chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ5682) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient had no known allergies and no other medical history. The patient also do not have other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Very sore entire shoulder where injection was administered. Large area 3inx4in of bright red skin surrounding injection site. Bad headache, lethargy, overall body aches. Fever of 99.0 to 99.8, and my temp is normally around 97.0-97.5. My wife and I have the same symptoms, with this, our second shot as we had with our first shot administered at same location on July 13, 2021. Symptoms lasted 3-4 days.
15-20 min after receiving TIV, patient complained of "tingling in upper gum." Patient questioned about other symptoms and denied. Observed for additional 15min. Patient stated "I'm better, really I'm fine. Called patient 90 min later and patient stated "I no longer have any tingling."
5/9/06, runny nose. 5/12/06 elevated temp 103.9. Elevated temp continued on 5/13/06 and 5/14/06 Woke up with rash on 5/15/06. Saw physician. Was given antibiotics.
Patients mother called the office on 2/9/15 reporting pt started stuttering significantly 2 days ago.
Narrative:  75 year old male, received his first dose of COVID-19 vaccine (Moderna) on 2/18/2021. PMH of stage III adenocarcinoma of the esophagus, Paget disease, Pott"s disease, GERD, COPD, BPH, afib. Was admitted 2/16/2021 for intractable epigastric pain, poor PO tolerance since esophageal stent (1/26). 3/24/2021 hemoptysis vs hematemesis. Patient threw up blood, hypotensive, hypoxic and increasingly lethargic. Admitted to MICU, code blue was called, patient expired at 5:07am.
Pt displayed swelling and pain at the site of injection that persisted for 3 days.  Additionally, patient experienced periodic shooting pain down to her hand and fingers that has lasted over 3 weeks.  She also developed a fever blister on her lip.
Patient's mother phoned the pharmacy and reported her daughter had a 3 in x 3 in warm red area where the injection was given. The patient complained that it itched but was not painful.  They consulted with a nurse in the family and determined it was an allergy to a component of the vaccine.  She was given Benadryl and Zyrtec and reported that it was helping with the itching.  I also recommended ice and ibuprofen or acetaminophen if there was any pain.  I requested a follow up if the symptoms worsened.
Patient report pain, inflammation and erythematous rash at injection site. Patient also received Fluzone HD in the same arm.  Patient took ibuprofen and benadryl on Day 1 and Day 2 of symptoms. On Day 3, patient reports improvement of rash and pain.
Severe swelling and pain at injection site with nausea headache fever chills and rash on body
UNCONTROLLABLE SHAKES; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19  VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 37 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: adhd, depression, dysthymia, intermittent anxiety, and post orgasmic illness syndrome. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 01 total administered on 24-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested.  The patient additionally received non-company suspect drugs included: tozinameran (dose number in series 2) ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported administered on 11-AUG-2021  for covid-19 prophylaxis; and elasomeran (dose number in series 3) ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for covid-19 prophylaxis. Age at time of vaccination 35 years old. Concomitant medications included atomoxetine, and naltrexone. On 11-AUG-2021, the patient experienced revaccination with different covid-19 vaccine(dose number in series 2) On 11-NOV-2022, the patient experienced suspected covid-19 infection (dose number in series 2). Patient received treatment from unspecified pfizer product for Covid-19 from 20-NOV-2022 to 26-NOV-2022. On 29-NOV-2022 23:00, on day 19 from onset of symptoms patient experienced extreme chills, body aches, and exhaustion. Had uncontrollable shakes for several hours despite being under a warm blanket (dose number in series 2). Treatment medications (dates unspecified) included: diclofenac, and Tylenol(paracetamol) which were taken several hours after symptom onset and symptoms improved but did not abate entirely. On 29-NOV-2022, Laboratory data included: Body temperature Multiple temperature readings 0f 96.2-96.4. Temperature then spike to 100.8 within 30 mins of taking Tylenol and diclofenac The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and elasomeran was not applicable and for unspecified pfizer product was drug discontinued. The patient was recovering from suspected covid-19 infection, and uncontrollable shakes, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
I started experiencing aching pain on my right side that comes and goes. I've had my gallbladder ultrasound and it was normal. I've also had a MRI which found a Hemangioma on my liver.
red spot rt thigh noticed 9APR98;today 6-9 lesions;
Rash 1.5 cm x 2.5 cm on (R) ant thigh developed 10 days after.
