chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Nurse). A 61-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 at 11:00 as dose 2, single (Lot number: EL9261) at the age of 60 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Celiac Dx", start date: 2017 (ongoing); "Asthma", start date: 2000 (ongoing); "Neuropathy", start date: 2017 (ongoing); "Seasonal allergies", start date: 1990 (ongoing). Concomitant medication(s) included: GABAPENTIN oral taken for neuropathy peripheral (ongoing); XYZAL oral taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (Dose: 1 ,Single, Date/Time: 08Jan2021, Time: 11:00, Anatomical site of injection: L Arm, Route of administration: Intramuscular, Lot number: EL0140), administration date: 08Jan2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "fever for 2 days after injection", "also got a rash on R buttock". The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash on R buttock"; PYREXIA (non-serious), outcome "unknown", described as "Fever for 2 days after injection". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200024801 same patient/reporter, different dose; PFIZER INC-PV202200024803 same patient/reporter, different dose;
chills, fever, muscle pain, headache (one day).  I took 1 Aleve pill, used a cold pad and rested swelling under armpit where shot was administered (this is day 2 and is still swollen).
This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 08-NOV-2016, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose and route not reported) from lot # M025194 with expiry date 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received; Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140:
pt called 2JAN97 states in OCT96 c/o n/v, h/a, weakness on & off x 2-3 wk;same sx returned in DEC96;pt was given flu vax 27SEP96, & felt fine till OCT96;
Started around 10:00pm 9/28/23 coughing, 11:00 runny nose, 11:30 neck was hurting feeling achy went to bed.  Woke up thru the night with extremely high fever, extreme chills, talking out of my head, I couldn't get out of to call anyone I just keep falling back to sleep but would wake up talking, yelling.  I had pain go across my upper back and down my left arm.  I thought maybe stroke, heart attack I was so out of it.  I remember having pain on both sides of the front of my head then my pain in my hands especially both my index fingers and knuckles were throbbing and couldn't bend them.  I would say my fever finally broke around 5:00 am.  I got up with terrible headache, my legs felt weak, kinda dizzy.  I texted my co-wrker to come get my work.  I slept all day till 11:30 Friday evening, got up went into bed.  This was a horrible frightening experience I will never go thru again.  You can keep your vaccines.
Fever of 102.5, vomiting, nausea, chills, sweating, stomach and back pain, body aches, muscle pain, sore arm, headache
I have a fever of 103.5, body aches, cold sweats, sore arm.
9MAR95 pt recvd vax & 3 days later area became reddened, hard afebrile; mom told to put warm compress on leg & APAP as needed; 7 days p/vax t>100 x 2 days; pt fussy; lt thigh nickel size br red, hot area; hard, fluctuant area beneath lump
feels fatigued; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 25th February 2021, 10 hrs after receiving Shingrix, the patient experienced headache. On 26th February 2021, the patient experienced fatigue. On an unknown date, the outcome of the fatigue and headache were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and headache to be related to Shingrix.  Additional details provided as follows: There were no events noted with dose 1. About 10 hours after receiving 2nd dose she experienced headache and after one day she experienced feels fatigued. Outcome of above events were not recovered/not resolved. Consented to follow up.
Information has been received from a registered nurse concerning a 15 to 18 month old child patient out of 20 who was vaccinated with VARIVAX (Oka/Merck, lot #659345/1915U). Approximately 13 to 15 days post vaccination, the patient have developed red, raised knot at the injection site. The child was seen at the office for follow up was given a prescription for KEFLEX. At the time of report, the event persisted. The nurse also reported that there were another 2 patients who had a similar experience with the same lot number (refer to WAES #s 0805USA04398 and 0805USA05445). A lot check has been initiated. Additional information is not expected as the nurse is unable to provide any additional details regarding the three patients. On 05-JUN-2008 adverse event lot check completion information was received. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. No further information is expected.
I started exp. itching in both underarms with irritation. I went to bed woke up 3am with hives and adrenaline rush. I applied Benadryl topical cream to soothe the itching. My heart was racing, On November 11, 2021 went to urgent care was accessed given a prednisone and to take Claritin, Benadryl. Then on Friday seen my doctor was given a steroid injection. I went to urgent care again on November 16, 2021 had blood work and continue to take prednisone. As of today still have hives nothing has changed. I have seen four doctors for my symptoms and had to miss 6 days of work due to not being able to sleep. I had a trip planned to leave on November 18, 2021 with my family had to cancel was advised by my doctor to not be in the sun.
The next morning after receiving the vaccine, I experienced extreme vertigo, muffled ears and ringing in my ears and nausea. This lasted for roughly 15 minutes. I also have shoulder pain the travels up my neck on the left side. I?ve also experienced expected adverse effects such as pain/soreness  on left arm and fatigue.
