chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no symptoms or additional adverse effects reported; incorrect product storage; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided.  On 26-JUN-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally second dose, lot # S005874, was a valid lot #, expiration date was reported as 03-OCT-2020, however after validation, expiration date was confirmed to be 31-OCT-2020. The vaccine was stored in 47.1 degrees Fahrenheit for 7 minutes. There was no previous temperature excursions. The storage was recorded by Digital Data Logger. There were no symptoms or additional adverse effects reported.
DAY AFTER INJECTION ARM SWOLLEN TO SIZE OF JAR LID AND WAS LUMPTY.
Patient received Smallpox vaccine on March 04 2003.  He was deployed on April 25 had an episode of exertional chest pain.  He was evacuated from theater back home.  He underwent two angiocatheterizations, with angioplasty and two stent placements.  His primary diagnosis was Coronary Artery Disease, with a possible mild AMI.
28 Year old  Female  presenting with chest pain for 2 days. Pain started gradually. It is described as pressure, radiating into nowhere. Pain is described as mild upon onset and is currently moderate. Pain is not worse with exercise. Patient has no decrease in exercise tolerance recently.  No new leg swelling.  Positive for nausea, vomiting, and diarrhea.  Multiple episodes of vomiting from approximately seven times today without blood.  Multiple episodes of diarrhea daily approximately 10 episodes per day without blood.  Patient has a history of C. difficile but has not been on antibiotics within the last 2 months.  Patient also had fever of 103 degrees Fahrenheit at home and she treated this with Tylenol prior to arrival.  She had COVID back in Feb 2021.
THIS is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that I received my second vaccine, the Pfizer vaccine a week ago on 14Apr2021 and it's been exactly one week after and last night I woke up around 10:30 to remove a long sleeve shirt I had on. I fell asleep while listening to a ball game and when I got up to remove it I had thinking spell, a dizzy spell and I felt rather weak and actually did hit the floor then I got up, I am fine, but I was just wondering this the reaction to the virus after a week. Could that possibly happen? that could get it dizzy spell along with feeling weak? When I got up the next morning I woke up carefully and I used the bed for support and everything and I was dizzy for about the first hour till I finally got some food in me and as the day went on I got more active and I don't have the dizzy spell anymore nor do I feel restless or  weak. So, I was just wondering could it be a reaction to the virus. Outcome of events was unknown.   No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
Chest pain; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: 6204) via an unspecified route of administration in Arm Left on 18Mar2021 10:45 as DOSE 2, SINGLE for covid-19 immunisation (at pharmacy). Patient didn't had covid prior to vaccination, patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medications lisinopril, allopurinol, foltanx, cartia xt, Motrin within 2weeks. Medical history included arthritis from an unknown date and unknown if ongoing, herpes zoster from 04Feb2020 to an unknown date, analgesic therapy from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; allopurinol (ALLOPURINOL) taken for an unspecified indication, start and stop date were not reported; calcium levomefolate, mecobalamin, pyridoxal phosphate (FOLTANX RF) taken for an unspecified indication, start and stop date were not reported; diltiazem hydrochloride (CARTIA XT) taken for an unspecified indication, start and stop date were not reported; ibuprofen (MOTRIN [IBUPROFEN]) taken for analgesic therapy, start and stop date were not reported; paracetamol (TYLENOL) taken for analgesic therapy, start and stop date were not reported. Patient had no allergies. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection,Batch/Lot Number:EN 6202) via unspecified route of administration on 25Feb2021 15:45 as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced chest pain on 30Mar2021 14:00. Therapeutic measures were taken as a result of chest pain was antiviral and pain prescription. The outcome of the event chest pain was recovering.  No follow-up attempts are possible; No further information is expected.
SORENESS OF BOTH ARM; This spontaneous report received from a consumer concerned an 83-year-old female. The patient's weight was 180 pounds, and height was 148 centimeters. The patient's concurrent conditions included high-blood pressure- 142/69, non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies. There was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21L, and batch number: 206A21L expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced soreness of both arm. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 142/69 mmHg.  Treatment medications (dates unspecified) included: Paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness of both arm. This report was non-serious.
