chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 3 weeks after my second vaccination,  I started having joint paint, starting in knees and fingers...the pain got worse and worse to where I couldn?t even walk up a flight of stairs or even tie my shoes.  I went to the doctor, had blood work drawn and they could see inflammation...I was put on prednisone.  They drew more blood and over the next month my pain grew worse to where nobody could even hug me.  I was then diagnosed with Lupus.  As the pain spread, my vision became blurry.  After a retina exam the doctor could see inflammation behind my eyes and I was sent to the Hospital...I was jaundice, developed kidney disease from the lupus, pancreatitis, and vasculitis all from the lupus.  My severe case put me in the ICU and I was hospitalized for almost a month.   I am now taking prednisone, hydroxychloroquine, Losartan, and I am currently receiving chemotherapy.  I?ve received chemo for the past three months, and I have three months to go, all to suppress my immune system that just would not calm down.   I am traveling two hours away for rheumatology, ophthalmology, and chemotherapy at hospital, and my vision has not returned completely all due to inflammation and overactive immune system.
Fever to 101.4, myalgia, extreme fatigue, headache, nausea (Pfizer-BioNTech COVID-19 Vaccine EUA)
2 hours after vaccine -fever, chills muscle aches adn stiffness.  treated with ibuprofen  and cold pack.    Next day - difficulty swallowing, chewing and speaking, alot of mucus in throat, difficulty breathing .   Was lethargic, dehydrated. Used inhalers , benedryl, musinex, Still have chills and fever, and headaches.  and aches.   Difficulty eating and drinking.  Was gagging and dry heaves. Called neurologist and family doctor and suggested go to ER.  (did not go because of fear of getting covid)   Too fatigued and week to walk. No Balance.  Had electrical shocks up and down body.  Immobile.  Still experiencing immobility a week later
Blurred short (reading) distance; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 09Apr2021 at 13:15 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known drug allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 15:00, the patient experienced blurred short (reading) distance. Over the course of 2-3 days, clear sight has returned. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. It was unknown whether the patient received any treatment for the event. The clinical outcome of the event blurred short (reading) distance was resolving at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Body ache; Headache; Fever (101); This is a spontaneous report from a contactable consumer, the patient. A 54-years old non-pregnant female patient received second dose of dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via unknown route of administration in the left arm on 23Mar2021 at 10:00, (at the age of 54-years-old) as a single dose for Covid-19 immunisation. Medical history was not reported. The patient previously received clarithromycin (BIAXIN) and unspecified sulfa for unspecified indication and experienced drug allergy. Concomitant medication included Levothyroxine (MANUFACTURER UNKNOWN) and unspecified vitamins (MANUFACTURER UNKNOWN) both for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via unknown route of administration in the left arm on 02Mar2021 at 10:00 (at the age of 54-years-old) as a single dose for Covid-19 immunisation. On 24Mar2021 at 12:00, the patient experienced headache, body aches and fever (101). The patient did not receive any treatment medication for adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, body aches and fever (101) were recovered on an unknown date at the time of this report.   No follow-up attempts are needed. No further information is expected.
Lesion "blotch" on abdomen 3 inches wide, 5 inches long, tapering at ends.  Patient applied topical antibiotic, burning upon application.  Site moist.
Dime sized redness right thigh, fever, fussy 9-10 days after vaccine given.
Initial report received on 11 December 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 12-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3784AA received on 26 April 2011, lot number C3926AA received on 13 June 2011, and lot number C3879AA received on 23 August 2011. The subject developed a cough on 07 March 2012, approximately 6 months after the last dose, and a paroxysmal cough with a whoop on 15 March 2012. The subject also developed cold like symptoms on 07 March 2012, posttusive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 16 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 16 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 27 March 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
deaf in one ear; This is a spontaneous report from a contactable consumer (patient's parent). This consumer reported for a 35-year-old male patient (son). A 35-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient had his first shot over a month before and is still deaf in one ear. He is 35. Reporter has stressed to all 4 of kids, DO NOT get the vaccine shots. Those need years of research, 3-5 years minimum. Add that to your list of side effects. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Lip started to tingle at 6 pm after vaccine.  Felt feverish and had soreness in left arm and left leg over night. Woke up unable to control  left side of Face including lips. Also had left eye irritation.  Went to ER, doctor is rolling out Bells Palsy. Treatment with steroid, anti viral, eyes drops, and eye ointment.
