chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blurry vision; Light headedness; Minor headache; This is a spontaneous report received from a contactable consumer, the patient. A 71 -year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via an unspecified route of administration on the left arm on 17Mar2021 at 15:00 hours as a single dose for COVID-19 immunisation. Medical history included elevated cholesterol and gout. Patient received other medication (unspecified) within 2 weeks of vaccination (unspecified). Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, at 19:00 hours, the patient experienced blurry vision, light headedness and minor headache. No therapeutic measures were taken as a result of the events. The clinical outcome for blurry vision, light headedness and minor headache were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Hair is falling out at root.  One week after vaccine hair loss was noticed, but a few weeks later hair loss is significant.
Patient was given an expired vaccine. Vaccine expired on 09/07/2021. Vaccine vial was mixed with a similar lot number vial. Expired vial lot #002B21A.
lot of pain in his arm and trouble lifting his arm; lot of pain in his arm and trouble lifting his arm; This spontaneous report was received from a male pharmacist referring to himself of unknown age. His pertinent medical history, concomitant medications and drug reactions/allergies were unknown. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly for prophylaxis (strength, dose, unit, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced a lot of pain in his arm and had trouble lifting his arm (pain in extremity and injected limb mobility decreased). The patient did not seek medical attention and was not treated for the events. The event was not cancer and no overdose was reported. The outcome of pain in extremity and injected limb mobility decreased was reported as recovered/resolved. Causality assessment of the events was not reported. No product quality complaint (PQC) was involved.
Patient fell, severe knee pain, very dizzy. Patient took his pain medication to relieve his pain. Patients arm had swelling the size of a "rock".
She donated plasma, then had tetanus shot, went to donor floor to sit and wait 15 min to see if reaction. She was on laptop sent e mail. Logged off. Started feeling hot, nauseated, got up and went to counter to tell staff, staff went to get nurse, staff got back, she was no longer at counter but had passed out on floor. She also states she has not eaten anything since 7pm 12/18/11.
MEDICAL ASSIATANT GAVE PATIENT A WHOLE VIAL INSTEAD OF 0.3ML
Pt received vaccine IM on 08/25, Mother called and reported on 08/26 that patient woke up with a swollen right upper arm, .hard to touch and , warm  at the injection site, also noted /and reported by parent that right lower arm is also kind of swollen.  Pediatrician saw patient today. Will RTC tomorrow for follow up check up.
Peripheral neuropathy documented by EMG with symptomatic onset 7-14 days after 2000 flu vaccine and worsened 7-14 days after 2002 flu and pneumococcal vaccine (1 wk after urinary infection)>. The 60 day follow up received on 8/11/03 states mild length-dependent primarily axonal peripheral neuropathy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as DOSE 5 (BOOSTER), SINGLE (lot number: GJ2524) at the age of 57 years, administered in the left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 30Oct2021 at 12:30 as DOSE 3 (BOOSTER), SINGLE (lot number: FF2590), administered in the left arm and on 02May2022 at 13:00 as DOSE 4 (BOOSTER), SINGLE (lot number: FJ4991), administered in the left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history was not reported. The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment." It was reported that the original symptoms were muscle aches and cough. The patient underwent the following laboratory tests and procedures: COVID-19 virus test (SARS-CoV-2 test): (Apr2023) Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
Itchiness began on 1/21/21 at injection site as well as pin prick itchy sensation on both legs. Large rash at injection site (mainly below actual injection site) began on 1/22/21- pink in color, warm
After vaccination patient got redness and swelling in left arm. Swelling and redness faded within a week but a small bump remained under the skin, first the size of a marble and now, 24 days later, size of a penny.
Pt started with arm rash that appears as hives 6 days post vaccine. Required treatment with prednisone for 5 days. After tx, rash reappeared and spread requiring 7 more days of prednisone. Rash has not reappeared since second round of steroids.
Severe, intense, deep shoulder joint pain. Onset of pain was 48 hours after vaccine shot. Pain is severe with forward movement of the arm, severely limiting range of motion.
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 13:45 as dose 1, single (Lot number: EL9261), in left arm, on 24Mar2021 at 13:45 as dose 2, single (Batch/Lot number: unknown), in left arm, on 12Oct2021 at 14:30 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 07Jun2022 at 11:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "hypothyroid-senior citizen" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: LEVOCETIRIZINE; SYNTHROID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID-19 Treatment; (26Jul2022) Negative; (26Jul2022) Negative; (31Jul2022) positive again; (05Aug2022) still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID. After treatment with PAXLOVID was completed on Thursday 26Jul2022, she had 2 negative tests and then symptoms returned around 31Jul2022 and tested positive again. On, 05Aug2022 and still testing positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient complains of a rash at the injection site, arm pain, and radiating elbow/elbow joint pain.
