chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a sore arm the evening of the first vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: EP6955) as dose 1, single and administered in arm left, administration date 23Apr2021 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hand sanitizer, reaction(s): "eczema", notes: Caller reports that he got eczema from using hand sanitizer.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Apr2021, outcome "recovered" (24Apr2021), described as "had a sore arm the evening of the first vaccine.".  Additional information: He reported he had a sore arm the evening of the first vaccine. The arm pain from the first shot lasted about a day. The arm pain after the second shot lasted about a day and a half. He stated that he only had a sore arm, that was all. Caller remarked that mostly everyone he know got a sore arm after the shot, like after getting a tetanus shot. Caller provided not other information regarding this statement. He wanted to know if there was a need for more doses/booster doses of the Pfizer Covid vaccine? He wanted to know more details on how someone was deemed immunocompromised in order to get a third dose of the vaccine. A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine was authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise."  No follow-up attempts are possible. No further information is expected.
After getting all three vaccine patient saw small drop of blood from injection site and fainted for 5 second. Called EMS. Lay pt down and checked BP 99/71 pulse 59  Pt did mention anxiety with needle and shot. No Medrol hx or allergy noted. BP rechecked 184/75 pulse 69
This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was unknown. On 25-AUG-2014 the patient was vaccinated with PEDVAXHIB (dose and route unspecified) (lot number: J016186 with expiry date of 24-OCT-2016) in the left leg. Concomitant medications were unknown. The nurse reported that refrigerator temperatures were out of range from 19-AUG-2014 to 26-AUG-2014 and the vaccines were viable. No adverse effects were reported. The outcome of the events was unkonwn. The causality of the events with PEDVAXHIB was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Nausea, sore throat, body ache, dizziness. Started 2 hours after the shot and lasted for 2 days.
PATIENT REPORTED A PAINFUL RASH THAT DEVELOPED ON HER LEFT HIP ONLY. IT IS THE SIZE OF A DECK OF PLAYING CARDS.. SHE STAED IT BLISTERED SOME AT FIRST THEN IS RED, SWOLLEN,  AND ITCHY WITH HEAT IN IT.
swelling under arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 16-years-old male patient received bnt162b2 (BNT162B2 Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31May2021 13:00 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE for covid-19 immunisation (16 years at the age of vaccination). The patient medical history was not reported.  No covid prior vaccination, no covid tested post vaccination and No Known allergies.  The historical vaccine includes BNT162B2 Dose number=1, Lot number: ew173, Administration date 14May2021, Administration time: 01:00 PM and Vaccine location= Left arm for Covid-19 immunisation (16 years). The patient's concomitant medications were not reported. The patient experienced swelling under arm on 02Jun2021. No treatment was received for the event. The outcome of the event was Resolving.  Follow-up attempts are completed. No further information is expected.
This case was reported by a healthcare professional, via another manufacturer (Merck), and described the occurrence of adverse reaction to vaccine in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of CERVARIX (details unknown). At an unspecified time after vaccination with CERVARIX, the subject experienced adverse reaction to vaccine. At the time of reporting the outcome of the event was unspecified. No further information was provided.
I have since developed chest pain that comes and goes.  I have seen  a cardiologist and he has assured me that this pain is not because of my heart.And yet, the pain continues.
Wrong vaccine given. Pfizer was my first series vaccine. The second dose of Pfizer should have been administered. Covid-19 Vaccination Record Card is incorrect. I recieved an email immediately after the vaccination stating I was due for the second dose in 28 days. I immediately asked the nurse who administered the vaccine why I recieved this email and she stated that they had accidentally administered the wrong vaccine.  symptoms to date: include pain at injection site; body aches; headache; nausea; fatigue.
Information has been received from a male consumer concerning his girlfriend of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose and route not provided), while she was pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was unknown. Additional information is not expected because the reporter declined to participate in answering questions within this report and no demographics of the physician was provided.
