chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to 7 unspecified patients. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with a dose of M-M-R II 0.5ml, subcutaneous injection (lot number and expiration date not reported) that were improperly stored, exposed to seven temperature excursions over two months for a maximum of 55 F for a total of 48 hours. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
diagnosed with Cancer after receiving the first dose; received the first dose of Shingrix about 2 years ago / now received the second dose on 10 Oct2020; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number KY5T4, expiry date 27th May 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In 2018, the patient received the 1st dose of Shingrix. On 10th October 2020, the patient received the 2nd dose of Shingrix. On 10th October 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were as follows: The reported batch number KY5P4 for Shingrix did not exist and was updated to KY5T4 as per the sales database. After receiving 1st dose of Shingrix, the patient experienced cancer. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not know the exact date. The reporter did not know which type of cancer patient had. The reporter consent to follow up. The case was considered as medication error with harm.
Heaviness feeling, Tiredness, weakness, dizziness, lack of appetite, chills,  fever 103 F
Information has been received from a registered nurse concerning a female patient of unknown age. The patient's concomitant therapy, concurrent condition, historical condition and drug reaction were not provided. On 29-JUL-2016, when she was 14 years old, the patient was vaccinated CERVARIX (strength, dose, route, lot# and expiration date were unknown) for human papillomavirus (HPV) vaccination. On 23-FEB-2017, the patient was vaccinated with GARDASIL 9 (strength, dose, route, lot# and expiration date were unknown) to complete the HPV vaccination series (interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
My adverse event started 6 months after my 5th dose on 12/01/2022. I had over whelming fatigue, shortness of breath, and cough. I tested once every week for COVID-19 infection but it was negative. My doctor doesn't even know what the cause is. He combined it with allergies and shortness of breath, was related to an abnormal pulmonary function test. Throughout 1 year I had 4 atrial fib which occurred on June 2021, October 2021, March 2022, and November 2022. I went to my doctor in December about shortness of breath and cough. He recommended to take SYMBICORT along with my other medication. If I try to do too much work I get shortness of breath easily. I get fatigue every day and I also have cough still now.
started getting a rash on both lower legs and went up to my stomach and part of my left arm (Red spots)
Tues - Administered vaccine Wed - Soreness turning into acute muscle pain around injection site and spreading through back and torso. Thur - breathing difficulty, rash appeared, severe pain throughout body, extreme skin sensitivity, elevated heart rate, nausea, dizziness.  Medical Records and Discharge Summary received 10/12/09.  Date of Admission:9/16/09-9/29/09.  Primary Diagnoses:  Anaphylactic shock secondary to flu shot.  Acute respiratory failure secondary to shock on admission.  Hypokalemia.  Hypomagnesemia.  Acute renal failure. Dehydration.  Malnutrition. Anemia. Assessment:  Patient was admitted to ED 30 minutes after receiving a flu shot c/o abdominal and back pain 9/10, and nausea.  In the ED she was found to be hypotensive and required triple pressors.  BP 84/48, systolics in the 60's, 70's, 80's. Her temperature was 92.7.  Patient was somewhat somnolent, but responsive to verbal commands.  Admitted to the ICU for stabilization.  Patient was transfused 2 units of packed red blood cells.  The patient went into respiratory failure requiring ventilator support secondary to shock. While on the ventilator, the patient was sedated. Pt. noted to be weak and hypocalcemic, she was given 1 gram of calcium IV, hypomagnesemia also present as well as thrombocytopenia.  She had severe metabolic lactic acidosis and profound acidemia and was on a bicarb drip being hyperventilated.  As BP normalized, she was weaned off two pressors.  Urinary output was decreased, but improved.  A central venous line was placed. Noted to have moderate cardiomegaly.  Pulmonary critical care, cardiology and nephrology consults were obtained.  In the ICU patient received supportive care including vent support, pressors and electrolytes as well as IV antibiotics.  As her condition stabilized, the patient was extubated, was doing much better and became stable.  Patient was discharged to a skilled nursing facility for further care.
patient reports constant left arm pain at site of injection that developed within a week of injection, >1 month now.  patient request to report/unclear clinically if attributable and normal exam.
stomach stuff after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach stuff after 1st dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, HCTZ and METOPROLOL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach stuff after 1st dose). At the time of the report, ABDOMINAL DISCOMFORT (stomach stuff after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Tylenol after booster dose.   This case was linked to MOD-2021-402868, MOD-2021-402869 (Patient Link).
shortness of breath; Chest pain; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female (not pregnant) patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 06May2021 at 11:00 (Lot Number: Ew0153) at 16-year-old as single dose for COVID-19 immunization. Medical history was not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 via an unspecified route of administration on the left arm on 15Apr2021 at 11:00 (Lot Number: Er8731) at 16-year-old as single dose for COVID-19 immunization. On 09May2021 at 06:00, the patient experienced chest pain, increased heart rate, shortness of breath. The events result in emergency room visit. The test and medication were received as treatment. The outcome of events was recovered in 2021.  No follow-up attempts are possible; no further information is expected.
