chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 55 year old female with penicillin allergy and unspecified allergies who on 10-Jan-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5 ml) (lot #651330/1048P), intramuscularly. Concomitant therapy included allergy shots and cholesterol medicine. On 10-Jan-2006 the patient's arm had a red swollen (size of an orange) reaction with a dark center in it. The area was located around the injection site. Also, the patient's symptoms included fever, nausea, headache and chills. On 12-Jan-2006 the patient was seen by a physician. The patient was given hydroxyzine hydrochloride (Atarax), dexamethasone (Decadron) and warm compresses. The patient's physician requested a lot check on this vaccination to rule out any contamination of the vaccination. The reporter considered the patient's experience to be an other important medical event (OMIC). Additional information has been requested.
5 days after vaccination with the first vaccine (she previously had COVID in December 2020) pt lost sight out of both eyes in the morning at school (4/12/2021). It started by her seeing spots, then both eyes went black. After about 5 minutes the left eye came back, blurry at first but returned to normal. She was seen at her local eye doctor 4/12, who referred her to retina specialist. 4/13 she was seen by the specialist who examined her and performed an angiogram.    He stated that her angiogram was normal, and that she had recovered her sign in her left eye, but has significant deficit in her right. SHe was admitted to the hospital on 4/13 for futher work up to ensure she had not had a stroke
I came down with symptoms when I woke up. I had the classic symptoms with coughing, fever, sore throat, and body aches. I took a home test and it was positive. I went to the urgent care and I was given Paxlovid. They wanted to give me Remdesivir as an injection, but it was noted I needed to stop taking Atorvastatin for a week, so we went with the Paxlovid. The Paxlovid had taken care of all the symptoms besides dizziness, headaches, and some heart arrhythmias. Yesterday evening was day 9 or 10. I just had a complete relapse. I had the worst sinus infection with burning sensations. It's just horrible. A lot of discharge and the cough is pretty bad. That's been my experience with COVID-19 so far.
On 3/6/2021 the patient presented to the ED with dyspnea and substernal chest pain that pretty much resolved as soon as she came in. She was admitted to rule out any cardiovascular events (none were apparent). Reason for admission: chest pain.
ARM TURNED REAL RED LIKE A BIG HIVE 6 INCHES LONG AND 2 TO 3 INCHES WIDE IT ITCHES, BURNS, FEELS HOT TO TOUCH AND PAIN, THIS HAS HAPPENED FOR THE LAST THREE YEARS AND SEEMS TO BE GETTING WORSE.
This spontaneous report as received from a Nurse Practitioner via company representative and refers to a 65 year old female patient. The patient's concurrent conditions include asthma and no information was provided regarding the patient's medical history or concomitant medications. On 15-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis and with influenza virus vaccine (lot number U1840AC, expiration date was not reported). On approximately, 15-SEP-2017, reported as "within 24 hours of administration of both vaccines", the patient developed redness over her entire body (generalised erythema), felt anxious, couldn't sleep and had a fever and itchiness, therefore, the patient was placed under therapy treatment with BENADRYL and prednisone (manufacturer unknown) on an unspecified date. On an unknown date, the patient was referred to the hospital due to the reaction and underlying asthma. On 24-SEP-2017, the patient assisted to the hospital but was not admitted. On 25-SEP-2017, the patient visited the physician's clinic, it was stated that the patient still had some erythema, so she was referred to a dermatologist, which the patient visited on an unknown date. On an unspecified date in March 2018, reported as "last week ", the patient visited the physician's clinic and she had fully recovered from the aforementioned events on an unknown date. The reporter did not provided the causality assessment between the events and therapy with PNEUMOVAX 23.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:29 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 63.62. No concomitant medication was reported. Batch number 030B21A underwent temperature excursion on 03-APR-2021 with temperature 34 degrees Fahrenheit at 9:00 AM . This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-APR-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
This case involves patient (unknown gender and age) who had flu (influenza), after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (Suspension for injection, lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) [unknown latency] following the administration of INFLUENZA VACCINE. It was reported "Got mine and 4 weeks later I'm on my 5th day of the flu, Horrible" It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information available on the batch number for this case.
Neck pain; Vaginal pain; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 07:30 (Lot number: ew0170) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: None. The following information was reported: NECK PAIN (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Neck pain"; VULVOVAGINAL PAIN (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Vaginal pain"; CHEST PAIN (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Chest pain". Therapeutic measures were not taken as a result of neck pain, vulvovaginal pain, chest pain.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine and other medications in two weeks. Since the vaccination, the patient had not been tested for COVID-19.
after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 12-month-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 25th July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Havrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter
testing positive for covid after getting 4 shots of Moderna vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (testing positive for covid after getting 4 shots of Moderna vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (testing positive for covid after getting 4 shots of Moderna vaccine.). At the time of the report, COVID-19 (testing positive for covid after getting 4 shots of Moderna vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient was not a clinical trial participant.  Treatment information was not provided by the reporter.  Company Comment: This spontaneous case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the fourth an unspecified dose of mRNA-1273 Vaccine. As reported, the patient tested positive for COVID-19 after getting 4 doses of the Moderna Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the fourth an unspecified dose of mRNA-1273 Vaccine. As reported, the patient tested positive for COVID-19 after getting 4 doses of the Moderna Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
felt achy; fever 100F; This case was reported by a consumer and described the occurrence of fever in a 59-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 2nd October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 2nd October 2020, 6 hrs after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced fever. In October 2020, the patient experienced general body pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the fever and general body pain to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows:  The case reported by patient himself. The developed a fever 100 degree F about 6 hours later which lasted overnight and into the next day. Less than a week, the patient felt achy.  Fever subsided 24 hours after injection. The patient saw only a small percentage of those in the trials had fever (less than 5 percentage). The patient would like to know the differences between the Fluvarix Quadrivalent vaccine administered to 2020- 2021 and the Fluvarix Quadrivalent vaccine that finished clinical trials around the 2017-2018 timeframe.
