chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/06/2008  Pt. States started itching on head then noticed on shoulder and breast area 6 hours after receiving the Flu shot. Also took Naprosyn.  States called PMD and was told to take Benadryl, 50mg. States it was effective, the next day started again 3 hours after taking Naprosyn.  States was told by PMD that "she should probably not receive flu shots anymore."
The next day hand began to itching and broke out in a rash tele- Health with Dr. family clinic, was prescribed  phenazone pack 10mg tablets for six days ; stayed clear for two days then the rash and itching returned and then call in to doctor and re- prescribe the same treatment plan done with the medicine however hand is itching and feels like leather. Treat plan for another visit on August 04,2021.
COMPLAINED OF FLU LIKE SYMPTOMS FOR 3 DAYS POST VACCINES AND HAD REDNESS AND SWELLING IN ARM AT 3 DAYS POST VACCINE WAS TX WITH ANTIBIOTICS FROM PRIMARY CARE PHYSICIAN. PRIMARY CARE PHYSICIAN CALLED 7/05/07 TO REPORT EVENTS.  HE CALLED REACTION MODERATE, BUT WANTED VAERS DONE.
my injection site was very itchy; headache; This is a spontaneous report from a contactable consumer (Patient) reported for herself that: A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer EM 9810; Expiration date: unknown), via unspecified route of administration in right arm on 02Mar2021 at 02:00 AM (at the age of 71-years-old) as second dose, single dose for COVID-19 immunisation. The medical history include T-3 incomplete Brown square paraplegic, kidney stones, arthritis, osteoporosis, high blood pressure, Pain, The concomitant medications include baclofen, valium, zyrtec [cetirizine hydrochloride], trazodone, the patient did not receive Covid prior vaccination. The patient did not tested covid post vaccination. No known allergies was reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3245; Expiration date: unknown), via unspecified route of administration in right arm on 09Feb2021 at 11:00 AM (at the age of 71-years-old) as first dose, single dose for COVID-19 immunisation. the patient had all symptoms expected no swollen lymph nodes, no fever and her injection site were very itchy for after the fourth day of second shot. The itching lasted 5 days. Now I just have a headache. On 06Jun2021, the patient experienced my injection site was very itchy, headache. The patient did not receive any treatment. The outcome of the event was Vaccination site pruritus recovered on 06Mar2021 and another event headache was recovering.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 13 year old female who was vaccinated with Gardasil.  Subsequently the patient experienced malaise, not feeling well, and body aches and pains after the first and second dose.  No other information was reported.  Additional information has been requested.
Bladder cancer; This spontaneous case was reported by a patient and describes the occurrence of BLADDER CANCER (Bladder cancer) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLADDER CANCER (Bladder cancer) (seriousness criterion medically significant). At the time of the report, BLADDER CANCER (Bladder cancer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter.  Patient stated that he was diagnosed with bladder cancer about 3 or 4 months after receiving the primary doses of the Moderna COVID 19 vaccine. This is 2nd diagnosis of bladder cancer. Patient was not sure when he received the doses, but the weather was warm. He did not have his doctor's information with him. He has an appointment with his doctor tomorrow, and he will ask his doctor for more information.   Patient has chemo coming up.  COMPANY COMMENT: This is a spontaneous case concerning an 86-year-old male patient with no clinical history who experienced the unexpected event of BLADDER CANCER  The events occurred unknown days after a dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about a dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning an 86-year-old male patient with no clinical history who experienced the unexpected event of BLADDER CANCER  The events occurred unknown days after a dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about a dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Loss of balance; This non-serious case was reported by a other health professional via call center representative and described the occurrence of loss of balance in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included parkinson's disease.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced loss of balance (Verbatim: Loss of balance). The outcome of the loss of balance was not reported.   It was unknown if the reporter considered the loss of balance to be related to Shingrix.     It was unknown if the company considered the loss of balance to be related to Shingrix.   Additional Information: GSK receipt date: 17-JUL-2023 A pharmacy asked for information regarding the use of Shingrix in patients suffering from Parkinson´s disease. The Healthcare professional mentioned that after receiving the first dose of Shingrix a patient with Parkinson´s disease reported loss of balance. The Healthcare professional said that loss of balance could happen because of the normal progression of Parkinson's, but he wanted to verify if there was information regarding Shingrix in patients with Parkinson's disease. The Healthcare professional declined to share patient information since he said loss of balance could not be an adverse event but a normal symptom of the progression of Parkinson´s disease.
