chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTERED FIRST DOSE MODERNA VACCINE: APPROX 10 MINUTES POST VACCINATION PATIENT STATED SHE WAS EXPERIENCING LIGHTHEADED, DIZZINESS. I HAD PATIENT LIE DOWN W/ FEET ELEVATED AND PLACED ICE PACK ON BACK OF NECK.  SYMPTOMS IMPROVED OVER 10 MINUTES. PATIENT WAS ABLE TO SIT WITHOUT RETURN OF SYMPTOMS. PATIENT KEPT ICE PACK ON BACK OF NECK FOR ADDITIONAL 15 MINUTES. PATIENT REMAINED AT PHARMACY FOR 30 MINUTES SYMPTOM FREE
poor balance-possible labrynthitis x 5 days;post vax;s/s lasted 2weeks;saw MD 3/31/99;
Bell's palsy Lt. Tx with Prednisone in decreased dosage. 12/3 and 12/9/2009 ED records for 12/1/2009, patient with c/o's lt facial droop, lt facial tingling, unable to close lt eye, limited lt eyebrow movement and slurred speech. Rx'd prednisone, Dc Dx: Bell's Palsy
Dizzy; Nauseous; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 04May2021 13:00 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received BNT162B2 for covid-19 immunization. It was reported that caller and her husband received the second dose of the Pfizer Covid-19 vaccine around 1 p.m. today. Caller stated that her husband started feeling dizzy and nauseous around 7-7:30 p.m. Caller stated the onset of these symptoms occurred very quickly. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No other AE; she discovered she was pregnant when the second dose was administered; This spontaneous retrospective report was received from a 37-year-old pregnant female patient who reported on herself. There was no information about the patient's concomitant therapies or medical history provided. Her concurrent conditions included gestational diabetes.  On an unknown date in October or November 2020, the patient was administered the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in December 2020, the patient became pregnant with last menstrual period (LMP) date calculated as an unspecified date in 2020. On an unknown date in the first week of January 2021, the patient was administered the second dose of the suspect vaccine, in the top shoulder muscle as HPV prevention (exact dose, route of administration, lot # and expiration date were not reported). At the reporting time, the doctor told her she could not receive the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) since she was pregnant. Estimated date of delivery (EDD) was 19-SEP-2021 (exposure during pregnancy). She gave birth on an an unknown date in 2021, the pregnancy outcome was live birth, fetal outcome was unknown. No adverse effects were reported.
CHILLS AND FEVER STARTED AT 8 PM, TEMPERATURE 101.8, AT 9:30 PM HEART RATE ELEVATED, WEAK, HEADACHE, BP 160/90, TOOK ONE 8 HOUR EXTRA STRENGTH TYLENOL AT MIDNIGHT. FEVER LESSENED AFTER 2 HOURS.UNABLE TO SLEEP, HEART RATE 107 ALL NIGHT, TEMP 100 F AT 10:30 AM SEPT 18. RESTING HEART RATE 90 S ALL DAY. FEVER GONE BY END OF THE DAY, BP STILL ELEVATED ALL DAY. HEADACHE/WEAK/TIRED. SEPT 19 FELT BETTER. BP AND HR BACK TO NORMAL BY 8 PM 120/80, HR 70 BPM. PERSISTANT HEADACHE UNTIL SEPT 20.