23 hours after injection: nausea, headache, facial swelling, swelling at injection site, swelling under armpit 48 hours after injection: leg pain, cramping in right calf, upper thigh bruising, continued pain in arm and armpit
This spontaneous report was received from the director of nursing regarding 5 unspecified patients of unknown demographics. There was no information about concurrent condition. Sometime between 18-APR-2015 and 23-OCT-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L012042, expired date as 18-NOV-2016, route, dose, dose number and strength were unspecified). On 18-NOV-2015 and 19-NOV-2015, unspecified patients were revaccinated with PNEUMOVAX 23 lot # L017406, expiration date 20-FEB-2017, 0.5ml intramuscularly. On an unknown date in November 2015, the patient developed cellulitis at the injection site. The outcome of cellulitis at the injection site was unknown. Causality between cellulitis at the injection site and PNEUMOVAX 23 was unknown. This is one of the two reports that received from the same source. Additional information has been requested.
Pt was admitted to hospital from the ED with complaints of chest pains on 4/3/21, after receiving the first dose of  vaccine 3/23/21. Per guidelines, all hospitalizations are reported.
Chills; Aches/pains; tiredness; This is a spontaneous report from a contactable consumer (patient).   A 32-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 06May2021 09:30, at the age of 32-years-old, (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included none.   There were no concomitant medications. The patient did not have COVID-10 prior vaccination.  On 06May2021, the patient experienced chills, aches, pains, and tiredness. The outcome of the events was recovering.  The patient has not been tested for COVID-19 post vaccination. No treatment was received for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mild rash mid back.; Slight metallic taste; Slight swelling of tongue; Slight full/swollen/numb feeling on lips.; Slight full/swollen/numb feeling on lips.; This is a spontaneous report from a contactable other Health Care Professional. A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:30 as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. Medical history included thyroid cancer, scoliosis, gastroesophageal reflux disease, irritable bowel syndrome, urinary tract infection, major depression, generalized anxiety disorder, post-traumatic stress disorder, multiple allergies, sjogren's syndrome from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (TIROSINT), hydroxychloroquine sulfate (PLAQUENIL S), gabapentin, budesonide (NASOCORT) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On 19Feb2021 12:45 the patient experienced mild rash mid back, slight metallic taste, slight swelling of tongue, slight full/swollen/numb feeling on lips. The outcome of event was not recovered.
Lethargy, chills.  Slept for most of the next day (2/25), felt fine the second day (2/26).
Patient with no prior indication of heart irregularity developed V. Arrythmia and Afib.
Information has been received from a physician concerning a 8 week old male who was vaccinated with the first dose of Rotateq.  Subsequently within a few days of receiving the vaccination, the patient experienced bloody stool.  The patient's bloody stool persisted.  The patient sought unspecified medical attention.  Upon internal review bloody stool was determined to be an other important medical event.  This is one of two reports received from the same source.  Additional information has been requested.
Low grade temp, weakness, minor muscle aches Weakness resulted in a fall. 2 Tylenol, rest     Temp down to 98.8 after three hours Weak the following day but able to function independently
17 year old female inadvertently administered 1st dose of Moderna Covid 19 Vaccine to a person under the age of 18.
1030AM 18NOV93 recvd vax -@ 245PM mom noticed pt having SOB & salvia from mouth, t102;
Minor intermitting chest pains started about 10 days after 2nd shot and continued to increase in duration
The pt experienced an allergic reaction to the DT vaccine that was given that morning. Broke out in a rash with a burning sensation. The pt vomited at the clinic and fainted for 1 second. Oxygen was given. Treated with epinephrine and Benadryl.
Sore arm only; This is a spontaneous report from a non-contactable other HCP (patient). A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via intramuscular on 22Dec2020 08:30 on left arm at a single dose for COVID-19 immunization. The patient allergy to Percocet and medical history included hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced sore arm only on 23Dec2020 18:00 and no treatment received. The outcome of the event was recovered in Dec2020.  No follow-up attempts are possible. No further information is expected.
Patient received Pfizer vaccine on 1/6/21, 1/27/21 and 11/3/21. Came to ER on 1/17/22 and was found to be COVID positive. was admitted for COVID-19 and possible aspiration PNA. Patient was tachycardic in ED saturating 88% on RA. Patient was placed on 6 L of oxygen on admission. She was started on azithromycin, rocephin, decadron and remedesivir. Pulmonology was consulted per protocol. Patient quickly improved and was weaned off oxygen. Per pulmonology patient likely has aspiration pneumonia. Patient will undergo swallow study in outpatient. She was discharged to facility in stable condition on room air with outpatient treatment for aspiration PNA with augmentin and prednisone to complete 5 days of treatment in total. During this stay, patient also had hypomagnesemia, which was corrected prior to discharge. Discharged on 1/19/22
Incorrect diluent volume (i.e., the vial contents were diluted with a diluent volume more than 1.8 ml, but a 0.3 ml dose was still administered.)