Within 1 minute of receiving vaccine, patient started to shake and appear to loose consciousness for about 30 seconds. She then came to and was disoriented for just a minute then could answer all questions asked of her (name, dob, where are you) She stated she had an intense headache, had trouble hearing but hear a buzzing sound. Mom was in the room as well, we gave her water and sat with her for about 10 minutes and she seemed weak but okay. They remained in the waiting area for another 15 minutes, she was feeling better and mom was comfortable to take her home as Mom is a Doctor.
confirmed about a blood clot/check me for a blood clot, I didn't have one but it was kind of like a thrombosis kind of thing; Both of my legs, lower part of my legs were swollen that night when I went to bed and they got really red, almost purply red; Both of my legs, lower part of my legs were swollen that night when I went to bed and they got really red, almost purply red; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated that after the first vaccine and it might be coincidental, the patient was not sure because the patient didn't know what to expect. Both of the patient's legs, lower part of the patient's legs was swollen that night (unspecified date) when the patient went to bed and they got really red, almost purply red and the patient stayed that way for a couple of days. The patient went to see the doctor two days later and doctor confirmed about a blood clot, so they did check the patient for a blood clot; the patient didn't have one, but it was kind of like a thrombosis kind of thing. So, the doctor put the patient on antibiotics for that. The patient asked if it is related to the shot, the patient didn't know it happened the same day the patient got the shot; so, the patient didn't know about that. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Information has been received from a consumer who reported a female child died after the second dose of MMR II (route and lot number not reported). Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-FEB-2010, the patient was inoculated with ZOSTAVAX by a physician for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-FEB-2010, the patient was treated by the hospital, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient has not reported an adverse reaction yet. she states she is okay. she was encouraged to call either her primary care provider or the pharmacy should an event occur. She was also instructed on what to look for.
Delayed localized reaction 1 week following injection: increased swelling, redness, warm to touch, spread in size over 24 hours
Headache, severe muscle aches and joint pain, diarrhea, chills and swelling and redness at injection site  Took tylenol to reduce the joint and muscle pain and headache. Symptoms resolved the next day
after receiving vaccine, pt developed redness to L side of face and arms. Also c/o shivering.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 10-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis. The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
Feb 2nd and 3rd had flushed feeling on face. Feb. 4th to present red, hot, itchy blotch on left arm.  During the course of this I experienced occasional chill and poor appetite.  However I could taste and smell food.  Was tested on Feb 8 for COVID-19.  Test negative.
Approximately 6 hrs after flu vaccine developed fatigue, general achiness, chills, joint pain, esp knees, sore throat, stuff nose, and cough. Hurts to walk, "Like mac truck hit me." No tick bites, no SOB, no rashes - taking ADVIL 600 mg q 4hrs w/o relief.
rash that looks like measles; rash on right side that goes around to back looks like diaper rash; This is a spontaneous report from a contactable pharmacist.  An 87-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation.  Medical history was none.  There were no concomitant medications.  The patient stated she had this injection 08Jan2021, states the following Thursday, 14Jan2021, she broke out with 2 different reactions, a rash that looks like measles all over, the second reaction is part on her back looks like a little kid has not had their diaper changed, like diaper rash, like half a belt from the right side to the back. States she is very concerned, the patient went to a dermatologist who she had a lot of faith in, doctor met her at the door, read about it but has never seen a reaction like this. States that they injected her with something and it worked in two different places. States she did a biopsy on her hip and took movies to show her students, called her and stated she need to report this event. The patient states she wants to know if she should get the second vaccine. States she used to be 5 foot 2 inches, shrunk prior to vaccine. The patient last night to report but she could not get through. Stated she got injection on right arm. The patient stated the rashes are trying to improve. States the rash that looks like measles started on the right side and now is all over. The patient stated she is allergic to bromines and swims in a bromine salt water heated swimming pool and this has nothing to do with it but the point she is saying is that she says your allergic to things and then not have reactions and sometimes you do. Both events were serious with criteria of medially signicant. The patient underwent lab tests and procedures which included biopsy: unknown results, body height: 5 foot 2 inches (States she used to be 5 foot 2 inches, shrunk prior to vaccine).  The outcome of the event rash that looks like measles was not recovered, while the outcome of the other event was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded.  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.
My COVID-19 symptoms started on 07/03/2022. I had fever, cough, runny nose, fatigue, and congestions. I did home COVID-19 test on 07/04/2022 which was negative. On 07/05/2022 I did another COVID-19 home test which was positive. I did a telehealth with PA from my doctor's office who prescribed me intravenous monoclonal infusion. On 03/2023 I noticed rash on my leg. It was a red, inflamed and itching between my knee and ankle on my left leg. The redness started to look purple so I went to my doctor. The doctor wasn't sure what it was. We did all kinds of blood work which was normal. He said it Vasculitis. He gave me an steroid cream. I still have fatigue but other symptoms are gone. I still have the rash when I touch it itches. It's getting better but very slowly.
