chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A increased Anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "A increased Anxiety". Therapeutic measures were taken as a result of anxiety.  Additional information: The patient wanted to know if he should reschedule his second shot. He said he finished a Pretnizone medication saturday after having a increased Anxiety. Gathered some demographics. Failed to read ISI. Transferred to PMI. AE reported. Transferred to Fact Sheet  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case, initially received on 15-Mar-2017, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Past medical history includes egg allergy. Concomitant medication: Not reported. Administration of company drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported, Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced severe nausea and vomiting after receiving an unspecified influenza vaccine. Reporter's comments: The pharmacist reported that the patient felt that this was due to the egg content of the unspecified influenza vaccine as the patient felt she had an egg allergy.
By 1/21/21 fatigue, headache, low grade fever, and sore in right arm around the area of shot with pain in all upper right quadrant of my body. - On 1/22/21 the fatigue, headache, low grade fever (99 - 100.4), and serious pain in upper right quadrant of whole body. 1/23/21 fatigue until mid-day, no fever, no headache, body ache continued to lesser degree Aches went away in by following Saturday
Left arm very sore-4 hours after injection.  Woke up 1/13/2021 nauseous, and very cold.  Through the day at work I was very cold, headache, had body aches, had a hard time breathing, and very exhausted.  On 1/13/2021 came home from work at 5:30pm and went straight to bed.  Very cold, shivering.  later I had a fever of 103.  I took 800 mg of Ibuprofen.  During the night I was cold and had the sweats on and off.  Today. 1/14/2021 I feel fine.  Just a little tired and my arm is still very sore.  I was diagnosed with Covid-19 on 7/24/2020.
Patient's caregiver complained of redness and swelling around injection site, about the size of 2 fists.
On day 8 after injection, site of injection became swollen, warm, tender and itchy.  Redness became worse overnight and continues to spread down my arm on day 9.  Started on Keflex on day 9.  On day 10, redness continues to spread and site still hard, warm and tender.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves patient (age and gender not reported) who experienced systemic rash reaction, while he/she received vaccine FLUBLOK QIV. The patient's past medical history included food allergy (egg allergy). The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2014, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot 441253F, expiry date: 22 Feb 2015. On an unspecified date, the patient developed a non-serious systemic rash reaction (rash), unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included no lab test.) Final diagnosis was systemic rash reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for systemic rash reaction. List of documents held by sender: none.
Breakthrough case admission after 2 vaccines Pfizer 1/25/22 Lot# 33025BD;  Pfizer 2/17/22 Lot# FK9846
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, stomach pains/aches, chills, severe low back pain Narrative:
Patient starting feeling pain and swelling in her arm the night that she received the vaccine. The next day she ran a fever of 101 all day and began getting hives across her chest. She took 3 aspirin. The 3rd day the hives were gone and the swelling reduced, but there was still a dark red spot at the injection site.
Janssen 3/11/21, Moderna 11/1/21, 11/2/22, 7/22/22. Positive on 12/14/22
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 10-MAR-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2016, administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of nodule injections site in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included prematurity. Concurrent vaccination included PREVNAR (non-gsk); Wyeth Labs; unknown; unknown given on 15 June 2013. Concurrent medications included Erythromycin ethyl succinate (EES), Multivitamins + iron and Zantac. On 15 June 2013 at 22:45 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). Within an unknown number of days after vaccination with PEDIARIX, the subject experienced nodule injections site. The subject was in the neonatal intensive care unit at the time of vaccination. The pharmacist documented that the immunization series was not discontinued or delayed. At the time of reporting the event was resolved. The pharmacist reported 4 other cases. See cases A1033993A, A1033994A, A1033995A, and A1033996A for details on the other cases.
