chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 3 to 5 years ago before the time of reporting). On 12th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th July 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm and extremities hot feeling of. On 14th July 2018, the patient experienced urticaria. On 18th July 2018, the patient experienced auricular swelling and vesicles. On an unknown date, the outcome of the swelling arm, urticaria and extremities hot feeling of were recovered/resolved and the outcome of the auricular swelling and vesicles were not recovered/not resolved. It was unknown if the reporter considered the swelling arm, auricular swelling, urticaria, vesicles and extremities hot feeling of to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient was the nurse. The patient did not receive any concomitant medication. On 12th July 2018, the patient swelling and hotness of left arm and resolved. On 14th July 2018, 2 days later the patient experienced huge welt on her right arm in the antecubital space and a welt on her 2nd toe of the right foot, both of these had resolved as well. On 17th July 2018, the patient had hives of her left forearm that resolved. On 18th July 2018, at night (the day before reporting) the patient noted vesicles on her left ear lobe and her ear lobe was swollen 4 times its normal size. The patient had not reported to her physician at this time reporting, but was encouraged to do so. The patient had declined HCP at this time as he was in other state and the patient was currently in other state.
Immunization given at 16:45. That evening pt was fed Enfamil formula and breast milk and a pinch of scrambled eggs. She developed a congested cough had emesis and developed a generalized urticarial eruption app 2 has after feeding (and 4-5 hrs) after immunizations. Taken to ER given Benadryl and Pediapred.
About 5 days  after receiving flu shot I had a bad case of Vertigo. went to emergency room thinking I had a stroke, they found nothing wrong.  I am not sure what brand the flu shot was, it was given at a pharmacy.
I received the Pfizer Bivalent COVID-19 booster on 11/22/2022. Within an hour of getting the shot, I started to have pain in the right arm that extended to the neck and shoulders, fatigue, and headache. On 11/26/2022, I started to get severe vertigo with nausea and vomiting, which lasted for about 3 days. The pain in the neck, arm, and shoulders, the fatigue, and the headache also continued at this time, and it wasn't until about 11/29/2022 that I was back at my baseline. On 12/4/2022, I woke up with a very sore throat, increased nasal congestion, headache, and fatigue. I didn't yet have a fever, but my temperature was about a degree higher than normal. I wasn't really sure what was happening, so I just drank warm fluids to soothe my throat and rested. When I woke up on 12/5/2022, I still had the same symptoms, but they were intensified. I took my temperature, which was 101. I took a home antigen test and got a positive result. From that point, I began isolating. I had a telehealth appointment later that day and was prescribed Paxlovid, which I began taking the evening of 12/6/2022. I continued to have a fever on and off through about 12/15/2022. My sore throat waxed and waned, and at the time of this writing, I still sometimes have a sore throat. My congestion is now better, but not completely gone. I still have fatigue, plus I have increased neuropathy, especially in the fingertips of both hands. On 12/16/2022, I took a home antigen test, which yielded a negative result. I also got a negative result when I tested again on 12/18/2022. I also continue to have increased shortness of breath and tachycardia with any activity; these symptoms became more pronounced when I developed other COVID-19 symptoms on 12/4/2022. I would like to add that I believe I was exposed to COVID-19 on 11/25/2022 or earlier, because I had not left my home since 11/25/2022.
FELT COMPLETELY FINE THE DAY OF THE SHOT.  WOKE UP THE NEXT MORNING AND COULD BARELY WALK.  MY BUTTOCK AREA WAS EXTREMELY TENSE AND HURT TO STAND OR WALK.  THE PAIN WENT DOWN BOTH OF MY LEGS, MORE PROMINENT ON THE LEFT SIDE.  I HAD BEEN FEELING THAT PAIN FOR A FEW WEEKS, BUT IT WAS A DULL ACHE, NOTHING DEBILITATING.  I HAVE BACK PAIN, BUT THIS WAS INTENSE AND NOT A PAIN I'VE FELT BEFORE.  AS THE DAY WENT ON, IT EVENTUALLY GOT A LITTLE BETTER.  WHEN I AWOKE THE NEXT DAY, I COULD BARELY GET OUT OF BED.  MY DAUGHTER HAD TO TAKE ME TO THE ER BECAUSE THE PAIN WAS SO INTENSE.