Nausea, fatigue, sweating, vomiting, difficulty breathing. Went back to doctor on 4/13/17 and was prescribed ZOFRAN and Prednisone.
29 March 2021- Noticed enlarged, tender lymph nodes in the left axilla ( same arm in which vaccine was received)Went to see family physician on 30 March 2021 and confirmed that they were enlarged lymph nodes.  Lymph nodes are still swollen/tender. Motrin taken to help with inflammation.  30 March 2021- Red, circular rash appeared on left arm, slightly below injection site. Appx. 2 in in diameter. Rash has almost cleared, with a faint outline still visible as of 2 April 2021. No treatment or medical services sought for rash.
FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on MAR-2021. This report was non-serious.
shingles; Death; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist in pharmacy. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of shingles was not provided. On 17-APR-2018, the patient died. Information regarding cause of death and autopsy was not provided.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
5 minutes after receiving Pfizer Covid vaccine  #1 patient complained of dizziness and throat tightness. Taken to first aid room, given 50mg benadryl. Progressed to severe shortness of breath and throat tightness. 0.5mg epinephrine administered. EMS summoned. Blood pressure 90's/50's. No improvement in shortness of breath. Patient became somnolent and difficult to arouse. Stridor noted. Second dose of epinephrine 0.5mg administered. Patient became more arousable with slight improvement in work of breathing. EMS on scene. Blood pressure 118/70. Patient transported to local hospital.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 08-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt to hosp with c/o chest pain and fever; positive for COVID; treated with remdesivir, dexamethasone; NSTEMI vs myocarditis; heart catherization not done due to COVID; EKG showed lateral ST elevation, nitroglycerin drip started; despite treatments, pt passed away later in the hospital
Information has been received from a registered nurse concerning a 25 year old female who in 2006 (date not reported) was vaccinated with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The nurse reported having "the syringe jam and could not administer the vaccine." The vaccine was given using a second syringe. The nurse also reported that the patient experienced "muscle pain in her arm, the arm of the jammed syringe." At the time of this report, the patient had not recovered. Additional information has been requested.
1./25/21  Racing heartbeat 5 minutes after vaccine lasted about 10 minutes 1/31/21 -2/1/21  Palpitations and erratic heartbeat continuous and lasted about 14 hours then became intermitent.  Cardiologist was        seen on 2/2/21.  Wore heart monitor for about 8 days. DX: Afib 2/20/21  awoke at 6:00 am.  The room was spinning, I became nauseous, had dry heaves and my legs began shaking uncontrollably.  911 was called and I was transported to the ER.  A CT scan,  chest xray, blood test, and urinalysis was performed.  DX: dehydration.  I was given meds for nausea and bactrim for a slight UTI (although I had no symptoms.
dizziness; His head felt like it was too heavy; threw up; flu like symptoms; discomfort in his neck; nausea; tiredness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (lot number: EL3249, expiration date: May2021) first dose on 13Jan2021 15:10 to 15: 20 intramuscular injection in right arm at single dose for covid-19 immunization. Medical history included Type II diabetes mellitus, High cholesterol and Blood pressure, all diagnosed about 15 years ago and ongoing. Concomitant medications included insulin glargine (LANTUS) for diabetes, insulin aspart (NOVOLOG) for diabetes, metformin for diabetes, lisinopril for High cholesterol and pravastatin to control blood pressure, all ongoing. None History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. None Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was None. He is supposed to get second dose on 04Feb2021. He sat for 15 minutes after getting the shot and he had no reaction. About an hour or two into his shift for work he started having nausea, tiredness, and his neck was killing him, like something was on his neck, a discomfort in his neck. He worked through his shift. He was going through discomfort flu-like symptoms through Friday (15Jan2021). He thought he was ok as of Sunday. He went to work yesterday and his shift started at 6am, he was ok and then through breakfast, the room started to spin and he was experiencing dizzy spells (18Jan2021), nausea and his neck was extremely uncomfortable. His head felt like it was too heavy. He went to his supervisor to ask to go to the back and he threw up once and then he threw up again. He had to leave work around 12-12:30. He was told to go home. He is to go back to work tomorrow. He is hoping that he feels better tomorrow. Treatment: He took Tylenol. He took a lift home and he stayed in bed all day yesterday. His wife gave him some soup last night. He is not experiencing tiredness, nausea, discomfort in his neck as of now since he is laying down and not on his feet. He feels ok and he is not really experiencing anything of the events mentioned right now since he is laying down and trying to rest. Events not require a visit to Emergency Room or Physician Office. The outcome of the events was unknown.