My right eye had a large subconjunctival hemorrhage which was verified my eye doctor today. I have never had anything like this and I am in good health. None of the usual risk factors are present. I am a nurse and I believe this is a result of the vaccination.
102 fever; injection site pain and swelling of 3 inches by 3 inches; joint pain; headache; slight nausea and disorientation.
Systemic: panic attack-Mild, Additional Details: Patient had a panic attack about 5 min after injection.  she stayed in the pharmacy under observation for 35 min.  a friend drove her home
Moderna COVID-19 Vaccine EUA:  4 hours after the injection, started the benign pain around the injection hole. It gradually disappeared over the following 3 days. In the 1st night after the injection, the immune system started fighting the vaccine, culminating in 39°C fever the following morning. Dozing in bed in polar dress under a triple blanket the entire day got the fever down to below 38°C. It was gone the next morning below 37°C.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Walnuts and Pecans" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19 as Paxlovid from 11Oct2023 to 15Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Thalamus stroke Visual disturbances, loss of balance, excessive sleepiness, garbled speech, left sided weakness
No side effects until almost 30 minutes later. Extreme fatigue, headache started setting in, and body aches. The headache and body aches are moderate however, the fatigue is extreme. Headache getting worse with flu like symptoms. Anxiety set in to a full blown panic attack approximately 3 hours after administration.
Swollen and painful under arm lymp nodes Swollen upper arm late effect 7 days
My arm began hurting within 4 hours of the administration and by 0130 1/9, I was in severe pain and had loss of range of motion. It did improve and by Wednesday 1/13 was almost resolved. It again started to have increased soreness and loss of range of motion over the weekend 1/16-1/17, and on Monday 1/18 I called my doctor. It again improved on Wednesday 1/20, but I kept my appointment and my doctor ordered an MRI.
ongoing headaches, tachycardia, weakness, fatigue, chills (10 days)
Covid 19 symptoms except significantly more severe  than when I contracted the disease initially (Nov 2020). Original illness required a 4 day stay in Intensive Care. Although more severe, fortunately the symptoms persisted for only 14 hours.
Arm soreness within an hour, followed by body aches, low grade fever, dizziness. Had pre-syncopal episode around 5pm, aborted by laying down abruptly. Left work early. Had significant body aches and chills overnight, and no sleep at all. Left work early, called in sick the next day. Medicated with acetaminophen 1000mg every 6 hours.
lump on rt upper thigh first noticed 3MAY95, 630PM when getting ready to give a bath; saw MD in ER 8:00; also pt has a fine macular rash on face et back-pink in color; lump is approx 3 cm anterior surface upper rt thigh;
Adverse Events: shortness of breath, chest pressure and tightness, chills, fever, fatigue, tiredness,  cough, chest tightness when stand Outcome: Myocarditis,
pt recv vax 28MAY97 & the next day parents reported to MD that pt had exp 3 episodes of facial flushing & had stiffness in bilat extremities;
Administrative error by the staff where she had her shot; Only a slight rash on the vaccination site; Fatigue; headache that started from mouth then jaw; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: not reported) dose 3 via an unspecified route of administration on 13Oct2021 as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1 and dose 2 single for covid-19 immunization. On an unspecified date in Oct2021, it was reported that patient had administrative error by the staff where she had her shot. The staff encoded the wrong date of birth, patient had no major side effects, only a slight rash on the vaccination site, fatigue, and headache that started from the mouth then jaw. It was reported that patient realized about the administrative error after visiting her gynecologist. The outcome of events was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
WARM TO TOUCH, SWELLING, PAIN, BLISTERS, RASH, REDNESS AT SITE.
LOST ABILITY TO SWEAT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On  2021, the subject experienced lost ability to sweat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lost ability to sweat was not reported. This report was non-serious.
