chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very High Alt, and AST levels; Very High Alt, and AST levels; August 18, dx with Graves Disease; fatigue; weakness; rapid heart rate; breathlessness; May began losing weight; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration at left arm on 03Mar2021 09:00 (at the age of 75-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration at left arm on 11Feb2021 09:00 (at the age of 75-year-old) as dose 1, single for COVID-19 immunisation. Medical history included High cholesterol, high blood pressure, gastric reflux and concomitant medication included lisinopril, atorvastatin, calcium, vitamin D and vitamin B. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did have COVID prior to vaccination and it was no COVID tested post vaccination. It was reported that Jan2021 had physical exam with blood work -all tests were within normal range. In May began losing weight, June2021 began experiencing fatigue, weakness, rapid heart rate, and breathlessness. 18Aug2021, dx with Graves Disease and Very High Alt, and AST levels. The patient underwent lab tests and procedures which included alanine aminotransferase increased: very high on 18Aug2021, aspartate aminotransferase increased: very high on 18Aug2021, blood test: normal on Jan2021, heart rate: rapid on Jun2021, physical examination: normal on Jan2021. The events were considered as serious disability or permanent damage. Patient visits physician office for the events and treatment received for the events. Outcome of events was not recovered.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 28-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered a bad case of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Shingles was considered to be disabling.
Chills and headache lasted for a day. Dizziness and fainting constantly, only happens when standing for a long period of time or bending. Referred to a cardiologist.
Pt. presented with small scattered papules on back & trunk, arms, & face. Diagnosis- Chickenpox.
I have got arthritis and I took the shot Friday at 10:00 clock and around Sunday at 03:00 in the morning, it got so bad; Headache; I am in too much pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Mar2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "I am in too much pain"; CONDITION AGGRAVATED (non-serious) with onset 21Mar2021 03:00, outcome "unknown", described as "I have got arthritis and I took the shot Friday at 10:00 clock and around Sunday at 03:00 in the morning, it got so bad".  Additional information: Consumer stated, "I just have one little question. All I want to ask was can I take Aleve for my headache? I have got arthritis and I took the shot Friday at 10:00 clock and around Sunday at 03:00 in the morning, it got so bad. I haven't taken some Aleve in case I am not supposed to." When clarified if consumer got the Pfizer Covid Vaccine, consumer stated, "I already got it like I said. I took the first shot on Friday 10:00 o' clock, I have to go back for the second shot and now I am experiencing pain with it. So, I wanted to take Aleve, if it is okay." Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number, Consumer further stated, "Let me call then because I am in too much pain and I have to take it." In response to further probing, consumer stated, "My phone is going to go off, so I will call this number first and find out what is going on."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per parent, patient acting appropriately yesterday afternoon and last night - playful. Parent woke up around 4:15 am and child not breathing.
Left arm presented with what appears to be a broken blood vessels in squiggly line rash appearance.  The area is mildly sore if she presses or lays on it.  She believes that this is due to the vaccine itself. She also reported burning, which she may feel is just her imagination.  Lastly, she reported weakness which she is unsure if it's due to her repetitive arm injury or the vaccine.   Patient reported chills, fever, body aches, and extreme fatigue for 3 days which gradually improved and were gone by the 4th day.
Divot at site of injection on right thigh measuring 2 1/2 cm x 1 1/2 cm. Complete loss of subcutaneous fat.
between the hr of 12Pm-4PM pt lost all feeling & movement in lower body, legs, & feet;pt taken to ER & they did an MRI & spinal tap tx w/steroids to reduce swelling in spine;
Headache, muscle ache (not just at the injection site, shoulders, neck, and knees hurt), stomach is lightly upset, and fatigue.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy was not provided. On 05-JAN-2017, the patient was vaccinated ROTATEQ oral liquid (orally, lot # M016919, expiration date 17-FEB-2018) for prophylaxis (strength and dose was unknown). During administration, the patient spit some of the vaccine into the medical assistant's eye. The nurse reported that the patient received a less than recommended dose of ROTATEQ due to the incident. The nurse could not verify  if the patient still received a full dose. No adverse effects were reported. This is one of two reports from the same source. MARRS: 1701USA003097 Additional information has been requested.; Sender's Comments: US-009507513-1701USA003097:
Patient received flu vaccine on 11/15/12. Few hours later developed mid back pain requiring trip to Emergency Room where she was admitted to the hospital, cardiac work up (-). Pain resolved the following day.
pt recv vax; approx 5 mins later,fell off chair;pale,lips cyanotic, legs rigid, arms & head w/ shaking movement x 15 sec;unconscious for 2 1/2 mins;regain consciousness,does not remember incident; mom took pt to er;
itching ten minutes after administration, itching, redness 2" induration 24 hours post vaccine
J&J Dose 5/10/21 (lot NA) COVID Positive 1/6/22 (pt reported) COVID Positive 1/20/22  1/20/22: Patient is a 76-year-old male with significant past medical history of diabetes mellitus type 2 - on insulin, coronary artery disease, systolic CHF - pacemaker ICD, paroxysmal atrial fibrillation - on Eliquis, non-Hodgkin's lymphoma, CKD 3B and obstructive sleep apnea. Patient is a nonsmoker nonalcoholic.  Lives with his wife. Able to ambulate without any assistive device .  Able to do all ADLs. Part-time he live in another area.  Recently patient started experiencing exertional shortness of breath, sore throat, dry cough, nasal congestion and stuffiness - upper respiratory like symptoms.  Appetite greatly reduced. Denies nausea vomiting chest pain fever or chills. On January 6th - he was diagnosed with COVID.  He was supposed to get antibody infusion. Patient decided to come here.  His wife drove.   In the emergency room evaluation - at rest, on room air he is saturating 90%.  With minimal activity, desaturating to 85%.  He had no home oxygen dependency.  Baseline creatinine 1.6 worsened to 2.37.  Chest x-ray shows bilateral infiltrates.  Fever 100.7. Influenza a and B negative.  D-dimer normal. With suspicion of superimposed bacterial pneumonia, in ER he  received Rocephin and azithromycin.   I examined patient in emergency room.  Patient is slightly anxious. Answering questions appropriately.  Patient denies having any chest pain, fever or diarrhea.  Said last 3 nights he experiences significant night sweats. Complains of generalized weakness. Discussed with patient about treatment options. Per hospital policy with GFR less than 30, remdesivir is not an option. Will hold diuretic and gently hydrate.  Recheck renal panel in a.m.  If GFR improve, can start on remdesivir.  Ordering Actemra. Patient had history of systolic congestive heart failure.  1/25/22: 76-year-old male with a history of T2 dm on insulin, CAD, systolic CHF, status post AICD placement, PAF on Eliquis, NHL, CKD 3B, morbid obesity and OSA.   He was admitted for acute hypoxia secondary to COVID-19 infection. He was initially diagnosed with COVID-19 on 01/06/2022.  He has been improving with gradual improvement in oxygenation. At this morning he is down to room air with O2 saturation of 94-95%.  He had an oxygen walk for home determination and requires no supplemental oxygen.  Two sets of blood cultures done on admission were positive for coagulase negative Staph but repeat blood culture x2 came back negative indicating the initial positive was a contaminant. He will be discharged on his pre-admission medications.  He will enroll in COVID safe at home program in the meantime.
No additional adverse events; Inbound call from nurse calling to report AE for MMR-II that was inadvertently given a second time within two weeks.  Nurse states that they misread the chart and administered a second dose of MMR-II two weeks after patient already received a dose on; This spontaneous report was received from a registered nurse concerning to a 6-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and previous drugs reactions or allergies were not provided.     On 19-OCT-2023, the patient was inadvertenly vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA) (M-M-R II) at a dose of 0.5 milliliter, lot # W025567 with an expiration date of 14-AUG-2024, for prophylaxis (strength, route of administration were not provided). The nurse stated that she misread the chart and administered a second dose of the vaccine two weeks after the patient already received the first dose (05-OCT-2023) (extra dose administered). No adverse event was reported.
01/11/2022- sore throat. 01/12/2022 - severe sore throat. 01/13/2022- fever, coughing, body aches, dizziness, again severe sore throat. I went to an Urgent Care- COVID-19 test- positive. They prescribed Paxlovid. 2 PCR test a day or 2 later and that came back positive also.  I had to go back and continue to be tested so I could continue to get the Ocrevus medication. I had to test negative in order to take the Ocrevus. 01/25- rapid test and that still came back as positive.  The vaccine is going to be less effective for a person who are taking Ocrevus. So I believe based on the fact that I am on this ocrevus medication is probably why I ended up with COVID-19 because I don't have the response to this vaccine. All 3 of my antibody test checked came back with no antibodies. After Pfizer dose 1- 0 antibodies, Pfizer dose 2- 0 antibodies, Pfizer dose 3- 0 antibodies. So to judge the vaccine this will be an unfair evaluation. It is the medication I am on that causes me to have  no immune response to the vaccine. In fairness to Pfizer and the vaccine I don't think we are evaluating it fairly.  The vaccine effectiveness prevents my immune system response from the Ocrevus medication I am taking. The Ocrevus is not allowing my immune system to respond to the vaccine. The vaccine is not the problem . The Ocrevus reduces the effectiveness of the vaccine to prevent the immune system in response to the vaccine. I have not recovered from the adverse event because I am still having fatigue, cognitive, and cough. I was told to get the EVU sheld to put the antibodies back into me. I have not tested to see the antibodies are in me, after a few weeks they are going to test me to see what the antibodies are at that point.
04/05/21-ct reports 10"-30" post vaccination- was flushed, nauseated, observed by  at clinic, ct stayed at clinic about 2hrs, then stayed in  overnight, as lives in a very remote area.  Couple days later developed itchy mottled rash, itchy, initially on stomach, chest, then L arm. 4/6- rash more intense, itchy- on back and arms, steady HA,Today-13 days post vaccine- rash not welts.  Had 2 telehealth visits, 1 in person appt w/ PCP,  tried different antihistamines, MD and client attempted to call J&J but 'not of any help' (per the client). Hx allergy to many chemicals in most COVID treatments. Ct gave verbal permission for  team member to contact her directly.
Received 1st dose 28Apr2021 has not received 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received 1st dose 28Apr2021 has not received 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received 1st dose 28Apr2021 has not received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received 1st dose 28Apr2021 has not received 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The patients were vaccinated with a dose of MMR II (lot #, dose and route not reported) on unspecified dates. The nurse reported that over the last 2 months (since approximately June 2012), patients may have been administered vaccinees that had been improperly stored. No adverse effects were reported. At the time of the report, the nurse was unable to confirm the number or identities of the patients who may have been involved. Additional information has been requested.
Difficulty breathing, onset of acute asthma symptoms with persistent coughing and mucous.  started at 8:45 PM
None noted in clinic. Parent called a told of error, did not report any issues with son. Called mom on Monday and she reports some arm soreness but no other issues.   Listed as 4th dose in series, Has had 3 Pfizer vaccines in past, last dose 8/22/2022
This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (tightness of the muscle), VACCINATION SITE BRUISING (bruising on arm of the injection), VACCINATION SITE ERYTHEMA (injections is light reddish pink) and VACCINATION SITE SWELLING (arm of the injections swelling) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (tightness of the muscle), VACCINATION SITE BRUISING (bruising on arm of the injection), VACCINATION SITE ERYTHEMA (injections is light reddish pink) and VACCINATION SITE SWELLING (arm of the injections swelling). At the time of the report, MUSCLE TIGHTNESS (tightness of the muscle), VACCINATION SITE BRUISING (bruising on arm of the injection), VACCINATION SITE ERYTHEMA (injections is light reddish pink) and VACCINATION SITE SWELLING (arm of the injections swelling) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
It started with ear pressure on the left side. Lots of sinus drainage and headache mostly on the left side. I was also fatigued and had lack of appetite. I didn't want to do anything. I just wanted to sit in my car for like three days. My doctor prescribed PAXLOVID for it.
On July 14, 2022, I began to run a fever.  I tested positive for COVID-19 with a home test.  I slept a lot because I was very tired.  I took Dayquil and Nyquil, Tylenol and Benadryl. I had a runny nose and a mild headache.  I was fatigued for several weeks.  I contacted my doctor on July 14th and prescribed Paxlovid and began taking it on July 15, 2022.
Second dose gave right arm pain but it resolved/The pain from the second dose resolved on its own; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Second dose gave right arm pain but it resolved/The pain from the second dose resolved on its own) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04AC21A and 09AB21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE, FENOFIBRATE, LISINOPRIL, LEVOTHYROXINE, TOPIRAMATE, OMEPRAZOLE and LIRAGLUTIDE (VICTOZA) for an unknown indication.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Second dose gave right arm pain but it resolved/The pain from the second dose resolved on its own). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Second dose gave right arm pain but it resolved/The pain from the second dose resolved on its own) had resolved.            This case was linked to MOD-2021-407132 (Patient Link).
day 1 sore arm started a couple of hours after shot,  got so painful could not touch arm or lift above head, lasted 2.5 days. low grade headache, started Saturday. Fever started on Sunday. Right now have left side tingling legs and arm.
This case was reported by a healthcare professional and described the occurrence of arrhythmia in a 17-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Approximately the first week in November 2008, the subject received unspecified dose of BOOSTRIX (.5 ml, unknown). In November 2008, 2 weeks after vaccination with BOOSTRIX, the subject experienced arrhythmia. Two weeks after the subject received BOOSTRIX, the subject orthodontist noticed when preparing got extract his wisdom teeth with pre-operation procedures for sedation, that his heart rate was slow and erratic. He did not have his teeth extracted. The 17-year-old was admitted to a hospital the week of 17 November 2008. He has seen many doctors since, with EKGs and other tests done. He is scheduled to get a pacemaker. The subject was hospitalised. At the time of reporting the event was unresolved.
Pt states minor headache developed after vaccination  PT monitored, VS at released from observation area were normal for this patient, states headache better but still present.
Pt had 2x3 cm patch of redness that was hot to the touch at injection site.
Planted 0.1ml Inactivated Polio from multidose vial in left forearm, instead of PPD. (PPD planted correctly in right forearm when error noted, several minutes later.) Site looked slightly red within 30 minutes and at 48 hours later still reddened, but not indurated but "not as bad" as the previous day.
Pt recvd MMR vax in JAN90 & 2 days following vax pt exp sz w/ a high fever; pt was hospitalized 5x w/in a month's time & each time w/a new sz; no further details were provided;
Itchy Rash over whole body, sore joints and chest pain. It feels like someone is sitting on your chest.
Patient admit post dialysis with fever to 101, hypotension requiring pressors.  Full infectious workup negative and he recovered within 24 hours.
In addition to CDC expected symptoms (swelling of the face, tiredness, headache,  muscle pain, chills) I experienced nausea, coughing, sore throat, vomiting or gaging after food or coffee.
This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red round bump, visibly raised, warm to the touch. Itches. Feels very hard when you press on it.
pale, staring, shaking - seizure like episode per parent.  not witnessed by staff.
15 year old received adult vaccine; This case was reported by a pharmacist via other manufacturer and described the occurrence of adult product administered to child in a 15-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child. On an unknown date, the outcome of the adult product administered to child was unknown.  Additional details were provided as follows: The patient inadvertently received adult dose of Havrix, which led to adult product administered to child. This case had been linked with case US2022AMR032557, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR032557:Same reporter
02/26/21 presented to EC with "hypertension and constipation"; from an  care facility.  02/26/21 lab SARS-CoV-2 (COVID-19) detected.