I have been diagnosed with Trigeminal Neuralgia which began on the night of the second shot.
patient reported hives on arms, chest, back. he also reported difficulty breathing . no treatment  yet. planned on taking benadryl and going to urgent care or ER
That evening around 11p, I got the vaccine around noon. I got a fever that went up to 103.1 and chills and body ache. I took Tylenol but it didn't help with the fever. For the next 4-5 days I had a headache and nausea and some arm pain that wasn't that significant. And about  a week later my lymph nodes throughout my entire body got swollen, behind my knees, collar bone, neck they were all painful and sore and lasted a week or two. The few by my neck and ear never went down so I went to the Dr. They did an ultrasound and it was enlarged but normal otherwise and it's still swollen.
Right deltoid became hot, red, swollen, firm, painful. 24 hours post injection advised OTC analgesics; ice packs.
patient states that she had 50% hearing loss in her left ear, along with breast pain on her left side.
TC received from stating pt seems to be in severe pain; severe hard crying off and on since vaccines received today.  Pt states left thigh is slightly swollen this RN could hear baby shrill in back ground.  Temp 99.! Instruction given to mom to report to PCP office for eval and to notify BCOH of disposition mother verbalized understanding
Approximately 2 hours after receiving vaccine client reported extreme pain at injection site, extreme thirst, shaking, freezing, slight breathing difficulty (no oxygen was needed in ER), Heart Rate over 140 at increased blood pressure.
Numbness and tingling of the face. Racing heartbeat. Mental Confusion. Patient went to ER and was given Benadryl after which the symptoms remitted.
Patient c/o tingling of face and pressure in the head. Pt states she has tingling of cheeks + head pressure. No other symptoms Exam - unremarkable by then Throat WNL Plan - F/u with PCP
Information has been received from a 37 year old female consumer who in 1993 was vaccinated 3 times with Hep-B vaccine recombinant (yeast) 10 mcg IM. In 2001, during pre-op testing for a cholecystectomy, lab blood work revealed that the pt was A, B, C, negative and her liver enzymes were elevated. The physician re-ran the liver enzyme test and it was normal. On 6/8/01, the pt underwent a cholecystectomy and during the procedure a liver biopsy was performed and revealed chronic hepatitis grade 2 and an inflammed liver. The pt reported that her medical history was such that she could only assume that her experience was from the vaccination. Upon internal review, the hepatitis was considered to be an "Other Important Medical Event". Additional information has been requested. F/U from the pt's physician it was reported that the pt did not have an adverse event after vaccination and that she did not have chronic hepatitis. No further info is available. F/U info from a woman in the physician's office noted that the pt's records indicated that she was not on any medications. The woman stated that she did recall that the pt was extremely anxious. No further info is available. F/U from a physician noted that this case was "an absolute non-issue". He stated that the pt did not have liver disease and there was no relation to her liver tests results and the vaccine. The physician stated that the pt had a gallstone problem. No further information is available. This report no longer meets the criteria for expedited submission because the serious event of hepatitis was removed as an adverse event.
Vaccine given 8/4/09;  Seen on 8/6/09 with 12cmx9cm localized reaction- red, swollen, warm with central urticaria.
About one year after receiving the Johnson and Johnson vaccine, I experienced what I thought was a heart attack while at work. My chest was hurting, my pulse went up to 160 resting and my hands and feet went numb. My wife drove me to the ER and they ran multiple tests. I had blood work drawn, an EKG and an X-Ray. I was put on a saline drip while there, but that is it. The hospital was not able to locate anything that may have caused the complications I was experiencing. I went to see my PCP and she has set me up with a Cardiologist. I will not see them for another three weeks. I'm still experiencing a spike in my heartrate even while doing something as simple as going to another room. I have been put on restrictions from my PCP to try and rule out certain options as for what could be causing the spike in my heartrate.
CHILLS, FEVER, HEADACHE, CELLULITIS IN LEFT ARM. TREATED WITH ANTIBIOTICS INJECTION, ORAL AND IV DRIP ANTIBIOTICS. SAW DR. 9/25, 9/26, 9/27, 9/28 AND 10/1.
Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2021 at 4:00 PM, 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 30-Dec-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). At the time of the report, PAIN IN EXTREMITY (Arm sore) had not resolved.            Concomitant medications were not reported.  Patient arm was really sore right now (at the time of report). She was asking for treatment recommendation. Can she take Aleve or ibuprofen. She had received the first two doses from Moderna as well. The soreness started not right after the  injection.
Rapid onset within 3 hours: pain first, stomach; 2nd back; third arms; fourth legs; fifth neck (sequentially). Ear ache and sore throat. MD Dx: Throat infection and reaction to immunization. Tx: ABX, medicated with codeine. No injection site trauma. As of 10/21, complaints resolving, only minor discomfort remains.