When I received the vaccination, I began to experience numbness and tingling in my left arm.  The numbness and tingling radiate down to my fingers- the ring finger and the pinky finger.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II. On an unknown date the patient experienced titer showed he was not immune to mumps or rubella. The pharmacist reported that he had titers drawn on an unspecified date and the titers showed that he was not immune to mumps or rubella but had immunity to measles. The pharmacist stated that he received a dose of M-M-R II on an unspecified date after the titers were drawn. The pharmacist reported that he does not think he has ever received a dose of M-M-R II prior to have the titers drawn but he is unsure. The outcome of titer showed he was not immune to mumps or rubella is unknown. Action taken with M-M-R II was not provided. The reporter did not report if the adverse events were related to the therapy drug. No further information was provided.
This spontaneous report as received from a nurse refers to a 55 year old patient. Medical history and concurrent conditions were not reported. On 31-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sore at injection site for four days after the shot, sore joints and back for two days, and congestion.  15 days after the shot (9/28) congestion remains (persistent) at low grade till mid-morning, low grade headaches on/off since injection (typically rare to get headaches - once every five years), and a itchy rash developed near the injection site.
Patient developed swelling in left arm day after shot was administered (3-17-04).  Mother called clinic late in day, and was advised to take child to ER secondary to mother's description of "very tight skin".  Mother took pt to ER.  Given Keflex and Benadryl in ER.  Mother brought pt to clinic 3-18-04 with left arm swelling resolving. Will follow up at clinic tomorrow PRN.  Mother given info re symptoms to report (increased swelling, fever, difficulty breathing).
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Severe
Developed itching at injection site which extended down arm and across chest approx 2 hrs after vaccination. Sxs had subsided by 4 hrs after vaccination and were totally gone the following day.
Patient fainted after getting 1st Pfizer dose. Patient stated that he hadn't had anything to eat or drink before coming in. Patient was given snacks and water. He was observed for 30 minutes and felt fine. Patient walked out the clinic without help.
as soon as vaccine was administered at 1715 Pt reported dizziness, palpitations and a sudden rush of heat w/shortness of breath. V/S checked BP 144/96 P86 T97.8 SPO2 99% room air. Electrolytes given for rehydration. Pt observed for additional 30 minutes. V/S rechecked at 1810 BP 138/82 P85 RR18 T97.8 SPO2-100% Pt reported feeling better. Discharged at 1815 Pt advised to report to ER if symptoms reoccur or worsen.
chills; This is a spontaneous report from a contactable consumer (patient).  A 45-years-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 5318, expiration date not reported), via an unspecified route of administration on the left arm, on 26Jan2021 at 09:45 at a single dose for Covid-19 immunization. The patient has no medical history and concomitant medications were not reported. The patient has no known allergies, not pregnant and no other vaccines in four weeks. The patient has no Covid prior to vaccination and not Covid tested post vaccination. The patient had chills on 27Jan2021. The patient did not receive treatment for the event. Outcome of the event was not recovered.
Participant experienced increased heart rate, and feeling hot about 2 hours after vaccinated/ no epi administered/ after ice pack to neck and resting, participant felt better.
The day of my vaccination, my arm was sore by 3PM, and I had a pretty bad headache and felt fatigue by 9PM. My left arm was sore. By bedtime, it was achy and even more sore. I woke up in the morning with extreme body pains and aches, and felt very nauseous. I could barely get out of bed. My headache felt more painful and I treaded very slightly during the day, feeling sluggish. A day or two after, my lymph nodes started swelling and I still had pretty severe body aches and some chills after the shot. I contacted my PCP who informed me to rest, take some ibuprofen, stay hydrated and ice my arm to relieve my symptoms. By about a week later, the symptoms had eased away and I was feeling better.
This spontaneous report was received from a 74-year-old female patient regarding herself. The patient's medical history included stroke. Current conditions included cancer, allergy to codeine, TOFRANIL and morphine. On an unknown date the patient was vaccinated a dose of with ZOSTAVAX (lot#, expiration date and route not reported). No concomitant medications were reported. The patient reported that after being administered the ZOSTAVAX she noticed a beet red, blister on her left arm and on the lower part of her breast. The blisters turned white and filled with puss and scabbed over. The patient had sought unspecified medical attention. No treatment was given for the events. Biopsy was performed on an unknown date in 2012, results unknown. Outcome of the reported events were unknown. Additional information has been requested.