local & regional inj site pain & swelling achiness, chills, fatigue, fever, nausea, arthralgia, back pain, myalgia, stiffness, dizziness, h/a occurred 3hr post inj tx w/ibuprofen sx subsided w/in 24hr;
ED to Hosp-Admission Discharged  9/15/2021 - 9/20/2021 (5 days) Hospital, MD Last attending ? Treatment team COVID-19   Hospital Problems          POA   * (Principal) COVID-19 Yes       Hypothyroidism Yes       Essential hypertension Yes       Chronic renal insufficiency, stage III (moderate) Yes       Hyponatremia Yes       Lab test positive for detection of COVID-19 virus Yes       Syncope and collapse Yes       Bradycardia Yes       PVC's (premature ventricular contractions) Yes          HPI:Patient is an 88 y.o. male.    Past medical history of chronic kidney disease stage III, hypertension, hypothyroidism, dyslipidemia, BPH, presented to the ER and was brought by an ambulance for evaluation of syncopal episode. Patient has been feeling pretty weak and having some mild cough.  He is also reporting some shortness of breath.  Patient also reported mild decrease in appetite.   Vitals in the ER showed mild bradycardia, lowest heart rate was 48, patient was started on BiPAP treatment but was not very hypoxemic.  Patient will obviously be started on oxygen treatment by nasal cannula Labs reviewed CBC and CMP and showed chronic anemia and hemoglobin was 11, acute hyponatremia, CKD stage III with GFR of 54.2 and normal BUN and creatinine. Troponin was minimally elevated.  Troponin was 0.03. ABG showed pH of 7.42 PCO2 of 37 and PO2 of 148 on current BiPAP treatment. COVID-19 was positive. Lactic acid was normal. UA was abnormal and urine and blood culture was obtained. Chest x-ray and CT chest was reviewed and was unremarkable.  CT chest showed possible bibasilar atelectasis versus early pneumonia.  CTA chest ruled out PE. CT head was unremarkable. EKG shows sinus bradycardia with first-degree AV block and right bundle branch block. Vitals was consulted   Hospital Course:   Patient was admitted after having a syncopal event at home.  He was found to be Covid positive, dehydrated and having profuse diarrhea.  Initially a rectal tube was placed however he stopped having diarrhea.  He did have stool studies including C. difficile performed and were negative.  It is thought that the diarrhea was solely related to his COVID-19.  He was treated with IV fluids and did not require any supplemental oxygen.  Echocardiogram was recommended due to his prior history of having moderately severe aortic stenosis and thought that this could be contributing to his syncopal episode especially if it had gotten worse.  Additionally he could have had his syncopal episode simply from being dehydrated and from being in a weakened state from being elderly and Covid positive.  PT and OT did work with the patient and it was felt that the patient was in a weakened state where rehab would be beneficial.  For that reason he was discharged to rehab where he and his wife will continue to improve their overall strength and functioning prior to returning home.  He does have hyponatremia and may need more liberalization of salt intake.
Body aches, pain & fever for 24 hours. Fever came back in less than 12 hours along with severe pain in the abdomen. Pain is so severe he cannot stand up straight, can barely walk and curls into the fetal position. This has been going on from Wednesday (8/18) and is still happening as I write this on Saturday (8/21).  I took him to a Medical Center,  on Friday (8/20) to have him checked for an appendicitis. The only thing they found was that he was slightly dehydrated. He was given a bag of fluids at the ER.  Since, he has been drinking water and Gatorade to stay hydrated.
I had mild symptoms, a runny nose, fatigue, muscle ache, I used a home COVID-19 test, that came back positive. I called my doctor to let her know I was positive who called in a prescription for Paxlovid. I started taking the medication on Monday. I was out of town, I cancelled my flight home, drove home instead. I was testing negative by March 26, 2023. I did get rebound on March 28, 2023. I took a second course of the Paxlovid. I am still not feeling very sick and awaiting the test to say negative so that I can come out of the house.
Sudden  sensorineural Hearing loss, tinnitus. Treatments methlyprednsolone (first) then high dose prednisone (second)
Pain at the injection site, sore arm; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 4-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2022 as dose 1, single (Lot number: FT9142, Expiration Date: Jan2023) at the age of 4 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Pain at the injection site, sore arm".  Additional Information: The patient had pain at the injection site, sore arm, with the first dose. No additional vaccines was administered on same date of the Pfizer suspect. The patient did not receive other vaccines within four weeks prior to COVID vaccine. No adverse event following prior vaccinations. The NDC number was 59267007804.
Left leg, swelling, and pain. Doesn't seem to be subsiding at this time.
On day 10 after the vaccine, 1/7/2021, a rash developed at the injection site.  Initially a red circle about the size of a nickel.  Has now spread to about a 2-3 inch area of pink/redness.  Occasional itchiness.  Slight warmth to the touch.  No pain.
U07.1 - Lab test positive for detection of COVID-19 virus U07.1 - COVID-19
26yo female pt arrived with left ear and left eye pain. Pt has swelling in her left eye. Pt complains that pain level is 8/10. Pt received smallpox vaccine 21APR2015 and complained of throbbing eye discomfort over the weekend. Pt complains of inability to sleep at night. Pt has sensitivity to light and discharge from left eye. Pt explained that discomfort escalated to pain 30APR2015, when she woke up her eye was red, burning, and had pain 5/10. Pt has no radiating pain. Pt complains of left ear pain beginning 30APR2015 4/10 and today 7/10. Pt taking Advil for pain. Pt complains of constant pain and has not been able to alleviate pain.
fever; aches, and pain; first dose over a year ago; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced fever, pain and incomplete course of vaccination. On an unknown date, the outcome of the fever and pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for 2nd dose. The reporter stated feeling there was no need to file adverse event, so did not provide further demographics. The patient experienced fever, aches and pain for a few days. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details were provided.   Follow up information was received on 28th October 2021: The reporter was unable to contact after corresponding phone attempts. The outcome of the callback performed was reported as FU NO - Permission Denied.
fatigue, headache, muscle ache - especially abdominal muscle ache, slight fever. These have lasted for 4 days so far. No treatment given other than bed rest.