LMP 9/15/21, first positive pregnancy test 10/20/21. first appointment with OBGYN 11/5/21 and US showed gestational sac without pregnancy content (measuring 4 weeks, 6 days). I started light cramping and bleeding bright red blood 11/6/21 afternoon and started passing clots and material in the evening with more intense, severe cramps/ contractions.
First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.
Pt experienced dizziness 5 min post receiving Tdap/Menveo/HPV-9- pt became clammy and nauseous- BP and P monitored - low. Pt kept X 20 min- sucker and juice given prior to vaccines- finished both.  Put cool pack on head- 20 min post vaccines pt felt much better- BP and P back to normal. Left with mom after being checked by Dr. No injury.
Felt lightheaded and nauseous. Sat down and passed out. Regained consciousness and had to lay down for several hours.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4482491-00 (AbbVie).  A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for hidradenitis; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter considered "covid-19" related to BNT162b2.  Additional information: In Jul2022, the patient experienced SICK WITH COVID. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of SICK WITH COVID was not provided. Drug: Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Unknown. Causality: Causality as per reporter (Drug/Vaccine): Possible. Did Event Abate After Stopping Drug? NA  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 information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:54 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
the flu shot was VERY painful, felt like hot metal being injected. I've never had a flu shot hurt like that before and i get one every year.  am questioning safety of what i was injected with.  i told nurse that hurt badly, she said she used the square needle.  wouldn't let me watch what she was doing either.   angel of death? or black widow?
marked erythema, edema & tenderness over upper arm; rx w/ice packs & DPH
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored dose of PROQUAD lot # M044020 for prophylaxis. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006677: US-009507513-1707USA006678: US-009507513-1707USA006679: US-009507513-1707USA006675: US-009507513-1707USA006676: US-009507513-1707USA006507:
Painful, itchy, firm, hot lump at injection site that developed within a few hours of booster (third) dose
Vomiting. Lowered or loss of consciousness. Fussiness. Pale. Weakness. The follow up received on 2/5/03 states diagnosed with milk allergy.
Patient presented 2 days after vaccine was given with new onset of symptoms that began yesterday.  They included swelling and puritis around both eyes, slight edema of lower lip, and a flat puretic rash on her neck.  She denies any c/o sob.  She was instructed to begin Claritin now and then tonight at bedtime to take 25mg of bendryl.  She was instruced to go directly to the ER if any difficulty in breathing occurs.  She did not identify any risk factors prior to the vaccine and she has had the flu vaccine in the past and did not have any problems.
I experienced 100 2.temp; extremely sore arm at the injection site.; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I experienced 100 2.temp"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "extremely sore arm at the injection site."; CHILLS (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient just had 4th vaccine yesterday 27Sep2023 At (Pharmacy withheld) with Pfizer. Patient experienced 100 2.temp extremely sore arm at the injection site, chills was hit pretty hard.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
2 hour 30 min after injection severe pain radiating down left arm from shoulder to forearm, unable to raise left arm. Persists through 12/24/2020. Acetaminophen start  at midnight every 6 hours without relief. Pain exacerbated with any movement of left arm.  Injection site high up on upper arm close to shoulder.
Temp-102 x's 2 days- Fatigue-Weakness- Left armpit sore swollen.
The patient did not have an adverse reaction, the patient was asymptomatic. The appropriate dose was given  7 days early. The patient was notified of the early dose and advised to return for the appropriate  time for the vaccine to be effective. the patient was rescheduled for the correct time for his second dose
Dose Given 1/20/21, sore arm after 1/20/21. Migraine headache developed evening 1/21 Intermittent tinnitus developed 1/21/21. Woke up with subjective hearing loss/fullness Left ear and mild vertigo with nystagmus on morning of  1/23/21.
About 2 hours after my first dose, I lost feeling in both my lower arms and hands. I was barely able to move my fingers or wrists. This lasted about 30 minutes. With my second dose, taken 2/1/2021, also the Pfizer vaccine, I was very ill in the middle night (vaccine taken at 11:15am). I had temperature of 102.5F, severe chills, trembling, and moving took too much effort. I was bedridden for about 8 hours. The symptoms improved quickly there after.
Client initially reported tingling/numbness in right ear. This progressed over next  ten minutes to tingling/numbness across her face and the roof of her mouth, she also reported difficulty swallowing. Client observed to be flushing across face and upper arms.  EMS called and transported client to local ER for evaluation.