Had PNEUMOVAX in right arm 11-2-10. Had pain at site - wakes him at night. No redness or edema at site. Called on 11-4-10 with adverse event. Using one ALEVE at bedtime with minimal pain relief. I asked him to review the PNEUMOVAX vis. May try over the counter ALEVE two times a day, 12 hours apart if tolerated. May use ice pack prn to site.
the patient miss the first dose of the three dose series; plunger wasn't working right and medication spilled out; Initial information was received on 01-Jun-2021 regarding an unsolicited valid non-serious case from a pharmacist. (GMI Inquiry number: 00623420).  It was reported that a female patient missed the first dose of the three dose series (missed dose) as plunger wasn't working right and medication spilled out (syringe issue) RABIES (HDC) VACCINE [IMOVAX RABIES] (Suspension For Injection) (lot number: T1C661M, expiry date: 17-Jun-2022) on an unknown date via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to Product dose omission issue and syringe issue.  At the time of report, no adverse event reported.  IMOVAX RABIES was dispensed to a customer to take to the doctor's office for administration, the product was not working right, she didn't speak to the doctor's office so the customer said the plunger wasn't working right and medication spilled out, they brought the empty IMOVAX RABIES syringe back and said they called Sanofi and filed a complaint and Sanofi said the pharmacy should call for a replacement. Reporter reports the replacement request is urgent because this caused the patient to miss the first dose of the three dose series, the patient needs to start her series as soon as possible for veterinary school.  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 by the regulatory authority. 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.
Information has been received from a physician concerning a patient who was vaccinated with one dose of ZOSTAVAX. The physician reported that the vaccine was administered using COMVAX as a diluent. The reporter had not heard of any reaction to this. A product quality complaint was not involved. Additional information has been requested.
noted that the moderna booster was not the bivalent booster but the original moderna. called the pt and informed him and he voiced no problems. provider was informed and office manager
Case visited hosp, admitted on 4/13, routine COVID tested (+). Hospital visit due to fever, other sxs indicating infection. Case has a pacemaker, currently dx'd as septic, and being treated in hosp for infection.
Menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days.; Menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of the vaccination and other vaccines within 4 weeks prior to the vaccination. On an unknown date in 2021, the patient experienced menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days. It was reported that the patient used to be very regular and 28-day cycle. This changes after vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, in 2021 the patient underwent COVID-19 test via nasal swab test and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days were not resolved at this time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever after 24 HRS, sick and in bed all day. From Tuesday to date - leg stiffness and some headaches.  Admitted to Hospital for testing, found lesion on brain.
Patient and his adult brother were in lobby waiting to be called up to window for payment when patient began to feel "as if he was going to faint". Adult brother called out for help,  upon arrival noticed patient was being held in a standing position by his brother and was supporting his head, patient's eyes were closed, lips were pale, palms of hands were cold and clammy. Instruction given to brother to sit patient back in chair and while giving instructions to brother patient opened his eyes, was able to focus on his brother then on me and asked what happened. From time of call for help to patient opening his eyes and speaking was no more than 15-20 seconds. Per patient and his brother he had been very nervous from vaccines, also mentioned that he had not eaten since early in the morning. Patient was taken into lab area and vitals done: 1410 - BP 137/69, Pulse 53, Resp 16, blood glucose 83mg/dL 1415 - BP 124/84, Pulse 88, Resp 16, lips noted to be pink in color 1422 - BP 118/79, Pulse 84, palms no longer cold or clammy Patient and his brother left clinic stating he felt fine, they refused that EMS be called. Brother and patient given instructions to go to nearest emergency room if he begins to feel unwell again and to take copy of immunization record so they will know what was administered  Call made to brother on 8/9/19, states he took patient to eat when they left clinic and has been doing well since, has not felt any symptoms as he did after vaccines. States they are planning to take patient to neurologist to assure nothing is wrong with him.
Developed Myalgias / cough 24Sept09, day after flu mist and 2 days after HUMIRA injection. He was treated with TAMIFLU.
Patient received the 3 immunizations listed in box 13 on 11/27/06. Mom called reported patient developed tem 101-104 within 24hours. Treated with Tylenol with slight relief then treated with Motrin. Called Health center 12/1/06 to report above incident. Today temp 100 taking oral fluids with no problems. Mom will contact Pediatrician today.