Patient got injection at 3:15PM on 10/11/13. At 7:30PM patient states she started having cold symptoms congestion, itching, weeping green stuff from eyes, sore throat, ringing in ears. Patient took Ibuprofen and went to bed. Patient called store on 10/12/13 at 11:00AM reports feeling better now.
PAIN, REDNESS AND SWELLING AT SITE OF SHOT, CHILLS, FEVER, ACHY FEELING; TOOK ASPIRIN, 4 WITHIN 8 HOURS, FEVER SUBSIDED; REDNESS AND SWELLING AND SORENESS AT SITE OF SHOT STILL THERE ON 03/04/2019.
Bivalent vaccine was given for initial COVID dose instead of monovalent vaccine.  No adverse effects were noted, pt was called later in day and was doing well.
Patient admitted to the hospital 1/29/22 for abdominal pain.  Was found to have acute appendicitis requiring surgical intervention.   Patient had a recent COVID diagnosis prior to hospitalization and tested positive again on 1/29/22 when tested at the hospital.  Patient was discharged 2/2/22.  Previously vaccinated with Pfizer 5/8/21 & 5/29/21.
Lips trembling, feeling cold with obvious chills, observed kept warm, started feeling dizzy, started crying no difficulty breathing.
High fever 103 degrees. Sever debilitating headache for 4 days arm where shot was given (L) red and sore for 3 weeks. Flashing lights in eyes. Dizziness for 3 weeks. No appetite.
a 17 year old football player that is bed-ridden, has heart problems, and was pulled out of school since getting the vaccine; he has lost 25 pounds; They had to pull the patient out of the school because he is so sick; pain in his chest; This is a spontaneous report from a contactable consumer.  A 17-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient was a 17 year old football player that was bed-ridden for 3 months and had heart problems on an unknown date. He also experienced pain in his chest and he had lost 25 pounds on an unknown date. The patient was pulled out of school on an unspecified date since getting the vaccine, because he was so sick. Outcome of all the events was unknown.The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
ER visit. Mom reports that for 32 seconds child starred into space and jerking arms X 2.
This spontaneous report was received from a Pharmacist (who was informed by another unknown patient) referring to a patient of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On an unknown date, at the same office visit the patient was vaccinated with 2 doses of M-M-R II (Lot #, expiration date, strength, dose and route were not provided) (overdose). No adverse event was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Information has been received form a female physician who on 7/30/02 had splashed herself in the eye with hep B vaccine recombinant 10mcg (642246/0032M) while trying to draw up a dose. She believed that she was exposed to just a few drops. At the time of this report on 7/30/02, her eye felt irritated. She sought unspecified medical attention.