Patient has not reported any adverse events; vaccine was given after the Beyond Use date of 3/3/2023
Arm swelling down to elbow red very sore achy Inness fatigue headache went to nurse practitioner after second day was given steroid cream and prednisone pills was much better in a couple days but felt fatigue for a few weeks
SFC recieved Flu vaccine at 12:15 pm 4 OCT 10 with no immediate reaction. PT presented to Clinic at 0810 5 OCT 10 stating that 10 hours after recieving the flu shot he broke out in a rash he then took Benadryl for symptoms. PT woke in the morning with facial swelling then came to clinic. PT arrived ambulatory in stable condition without distress. PT was treated with Dexamethasone 16mg, and given Zantac, prednisone, and hydroxyzine to go home with. PT was discharged from clinic at 0847 and stated felt better prior to leaving.
Case number PHEH2014US011937, is an initial spontaneous report from a pharmacist received on 12 Jun 2014. This report refers to a 17 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The pharmacist reported that the patient had received only the CYW-135 liquid component of MENVEO (batch number: M13046) intramuscular on 11 Jun 2014. No adverse event was reported.
Information regarding PREVNAR was received from a healthcare professional regarding a 20-month-old male patient who experienced low PREVNAR titer levels for Serotypes 4, 9 and 23. The patient received the fourth dose on 08-May-2009. After testing on 08-Jan-2010 for immunogenicity, it was revealed that the patient had low PREVNAR titer levels for Serotypes 4, 9 and 23. The outcome is unknown. No additional information was available at the time of this report.
Patient was scheduled for 15 month shots 11/8/2011.  Patient was given DTaP, Hib, MMR, and was inadvertently given Zostavax instead of varicella.  0.5ml Error was discovered when entering vaccines.  Parents were notified and explained.  No adverse reactions reported.
Sweating all night at home, reports diarrhea, feels ill but went school - educated mom may give TYELNOL/Ibuprofen, BENADRYL
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 09-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K000456 and expiry date: 15-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Rash that progressed into hives by 11/17/2009; shot epidefrine and Atarax oral; Atarax and Zyrtec prescribed.
Significant diarrhea without blood up to 8-10 stool a day for 6 days.
Night of vaccination had fever to 102.0. Vomited after dinner and x 3 on 9/20/2017. Afebrile 9/21/2017.
Headache; facial and feet numbness/Numbness of the face in temple area/back of head like cheek bones cheek temples, nose area as well got numb; numb from lip, top of lip; tingling sensation; This is a spontaneous case received from a contactable two consumers (one was patient) via medical information team and Pfizer Sponsored Program.   A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 05Apr2021 (age at vaccination 50-year-old) as dose 1 single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced facial and feet numbness within 15 min of having vaccine and lasted several hours, Numbness of the face in temple area, turned numb from lip, top of lip to back of head like cheek bones, cheek temples, nose area as well got numb and some tingling sensation as if she had nonvaccine on 05Apr2021. The next day had a slight headache on 06Apr2021. Asking if it was safe for her to get the 2nd shot. Patient was not taking any medications. The outcome of events was unknown.   No follow-up attempts were needed; information about lot/batch number could not be obtained.
Immunization: COVID-19 PFizer-BioNtech 12yrs-adult, external adminstration  I95.9 HYPOTENSION 4/1/2022 ALZHEIMERS DISEASE
temp A 101 w/APAP, screamed for 3-4 hrs high pitched pt unconsolable; leg red & swollen where recvd DTP vax; irritable & waking q 1 to 2 hrs throughout the noc;
No reaction at time of vaccination.  Reported by family that pt. died on 1/29/2021. Coroner does not believe this was related to vaccine, but requested to report to VAERs
Pt was diagnosed with COVID-19 on 3/5/22. Some chest pain, shortness of breath, diaphoresis, and worsening dyspnea
Pfizer / BioNTech: Dose Number: 1, 2 ,3 4; Paxlovid: Treatment of COVID-19/ testing positive; Pfizer / BioNTech: Dose Number: 1, 2 ,3 4; Paxlovid: Treatment of COVID-19/ testing positive; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 61-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), on 29Nov2021 as dose 3 (booster), single (Lot number: FJ1620) and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Pfizer / BioNTech: Dose Number: 1, 2 ,3 4; Paxlovid: Treatment of COVID-19/ testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: again 6 days after completion of Paxlovid; (27Jun2022) Positive, notes: again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Took Paxlovid for breakthrough infection on 17Jun (completed 21Jun2022) with subsequent recurrence of Covid symptoms and testing positive again 6 days after completion of Paxlovid (testing positive again on 27Jun2022).  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 in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
COVID-19 breakthrough. It started out with a kind of respiratory pressure and heart burn. As it progressed I got body aches and non-productive painful cough, transient headache, lose of smell and fatigue. I also had runny nose and sneezing. I still have fatigue, infrequent productive cough and runny nose. My sense of smell is about 40 percent.