arm is extremely sore; sniffles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is extremely sore) and RHINORRHOEA (sniffles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is extremely sore) and RHINORRHOEA (sniffles). At the time of the report, PAIN IN EXTREMITY (arm is extremely sore) and RHINORRHOEA (sniffles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
short of breath; feeling extremely anxious; numbness around mouth; metal taste; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Rrght arm on 22Jul2021 at 10:45 (at the age of 62-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient experienced at first on 22Jul2021 at 11:54 numbness around mouth and a metal taste which lasted a couple hours. On day 3 (on 24Jul2021) started feeling extremely anxious like she could jump out of her skin and short of breath. The patient received treatment for events. It was reported that an extra Ativan was given to try to help the extreme anxiety. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The patient did not have COVID prior vaccination and she was not COVID tested post vaccination. Numbness around mouth and metal taste were resolved, the other events were not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
pt fainted. pt was standing and dropped to the floor via his mother's lap-mom states he didn't hit is head.  after regaining consciousness pt was very pale and was yawning frequently. He did state that his face hurt but after drinking water he said it felt better.  A cold pack was applied to the patient's wrist and he briefly lied on the floor with elevated feet to bring blood flow back to his head.    I did recommend that mom call the patient's pcp to follow up and she stated she would
Concurrent medical condition and medications were not specified. The vaccinee had no known allergies and no illnesses at the time of the vax. On an unspecified date, the vaccinee received his first injection of Havrix. In July 01, the vaccinee received injections of inactivated poliomyelitis virus vax (Ipol) and Typhoid vax. In June 01, and  July 01, the vaccinee received his first and 2nd injections of Hep B vax Recombinant respectively. It was reported that in Oct. 01, he underwent a "routine physical" at a tertiary care center. An unspecified "clotting study" was performed. The vaccinee reported that "the clotting study showed prolonged clotting in one arm, but that the other arm was normal." To the nurse practitioner's understanding, the test was repeated and the results then were normal. An electrophoresis was performed that showed an immunoglobulin G spike. On 1/18/02, the vaccinee received his 2nd injection of Havrix. On that date, he also received his 3rd dose of Engerix-B. He received 2 injections of the 10 mcg pediatric formulation, to provide the adult dose of 20 mcg. On 1/21/02, the vaccinee developed a "moderate-size" hematoma at the Havrix inject site. It was treated w/moist, warm compresses three times daily. The reporter stated that the hematoma was moderate in intensity and possibly related to Havrix but may have also been associated w/the PT's prolonged clotting time in Oct. 01. The vaccinee also complained of sore arms, tiredness, and "vague" myalgia; the exact onset of these Sx's were unknown. As of 1/28/02, the hematoma was "resolving well". As of 2/27/02, the outcomes of the sore arms, tiredness, myalgia, and immunoglobulin G spike were unknown.
Stroke; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        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.   No concomitant medication was reported.  No treatment medication was reported.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
After 24 hours of vaccination patient noticed a rash of hives all over her body with itching. Patient self treated with loratadine and had some relief. Patient presented to the pharmacy 15 days after the vaccine to notify pharmacy that the hives were still present and was still itching. Patient was recommended to see a doctor.
6/19/03: pt presents with redness and sl. swelling noted around injection site of Lt arm. Area is warm to touch and tender. Mother explained the onset of symptoms as being "the next day" and "looks better today." Pt treated by MD and ordered Atarax 3x day and warm compresses.
Initial and follow-up information has been received from a physician and a medical assistant concerning a 13 year old female patient who on 29-MAY-2007 was scheduled to be vaccinated with a dose of Gardasil (Lot #655324/0089U). However, when the medical assistant attempted to administer the vaccination, "the plunger would not depress," and blood was aspirated into the syringe. The CMA added that she had made 2 unsuccessful attempts to get the syringe to work. The physician reported that "the UltraSafe mechanism had not activated," so the patient did not get the vaccination, and had to be rescheduled " due to a defective (Gardasil) syringe." Follow up information received from a nurse, confirmed the above events, and added that actually there was no medication in the syringe. She reported the patient still has not received the vaccination. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old female subject who was vaccinated with Infanrix, GlaxoSmithKline. The subject's medical history included abdominal pain. The subject had no adverse events following receipt of prior immunizations. Concurrent medications included Paracetamol (Tylenol). On 01 February 2007 at 2:00 p.m., the subject received 5th dose of Infanrix in the left arm. On 01 February 2007, less than one day after vaccination with Infanrix, the subject experienced swelling injection site. The event resolved on an unspecified date on or after 01February2007 and on or before 16 February 2007.
