chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 63-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, several hours after receiving SHINGRIX, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was recovered/resolved. It was unknown if the reporter considered the blurred vision to be related to SHINGRIX. Additional details were provided as follows: In the late afternoon, the patient received the dose of SHINGRIX in the right arm. The next morning after vaccination, at around 07:00 hours, the patient was driving to work and noticed that her vision was blurry. The patient determined that it was only her right eye that was blurry. At around 09:00 hours, the patient worked at her physician's office for checkup. The physician could not find anything, but send the patient to the emergency room. At 12:00 noon, the patient went to the emergency room and blood was taken, blood pressure was checked and had a magnetic resonance imaging (MRI). Everything came back to normal. The physician referred the patient to an eye specialist for the next day. At around 19:00 hours, the blurry vision was resolved. The next day, the patient went to the eye specialist and everything came back normal. The reported gave permission for her physician to be contacted. No more information was available.
Noted redness and swelling on left thigh yesterday. Today is 6 cm in diameter, warm, firm to touch. Will use ice/cool packs and BENADRYL as needed. (Was seen in office by PAC today).
fever; fatigue; body ache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 40 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 11:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 16:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included thalassaemia beta from an unknown date and unknown if ongoing. Other medications in two weeks: Blisovi. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever on 03Apr2021 06:00 with outcome of recovering, fatigue on 03Apr2021 06:00 with outcome of recovering and body ache on 03Apr2021 06:00 with outcome of recovering.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
On the day of immunizations the infant had no problem. However, the next day the infant had 13 hours with no sleep followed by 10 minutes of sleep, then a seizure lasting less than 60 seconds. The infant was taken to the ER, a chest x-ray was done. Visited Ped. Upper GI done on 05/07/01 with normal results.
Patient fainted about 15 seconds after vaccine was given. He was given water, various types of sugar products. Patient stated that he had not eaten all day. Vitals were taken and all were within normal range (119SBP, %SO2 98 and PP 85). Patient was conscious and coherent. He was observed for another hour after which final vitals were taken and he was still within normal range (129/86, %SO2 98, PP70).  He was able to call a friend to pick him up.
Over the last 36 hours: 102.8 degree fever, nausea, repeated vomiting, chills, body aches, other severe flu like symptoms.
Nothing too bad, some vomiting but mostly diarreah.  Red sore right arm, but nothing horrible.  All in time?.
pt recv vax;17may96 devel a varicella like rash on back and shoulders and presented to MD;rash described as 20-25 fluid filled vesicles;MD felt this was a case of breakthrough chicken pox;vesicles fading by 19may96;
Patient received injection at 1210pm at 1230pm she came back with dizziness, increase BP (140/100), pulse 72, tightness of chest. 1240pm BP 140/95, pulse 76 decrease tightness of chest and decrease dizziness 1250pm BP 146/86 pulse 80 still slight tightness of chest and dizziness. Patient went to Urgent Care.
This spontaneous report as received from a registered nurse refers to patients with unknown age and sex. On unknown dates, since 02-OCT-2014 patients were vaccinated with PNEUMOVAX23 (lot#, route and dose unknown) which had been exposed to temperatures outside of the recommended range. No adverse experience had been reported. It was not specified if patients sought for medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; headache that has turned into migraine.; headache that has turned into migraine.; This is a spontaneous report from a contactable other Healthcare Professional.  A 50-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), intramuscular at right arm on 14Jan2021 13:00 at single dose for covid-19 immunization. Medical history included allergies to penicillin and sulfa. Concomitant medication included bupropion, propranolol, topiramate, sertraline, montelukast, alprazolam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first dose of BNT162B2 (lot number: EL1284) on 27Dec2020 02:30 PM intramuscularly at right arm for covid-19 immunization. The patient experienced swelling of forearm, trouble with movement in right hand and heaviness in same arm. Hives, itching, headache that had turned into migraine. The symptoms started the day after the injection (15Jan2021). No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Information has been received from a medical assistant (M.A.) concerning a 26 year old female patient with dysplasia and a history of chickenpox, abnormal papanicolaou smear test who on 05-JUN-2007 was vaccinated in the right arm with a second dose of Gardasil lot #657737/0522U. Concomitant therapy included AVIANE 28. On 05-JUN-2007, after she received the second injection and later that night her right hand was swollen and red. she went to the emergency room (E.R.) because her stomach and right side was hurting and the right hand was red and swollen. The patient was seen in the office on 06-JUN-2007 and the fingers were swollen, blue and the right hand was very cold. The patient had blood drawn from the right forearm the same day as receiving Gardasil. She did not have any problems from the 1st injection. The patient was doing fine and has not come back to the office since 06-JUN-2007. Additional information has been requested.