Partial vision loss, grayed-out central arc (like Amazon smile), R eye. First 3 days detectable in light; after that only and always while dark-adapting (so 10-15 min);  x 5 weeks; then completely resolved.
02/14/06 awoke with peripheral neuropathy, 02/17/06 neuropathy progressed and continued to progress including partial left VI palsy., facial dysplasia, lower leg weakness and numbness, 2/18-3/1 received IV steroids, 3/6-3/9/06 got IVIG recovery gradual over next 2-3 months. DC Summary for DOS 02/18-03/01/06 DX:peripheral mononeuropathy multiplex. Possible subacute bacterial endocarditis. Complained of double vision and facial weakness.
Vertigo, headache, nausea/vomiting for 2 days. Occasional dizziness continued  for a month.
Day 9 post vaccination small, red, papular rash appeared on chest and back with isolated lesions on both cheeks, arms and legs. Lesions blanched and pattern was diffuse. Day 10 rash on body started to fade. Day 11 rash on face more prominent for approximately 6 hours then faded. Child remained afebrile for duration of rash, with normal activity and appetite, alert, and engaging. Day 12 rash on face fading, rash on body almost gone, no new lesions noted.
tested positive for COVID/ Got COVID after being vaccinated; tested positive for COVID/ Got COVID after being vaccinated; This is a spontaneous report from a contactable nurse and consumer. A 59-year-old female patient (unknown if pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 15Jan2021 12:30 (Lot: EL3248; Expiry: Apr2021) as 1 st dose, single then on 05Feb2021 14:15 (Lot: EL3248; Expiry: Apr2021) as 2 nd dose, single; both intramuscular in left arm (at the age of 59-years-old) for covid-19 immunisation. The vaccination facility type was workplace clinic and not administered at a military facility. It was unknown if pregnant at the time of vaccination. No additional vaccines administered on same date of bnt162b2. The patient did not have covid and was not diagnosed prior vaccination. The other vaccine in four weeks was unknown. The patient had no medical history, no family history and no concomitant medications. Since vaccination, the patient got tested on the 23Apr2021 for COVID-19 and got results back tested positive for COVID on 24Apr2021 PCR Nasal Swab with no treatment. The patient got COVID after being vaccinated. The patient got COVID after getting both vaccines. The patient started getting symptoms on Wednesday evening (on 21Apr2021). That evening she experienced a head cold, she was stuffy, headache, runny nose, and sore throat. The nurse considered the event as non-serious as did not resulted in death, non-life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. The patient wanted to call to let Pfizer know that even though she was vaccinated she did contract COVID. She had it now. The event did not require emergency room nor physician office visit. The patient thought the vaccine helped her. Her husband had COVID and she got it from him, but he didn't get vaccinated. The husband's case was a lot worse than hers and she thinks it has helped her not have a bad case. The patient was in no way blaming Pfizer, she just wanted to say that it made it less of a bad case. The outcome of the events was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Vaccination Failure, COVID-19 and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
On 12/9/99, the pt experienced a fever. On 12/12/99, she experienced over 100 chickenpox type makrs. They were reported to look like the wild type of chickenpox.
In following January, began feeling muscle pain and became progressively worse.  In February 2022, I could not put a shirt on due to shoulder pain and I could not sleep in my flat bed due to pain. I finally went to hospital and was refered to my Rheumatolgy dept. and Dr. who diagnoses PRM and puts me on Prednisone. I am getting better.
