chrisvoncsefalvay/vaers-outcomes huggingface dataset:
once got the flu; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves an adult patient in forties of unknown gender, who once got the flu (influenza), while he/she received influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), concurrent conditions and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received influenza vaccine (batch number and expiry date unknown) at an unknown dose via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) after starting the suspect vaccine therapy, The patient never had the flu before but got the shot once got the flu (influenza) and 30 years later haven't had it.  No lab data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, outcome was unknown for flu.  There will be no information available on the batch number for this case.
This is a spontaneous report obtained from a contactable pharmacist. A patient of an unspecified age and gender received, on an unknown date, PREVNAR 13 at single dose and FLUAD; both for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccinations, the patient experienced 'itching all over'. Clinical outcome was unknown at time of this report. The information on the lot number has been requested.
Tested positive for the flu; Tested positive for the flu/Lack of efficacy; This spontaneous case was received on 23-Nov-2022 other healthcare professional via Regulatory Communications (reference number: SEQW22-06038) and concerned a 2-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 11-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B. The batch number reported was 348368 and expiry date was 30-Jun-2023.  On 22-Nov-2022, 1 month and 11 days after receiving Flucelvax Quadrivalent, the patient developed fever in daycare.   On 23-Nov-2022, the patient was taken to her primary care doctor to make sure it was not an ear infection. The patient was subjected to a flu test which turned out positive (explicitly coded as 'Vaccination failure').  On an unspecified date in Nov-2022, the patient took 'fever reduction' Tylenol (paracetamol) and was prescribed Tamiflu (oseltamivir phosphate). The patient was presently on Tamiflu at the time of report.   At the time of initial repoting on 23-Nov-2022, the patient had not recovered from the event of flu.   The reporter did not provide a causality assessment.  The event of 'flu' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 2-year-old, female patient was vaccinated with Flucelvax Quadrivalent. 1 month and 11 days after vaccination, the patient developed fever. Next day, the patient was subjected to a flu test which turned out positive (explicitly coded as 'Vaccination failure'). The patient's medical history and concomitant medications were not reported. Based on provided information, causal role of the suspect product is assessed as possibly related for both events, influenza and vaccination failure.; Sender's Comments: A 2-year-old, female patient was vaccinated with Flucelvax Quadrivalent. 1 month and 11 days after vaccination, the patient developed fever. Next day, the patient was subjected to a flu test which turned out positive (explicitly coded as 'Vaccination failure'). The patient's medical history and concomitant medications were not reported. Based on provided information, causal role of the suspect product is assessed as possibly related for both events, influenza and vaccination failure.
This spontaneous report was received from a physician concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unspecified date in 2016 (reported as "last year"), the patient was vaccinated with PNEUMOVAX 23 single dose (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date after receiving the vaccine of PNEUMOVAX 23, the patient developed fever. At the time of reporting, the outcome of the event was not reported. The causal relationship between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
thyroid cancer; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 22Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer BioNTech COVID 19 vaccine on 22Mar2021 and she also had a biopsy done the same day. She has subsequently found out she has thyroid cancer and is currently at a cancer clinic to have surgery.  Her doctors have recommended waiting 2 weeks after surgery to receive the vaccine. She was supposed to receive second dose on 19Apr2021 but will be unable to make this appointment. She called her Pharmacy and they said they are unable to reschedule her appointment. She then called the pharmacy and they told her she was unable to reschedule her vaccine she had to go to another pharmacy. She asked how long can she wait to receive the second dose of the vaccine and how she can schedule the second dose. She was very upset Pfizer could not directly give her a vaccine or schedule a vaccine for her due to her extenuating circumstance. She said she had been on hold a very long time and is upset that Pfizer can't do anything. The government doesn't care about her and neither does Pfizer. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Bed bound; Cough; Blotchy skin; numb lilps; wheeze; Shoulder pain; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bed bound), COUGH (Cough), RASH MACULAR (Blotchy skin), HYPOAESTHESIA ORAL (numb lilps) and WHEEZING (wheeze) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (tree nuts), Pollen allergy, Allergy to animal (dogs) and Allergy to animal (cats).    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced BEDRIDDEN (Bed bound), COUGH (Cough), RASH MACULAR (Blotchy skin), HYPOAESTHESIA ORAL (numb lilps), WHEEZING (wheeze), ARTHRALGIA (Shoulder pain), HEADACHE (Headache) and PYREXIA (Fever). On 25-May-2021, BEDRIDDEN (Bed bound), COUGH (Cough), RASH MACULAR (Blotchy skin), HYPOAESTHESIA ORAL (numb lilps), WHEEZING (wheeze), ARTHRALGIA (Shoulder pain), HEADACHE (Headache) and PYREXIA (Fever) had resolved.            This case was linked to MOD-2021-076400 (Patient Link).
body aches; fatigue; very swollen underneath my armpit; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced general body pain, fatigue and local swelling. On an unknown date, the outcome of the general body pain, fatigue and local swelling were unknown.   It was unknown if the reporter considered the general body pain, fatigue and local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had 2nd Shingrix vaccine 2 days ago and experienced body aches and fatigue. At the time of reporting it was very swollen underneath armpit.  The patient asked if this was normal?