Information has been received from a nurse concerning an approximately 19 month old patient who in approximately September 2010, was vaccinated with a dose of PROQUAD (Lot# unknown). In approximately September 2010, the patient experienced swelling at injection site, fever, vomiting, crying, screaming and fussiness. At the time of the report, the patient had recovered. It was unknown if the patient sought medical attention. The nurse said that the office no longer gave the first dose of PROQUAD in the younger patients, they only gave it to 4-6 year old patients now. This is one of several reports from the same source. Additional information is not expected.
Towards the end of the 5 hours "I" also experienced mild chills. "I" have never experienced this before; On the day of taking the vaccine when "I" went to bed my body started shaking uncontrollably.; "I" was unable to sleep; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 03Mar2021 at 10:45 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 10Feb2021 at 11:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. On 03Mar2021 at 23:00, the patient went to bed and his body started shaking uncontrollably. This lasted for 5 hours and the patient was unable to sleep. 04Mar2021, towards the end of the 5 hours, the patient experienced mild chills. The patient had never experienced this before. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shaking uncontrollably was resolved after 5 hours on 04 Mar2021 at 04:00; while that of the events mild chills and unable to sleep was recovered on 04Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient tested positive for COVID-19 on 8/16/21. Admitted for severe generalized weakness. Patient still receiving hospital treatment.
Patient reports lightheadedness, numbness in L arm, throat tightening.  Had patient lay flat with legs up.  Patient began to feel better.  Patient states she has this same reaction with other procedures, bloodwork, etc.
Starting coughing feeling like throat was closing up, thought I was having an asthma attack, took 2 puffs of inhaler went to bed, at 1:25am starting feeling freezing cold, achy all over took temperature it was 100.9 noticed face was swelling and eyes had turned red. My lips were swelling as well as extremities. Headache as well as body aches and itchy feeling all over.
Received Moderna Vaccine at 11:36, waited 30 minutes per Dr. recommendation. Left hospital, starting driving home and felt lips tingling and bilateral sides of tongue feeling thick and words sounding thick.  Return to the Vaccine clinic at the hospital in 5 mins .  Escorted to the emergency dept.  BP 203/95,  HR 80s, O2 Sats 94% room air.
Patient received second dose of Pfizer COVID-19 vaccine 7 days sooner than due date (5/18/2021), patient remained in store for 15 minutes with no reactions.
Delayed more than 42 days for 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed more than 42 days for 2nd shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed more than 42 days for 2nd shot). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed more than 42 days for 2nd shot) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.
Initial and follow-up information has been received from a certified medical assistant concerning a 15 year old female with no medical history and no drug allergies, who on 31-DEC-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL (Lot# 658560/1062U). There were no concomitant medications. Subsequently, the patient was pregnant. The patient had an office visit. An ultrasound was performed. The patient's last menstrual period was 30-NOV-2007 and her estimated delivery date was 11-AUG-2008. No product quality complaint was involved. In January 2008 the patient had an elective termination. It was unknown if the fetus was normal and if the products of conception were examined. The patient had no previous pregnancies. Upon internal review the elective termination was considered to be an other important medical event. Additional information is not expected.
light headedness; shortness of breath; headache; some nausea; get some redness to her neck and upper chest; Had elevated BPs; This is a spontaneous report from a contactable pharmacist. A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EH9899), intramuscularly on right arm on 15Dec2020 at 13:30 at single dose for immunization. The COVID-19 vaccine was administered in hospital.  Medical history included arrhythmia - right bundle branch block, GERD (Gastrooesophageal reflux disease), spinal headache, allergy to gabapentin, adhesive, duloxetine hydrochloride (CYMBALTA). The patient wears contact lenses. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN, 5-325 mg), omeprazole, meloxicam, docusate sodium, sennoside a+b (SENNA AND DOCUSATE SODIUM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Within a few minutes of receiving the shot on 15Dec2020, the patient developed lightheadedness, shortness of breath, headache, and some nausea and was taken to the ED (emergency department). She did get some redness to her neck and upper chest, had elevated blood pressure. O2 saturation was fine. The patient received treatment for the events which included acetaminophen (TYLENOL), dexamethasone, diphenhydramine, famotidine, ketorolac, ondansetron, and 1 L normal saline in ED. The patient was prescribed adrenalin autoinjector (EPIPEN) and prednisone and discharged home. Since the vaccination, the patient hadn't been tested for COVID-19. Outcome of reactions was resolved in Dec2020.; Sender's Comments: Based on the close temporal relationship and the description of the events lightheadedness, shortness of breath, headache, nausea, erythema and high blood pressure, there is a reasonable possibility that the events are related to BNT162b2 vaccine. The case will be reassessed upon receipt of follow up information.