1.5" by 1.5" raised area 1 day after injection. Center 0.5" diameter area was reddish. Raised area went away perhaps a day later. Red area has progressed to a rough, red area maybe 1" diameter at time of report (12 days post injection).
patient fainted. was unconscious for 10-20 seconds. We positioned her on the floor and supported her. She regained consciousness, but was very hot and sweaty. we gave her some wate
Fever; Shivers; Tiredness; Dry mouth; Weird mouth taste and changes in flavor; Leg pain and cramps; Leg pain and cramps; Headache; General discomfort and skin hypersensitivity; General discomfort and skin hypersensitivity; Chest Pressure; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 29-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, in left arm on 25May2021 at 16:15 (at the age of 29-years-old) as 2nd dose, single for covid-19 immunization. The patient previously took the first dose of bnt162b2 (Lot number: EW0173) on 04May2021 at 04:30 PM (at the age of 29-years-old). Patient was allergic to Dewormers. The patient's concomitant medications were not reported. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25May2021, the patient experienced fever, shivers, tiredness, dry mouth, weird mouth taste and changes in flavor, leg pain and cramps, chest pressure, headache, general discomfort and skin hypersensitivity. No treatment was received by the patient. Outcome of the events was not recovered.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed 11 lesions and was diagnosed with chickenpox. The pt was afebrile.
Tinnitus-ringing in the ears. I have never had this in my life before now I do. Sometimes all day, sometimes only when laying down.
This spontaneous report was received from a registered pharmacist refers to a female patient of unknown age with allergy to sulfa and allergy to quinolones. On 29-DEC-2012 the patient was vaccinated with a dose of, .65 milliliters (ml) ZOSTAVAX (lot# H013944, expiration date 25-OCT-2013) subcutaneously in the left posterior arm. Concomitant medications included estrogen and occasional unspecified antibiotics. The patient reported that she experienced pain in her eye on an unknown date in December 2012 (reported as very soon after receiving ZOSTAVAX). The pain in her eye resolved on an unknown date. The patient developed a rash on her face that extends "from around her nose and to her eye sockets." The pharmacist had observed the rash, and she reported that the rash was "not oozing". It did not appear to be vesicular, and the patient's nurse practitioner examined the patient and said that she "had never seen anything like it". No treatment was recommended for the patient. The patient called on 04-JAN-2013. She stated on 31-DEC-2012 she began to "feel like something was in the right eye." On 02-JAN-2013 she developed "a rash on the entire right side of her face". The patient started valacyclovir on 04-JAN-2013 (reported as today). The patient had not recovered. No lab diagnostic studies were performed. The patient sought medical attention for the events by consulting the pharmacist and the nurse practitioner. Additional information has been requested.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient has hives that started 1 week after vaccine and has not resolved.  patient has taken allergy antihistamines
The patient was halfway home when they started to experience a cold shiver and felt the need to throw up. The patient pulled over on the side of the road and for the next 20 minutes was throwing up. Upon arrival at home, the patient was throwing up 2 hours after vaccination and still experiencing a cold shiver, using two blankets and a coat with no relief. The patient also reported a migraine occuring at this time which they took Tylenol for. They then proceeded to sleep for the rest of the day. The next morning patient reported throwing up had stopped and the headache was still present but alleviating.
Patient was observed post Covid-19 immunization for 30 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  warmness,flushed, "jitterness". Symptoms occurred 21 minutes into her 30 minute observation. Assessment : Time of assessment 1154.  Alert and oriented. Nausea, Unlabored, breathing, Heart rate normal Actions taken:  Vitals sign taken  1158AM 140/73,69HR, 98%, 1217PM 124/97,86HR,95% Patient was observed an additional 32 minutes after symptoms occurred.   Medications administered: No medication administered.   Disposition: Instructed to see primary doctor for non-severe reactions. Instructed to call 911 or be seen in Emergency Room for severe reactions. Patient sated "jitterness" was down from a 10 to a 2.
I had a slight headache prior to the vac one that lasted through the next day so I?m not sure if the vaccine contributed to it. Around 530 pm I started feeling fatigue and a slight wave of nausea. The nausea did not last long. By 6:30 pm  I was exhausted and began having chills - my feet especially felt cold. I then crashed hard and slept for a few hours. The next morning my arm was slightly sore and by the evening I felt extra tired.
Coworker presented at pharmacy indicating that around Christmas, patient was known to have been admitted to a clinic with paralysis from the waist down and that it was mentioned to be possibly related to the flu shot. Spouse came to pharmacy 1/27/11 to confirm.