Adverse event was that 3rd dose was given only 6 weeks after 2nd dose, instead of 8 weeks Patient developed a fever the evening of the vaccine and reported to the ED on 4/19 for coughing
PATIENT RECEIVED SHOT ON 2/20/19 AROUND 6 PM AND STARTED DEVELOPING ALLERGIC REACTION THAT NIGHT AROUND 1 AM. PT REPORTED SWELLING IN MOUTH, SHIVERING AND TROUBLE BREATHING. PT TOOK BENADRYL AROUND 3 AM AND SYMPTOMS IMPROVED THEREAFTER. ADVISED PT TO CONTACT MD IF SYMPTOMS CONTINUE OR GET WORSE. PT REPORTS NO PREVIOUS REACTIONS TO FLU SHOTS.
breathing is worse than it has ever been since getting the vaccine/breathing has been compromised; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing is worse than it has ever been since getting the vaccine/breathing has been compromised) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 DYSPNOEA (breathing is worse than it has ever been since getting the vaccine/breathing has been compromised). At the time of the report, DYSPNOEA (breathing is worse than it has ever been since getting the vaccine/breathing has been compromised) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
fatigue, swollen arm with axillary lymph node swelling too, redness and itching and body aches, fuzzy mentation
Itchy red hive like rash on bilateral extremities. Treated and resolved with Benadryl.
developed "Bell Palsy" between 48-72 hours after his second shot; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 01May2021 10:00 (at age of 39-year-old) (lot number: EW0167) as single dose for covid-19 immunisation. Medical history included high cholesterol. No known allergies. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in arm left on an unknown date in Apr2021 10:00 (lot number: EW0153) for covid-19 immunization. The patient developed "Bell Palsy" between 48-72 hours after his second shot. The event start date was on 03May2021 14:00. The event resulted in doctor or other healthcare professional office/clinic visit. The event resulted in Emergency room/department or urgent care. No covid prior vaccination, no covid tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event included prednisone and valacyclovir. Event outcome was not recovered.
pt became faint immediately after injection, came to and had bp 103/60/60, elevated legs and provided water, pt waited 30 minutes and felt better. Left for home together with companion. Bp upon leaving was 103/59/60.
Delayed hypersensitivity  reaction to Moderna Covid-19 vaccine booster (?Covid arm?)
Persistent pain at site of injection in left arm for one month.  No abnormal findings on physical exam.
This is a spontaneous report from a contactable other health professional via a Pfizer sales representative and from a contactable nurse. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose for immunization and on the same date MENACTRA, via an unspecified route of administration for immunization. Medical history and concomitant medications were not reported. The patient experienced weakness, felt like right side of the body lost strength and jaw was tightened, all on an unspecified date with outcome unknown. Follow-up (05Jul2016): New information reported from a contactable nurse includes: country of incidence updated.
Patient started experiencing fatigue and hotness within 30 minutes of receiving vaccine. Patient then progressed to shortness of breath and hypertensive with no facial swelling.
I received J&J vaccine after 6 days of receiving the vaccine I got very bad headaches and my left leg getting num have difficulty of eating and drinking I felt like it?s a lump in my throat my left ear got problem when I move around my left ear gets hurt and feel like a airplane feeling that air stock in my ear
pain in his left wrist; arm pain and swelling to left arm; arm pain and swelling to left arm; swollen under side of his arm where he got the vaccine injected; pain in his left wrist, which was the same arm that he received his injection; This is a spontaneous report from a contactable consumer, the patient. A 84-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 13Feb2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9262), via an unspecified route of administration, administered in left arm on 23Jan2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. Medical history included hypertension, occasionally rapid heart beat, blood cholesterol abnormal, cardiac operation (9 years ago, macular degeneration (in each eye and puts eyedrops in and occasionally they give him injections). Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]; 10mg everyday) taken for blood cholesterol abnormal; estradiol (ESTROGEN; 10mg everyday). The patient did not have any other recent vaccinations or started any new medications. The patient reported practically had no symptoms with either shot. After his first dose he had one day where his blood pressure went very low but by the time he talked to his cardiologist it had gone back to normal and was taking pills, it was under control. Yesterday afternoon he experienced pain in his left wrist, which was the same arm that he received his injection, and describes the pain as not too bad. He states that when he uses his wrist in certain positions, the pain "shoots up." This morning on the lower part of his left arm ("not the top where I got the injection") he has "slight pain." He says this morning his upper arm on the underside where he got it on the left side is swollen. He says he would like to know can it be from vaccine, though maybe he could have strained his wrist, it happened yesterday evening, he had wrist pain and swollen under side of his arm where he got the vaccine injected. He says yesterday late afternoon was the first time, it could be something else, it was the same arm this morning he has a little pain to his upper arm that was not on injection side but below, under it. The patient did not received any treatment, it was not serious pain, it was low level pain, when he uses his wrist and turns it, it comes in more prominent. He says it was not pain that bothers him, if it was not related to the vaccine then he most likely strained his arm.  No follow-up attempts are possible. No further information is expected.