One week ago well check-had PENTACEL in left thigh-knot underneath and raised-was given a prescription for KEFLEX yesterday to treat it with a dx of cellulitis, initially rash was just over the leg-at basically the injection site-but before giving KEFLEX he started breaking out everywhere-every time he has gotten PENTACEL he has gotten a mild reaction-but nothing like this-NOW has hives multiple places-no new foods-no new detergent- have tried BENADRYL-but is has not helped much-rash for a couple of days-worse overnight so came back for a second eval.
Pt. presented with leg pain up until he started a fever 5 days after his vaccinations on the 16th of June 16th, 2013. This was not his first adverse reaction. He presented with 104 fever and seizure activity after each well visit vaccine. This one was the first where we were worried for his fever getting so severe and at the point made the appointment to check on him on the 17th of June 2013.
Monkeypox despite completion of Jynneos vaccination; Case reference number US-BN-2022-004175 is a spontaneous case report initially received on 21-Oct-22 from physician via Bavarian Nordic (reference: BN_2022_02595) and concerns a patient of unknown age or gender.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, as reported in July, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose reported as 'first full dose', through unknown route of administration, at unknown anatomical location, for unknown indication.  On an unspecified date, as reported in August, the patient was vaccinated with a second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose reported as 'second microdose', through unknown route of administration, at unknown anatomical location, for unknown indication.  On unspecified date, the patient developed monkeypox despite completion of Jynneos vaccination.  As reported, the patient developed milder symptoms.  At the time of this report, the event outcome was unknown.   The reporter did not provide a seriousness assessment and a causality assessment.  This case is linked with the case US-BN-2022-004174 (same reporter).  No further information was provided.; Reporter's Comments: A patient of unknown age and gender developed monkeypox (patient developed milder symptoms) despite completion of Jynneos vaccination. Monkeypox are unlisted and unexpected according to CCDS v1 and USPI. Vaccination with Jynneos may not protect all recipients and may not result in protection in all cases. The outcome was unknown. The patient's medical history and concomitant medications details were not provided. Causality is therefore assessed as not related to suspect product but to environmental factors. The case is serious due to medical significance.; Sender's Comments: A patient of unknown age and gender developed monkeypox (patient developed milder symptoms) despite completion of Jynneos vaccination. Monkeypox are unlisted and unexpected according to CCDS v1 and USPI. Vaccination with Jynneos may not protect all recipients and may not result in protection in all cases. The outcome was unknown. The patient's medical history and concomitant medications details were not provided. Causality is therefore assessed as not related to suspect product but to environmental factors. The case is serious due to medical significance.
Client verbalized feeling lightheadedness.  Evaluated by Fire Rescue.  Patient was released to go home after symptoms were resolved at 10:58 am.
Friend called reported pt exp inc temp since nite p/vax, chills, achey feeling all over; t103.7 to ER poss virus or rxn to MMR; 30AUG91 back pain, fever seems to be going down;
pt recvd vax & went to ER w/a sinus infect; treated w/Biaxin; morning of 3JAN93 devel itchiness of the scalp & then later hives all over boyd; went to ER 4JAN93 & discontinued Biaxin & Entex;
Developed tinnitus was within 1 week of 2nd dose, gradually worsened and became constant within a week of onset, still have today. Did some research, attempted wax cleaning of ears, lifestyle change (no alcohol, avoided sugars, but unable to avoid my caffeine), bought herbal supplements called tinnitus 911, nothing helping. Just a constant high pitched whine I hear in both ears all the time, some days louder than others. I do not have the other symptoms often associated with this (nausea or vertigo).
generalized rash & arthralgias beginning 5 days p/vax & lasting 3 days;
This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M038856 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. Lot M038856 was stored in the range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours No previous temperature excursion The call was not because of a "data logger" Additional information has been requested.
MMR/VARIVAX/HEPA/influenza given 10/23/07; Fever to 103 on 10/31/07 - 11/3/07; Rash on 11/4/07
Fever over 103 degrees.  Nausea.  Muscles stiffness.  Body aches. Headache.  Blurred vision.
Patient presented to the pharmacy on 9/6/2020 explaining she had a reaction to the Shingrix vaccine.  She presented with a red/purple rash covering her abdominal area, as well as a red rash with spots on her back.  She said symptoms started on 9/5/2020 and that the rash felt tender at the time, but that she does not feel any pain/tenderness now.