Right arm was very swollen and red. Pt stated it was itchy, and warm to the touch. Slightly Painful. Started 12/14/219 (day after vaccine was received)
Swelling, redness, hot to touch, hard lump in center of the red swelling approx 2x3 inch circle.
injection site right arm warm to the touch; sore injection site; had a low grade fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site right arm warm to the touch), VACCINATION SITE PAIN (sore injection site), PYREXIA (had a low grade fever) and NAUSEA (nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MWA and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site right arm warm to the touch), VACCINATION SITE PAIN (sore injection site), PYREXIA (had a low grade fever) and NAUSEA (nausea). At the time of the report, VACCINATION SITE WARMTH (injection site right arm warm to the touch), VACCINATION SITE PAIN (sore injection site), PYREXIA (had a low grade fever) and NAUSEA (nausea) outcome was unknown.            No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-371357, MOD-2021-369457.
Patient immunization 4-8-08.  Mom reported patient c/o itching and rash spots on body-back, stomach, under arms.  4-9-08 patient seen by primary care physician - pt given  ORAPRED 2x2 p.o. q 8-12 hours for itchy rash.  Next day on 4-10-08 4 lesions on back, 7 on stomach & neck-breakthrough varicella lesions-covered with calamine lotion.  Call made to CDC for consultation reference # 1-51742834.
pt recv vax; 4-5 hr later, had 5-6 hr cont high pitched screaming;
Patient received half of the dose as about half of the dose squirted out the syringe around where the needle is screwed onto the syringe. Consulted with MD and patient did not receive additional dose.
Ringing in my ears after 2nd dose everyday; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on an unknown date in Mar2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included Type 1, Hashimotos, asthma, Ulcerative Colitis, allergies, penicillin allergy and sulfonamide allergy(sulfa). The patient previously received doxycycline (MANUFACTURER UNKNOWN) and Erythromycin (MANUFACTURER UNKNOWN) on unknown dates for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetrizine hydrochloride (ZYRTEC), insulin aspart (NOVOLOG), budesonide (PULMICORT),calcium ascorbate (ESTER C), folic acid (FOLATE), levothyroxine (LEVOTHYROXIN); all from unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) on 02Mar2021 at 12:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 30Mar2021 the patient experienced ringing in the ears after second dose every day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event.  On 20Apr2021, the patient underwent Nasal swab,, SARS CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event ringing in the ears was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Case number PHEH2013US023736 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 74-years-old male patient. His medical history and concomitant  medications were not reported. He was vaccinated with an expired dose of FLUVIRIN 2012/2013 (batch number: 123303, expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reporting following maladministration.
Pt stated after receiving FLUMIST, started to c/o sinus pain, chills, itchy eyes + stated "feels something in my chest, cannot explain what it is". Pt still has this symptoms at this time.
Pt experienced a sore lt arm at the injection site persisting for 5 days. Also, pain radiating into the shoulder & neck was observed. Adverse rx was also reported to FDA by reporter.
On Oct 29th c/o numb, cold spot on right thigh that would come and go. The next day the same thing happened but more frequently. At the injection site of left deltoid she had some generalized stiffness and soreness which always occurs for her after a flu shot. This lasted for a couple of days. In addition to thigh the numbness also occured in right arm above the elbow. Same sensation, coming and going. C/o fatigue and weakness, and c/o extreme heat emanating from her head, felt like head was on fire. Saturday felt Ok when awakened but decided to go to Urgent Care anyway. What was a cold numbness became a white hot pain. In addition she c/o of intermittent numbness in neck, tops of shoulders, back, toes and left shin. C/o low back pain, fatigue, nausea and felt ill all over. In the evening she had the head burning again. To touch she was cool but felt like ears and cheeks were on fire. On Sunday felt better other than a little bit faint. On Monday intermittent feeling of weakness and fatigue and a few episodes of the white hot pain in head. Some muscle soreness in joints especially in wrists, right hip and neck. Occasionally felt sharp pin like sensation in neck and back. Also had some numbness and ringing in her ears. Had blood drawn for CBC and basic metabolic panel on 11/3. No results are back yet. Felt better Tuesday but had shooting needle-like pain in fingers of left hand. Some numbness in left leg and arm. Today she feels like her cheeks and ears are on fire and she just doesn't feel well at all. She has not been able to see her regular physician as of this time. Trying to make an appt with his covering physician. She was advised by Urgent Care physician to go to the Emergency Room if she has numbness that does not go away or if she starts vomiting.