Patient who received vaccination was 16 years old.  Interviewed dad. reports that patient had a mildly sore arm for a day and denies any other side effects, issues, or concerns.
My upper arm hurts even 5 weeks after my flu shot. I can't lift my arm without it hurting real bad and the pain keeps me awake at night. I can't put shirts on or off over my head without intense pain.
This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Cellulitis at injection site. Went to ED to get checked out. Also had severe vertigo.
did not seroconvert; did not seroconvert/ blod work checked about a month ago, which showed no antibodies to measles; blod work checked about a month ago, which showed no antibodies to measles; This spontaneous report was received from a physician who was reporting on his wife, currently 43-year-old female patient. The patient's current conditions included colitis ulcerative and in vitro fertilisation (IVF) treatment. The patient had no concomitant therapies, drug reactions or allergies. On an unknown dates (reported as years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (exact doses, frequency, routes of administration, injection sites, lot # and expiration dates were not reported) several times due to being a healthcare provider and also due to receiving IVF treatment. The reporter stated that the patient did not seroconvert after measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and in approximately June 2019 (reported as about a month ago), the patient had her blood work checked, which showed no antibodies to measles. There were no treatments given for the events. The outcome of events was unknown. The relatedness between events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
mom stated pt had start of rash on lt leg but was not on leg which vax given; pt afebrile; vax given in morning mom called around noon;
This spontaneous report was received from a consumer refers to herself of an unknown age. The patient's medical history and concomitant medication were not reported. On an unspecified date the patient received her first dose of GARDASIL (dose, frequency, route and lot# were unknown) for prophylaxis and then on another unspecified date she received GARDASIL 9 (dose, frequency, route and lot# were unknown) for prophylaxis which was other than indicated in the prescribing information. No adverse events was reported at the time of the class.
presents to the hospital with generalized weakness, shortness of breath and a fall. COVID-19 infection -lactic acid normal on admission -Not hypoxemic but is complaining of shortness of breath on admission.  -CXR on admission 8/2 Bilateral airspace/interstitial opacity, concerning for pneumonitis,-Received Decadron and DuoNeb breathing treatments.  Shortness of breath improved
Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck; Muscle pain; muscles in my neck are all tied up between my shoulder blades, my shoulders all was shrugging and I could never release the muscles back that is what I felt like.; Could never release the muscles back that is what I felt like/My muscles never acted this way; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Nurse reported that she had severe side effects but not an allergic reaction. She had the vaccine on Thursday (31Dec2020) and by Sunday (02Jan2021), she had a horrible headache, all the muscles in her shoulders and back were tightened up. And all the week long, she kept trying to keep care with hot packs and cold packs and Advil and Maxalt and all kind of things but could not. Yesterday morning (as reported), she lifted nothing heavy, did nothing different at all and she could not pick her head up. Patient had to seek for medical attention just at her doctor's office not at the hospital. She had to have somebody and take care of muscle pain. She still have the muscle pain she do have to go back but they did give a muscle relaxant. Patient reported that she never had a reaction ever like this. Nurse further stated that she didn't do anything as a precursor before the vaccine or after the vaccine. The muscles in her neck were all tied up between her shoulder blades, and her shoulders all was shrugging and could never release the muscles back that was what she felt like. Nurse stated that she just have to take the second shot, that was just the first one. Somebody told her that she have to report it because it took her off the work for two days. And her muscles were still tight and at all the way to my neck and still have headache. She had a shot on 31Dec2020, and symptoms started on the 2nd. Patient reported that she never had such kind of pain before and her muscles never acted this way. She was advised by her healthcare provider that there were side effects and this one she consider severe. She was advised to continue to take the second one. Outcome of the events headache/could not pick my head up and all the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck were not recovered; outcome of the rest of events was unknown.  Information on the Lot/Batch number has been requested.
involuntary upward  gaze starling evening of shots persisted until next AM & was gone when child woke up;
Received varicella vaccine at 2:30 p.m. Denied problems with previous vaccine-went to E.R. at 3:40 p.m. C/O itching and swelling of throat-treated with epinephrine and DECADRON and discharged at 8:30 p.m.
