberculin purified protein derivative (MANTOUX SKIN TEST) administered in her left arm on 08-NOV-2007. On 10-NOV-2007, the developed body aches, chills and a fever (101 degrees Fahrenheit). No medical attention was sought. It was reported that on 11-NOV-2007, the patient had fully recovered. A product quality complaint was not reported. Additional information has been requested.
developed dizziness, headache, body aches, chills, nausea, and diarrhea that lasted from late Friday night 1/1/21 to 1/2/21, then experienced mild headache and body aches on 1/3/21. Symptoms resolved 1/4/21.
Started with Hives/Diffuse rash day 2 post vaccination given Hydroxyzine 25mg prednisone 20mg Day 3 was admitted to Hospital with Fever Diagnosed with Sepsis, Acute Renal failure and Hyponatremia released 7-22-19
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, since 26-FEB-2015, the patients were vaccinated with improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 128 hours. The highest recorded temperature was 49 F (9.444444444). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Left-sided Headache , Facial Nerve Spasm, Slight Droop left side of lip, multiple blisters on left side of tongue.   Lasted for approximately 3-4 days  Resolved -  No symptoms 12/26/2020
Pt received 1 dose of flu vaccine on 10/31/03. Approx 20 minutes later pt c/o numbness in lips and tightness in throat. Pt took po Benadryl and symptoms slowly subsided. Refused 911.
Sore Injection Site; Chills; Body aches; Painful Breathing after Second Vaccine (Chest hurts on deep breathing); Pain Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DYSPNOEA (Painful Breathing after Second Vaccine (Chest hurts on deep breathing)), VACCINATION SITE PAIN (Pain Left Arm), VACCINATION SITE PAIN (Sore Injection Site) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain Left Arm). On 13-Apr-2021, the patient experienced PAIN (Body aches), DYSPNOEA (Painful Breathing after Second Vaccine (Chest hurts on deep breathing)) and CHILLS (Chills). On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Injection Site). At the time of the report, PAIN (Body aches), DYSPNOEA (Painful Breathing after Second Vaccine (Chest hurts on deep breathing)), VACCINATION SITE PAIN (Pain Left Arm), VACCINATION SITE PAIN (Sore Injection Site) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076754 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076754:
This spontaneous report was received from a physician referring a female patient of unknown age, who was a nurse also. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in January 2017 (reported as "last week"), the patient was vaccinated with a dose of ZOSTAVAX, for prophylaxis (dose, route, lot # and expiration date were not reported). On 21-JAN-2017, the patient experienced an injection site reaction that was "painful to touch", with little "blisters" and "swelling"; and was about "1-2 inches in diameter". It was stated that the patient recovered from the events on 23-JAN-2017 (also reported as 23-JAN-2016). A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information is not expected because the reporter refused additional contact.
First dose on 12/18/2020  Second dose on 1/04/2021 Intermittent heart palpitations began early am on Monday, Jan 11th and occurred again on Tuesday, Jan 12th am (worked nightshift). Again appeared the evening of Wed, Jan 13th.   On Thursday, Jan. 14, made appt with my primary MD and appt was at 3 pm the same day. EKG performed at office and was Normal sinus rhythm.  BP and HR normal too.  MD advised to monitor and call back as needed.
Slight dizziness. "Blank spots" in vision. Extreme fatigue. Slept on and off for 48 hours. Chills, could not stay warm. Took blood pressure, showed irregular heartbeat. Focus and concentration have been affected negatively- affecting work.  Put on Elliquist. Still on Elliquist. Several cardiac test have been done. Repeated bouts of Afib. Put on anti Afib medication Sotalol, 80ml.  After Ablation on August 16, Afib normalized, taken of Sotalol. Started Sotalol on May 2th.