Feelings of elevated heart rate w/increased anxiety; HR 120, O2 Sat 99% RA Rest, Po hydration, "feeling better" s/p 30 min. monitoring, symptoms subside Released home
Weakness; I am still lot tired and achy; I am still lot tired and achy; Arm hurt really bad; Rash all over my stomach and back; Exhaust; Dizziness; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 49-years-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 15Feb2021 (Batch/Lot Number: EL9267) (at the age of 49-years-old) as SINGLE for covid-19 immunisation. Medical history included blood pressure high and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication(s) included atenolol; levothyroxine sodium (SYNTHROID); omeprazole (PROTONIX [OMEPRAZOLE]), metoclopramide and lisinopril; all taken for an unspecified indication, start and stop date were not reported. The patient got vaccine 3 days ago and the first night the patient had the dizziness (Voice feeble) but it went away and second day arm hurt really bad. Then yesterday was exhaust and now today the patient got rash all over abdomen (Voice break) and back when woken up. The patient was extremely tired and should get the second shot or not. Now, rash all over stomach and back. When probed for the outcome of the event, the dizziness and weakness improved but, still lot tired and achy, just not feeling well and rash is concerning at this point. The outcome of events dizziness and weakness was recovering, whereas, still lot tired and achy was not recovered. Other events was unknown.  Follow-up attempts completed. No further information expected.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction within 3-4 minutes after) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Immunocompromised. Previously administered products included for an unreported indication: METHOTREXATE (Stopped 1 week before Vaccination). Concurrent medical conditions included Drug allergy (Anaphylactic reaction, mild, swollen lips). On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction within 3-4 minutes after) (seriousness criteria hospitalization and medically significant), DYSGEUSIA (Metallic taste), PHARYNGEAL SWELLING (Throat started to feel like it was closing/swelling), FEEDING DISORDER (Could not eat), FLUSHING (Whole upper body was flushed), DISCOMFORT (Whole upper body felt like it got heavy), SWOLLEN TONGUE (Tongue was swollen) and ASTHENIA (Left side was so weak). The patient was hospitalized from 30-Mar-2021 to 31-Mar-2021 due to ANAPHYLACTIC REACTION. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction within 3-4 minutes after), DYSGEUSIA (Metallic taste), PHARYNGEAL SWELLING (Throat started to feel like it was closing/swelling), FEEDING DISORDER (Could not eat), FLUSHING (Whole upper body was flushed), DISCOMFORT (Whole upper body felt like it got heavy), SWOLLEN TONGUE (Tongue was swollen), ASTHENIA (Left side was so weak) and HEADACHE (Headache) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Sender's Comments: This case concerns a 53-year-old female hospitalized with a serious expected event of anaphylactic reaction, and non-serious unexpected pharyngeal swelling, swollen tongue, dysgeusia, feeding disorder, flushing, discomfort, asthenia and expected headache. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The patient said she got her arm all red and inflamed and sore. Complained of soreness for a couple of weeks after the vaccine. Did not have problems with vaccine in past.
tachycardia (HR 150s); hypertension (BP 180/110s); This is a spontaneous report from the contactable nurse.   A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 from Sep2020. Concomitant medications were not reported. On 17Dec2020, approximately 5 min after receiving the vaccine, the patient experienced tachycardia (HR 150s) and hypertension (BP 180/110s). Therapeutic measures were taken as a result of the events and included treatment with labetolol. Outcome of the events was unknown.   Information about lot/batch number are requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, tachycardia and hypertension, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
In December of 2022, I was having congestion and runny nose. It just stayed and I started feeling tired and noticed that a cough was with it. It got worse. I never had a stuffy nose, just constant drainage and getting to my chest. I started to get pains in my chest. It was like pressure around my heart. Especially when I layed down, it was something was moving around in my chest, it was painful. I let myself be sick for about a month, before contacting my doctor.  He later said I sinititis. I did get chills a low grade fever to 100. Finally I was feeling better when I did go to the doctor, The congestion and drainage was terrible. I was prescribed a couple of antibiotics. I had some headaches with it also. I don't have the symptoms now. I chalk up what is now to allergies.  I think this all lasted to the end February.
misadministration.  no adverse reaction. after administering Dtap #4 and Prevnar #4 on 9-30-08. Found out client already recieved Dtap #4 and Prevnar #4 in May 2008. Client recieved extra
Pt called office stated he was feeling nauseous and had vomited. Stated he received Flu vaccine before and had no issues. Called pt at 14:55 to check on him - he was at work, stated nausea and sweating decreased, he took Tylenol and axixity decreased. Stated he would se how he felt tomorrow morning.
1st 36 hours - fatigue, headache, chills, minor nausea, minor body aches and queasy stomach. Last 12 hours - diarrhea. All symptoms were gone after 48 hours.