Both vaccines were given between 8:30 a.m. and 8:40 a.m. and felt nothing out of the ordinary.  At 6:00 p.m., I suddenly started feeling exhausted/fatigued, and sleepy, with body aches, back pain, and soreness at both injection sites. I took 2-220mg of ibuprofen and took a nap. At 8:30 p.m. I started experiencing a fast heartbeat, jabbing chest pains on the right & left sides of the sternum, elevated blood pressure, red skin rash on the upper back, exhaustion/fatigue, body aches, back pain, injection site soreness, and overall I felt unwell. I took a naproxen 200mg and took another nap. I have since gotten better but The first 48 hours I just slept.
Patient not sure of exact time reaction start, but believes it was around an hour or two after vaccination. She noted tingling of her lips and visible swelling. She went the ER and was given Benadryl. She is unsure of exact dosage. At the time of discussion (approximately 8 hours after vaccination) she notes some mild swelling still present.
Hyperventilation Shortness of breath Numbness Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra), trail Code MTA30 Subject #23300291 Initial report received on 20/Mar/2006 from an investigator participating in the above mentioned trail in the USA under the reference number MTA30. A 15 year old female subject developed hyperventilation the same day as she received a dose of Menactra. The lot number was not reported. The event was considered to be non-serious. No treatment or recover status information was provided. Follow-up information on 29/Mar/2006. Five minutes post-vaccination, the subject began complaining of a feeling of shortness of breath and as if her throat felt "heaving". She began to hyperventilate and experienced perioral and fingertip numbness. She remained alert with normal speech, and her lungs were clear bilaterally. The symptoms lasted approximately 30 minutes. The subject was diagnosed with hyperventilation and at the time of this report, the subject had recovered. According to the investigator the event was related to the study vaccine.
Approximately 5-6 days after 2nd vaccine I had tenderness in right arm pit, that progressed to swelling of Right breast and rib with discoloration and warm to the touch.  On 4/28/21 my Radiation Oncologist believed it was an infection and prescribed Cephalexin 750mg 3xs daily for 10 days.  No significant improvement took 10 more days of Cephalexin.  Still not resolve and on 5/11/21 saw the Surgical Oncologist's Nurse Practitioner who gave me Cefadroxil 500mg 2x daily for 14 days and Mometasone 1x daily for 10 days.  Still not resolved and Surgeon requested an ultrasound that showed no fluid but much inflammation in right breast.  Now on Clindamycin 500mg 3xs daily for 15 days beginning 6/18/21.  I believe it is Radiation Recall Phenomenon because timeline, symptoms fit the occurrence after my second Covid vaccine. Condition not resolved.
Bruising, low energy, swollen legs, hard to breath, shaking, hard to concentrate
Fully vaccinated and boosted 11/4/21.  COVID infection breakthrough, asymptomatic
patient was given vaccine on 7/13/22 which had a refrigeration expiration date of 7/2/2022.
Bump fluid filled; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. In October 2019, 3 days after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient experienced a bump on the left elbow following a dose of Shingrix. The bump was described as fluid filled. The health care professional reported that the bump developed approximately 72 hours after the dose of Shingrix was administered. The bump has not worsened or improved since it developed. The reporter consented to follow up.
Hives, swelling of the face and throat, difficulty breathing, dizziness and itching, fatigue, headaches, hoarseness, and weakness.
No Treatment / no adverse event / vaccine was administrated outside Monera's storage and handing recommendation  as outlined in the fact sheet for health care providers
Patient had requested and been signed up to receive Pfizer COVID vaccine dose 1. Patient was mistakenly administered Shingrix. Patient had already had the two recommended doses of Shingrix.
about 6 hrs p/vax pt devel SOB & wheeze; pt was not eval until the next day;
Within an hour, but after leaving facility, my throat felt like it had a tumor-like swelling that could be felt when swallowing.  It did not cause prophylaxis. Took Benadryl and it subsided later in day.
Injection site reaction the size of a quarter that progressed to the size of a softball with skin raised approximately 4 cm, tenderness, swelling, redness, and tingling to the fingers. Patient was treated with clindamycin and tylenol # 3, redness and swelling has significantly decreased. Tingling sensation in the arm is still present along with decreased range of movement.
Large red area at site of injection, warm to the touch.  Got bigger and redder in the 3 days after injection
Within one hour of vaccination began having headache that lasted several days.  Within 2 hours of vaccination began having painful bruising of arm where received injection from elbow to shoulder and red-raised rash covering area.  Rash, bruising and pain lasted approximately one week.  Did not see a physician for this, however was diagnosed with strep on 11/23/09.
Moderately severe headache lasting all day. Primarily behind right eye. Bad enough to go home from work. Headache resolved on the third day. Soreness on sides of neck and adams apple. The soreness is persisting on the third day.
Since the 2nd dose of my COVID-19 vaccine, I have been reacting significantly more to mosquito bites.  The site of the bite swells large and becomes red. It causes pain at the site of the bite and in the nerves located in the portion of my body I received the bite.