Received TDAP 9/29/10. Starting 10/1/10 developed dime-sized red lump at injection site. Lump has increased size to half-dollar size 10/4, red, swollen warm to touch. Increase arm soreness. Referred for PMD evaluation.
20MAY96 mom called to report that pt wouldn't move lt arm x 3 days;fever started 15MAY96 in evening;did not check but said screamed incoherently & gave APAP & cooled in tub;appetite dec-ate & drank 7up;diarrhea started 17MAY;slept a lot
This 17 year old patient came into the office for a covid booster vaccine. I was only administering Moderna vaccines on Friday 1/14/22. I gave him the low dose moderna vaccine (0.25). He did NOT have any adverse reaction to the vaccine.
red lump on thigh 6x4 1/2cm area w/erythema & induration lt ant thigh; tender 1/2 cm lt groin nod; Augmentin w/imporvement;
Rash with later tingling in hands. Went to Urgent (not emergency room) Care. Then I followed up with a visit to my primary because I was still having problems with the tingling in my hands. I am saying I am recovered based on my current status, but I don't full know the damage inflicted by the shots.
Immediately after, I felt tired and had some night sweats. But after 4 days I got really lightheaded. Sweaty and cold.  I'm about 5 weeks pregnant.
Chronic, shooting pain in right hip / sciatic area. Painful enough to prevent sleeping / sitting / walking. I have been taking Aleve / Advil routinely since the pain started. It helps a little but doesn't completely ease the discomfort.
This is a spontaneous report from a contactable medical assistant. A 74-year-old female patient received on 08Aug2014 at 09:30 PREVNAR 13 (lot. G63300, expiration date 14Sep2014) in left arm, at 0.5 ml single to prevent pneumonia. Medical history included diabetes from 2007 due to which she was taking unspecified medication and hypothyroidism from 2008. Concomitant medication included SYNTHROID and metformin hydrochloride, JANUMET. On 09Aug2014 the patient experienced headache and on 10Aug2014 she experienced fever and rashes in left arm was red, warm, kind of bruise and little swollen and was all around and on top of the site were injection was given. The patient visited doctor's office on 13Aug2014 for the adverse events. She started taking unspecified antibiotics since 13Aug2014 for headache. The patient underwent lab tests which showed full blood count normal on 13Aug2014. The outcome of all the event was unknown. The medical assistance believed that the events were due to vaccine as the patient experienced the events after PREVNAR 13 vaccine administration and as she had rashes in left arm which was red, warm, kind of bruise and little swollen and was all around and on top of the site where injection was given. Follow-up (22Sep2014): New information from a contactable consumer included confirmation of lot Number and Expiration date. Follow-up (14Nov2014): Follow-up attempts completed. No further information expected.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. An 84-year-old male patient of unknown race/ethnicity received in Mar2016 (during 6 month home visit) a single dose of PREVNAR 13 for immunization. Medical history included dementia. Concomitant medications were not reported. On an unspecified date in 2016, the patient reported initially pain at injection site then became sick within couple of days and fever and chills and stiff neck and pain in joints also reported balance problems. Patient was visited at the emergency room where they really couldn't find anything wrong with him. Symptoms persisted, may be got little better over time. In Jul2016 patient died. No autopsy was performed. Reported Cause(s) of Death: unknown cause of death.
Patient reports rash and burning sensation to face and some discomfort at neck.  Claritin and ibuprofen OTC and if any worsening symptoms, instructed to report to the ED.
10:10: Left deltoid (+) edema, (+) erythema (+) pain.  Administered Benadryl 50mg IM left deltoid.  11:00: Discharge to home with resolution of symptoms (-) shortness of breath, (-) no respiratory distress.