liver pain,  fever 101July 23-24, 2022 8:00 am foggy mind/lightheaded/dizzy/ July 23, 2022 8:00 am lower legs and toes convulsions July 24--28, 2022 severe heart failure July 26- present requiring 13 days hospitalization, treatment with IV diuretics, Lassix and increased dose , twice my normal oral lassie 80mg twice daily instead 40 twice daily, still elevated heart failure pulmonary edema, severe shortness of breath July 23-present August 30, 2022 pneumonia- treated with 5 days IV Rocephin July30-August 2, 2022 bilateral leg convulsions July 24-July 30, 2022 treated with Gabapentin, still not resolved
No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 03-year-old female patient. On 17-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
This spontaneous report was received from a nurse refers to a 30 year old patient with unknown gender. No pertinent medical history was reported. On 02-FEB-2015, 30 year old patient was vaccinated with the 1st dose of GARDASIL. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Approximately 12 hours after the shot, I began having muscle aches, headache, chills, fever, and extreme fatigue. I ran a fever that fluctuated between 101 and 103 for 2 days. I had a migraine headache that lasted for 5 days with no relief, even with migraine medication.  I also developed a red, hot, itchy rash at the injection site within 24 hours of the injection. Since I had this reaction with the first shot, we used the other arm this time, but I still had the same reaction.
Patient had 1st dose of Moderna on 4/21/21, 2nd dose of Moderna on 12/3/2021, and a booster dose of Moderna 3-15-2022. Only symptom after booster dose was a sore arm.
Initially, chills which has resolved. Now experiencing sensation, warm to touch, redness and inflammation to injection site (right arm)
AROUND DAY 3 POST-VACCINATION, PATIENT NOTICED SIGNIFICANT HAIR LOSS. THIS CONTINUED FOR 3 OR 4 DAYS AND HAS GRADUALLY LESSENED TO THE PRESENT TIME.  AS OF TODAY'S DATE, PATIENT FEELS HAIR CONDITION IS SIMILAR TO WHAT IT WAS PRE-VACCINATION. (SYMPTOMS GRADUALLY DIMINISHED AND WERE ONLY SEVERE FOR 4 OR SO DAYS)
Immunization given on 7/16/08 at 10:30 am. On 7/18/08 at 8:00 pm mother stated "It started with 2 "bug bite looking spots" on abdomen, chest and in armpits. Next morning on 7/14/08 they were welt like, larger and had spread more on abdomen/chest/under arms. On 7/20/08 except for buttocks had red and purple welt like spots taken to ER where hands had swelled and face also. Given BENADRYL, PREDNISONE. Diagnosed with immunization reaction.
Patient called to complain that she was feeling nauseous and had thrown up a little bit. She stated that she stated to feel sick about 30 minutes ago and finally threw up. She wanted to know what to do.  I contacted Sanofi Pasteur for assistance. They recommended asking patient to seek medical attention if symptoms worsen. The patient got in contact with her oncologist and was told that she could have a reaction to the vaccine and to wait 24 hours to see if symptoms improve.  He provided her with his cell phone number if she needed to get in contact with him.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FJ5682) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Yeast infection treatment" (unspecified if ongoing). Concomitant medication(s) included: MONISTAT 3 taken for fungal infection, start date: 12Jun2022, stop date: 14Jun2022. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline", notes: Known allergies: tetracycline. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Full rebound of covid symptoms. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical information: She had other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare professional, via MassBiologics, who was referring to a 42 year-old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On 03-MAY-2017, the patient was vaccinated with M-M-R II lot # M029229, albumin status: rHA, site of administration: hip (strength, dose, frequency, expiration date and route of administration were not reported) for prophylaxis. Other suspect therapies included tuberculin purified protein derivative, poliovirus vaccine inactivated, TETANUS AND DIPHTHERIA TOXOIDS ADSORBED. Concomitant therapies included SYNTHROID. On 06-MAY-2017, the patient experienced redness, that got increasingly bigger and swelling around the site of administration (right deltoid). It was also reported that the patient had shooting pain down the right hand, numbness, tingling, weakness, neck pain and stiffness. It was also reported, the patient felt both sore and lethargic on 06-MAY-2017. On 03-JUN-2017 (reported as 1 month post-administration), the patient visited the doctor's office. No treatment was reported. On 28-AUG-2017, the outcome of the adverse events was reported as unknown. The relatedness between M-M-R II and the adverse events was not reported.
This spontaneous report was received from a pharmacist, concerning a 62 year old male patient with pain in his left shoulder. The patient had not known drug reactions/allergies. On 26-OCT-2013, the patient received a dose of ZOSTAVAX, 0.65 ml, subcutaneous in the left arm (Lot # and expiration date were not provided). There was no concomitant medication. It was reported that the patient had pain in his left shoulder which began about a year ago (approximately in December 2012), and she has not seen a physician about this shoulder pain and it's etiology was unknown. The reporter stated that he received the dose of ZOSTAVAX in his left arm on 26-OCT-2013, and the pain in his shoulder increased. It was stated that he has not yet seen a physician, but was planning to. The patient had not received any treatment for the event and no laboratory diagnostic test has been performed. The patient sought medical attention by pharmacy visit. At the time of the report, the patient had not recovered from the event. The relatedness between the event and the suspect therapy was not provided. Additional information has been requested.