R cheek numbness; This is a spontaneous report from a non-contactable pharmacist. A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 28Jan2021 (Batch/Lot Number: EL9262) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. After the patient received the vaccine, she experienced R cheek numbness. On 30Jan2021 (2 days post-vaccine) the patient took Aleve and the numbness went away halfway through the day. 01Feb2021, was first day without numbness. Her face still feels tight on the affected side. Reporter assessed the event as non serious. It was unknown if the patient has been tested for COVID-19 since the vaccination. Outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number G327T, expiry date 12th May 2023) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On 30th December 2021, the patient received the 3rd dose of Shingrix. On 30th December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: Nurse practitioner reported that patient received three doses of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Severe joint pain in both knees. Pain is constant and radiates down legs; worse when trying to walk. Pain is continuous and progressively getting worse since Saturday, March 20. There is no relief. Taking Aleve makes it tolerable but it is extremely painful to do daily activities.
Patient experienced nodule in R Arm. Ear swollen from nose to throat, Back pain with shooting sensation to L leg.
Pfizer BioNTech-Covid-19 vaccine EUA--4/10/2021 started having abdominal pain radiating to back, left chest pain and it progressively got worse. 4/13/21 called PCP to make appointment for 4/14/21, ended up going to ER  on 4/14/21 they did EKG, blood work ultrasound of abdomen, X-ray and CT scan. They discovered the clot in portal vein to the liver. ER  prescribed blood thinners, states she went back on the 15th because pain was not improving. She saw Dr., hematology, on 4/19/21 she thinks the clot is from the COVID vaccine.
The patient called the following day (more than 24 hours). She said that the night of the vaccine (11/7/17) she experienced redness, swelling, heat and soreness around the injection site and traveled to above the elbow, as well as dripping down the throat and coughing. She took Ibuprofen 11/7/17. She called and spoke to the pharmacist 11/8/17, 5:40 pm, to report the reaction. The dripping down the throat and coughing had cleared, but she still had the reaction on her arm and was feeling nauseated. This is when she remembered her allergy to mammalian meat and disclosed it, along with that she ate ground beef for dinner. The patient read her VIS and thought she was just having a typical reaction, but wanted to check. She was instructed to take ZYRTEC or BENADRYL (she had BENADRYL at home) and to apply a cool compress. Also, if her reaction got worse she was instructed to go to the ER. She did state that she had an EPIPEN at home if she needed it. A follow up call was initiated at 9:15 am, 11/9/17, however a message had to be left.
A co worker who was vaccinated tested positive for COVID; A co worker who was vaccinated tested positive for COVID; This is a spontaneous report from a non-contactable consumer (patient's co-worker).   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the reporter's co-worker who was vaccinated tested positive for covid. The patient had drug ineffective and covid. The Caller confirmed that she was inquiring about the Pfizer COVID-19 vaccine. The caller had not gotten the vaccine yet and with the medications that she takes she is looking for clinical trial information, she has looked at Moderna and is looking for a PDF like page about the results of the trial and at the end of the call the caller stated she needed to leave because she had to go get tested as a co worker who was vaccinated tested positive for COVID so she now has to get tested, the caller has not yet received the vaccine, And then she rushed off the phone and hung up. The patient underwent lab tests and procedures which included Covid-test and result was positive on an unknown date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Fever, Chills, Headache, Fatigue, Nausea, Joint Pain. Symptoms lessened within 12 to 18 hours and got progressively better. No treatment sought.
tested positive for COVID-19; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011l20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included monoclonal antibody infusion No relevant concomitant medications were reported.
10-28-2016 Patient came in with large painful rash on small of (L) lower back. Diagnosed with shingles. Prescribed Acyclovir. Resolved. Had both varicella vaccines.
arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs are provided. No treatment.
Severe pain at injection site, pt called clinic 11/24/09 in the morning and was advised to go urgent care for evaluation- pt went.
Red and swollen approx. 5-6 cm to LA. Ice compress, BENADRYL, MOTRIN.
I had a weird cool, numb, and weird sensation going through my arm and into my neck and lips right after receiving the vaccination. My neck and chest to my sternum was numb. It was aching all while I was in class that day and until I got home. The numbness spread through my arm and legs. I called my doctor who informed me to contact local Pharmacy. Pharmacy informed to take Benadryl in case I was having an allergic reaction to the vaccine and if persisted to go to urgent care. The Benadryl helped reduce the redness and soreness, but the numbness was still there. So I went to local Urgent Care on 01/27/2022, and the doctor who saw me didn't want to administer anything because he didn't want make it worse, I but emphasized I didn't want the problem to get worse and become a respiratory problem. So the doctor at urgent care prescribed me Solu-Medrol and to continue taking Benadryl. I'm still taking to both prescriptions until my doctor's appointment tomorrow, 02/01/2022.