States had no problem when vaccine given, about hours later site to injection started swelling. States that every day swelling was increasing difficulty icing it. About 3 days later could not move again. Thinks had fever 7-30-11 - did not check temp. Today 8/3/11 still itching/burning sensation. Went to see MD today 8/3/11 told had infection, given antibiotics will return with MD on 8/5/11.
Pt states LT deltoid spasmed @ time of injection; numbing pain radiated down the LT arm.  Since that time, the pain has persisted, sometimes severe.
Call from friend 9/17/12. Reports patient complaint today of LA soreness last night. Now (approximately 12 noon) arm red, hot from site of injection down approximately 5" and half way around arm. Advised to call MD as it was so long after injection and see MD, apply cool compress. 9/18/12 to hospital, dx cellulitis.
Information has been received from a nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PEDVAXHIB lot # M027884 and expiration date on 19-APR-2019 (Strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. On 20-JAN-2017, the vaccines had an unspecified temperature excursion (reported as "> 8 Celsius (C) but < 25 C) for 1 hour and 26 minutes. Also it was reported that the vaccines had six previous temperature excursions of unspecified temperatures (all reported as "> 8 Celsius (C) but < 25 C) for 1 hour and 9 minutes; 22 minutes; 25 minutes; 24 minutes; 1 hour and 12 minutes and 26 minutes, on 30-NOV-2016; 22-DEC-2016; 27-DEC-2016; 06-JAN-2017; 12-JAN-2017 and 14-JAN-2017 respectively. It was confirmed that a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA002235: US-009507513-1702USA002234.
I was having difficulty breathing. I noticed my heart was racing and I had a lingering cough. I also had pain at the injection site. So I went to the urgent care center. They triaged me and advised me to take OTC medicine for muscle pain and tested for COVID which was negative. 2 weeks later I went back and they prescribed cough syrup for the lingering cough. The remaining symptoms did not get better and I tested positive for COVID 3 months later. The coughing and shortness of breath continued I was given an infusion. After the infusion I caught pneumonia. I went back to urgent care and had a breathing treatment. I was prescribed cough syrup and nasal spray. I was also diagnosed with strep as well. I was given albuterol. The cough resolved in November or December. I still have a brain fog at times.
Patient falsified DOB when registering for vaccination, stating the minor was 12/17/2016. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 2/17/2017 which made the vaccine a contraindication. No known adverse reactions noted.
Patient states that he felt fine for 30 mins after shot, then blacked out on his ride home and forgot the whole ride which was a bizarre experience. Then he had a horrific cough which he felt may have cracked a rib.
Writer spoke with the medical assistant who gave the injection error and got this information: Patient came to our clinic for a Follow UP OB visit for her first trimester. MD asked for her patient to receive the Flu vaccine. In that clinic, there is a medication refrigerator that is shared with internal medicine. Per the MA, there were many injections in that refrigerator and she grabbed the wrong medication. She was unaware and proceeded to give the patient the Influenza vaccine for 65+ in her left deltoid. After administration, she went to document it in our System, but she had issues documenting the injection. So she went to ask the RN for help. It was then did they both realize the wrong vaccine was given. They then notified the doctor and management. The patient had no adverse reactions and from the providers who reviewed this, there are no adverse reaction to fetal wellbeing. Patient was told of incident and aware there are no side effects or fetal harm. Our MA is going through educational remediation before she can restart giving injections.
headache; sore arm; This is a spontaneous report from a contactable consumer (patient).  A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6203; Expiration Date: Jun2021) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced  on an unspecified date headache and  sore arm. Outcome of events was unknown.    No follow-up attempts are possible. No further information is expected.
When I got home from work, I fell asleep, and when I woke up, I was itchy all over. I took a benadryl, and then I went to sleep. When I woke up the next morning, I still felt itchy all over. I worked from home all day today, and after seeing that no one had experienced itching all over online, I decided to schedule an appointment with my doctor for later in the afternoon (after work). Until then, I tried to use some anti-itch cream to help relieve some of the itchiness and overall discomfort. It did not help at all. By the time I went to the doctor, my arms were splotchy and my legs were a little splotchy. I had not really noticed it because I was working in very low lighting all day, but when I went in the doctor's office, the nurse asked about it. It was definitely NOT normal, and the doctor checked both of my arms, my back, my tummy, and my legs. I had some slight splotching on my legs, but my back and tummy were okay. Both of my arms had the worst of it. The doctor then gave me a steroid shot and a prescription to help with the allergic reaction.
For unknown reason (not documented in chart) patient received the first Pfizer COVID-19 Vaccine dose on 07/14/21, the  second dose of Pfizer COVID-19 Vaccine on 08/04/21 and the third/booster dose on 12/20/2021 which is earlier than the required 5 months and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.