As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021.    This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 013L20A and 039k20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No Treatment information was reported.  Patient reported that her spike protein from the covid 19 moderna vaccine was 2,500 and was not going down from july and this was also the result of having moderna booster on 13 Aug 2021.   This case was linked to MOD-2021-010198, MOD-2021-064882.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up Document received and includes no new information.
Diluent not used when drawing up this patient's COVID vaccine. Administered without first mixing with diluent.
Nearly  continuous headache behind the eyes since the evening of vaccine shot (11 days as of current date). Sometimes dull throb, sometimes sharp pain usually on left side (same side as vaccine shot). Sensitivity to light. When pain is sharper causes indigestion and nausea. Pain goes away if I take  ibuprofen, but always returns and persists overnight. I don't like taking ibuprofen or acetaminophen more than once a day or for continuous days. Acupuncture worked for a short time. Affects my ability to concentrate and work on computer or watch TV. What other natural treatment will help? How much longer will this last?
Information has been received from a registered nurse concerning a 9 year old male who on 23 APR 1997 was vaccinated with varicella virus vaccine live (lot #621071/1552D) subcutaneously in the left arm. On 21 JUN 2001, the patient presented with a vesicular rash with distribution all over her body. No other symptoms were noted. The registered nurse also reported on another patient who had an experience following vaccination with varicella virus vaccine live (WAES#01062327). In follow up the registered nurse reported that the patient presented on 21 JUN 2001 with a rash for 4 days, erythematous, papulopustular vesicular exanthem in groin area, trunk, back, back of legs, 1/2 cm in size, numerous lesions, pruritic, afebrile. In followup, the registered nurse reported that the patient recovered 26 JUN 2001. No further information is available.
COVID-19; rash/ rash on his back/ felt bumpy like he scraped or fell; not bleed but felt itchy; This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received Shingrix. On 13th March 2020, 70 days after receiving Shingrix, the patient experienced coronavirus infection (serious criteria GSK medically significant). In March 2020, the patient experienced papular rash and itchy rash. On an unknown date, the outcome of the coronavirus infection, papular rash and itchy rash were unknown.   It was unknown if the reporter considered the coronavirus infection, papular rash and itchy rash to be related to Shingrix.  Additional information was provided as follows: On 13th March 2020, the patient contracted COVID-19. Between 2 and 3 months, after receiveng vaccine, the patient developed a rash at the base of his spine that was 1 inch long half inch wide. It did not bleed but felt itchy. Between 3 and 4 months, the patient developed another rash half way up on his back near the spine. It was not itching but felt bumpy like he scraped or fell. Two weeks later, he developed another rash on the backside of his arm near his elbow and wrist. The reporter consented to follow up.
Client which is employee was given pediatric dose of Hep B and so an additional dose was needed to administer the complete dose.
Pt recvd 1st hep B vax 28JAN91 & later devel herpes simplex viral infection on nose.Tx w/ Zovirax ointment.
"If a patient has had the bivalent vaccine back in Oct2022 (so it's been 6 months after the latest dose) and they get the virus - when can they get a second dose of the bivalent vaccine?; "If a patient has had the bivalent vaccine back in Oct2022 (so it's been 6 months after the latest dose) and they get the virus - when can they get a second dose of the bivalent vaccine?; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as ""If a patient has had the bivalent vaccine back in Oct2022 (so it's been 6 months after the latest dose) and they get the virus - when can they get a second dose of the bivalent vaccine?". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: Caller was a provider and asking on behalf of a patient and inquiring  if a patient got the Pfizer covid-19 vaccine bivalent and they acquired covid-19 virus now what is the recommendation regards to it. and added how many months before they use Paxlovid. Les's say that a patient tests positive (PCR), vaccinated, and takes Paxlovid within 5 days. This has happened to many patients.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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-202300176620 same patient, different product/events;
SHORT OF BREATH,, SINUS PRESSURE, NASAL CONGESTION, DEVELOPED A PULMONARY EMBOLISM
Headache, Myalgia, Rash, chills, chest pain, rigors, fatigue Narrative:  Other Relevant History: