chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 18 months old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 27-JUN-2016, when the patient was 1 year old, he/she received the first dose of VAQTA injection (dose, route of administration, anatomical location, lot # and expiry were not specified) for prophylaxis. On 19-DEC-2016, at the age of 18 months, the patient was vaccinated with the second dose of VAQTA injection (dose, route of administration, anatomical location, lot # and expiry were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
itchy blotchy rash; itchy elbows/my back was itching; elbows were dry; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0165, expiration date was not reported), via an unspecified route of administration, administered in right arm on 04May2021 10:30 (at the age of 39-years-old) as dose 1, single for covid-19 immunization. The patient medical history included known allergies to bactrim, yogurt only. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications 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. It was reported that last wednesday on 12May2021 patient started with itchy elbows. She put lotion on thinking my elbows were dry but she would wake up itching. Shortly after her back was itching. As of yesterday 17May she noticed around 3:30pm a red blotchy rash on birth arms. As the day/night went on it spread to my stomach. When she woke up she was covered from head (in my scalp) to toe with this itchy blotchy rash. She went to urgent care at 10:30 this morning 18May. They gave her liquid prednisone and a prescription to take for a week. The only thing she have done differently was get the Pfizer vaccine exactly two weeks ago from today Tuesday. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room visit. Therapeutic measures were taken as a result of itchy elbows/my back was itching, elbows were dry, itchy blotchy rash. Prednisone was received as treatment for the adverse events. device timestamp 18May2021. The reporter assessed the seriousness as non-serious as events did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
rednessat the injection site; swelling at the injection site; This spontaneous report was received from a safety clinical coordinator and a nurse referring to a 12-months-old female patient. Her concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not provided.  On 15-AUG-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis, lot# R036582 expiration date on 17-DEC-2020 (dose, strength and route of administration were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis, lot# R035225 expiration date on 04-DEC-2020 (dose, strength and route of administration were not provided). Other suspect therapies included sterile diluent, with Lot number: N030845 and expiration date: 12-JUN-2020 lot number: N028091 and expiration date:10-MAR-2020; lot number: R036582 and expiration date: 17-DEC-2020; and lot number: N028744 and expiration date: 11-MAR-2020; lot number: N028746 and expiration date: 17-MAR-2020 which the lot check for all numbers was requested by the reporter and upon internal review all number were verified.  On 15-AUG-2019, immediately after the vaccinations, the patient experienced "redness and swelling at the injection site".  The events were treated with Benadryl and ice; Laboratory diagnostic or studies were not reported. The outcome of injection site erythema and injection site swelling was reported as resolved on the same day.  The casualty assessment between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), varicella virus vaccine live (Oka/Merck) (VARIVAX, the sterile diluent and the occurred events was not reported. This is one of several same reporter cases.; Sender's Comments:  US-009507513-1908USA007079: US-009507513-1908USA007014:
Patient called to report that she received her 2nd dose on 1/7 @ 1000 and then the next day she started having a HA. On Sat she had a temp of 99.0 and it subsided. Then on sun she began to have chills, fever, and lymph nodes were swollen under her arm and neck and went to the ER and given steriods. Symptoms have resolved as of now.  Patient received the BioNTech Pfzier vaccine
It started as a sore throat (red and swelling), which I went to urgent care for and tested negative for strep and covid. Symptoms continued to worsen with burning in the ears and then a rash began to form on my left breast and in my left armpit. At first, it was just itchy then it became swollen and turned into very painful blisters. 4/13-4/26
Nausea, dizziness, lump in throat, rapid heartbeat, suppressed breathing, headache, muscle pain, chills, joint pain, fever, injection site swollen, hot, and red size of 50 cent piece
pt recv vax & devel alopecia in a small area which was not d/t the cradle cap; pts hair grew back & pt recovered; parents did not want pt to received 3rd dose of vax;
I experienced a protracted head cold following the second dose of the Moderna Vaccine (roughly 6 weeks in length). During the course of this cold I experienced fullness in my left ear which I could not unblock. I went to the ENT to have my ears checked -- they gave me an exam and hearing test and diagnosed me with Idiopathic Sudden Sensorineural Hearing Loss and started me on a high-dose regimen of Prednisone. When my ear unblocked I had noticeable hearing loss in my left ear. I ended up undergoing Hyperbaric Oxygen Therapy in order to help restore my hearing. I now have my hearing restored thanks to the combination of Hyperbarics and Corticosteroids. Please, Please, Please investigate these reports of hearing loss, I could have lost my hearing had I not acted as quickly as I did to seek treatment. This is a severe, life-altering side-effect people need to be aware of so that they can have treatment as soon as possible. I believe in the vaccine, but I also think ALL potential side effects need to be adequately disclosed to the public.
For six days: I had headache; nausea; body aches; decreased appetite; on and off fevers and fatigue. Went to Respiratory clinic - COVID - negative test (day after my vaccine - COVID test; re-COVID tested at six days out - both normal/negative).  Dx'd with Mono. No treatment. Symptoms have resolved for most part - only occasional fatigue.  Had second Pfizer dose - 1/22/2021 - No other symptoms after that vaccine.
Temp at 6 p.m. 102.3 deg F. Gave Motrin. 8:30 p.m. - temp 103.9 deg F. Went up to 104.4. Started jerking. Eyes rolled back in head. Next morning 104.8 deg F. Went to ER both days.
Warmth and redness approximately 4-4.5 cm in diameter-Patient denies itching but states sited is painful to the touch.
Severe shooting pain through whole body, Headache, High Fever, Dizziness, Vomiting, Could barley walk it was so painful. The side effects lasted 4 days.
received a dose from a vial that was transported outside of the recommended policy; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (received a dose from a vial that was transported outside of the recommended policy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (received a dose from a vial that was transported outside of the recommended policy). On 29-Jan-2022, PRODUCT STORAGE ERROR (received a dose from a vial that was transported outside of the recommended policy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, the patient received a dose from a vial that was transported outside of the recommended policy. Vial was removed from the cooler (unpunctured), placed in a glove with two ice cubes and transported for 15 minutes to a different location. Upon new site, vaccine was then punctured, and dose was administered.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Followup contains no newinformation.
Subsequent to receiving vax, the pt developed a severe nosebleed. The pt recovered.
PROFOUND BLEEDING; CLOTTING; SUSPECT DYSFIBRINOGENEMIA; This spontaneous report received from a health care professional via a Regulatory Authority and concerned a 48 year old, female. The patient's height, weight and medical history were not reported. The patient was not pregnant at the time of reporting. The patient had no other illness at the time of vaccination, no chronic or long-standing health conditions, the patient was healthy without history of dysfibrinogenemia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the patient experienced profound bleeding, and clotting and was suspected to have dysfibrinogenemia. The patient was currently hospitalized for the events (date unspecified).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from profound bleeding, clotting, and suspected dysfibrinogenemia. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). Sender's Comments: VO:-covid-19 vaccine ad26.cov2.s -profound bleeding, clotting, suspect dysfibrinogenemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Reported had severe headache the same night.  Worse the next day.  Tongue and lip swelling. BP spiked, severe headache, severe abd pain, seen at Urgent Care and sent to ER. Given meds and sent home. Next day seem at clinic and again sent to ER. . Given IV fluids, IV meds and after four hrs sent home. Experienced extreme weakness. Could barely get out of chair or walk. ED visit 1/15/2021 for acute nonintractable headache, epigastric pain, adverse effect of vaccine. Presents to the ER with epigastric abdominal pain, nausea, and headache after receiving second dose of Pfizer COVID-19 vaccination yesterday at 6 AM. Patient states symptoms started last night. Treated with IV fluids, Reglan, Benadryl, Toradol, and Floricet. Abdominal pain totally resolved and headache pain improved. Discharged to home with prescription for Reglan 10mg PRN. She does have a history of chronic migraines and already has Maxalt at home and was given a prescription for Floricet today which she is already filled.
Heaviness on chest (still on going--breathless after speaking/difficulty breathing); began 4 days after vaccine was given. 1st it was just fatigue and breathlessness, then I got a tingling feeling on left side of chest and tightness. After ER visit I was advised to take Zyrtec and Benadryl. I've paired it with Mucinex to get rid of phlegm build-up and the doctor prescribed Prednisone which I'm going to start today (03/15/2021). So far I have less tightness/less tingling in heart area (still occurs randomly but not as opten) but still get fatigued and breathless real quick. I've also had sporadic headaches brain fog, body chills/aches/weakness/difficulty concentrating. Also had face numbness for 4 days.
received shot at 10:45 am - symptoms began at 10pm same day chills, body aches, very painful, tender swollen lymph nodes under arm pit of injection site
Leg swelling started on April 9th, had ultrasound to check for blood clot.  Negative for blood clot.  Still swollen doctor told me to report it to vaccine page
rheumatoid arthritis symptoms worsened; rheumatoid arthritis symptoms worsened; uncomfortable; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (141003).  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete , Manufacturer Unknown), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), RHEUMATOID ARTHRITIS (medically significant), outcome "unknown" and all described as "rheumatoid arthritis symptoms worsened"; MALAISE (non-serious), outcome "unknown", described as "uncomfortable".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Rheumatoid arthritis and Rheumatoid arthritis aggravated which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.
Rash, swelling of face and at injection site LD, Benadryl every 6 hours.
Patient is a foreign exchange student staying with a local host family. When the patient and host family were asked for a birthday down at the drop off window it was inputted to make the patient 18 years old. Once the paper work was filled out it had a different birth year than originally given making patient 15 instead. The pharmacist went to double check with host parent (child speaks very little English) for age (as this was an 18 and up Moderna vaccine) and it appeared they believed the birthdate given at the drop off window was correct and not birth year on consent form and pharmacist notated that birth year onto the PQCF. The host parent was asked at 2nd visit (28 days later) if this may have been possible and they said there was confusion on birthdate originally but the birthdate making patient 15 was the correct birthday. On second visit host parent was informed what happened and that pfizer would need to be given to complete series instead of Moderna. They understood and were fine with that. Host parent was also asked if the child experienced any side effects from the dose of moderna and none had been noted. Host parent was very kind and understanding. They waited patiently while we made some calls and double checked CDC guidance. They did not mention any upset or anger and stated they were grateful patient was able to complete series. They were informed if patient would qualify for booster eventually, current recommendations would be to continue with pfizer.
This spontaneous report as received from a physician refers to a 67 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in left deltoid, lot # L042846, expiration date: 15-SEP-2017). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
pt recv vax 30AUG96 & mom states pt c/o dizziness, c/o nausea then fainted 30 sec outside of clinic building;mom brought pt back to clinic w/condition;BP 106/70;stable to walk d/c home w/mom;
About after a day after receiving the first dose of the vaccine I noticed that I had right knee pain coming from my knee joint. It is at its worst after I keep it in the same position for a few minutes then try to move it. Prior to the vaccine I never had any knee issues and it is only in the right knee
Fever; Tired/exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (Tired/exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676, 028a21a and 012a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 PYREXIA (Fever) and FATIGUE (Tired/exhaustion). At the time of the report, PYREXIA (Fever) and FATIGUE (Tired/exhaustion) outcome was unknown.            No Concomitant informations were reported. No Treatment informations were reported
p/ recv vax 3/20/98 pt 11 days later devel chickenpox.
Information has been received from a nurse practitioner concerning a 10 year old female who in November 2006 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On 20-MAR-2007, about 4 months later, the patient experienced rash breakthrough. An approximately 20 lesions were scattered around her body that looked like chicken pox lesions. The patient had no fever and was not even itchy. Additional information from the nurse practitioner indicated that the patient was seen months ago and she had no record of who the patient was at this time. No additional information is expected.
Head ache; Sinus infection/sinus issues/sinus headache (facial pressure and pain); light headedness/brain fog; pains; queasy stomach; fatigue; muscle aches; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (queasy stomach), SINUSITIS (sinus infection/sinus issues/sinus headache (facial pressure and pain)), DIZZINESS (light headedness/brain fog), PAIN (pains) and HEADACHE (Head ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  The patient's past medical history included Low back pain in 2012 and Hip bursitis in 2016. Concurrent medical conditions included Fish allergy. Concomitant products included RALOXIFENE for Breast cancer, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZID) for Water retention.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (queasy stomach), PAIN (pains), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (FEVER). On 18-Feb-2021, the patient experienced SINUSITIS (sinus infection/sinus issues/sinus headache (facial pressure and pain)), DIZZINESS (light headedness/brain fog) and HEADACHE (Head ache). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of UNK UNK, qid and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Adverse event, at an unspecified dose and frequency. On 23-Feb-2021, DIZZINESS (light headedness/brain fog), HEADACHE (Head ache) and FATIGUE (fatigue) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (queasy stomach), PAIN (pains), MYALGIA (muscle aches) and PYREXIA (FEVER) was resolving and SINUSITIS (sinus infection/sinus issues/sinus headache (facial pressure and pain)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: New events and their outcome updated. Concomitant and treatment drugs details added. Action taken with drug updated. On 06-Jul-2021: NNI FU - No new information was provided.
Child had a well child exam on 4/13/15 and received vaccines. 48 hours later parents had a hard time waking child up. Was taken to ER and alert at that time. Child had a URI so I saw later in day. Lab normal. EEG normal. Child doing well.
pt recv vax; swelling, redness, rash, feverish, itching, burning in middle part of arm;used warm compresses; took Keflex; dph cream;f/u tx by MD;
After administering shot pt was bleeding a lot and broke on a rash. Pt stayed with Rph until she felt better she took some BENADRYL that she had prescribed.
Moderna first dose give 4/16/2021, a Pfizer second dose was given on 5/7/2021.
Approx 15 hours post injection, (2/14/19) I awoke feeling sore at the site of the injection and also experienced a headache and fatigue. Throughout the next several hours I experienced a headache, fatigue, chills and nausea. Approx. 24 hours later I took my temperature and had a temperature of 100.6. On the morning of 2/15/19 I noticed a small red rash and slight swelling several inches below the injection site and to the inside of my upper right arm. I still was experiencing fatigue but fever was gone. The next 2 days the pain at the injection site decreased significantly but I noticed the rash and swelling had increased in size and felt warm to the touch. On Monday, 2/18/2019 all other symptoms have disappeared except for the rash and swelling that have increased significantly.
Awoke with tingling in (L) side of face on the morning after receiving influenza vaccine. Pt felt eye would not open completely, had numbness sensation over (L) side of face, lips & mouth. No meds & no treatment given.