This spontaneous report was received from a pharmacist refers to a multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L031271 and expiration date 19-NOV-2016, (dose and route of administration were not reported). There were no concomitant medications provided. No adverse effects were reported. The reporter described the temperature excursion as follows: "Temperature: Highest of 24F for 15 minutes increment; Time frame: Total out of range was 1 hour and 45 minutes; outcome of excursion; ZOSTAVAX was supported until expiry". There was no previous temperature excursion. There was no product quality issue involved. Additional information has been requested.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (dose and route of administration were not reported) lot # L035129, expiration date: 14-SEP-2017, for prophylaxis. The dose was stored at temperatures -14 degrees Celsius to -10 degrees Celsius for a total time of 2 hours. A digital data logger was not involved. A previous temperature excursion was reported at -9 degrees Celsius to 8 degrees Celsius for a total time of 7 hours and 45 minutes. No adverse effects were reported. Additional information has been requested.
Received the COVID vaccine on 02/12/21 in left arm and experienced pain immediately secondary to receiving the vaccine that has persisted on and off for months. Currently still experiencing pain/nerve pain. In March of 2021-underwent 6 weeks of Physical Therapy treatment with limited pain relief. May 2021-Got referral from Primary Care Doctor to Dr. who is a Physiatrist. Underwent 3 Osteopathic manipulations with limited relief. Dr. suspects COVID vaccine triggered an adverse response. July 16, 2021- Had an X-Ray done. X-ray showed  slight C7 narrowing.  Underwent 3 Osteopathic manipulations with limited relief. 9/21/20 Had an MRI scan of cervical spine and left shoulder. 9/28/21 Had follow-up with Dr. and MRI showed Cervical narrowing from C5-C7 with mild subacromial/ subdeltoid bursitis. 10/04/21 Had follow up phone appointment with PCP and was told that the COVID vaccine was suspected to have triggered the issues I'm experiencing.
This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (from  his elbow to his finger tips, he lost a lot of mobility/but can't use his left arm like he use to), LIMB DISCOMFORT (some days can use arm really well/other days seem like is not alot of muscle there/can't carry anything more 50 pounds), PAIN IN EXTREMITY (had symptoms/the first three days suck/his left arm hurt) and FEELING ABNORMAL (It is like a felling like the body telling him like a disconfirm felling, not a pain or ache) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2022, the patient experienced MOBILITY DECREASED (from  his elbow to his finger tips, he lost a lot  of mobility/but can't use his left arm like he use to) and PAIN IN EXTREMITY (had symptoms/the first three days suck/his left arm hurt). On an unknown date, the patient experienced LIMB DISCOMFORT (some days can use arm really well/other days seem like is not alot of muscle there/can't carry anything  more 50 pounds) and FEELING ABNORMAL (It is like a felling like the body telling him like a disconfirm felling, not a pain or ache). At the time of the report, MOBILITY DECREASED (from  his elbow to his finger tips, he lost a lot  of mobility/but can't use his left arm like he use to) and LIMB DISCOMFORT (some days can use arm really well/other days seem like is not alot of muscle there/can't carry anything  more 50 pounds) had not resolved and PAIN IN EXTREMITY (had symptoms/the first three days suck/his left arm hurt) and FEELING ABNORMAL (It is like a felling like the body telling him like a disconfirm felling, not a pain or ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was provided by the reporter. Patient reported that symptoms was not got worse or better, but remains the same. No treatment was provided by the reporter.