Begin to break out with Eczema after first dose on my back and my arms; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medication received within two weeks of vaccination was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021, the patient began to break out with eczema after first dose on her back and her arms. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of eczema after first dose on her back and her arms and included treatment with steroids - prednisone. The clinical outcome of the event began to break out with eczema after first dose on her back and her arms was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
swelling in legs/feet, shortness of breath, fatigue, irritating cough, pitting edema in lower legs, CHF
Immunization site became red, swollen, hard and itchy.  Hydrocortisone cream 1% and ice were applied.
Metallic taste; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant  medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 the patient experienced metallic taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event metallic taste was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
TDaP erroneusly administered ID instead of IM. Local reaction noted on 17 Oct 2014.
skin growth; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient).  A male patient an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation: Solution for injection, Lot Number was not reported), dose 1 via an unspecified route of administration on an unspecified date as  single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had skin growth. The patient reported as his doctor prescribed him a Fluorouracil Cream for skin growth. The outcome of event was unknown.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected
Information has been received from a consumer concerning his 77 year old wife with sulfonamide, penicillin, DARVOCET, TALWIN, DEMEROL, CIPRO, "BINRA TAB", "ERYTAHCION", MORPHINE, codeine, CLARITIN, "MUSCLE RELAXERS" allergy and dye allergy who on 09-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included lisinopril and furosemide. On 09-SEP-2010 the patient developed red patch, itching and rash. No medical attention was sought. The patient's red patch and itching and rash persisted. Additional information has been requested.
First night, I was okay until about 10 pm - chills - my teeth was chattering  I had never experienced , hot, threw up all night and I had to miss work. I was really sick for the next few days. I was tired, too. The reflux made me go to the doctor - a couple weeks after vaccine. Increased symptoms of it real bad. They increased my Omeprazole dose from 20-40 mg. I have loose stools. They added a nose spray as well.  I had had my allergy shots the same week as I had my vaccine.
Patient presented to the ED and was subsequently hospitalized for Right lower lobe pneumonia within 6 weeks of receiving covid vaccination.
This spontaneous report was received from the patient's mother referring to a 11 month old female patient. The patient had no pertinent medical history, concomitant medications, or drug reactions/allergies. The patient's concurrent conditions were not reported. In December 2017, the patient was vaccinated with LIQUID PEDVAXHIB 1 x 0.5 ml dose via intramuscular (dose, concentration, dose number, frequency,and anatomical location were unknown), with lot # N024569 and expiration date on 07-FEB-2020, as vaccination against Haemophilus influenzae type b (HIB). In February 2018, the patient experienced severe hives and rashes, vomiting and developed food allergies to almost everything. It was also reported that she was not growing and something was wrong with her immune system. The patient had sought medical attention and had visited an Immunologist, a Gastroenterologist Specialist, and Allergist, a Nutritionist in addition to her Pediatrician and a second Nurse Practitioner. No treatment was given to the patient for the events. A blood work and numerous other unspecified lab tests were performed, however the results were not provided. At the time of the report, the outcome of the events growth retardation, vomiting, rash, urticaria, food allergy and immune system disorder was not resolved. The reporter did not mention the causality assessment between the events and haemophilus b conjugate vaccine LIQUID PEDVAXHIB. Upon internal review, growth retardation was determined to be a medically significant event.
Still dont feel normal; Fever creeping up to 102.7; Fever; Hallucinations; Very weak; Dont feel like myself; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant) and ASTHENIA (Very weak). 05-Sep-2021, the patient experienced FEELING ABNORMAL (Dont feel like myself). On 05-Sep-2021 at 5:00 PM, the patient experienced PYREXIA (Fever). On 07-Sep-2021, the patient experienced FEELING ABNORMAL (Still dont feel normal) and PYREXIA (Fever creeping up to 102.7). On 07-Sep-2021, HALLUCINATION (Hallucinations) had resolved. At the time of the report, ASTHENIA (Very weak), FEELING ABNORMAL (Dont feel like myself), FEELING ABNORMAL (Still dont feel normal), PYREXIA (Fever) and PYREXIA (Fever creeping up to 102.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, Body temperature: 102.7 (High) 102.7 F.         Concomitant medications were not reported .  Reported that patient got the booster of Moderna. she experienced hallucinations from it, The patient states she started with a fever on Sunday 05-Sep-2021 about 5 PM, The hallucinations started between 10-12 PM, She was very weak, and she still doesn't feel normal on 07Sep2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.
Chills, fatigue, night sweats, fever, congestion, cough from congestion. The weirdest was a golf ball sized swelling of injection site that worsened every day, itching and warm to touch.