Skin sensitivity, irritation, itchiness.   Light scratches or rubbing from clothes causes red blotches, sometimes raised. Fades away after several hours. Happens all over. After consulting my doctor I've switched from Claritan to Zyrtec. So far it hasn't seemed to improve my symptoms. I have taken Zyrtec for 3 days so far.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 33 year old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; SULFASALAZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Reporting because Moderna shot was given 2 days early at 22 days verus 24 days per CDC guidelines. Patient got first Moderna shot on 5/15/21, previous pharmacist wrote on patient vaccination card 6/6/21, instead of 6/8/21.  Patient did not experience any side effects on 6/6/21 when Moderna shot was given.  We reached out to patient on 6/8/21 but phone went to voice message.
rhabdomyolysis; The hospital now suspects that Legionella (test was positive 3/10; severe myalgia / began to complain of muscle pain; began to complain of weakness; bed bound / was unable to get out of the bed without assistance; CK levels were >30,000 / CK levels were >30K for 3 days, they are now down to 20K.; This case was reported by a pharmacist and described the occurrence of rhabdomyolysis in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX-23) for prophylaxis.   The patient's past medical history included liver transplant.   On 29th February 2020, the patient received Shingrix and PNEUMOVAX-23. On 3rd March 2020, 3 days after receiving Shingrix, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), legionella infection (serious criteria hospitalization and GSK medically significant), myalgia (serious criteria hospitalization), weakness (serious criteria hospitalization) and bedridden (serious criteria hospitalization). On 6th March 2020, the patient experienced creatine kinase increased (serious criteria hospitalization). On an unknown date, the outcome of the rhabdomyolysis, legionella infection, myalgia, weakness and bedridden were unknown and the outcome of the creatine kinase increased was recovered/resolved.   It was unknown if the reporter considered the rhabdomyolysis, legionella infection, myalgia, weakness, bedridden and creatine kinase increased to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine Shingrix and pneumovax-23  at a pharmacy then experienced severe muscle pain ,weakness and unable to get out of the bed without assistance. The patient was transported via ambulance to the hospital on March 2020 and CK levels were greater than 30,000 for the last 3 days, they are now down to 20K. The hospital now suspects that Legionella test was positive was the cause of the rhabdomyolysis. The reporter medically treating him, by attending wanted to see if there were any other case reports of rhabdomyolysis with the vaccine
light headed; soreness to site of injection; felt a random itch run along from my hand to up along my arm; some warmth to the site; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer), intramuscularly on 23Dec2020 07:30AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included depression from an unknown date. No allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. Concomitant medication included fluoxetine. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. At the day of 23Dec2020 at 7:30 am the time of injection patient felt okay. She was let go to go back straight in to work. Once at work she felt light headed for 30 minutes with soreness to site of injection. Patient also felt a random itch run along from her hand to up along her arm. She applied lotion to the site if irritation for some comfort. The next 2 days patient still felt soreness and some warmth to the site. It's unknown if patient received treatment for the other adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The date report was first received from source was 27Dec2020. The events were reported as non-serious.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Right elbow swole vup to two to three times its normal size. Both feet swole up and was so sensitive I could not touch the floor or stand. Was hospitalized for a total of eleven days.
Patient's mother brought him back into clinic with C/O swelling to right arm after injection. Proquad vaccine administered to right arm on 4/8/15.
This spontaneous report has been received from a registered nurse refers to an unspecified patient of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9 (route of administration, dose and frequency were not provided)  lot # M017983, and expiration date 30-MAY-2018 for prophylaxis. The reporter stated that the temperature range of the vaccine was 32F and 36F and the time frame was 24 hours, also she stated that there was not previous temperature excursion, this information was administered in a data logger. No adverse effect was reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014621:US-009507513-1701USA000712:
Patient received her 2nd dose of Pfizer. She was counseled to sit and stay for 15 minutes. She was sitting and then suddenly she fainted. When this happened, her glasses cut her skin open on her forehead along her left eyebrow. Her blood pressure was 100/61. We called 911 and then came and took her to the hospital.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 14-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 lot number K003074 with expiration date of 13-MAR-2015 (route of administration and anatomical location were unknown. The sum of hours of the vaccine excursion was 376 hours and the lowest recorded temperature reported was 33 degrees F (0.555555556 Celsius degrees). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
Went limp while drinking bottle, eyes rolled back, rushed to hospital. Seizure began in hospital 5 minutes (est.) 100 degree temperature in hospital. Right side flaccid, paralysis about 24 hours. Red dots appeared on thorax.
This spontaneous report was received from a register nurse concerning a 56 year old female patient with not pertinent medical history or drug/reactions allergies who on 20-AUG-2012 was vaccinated with a dose of ZOSTAVAX, subcutaneous in her right arm (lot number reported as 0564AE, expiration date 21-MAR-2013) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, intramuscular in her left arm. No other co-suspects were reported. The nurse stated that on 21-AUG-2012, the patient developed a 2 inch red area and lump around the injection site where the ZOSTAVAX was administered. The patient was given warm or cold compresses. At the time of the report, the patient was recovering form the events. Additional information has been requested.