Pt recvd 2 doses of Engerix-B & 2 wks later devel erythema nodosum, swelling of lower legs & ankles;
Fever - 100.4 Headache Body ache slight nausea    receiving vaccine All these occurred on the next day of
Arm from just above the elbow to the top of her shoulder, became red, swollen, indurated but not tender within 24 hours, post vax. Had a fever, 3 days, post vax, and an URI.
had fever 103; cried cont for @ least 8hrs; mom gave APAP & bathed w/alcohol;
MMRV given in rt lat thigh sub Q on 2-5-07 Mon at 2:30pm, site reaction was noticed about 24 hours later. Small bumps under the skin 6x6 inch area red, hot, swollen and painful developed and lasted 48 hours before it began to resolve.
Respiratory Distress      Pt C19+. Upon EMS arrival pt O2 sats 88%. Upon arrival pt on nonrebreater at 95%. a 95y.o. male Presents to the emergency department for difficulty in breathing. Lesion found to be saturating 81% on room air. He tested positive for covid?19 one week ago. Patient has a history of CVA and is nonverbal. Further history is limited. He is reportedly at his baseline.   Review of Systems  Unable to perform ROS: Patient nonverbal  The patient is a 95y.o. male who presented on 11/9/2021 with a  History of atrial fibrillation on eliquis, HTN, HLD, heart failure, CVA - non verbal or minimally verbal at baseline who presented to hospital via EMS for DIB. He was saturating in low 80s on RA. He tested positive for COVID 11/2 and was having worsening of his breathing. He was also having subjective fever and some cough noted. In the ED he was in acute renal failure with creatinine of 3.51 with history of CKD 3A, BUN was 121. Troponin was elevated at 1.87, inflammatory markers were elevated, procalcitonin was 1.56. ID, nephrology, and cardiology were all consulted. He was started on steroids, remdesivir, and heparin drip. CXR showed Hazy multifocal reticular airspace disease concerning for underlying atypical infectious process. He was ultimately placed on HFNC and still saturating in low 90s. He was also in atrial fibrillation with RVR and unable to take oral medications so was transitioned to metoprolol pushes which did not have much affect on his heart rate. I did have at length discussions with the family/guardians multiple times everyday to update them on his condition. He was progressively worsening and was going into multi organ failure they were in agreement with comfort medications but wanted antibiotics continued. Code status was changed to complete no code on 11/11. He continued to have increasing oxygen requirements. Palliative care team did meet with family as well. He ultimately passed and was pronounced on 11/12 at 0750 am. Family was notified by the resident.  11/12/2021 patient expired
Monday got vaccine about 4pm fine right away & Mon Tues noticed some itching at site, breathing little stressed - used inhaler. Currently red/itchy/warm/swollen at site. Will take BENADRYL & inform Dr.
Drop in BP; Increase heart rate; Severe headache; Slight rash on forearms; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 02:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to dust, mold, grass, animals and aloe and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included loratadine (ALAVERT), taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin; clavulanic acid (AUGMENTIN) and levofloxacin (LEVOQUIN) and experienced drug allergy. On 21Apr2021, 4 days after the vaccination, the patient experienced slight rash on forearms. On 01May2021 and 02May2021, 14 and 15 days after the vaccination, the patient experienced severe headache. On 03May2021, 16 days after the vaccination, the patient experienced drop in blood pressure (BP) and increase heart rate. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight rash on forearms was resolved on an unknown date in 2021 while severe headache, drop in BP and increase heart rate was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
caller is having problems with her eyes; bad headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE DISORDER (non-serious), outcome "unknown", described as "caller is having problems with her eyes"; HEADACHE (non-serious), outcome "unknown", described as "bad headache".  Additional information: Patient stated that she got the first vaccine from Pfizer and that Pfizer gave her a sheet that says 4/13 but the whole time she was looking at the sheet she always saw 4/14 and she did not know why, might had trouble with her eyes. Patient was looking at the 4 in front and the 4 in the back. She always thought she was coming at 14, on the 14th. Patient always had this paper on her end table, it is ridiculous. Whole time, she does not know, maybe she was having problems with her eyes. She is seeing in reverse, so she does not know. Patient thought it was a 14 and not a 13. Patient does not know how to get a hold of the place where she got her first vaccine. Patient was already scheduled for her second dose and there was nothing to report. Patient had her first dose, but she does not had the second, she missed her second vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid 19 Pfizer 6 month-4 year vaccine given 0.3 ml dose, however, vial was not diluted with 1.1 cc normal saline as recommended by vaccine manufacturer