Information has been received from a physician, the author of the literature report, concerning a 109 days infant, gender unknown. The infant was a preterm baby and had low birth weight of <1000g. This was a prospective observational cohort study in all VLBW infants who were discharged from the NICU from May 1, 2008 to April 22, 2010 when rotavirus vaccination (manufacturer unknown) with RV5 was provided at discharge to all age-eligible infants. The medical records of the infants were reviewed, and pertinent demographic, clinical, and laboratory data were recorded. The number of infants who received the rotavirus vaccine, the number of missed opportunities for vaccination, and the number of infants falling outside the recommended time period for vaccination were recorded and analyzed. There were no complications noted on follow-up. On an unknown date the infant was vaccinated despite being older than the recommended age limit at the time of discharge. Rotavirus vaccination (manufacturer unknown) is recommended for use in preterm infants at the time of discharge from the NICU as long as they are clinically stable and have an age range of 42 to 104 days V.10. Our study highlights the limitations of the currently recommended schedule for rotavirus vaccination, because 22% of all VLBW infants were too old at discharge to receive the vaccine. In addition 52% of all ELBW infants discharged from the NICU were older than 104 days and also were not vaccinated. This is one of four reports received from the same source. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
sore arm started 6 hours after injection (same side and site and injection) day 1 (the next day, 24 hours later)  hot flashes including sweating and flushing lasting 30 minutes, tiredness, headache (brief flashes of pain that did not last more than 1 minute) muscle aches and joint aches esp to large joints (hips, back to pelvis, shoulders) a general slight feeling if "i don't feel well or not quite right", and continued arm soreness day 2 (48 hours after injection) noted upoon awakening swollen tender axilla (ipsisteral to injection arm)  fatigue and general feeling of not being well, including slight increased effort for breathing (deeper breaths more frequently than normal).  no headache and joint pain less but not gone.  day 3 (72 hours after injenction)  back to my old crabby self :o)  still have Left axilla adenopathy but less tender and swollen -this had happened previously with other vaccinations.
State uncontrollable shakes several hours after shot. States chills for 2 days.
Nausea; Loss of Appetite; Fever; Shivering; Malaise; Feeling bad; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced nausea, appetite lost, fever, shivering, malaise and feeling bad. On an unknown date, the outcome of the nausea, appetite lost, fever, shivering, malaise and feeling bad were unknown.   It was unknown if the reporter considered the nausea, appetite lost, fever, shivering, malaise and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix, and experienced some reactions including nausea, no appetite, fever, shivering, feels bad (malaise), and has been in bed all day a day. For tolerance to 2nd  dose, refer case US2019207606. The reporter consented to follow up.
phantom pain; This spontaneous case was reported by a consumer and describes the occurrence of PHANTOM LIMB SYNDROME (phantom pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     The patient's past medical history included Amputation.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PHANTOM LIMB SYNDROME (phantom pain). At the time of the report, PHANTOM LIMB SYNDROME (phantom pain) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received on 22-JUL-2021 contains no significant information. Case corrected from initial version, relevant medical history ongoing updated, dose no. updated, 1st dosage regimen added, Action taken, de-challenge and re-challenge updated, narrative regenerated. On 23-Jul-2021: Patient initials updated
Ending up in the Emergency Room with numbness and tingling in all extremities - hands and feet.   All tests performed at the ER came back normal or negative, but during the stay, my bladder shut down and they had to twice insert a catheter so they could empty the bladder.  Subsequently, I have had persistent and constant joint pain in both shoulders, wrists, hands and knees.  Dr's have taken X-Rays and MRI's of most of the joints but can find nothing.   The joints are in constant and debillatating pain.
Pt recvd 2 doses of Engerix-B following a puncture wound; pt exp extreme fatigue, flu-like sx, t100.6 fever & h/a; tx included APAP; sx resolved w/in 1 wk although pt does not feel entirely back to nl;