Received 1st Hepatitis B on 6/25/08. Developed right knee pain with swelling, so tender unable to walk. Developed symptom within 1st 24 hours of vaccine, no fever or other symptoms. Lasted 2 days. Did not seek treatment.
Pins-and-needles sensation on arms and back, with hypersensitivity of skin such that even contact with bedsheets was painful. Seemed to come on suddenly. Subsided within about 2 hours.
Spasms of the hands/face to resemble seizures every 3-5 minutes for over 24 hours.
Swelling, redness, slightly raised, size of a quarter, round, itchy like a rash, distal to injection site about 1.5 inches
The patient received the Moderna vaccine instead of the Pfizer that is approved for pediatric use.  No side effects or symptoms noted per patient's mom.
tested positive for COVID19 on 05Sep2021 or 06Sep2021; tested positive for COVID19 on 05Sep 2021 or 06Sep2021; This is a spontaneous report from a program from a contactable consumer (patient). A 39-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 (Lot number was not reported) as single dose (at age of 39-year-old), and first dose was administered via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose, both for covid-19 immunisation. Medical history included ongoing obesity. Concomitant medications were not reported. In Sep2021 (reported as on 05Sep2021 or 06Sep2021) the patient was tested positive for covid19. The patient underwent laboratory tests and procedures which included sars-cov-2 test positive in Sep2021 (reported as on 05Sep2021 or 06Sep2021). It was reported that patient already received both doses of the Pfizer BioNTech COVID19 vaccine and the second dose was around late Mar2021. Patient tested positive for COVID19 on 05Sep2021 or 06Sep2021 and has fully recovered. It was reported that six months before the time of the report, patient had his second dose of the Pfizer Covid Vaccine. It has been 3 weeks since he got the Covid Virus. Reporter stated she was wanting to know when patient could take the booster vaccine. Patient tested positive around the 05Sep2021 or 06Sep2021 and he has fully recovered. No treatment was received for the event. Patient recovered on unknown date.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Female caucasian client 64 years old in a wheelchair came with husband at 2:00 PM to get her 1st dose of the Covid 19 Vaccine. Husband reported patient passed out before when they were drawing her blood out years ago. LVN called on site MD to the table to consult with patient and husband on the best way on how to prevent client for passing out. MD advice client to drink fluids first and position patient head leaning down to prevent from passing out. At 2:14 PM Covid 19 Vaccine EW0158 administered to patient left arm Intramuscularly by LVN. Client reported she was having chest pain at around 2:24 PM. Immediately 911 was called and on site EMT's. Patient vitals signs are stable
This patient had a syncopal episode appoximately 15 to 30 seconds after she received her second Gardasil in the office today. She had  no adverse events with her first Gardasil immunization. The patient was sitting on the exam table at the time of vaccine administration and when she had the syncopal event. She feel forward off the exam table and struck the right frontal part of her head sustaining a hematoma in the area. After the patient regain conscienceness, she had a headache and nausea. No emesis has occurred since the injury.   The patient was re-examined and monitored. She was administered acetominophen and Pedialyte. Mother reported that she had not eaten breakfast prior to her office visit. It took greater than hour for the patient to feel strong enough to ambulate from the office. Follow up this afternoon revealed that patient continues to have a headache and neck pain. Will continue to montior mental status and concussion symptoms.
Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to touch, dry; Skin Lesion on right back of calf Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to touch, dry; Skin Lesion on right back of calf Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to touch, dry; Skin Lesion on right back of calf Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to touch, dry; Skin Lesion on right back of calf Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to touch, dry; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on 18Jan2021 11:00 at SINGLE DOSE at left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included allergies to Penicillin. The patient had no other medical history. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced skin lesion on right back of calf from 19Jan2021. It was about 3/4 in size, flaky, dark red and purple, tender to touch, dry and after several days of careful care and cleaning it had not gotten better or gone away. Outcome of the events was not recovered. No treatment received for the adverse event.
Vaginal bleeding (like period) but after menopause. I haven?t had a period since 2018 and yesterday I basically got my period again.  Lots of backache and ovary pain.
Developed an environmental illness (mast cell activation syndrome) from mold exposure; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient, self-reporting). A 30-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Jul2021 as single dose for COVID-19 immunization. No medical history and no concomitant medications were not reported. It was reported that she got the first dose a few weeks ago. She has now developed an environmental illness caused by molds which has resulted in her developing a symptom called mast cell syndrome. The patient explains she was at a fragile state and finds she was reacting to benign medication and supplements. She goes on to explain she had delayed reaction to the first dose that started a week later, for 2 weeks was very fatigued. The patient wants to know if have any information on people with environmental illness getting the shot and if it is recommended that she take the second shot. The outcome for the events was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (05Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.