11:00 pt reports "mild oral itching, breathing feels different , not asthma related" 11:05 pt brought to Triage 1 reports "throat feels tight" 11:06 MD consult, HR 78, 02 98%, RA 11:20 pt given Benadryl PO 50mg.
Once in the monitoring area, the patient (who is a Facility staff member) was sweating profusely, had increased BP, was unresponsive (but was conscious). She was tended to by the Facility Director of Nursing. The facility called 911, EMT's took pt to hospital. She was released after 2 hours and was back at work the next day.
there could be a link between Polyarteritis Nodosa (PAN) with the Pfizer Covid-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: POLYARTERITIS NODOSA (medically significant), outcome "unknown", described as "there could be a link between Polyarteritis Nodosa (PAN) with the Pfizer Covid-19 vaccine". Clinical course: Caller wants to know if there are any AE reports of Polyarteritis Nodosa (PAN) or anyone that has developed this condition. Caller wants to check if there are reports of Polyarteritis Nodosa outside the clinical trials. Caller states that this condition (Polyarteritis Nodosa) is serious as her brother died from it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I IMMEDIATELY FELT LIGHT HEADED WITH A FAST HEARTBEAT AND UNSTEADY. MY HEAD FELT VERY HEAVY AND MY BLOOD PRESSURE ( WHICH IS NORMALLY LOW WENT TO 160/86). AFTER ABOUT 45 MINUTES I FELT WELL ENOUGH TO DRIVE HOME. MY LAST BP READING WAS 150/75. AGAIN TODAY  ( 1 DAY LATER )  AT MID-MORNING I GOT UP FROM DESK AND FELT LIGHT-HEADED AND JUST A BIT UNSTEADY. NOT SURE IF THIS IS AN ALLERGIC REACTION BUT ACCORDING TO PFIZER'S FACT SHEET "FAST HEARTBEAT AND DIZZINESS / WEAKNESS" ARE CONSIDERED SEVERE ALLERGIC REACTIONS!
Difficulty breathing upon going to bed/ shortness of breath had to sleep  flat on my stomach constantly blowing for 3-5 hours until I fell asleep from exhaustion of standing in line for five hours to get vaccinated. Awoke with rash on both forearms. I awoke this morning and breathing was "normal".  I drank lots of water this morning to combat rash and it seems to be going away.
Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101.9) Body ache Chills Upset stomach/ no appetite
Appox. 2 mins after pt. received a flu vaccine, she became unconscious and unresponsive. Pt was sitting in a chair with her head slumped to the left with her eyes flickering. Pt was still breathing but would not respond. I call for help immediately. Staff came in the room to assist. Pt placed on oxygen via face mask at 10LPM IV 20g started in (R) hand with NS running wide open. EKG and blood glucose started 911 was called for Pt. Pt was alert and oriented when leaving.
PAIN AND SLIGHT SWELLING IN INJECTION ARM. NO REDNESS, NO RASH. STARTED IN AFTERNOON AFTER 1ST DOSE OF MODERNA. CONTINUED TO TODAY (6/29/2021) AND PATIENT STATED THEY WERE ON THEIR WAY TO THE PHYSICIAN TO BE EVALUATED. PATIENT WAS AMBULATORY AND, OTHER THAN PAIN AT INJECTION SITE, SEEMED TO BE IN GOOD HEALTH.
I had an "off" taste when eating & drinking , plus a funny smell when being in our truck. However, I was the only person that could smell it. It was like an antiseptic smell & if you could imagine what that might taste like, that is the best way to describe the strange test I got while eating & drinking. This lasted about a week. Plus, my left arm where I received the injection was sore for about 2 - 3 days, but I suppose that's to be expected.