chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very sore arm for less than 24 hours; developed pimples/hives inside of mouth/hives all over the patient torso; developed pimples/hives inside of mouth; red throat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN6208, Expiry Date: Not Reported), via an unspecified route of administration, administered in left arm on 14Mar2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included environmental allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. The patient took other medications (concomitant therapy) in two weeks of vaccination. Historical vaccine included, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL9266, Expiry Date: Not Reported), via an unspecified route of administration, administered in left arm on 21Feb2021 (at the age of 57-year-old) at 10:30 as dose 1, single for covid-19 immunization and experienced extremely tired on day 3. The patient was not diagnosed with covid prior vaccination. The patient was not tested for covid post vaccination. On an unknown date Mar2021, at 8:00 after the second dose the patient experienced very sore arm for less than 24 hours, a few days later developed pimples/hives inside of mouth and had a very red throat, non-painful throat. Pimple come and go, 4 Weeks later woke up to hives all over the patient torso along with the pimples in mouth. Hive went away after about a week. Redness in throat was at a minimum but still getting a smaller pimple almost every day. Saw ENT and Dentist about throat not linking the possible connection to the vaccine. Both felt there was nothing serious to be concerned with. The Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Outcome of the event sore arm was recovered in 2021 and for rest all events outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Progressive leg weakness beginning on 10/17/22. Patient had to use a cane at time of presentation. Received 5 days of IVIG. strength intact but difficulty with lower extremity control, loss of vibration and proprioception.
This spontaneous report was received from a registered nurse regarding an adult patient of unknown gender. Information on the concurrent conditions and medical history of the patient were not reported. On 03-MAY-2016 the patient was vaccinated subcutaneously with a dose of PROQUAD batch/lot # L017146, expiry date 13-MAY-2017 (dose number, dose units and anatomical location were not specified) and M-M-R II lot/batch #L023113, expiry date 24-DEC-2016 (dose number, dose units and anatomical location were not specified) (overdose). Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
This spontaneous report was receive from a medical assistant refers to an unknown number of patients of unknown ages and genders. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with unspecified improperly stored dose of (Oka/Merck) VARIVAX, lot number reported as L017145 expiration date 13-MAY-2017, lot number L001325 expiration date 13-JAN-2017 and lot number L009206 expiration date 17-MAR-2017 (route of administration and anatomical location were not reported). There were not concomitant medications provided. No adverse effects were reported and there was no product quality issue involved. This is one of several cases from the same source. Additional information has been requested.
Extreme burning soreness, tightness which then led to spasms up and down my arm, for first week, then moving up to shoulder area causing intense pain in neck continued for 3 weeks.
She got her vaccine started off by feeling sort of "spacy", and that then made her extremely weak and tired (muscle weakness).  As it moved into the evening the knuckles of the top of her hands had electrical nerve sensation, but was all over in all of her joints.  Her hands were the most noticeable to her, but was also in her knees, hips, ankles. She had taken 2 Motrin before she went to bed and was unable to sleep due to the pain.  She also had a horrible headache, which she does not tend to have, and it was probably one of the worse she has ever had.  The electrical impulses lasted that night, but the muscle aches, joint aching and the headache went on for 2-3 more days.  She was then left for another 3 days extremely weak and tired.  She is now OK, feels more herself starting yesterday 5/31/22.    With the other vaccines she did have similar reactions, but not as long and not the electrical sensations and achy joints like she did with this one.  Those reactions lasted for only a couple of days as well as the weakness and fatigue, but this one has been worse.
pt recv vax & sought medical attention & was dx w/mild mid frequency hearing loss bilat w/nl hearing @ frequencies;
This case was reported by a nurse via sales rep and described the occurrence of nausea in a 37-year-old female patient who received FLUARIX Quadrivalent (batch number XC23D, expiry date 30th June 2016). On 6th October 2015, the patient received the 1st dose of FLUARIX Quadrivalent .5 ml. On 6th October 2015, 45 min after receiving FLUARIX Quadrivalent, the patient experienced nausea, fever, vomiting, headache and chills. The patient was treated with antibiotics nos (Iv Antibitics (Nos)), antiemetics and antinauseants (Antiemetic) and analgesic, nos (Pain Medication). On an unknown date, the outcome of the nausea, vomiting, headache and chills were unknown and the outocme of the fever was not reported. It was unknown if the reporter considered the nausea, fever, vomiting, headache and chills to be related to FLUARIX Quadrivalent. Additional details were provided as follows: This case was previously reproted to the manufacturer. This case was reported by a nurse via email to GlaxoSmithKline's sale representative. The reproting nurse was the director of nuring. The nurse made a comment that theygave a FLUARIX QIV vaccine to the paitnet, who was one of their employees. About 1 hr (approximately 45 minutes) after the vaccination with FLUARIX QIV, the patient experienced nausea, headache and chills. The patient's body temperature raised up to 103 degrees F. On 6th October 2015, less than a day after vacciantion, the patient eventually vomited. The patietn was started on Intravenous therapy, given an anti nausea regimen, some unspecified pain medication and was then transported to the hospital becasue the labs at the nursing were off. On the day of reporting, in the afternoon, the supervising nurse called to report that the patient was sent for blood work and clarified that the labs were closed. It was unknown if patient stayed overnigh at the hospital. No additioanl details were provided.
Pt presented to the hospital, 8 days after 2nd COVID shot with TIA and mental confusion. LP consistent with bacterial menigitis but no growth per cultures, and negative meningoencephalitis panel. Slow improvement on broad spectrum Tx
Red, raised, warm baseball size area on left deltoid. Arm was sore for 3 days.
Patient passed out about a minute or two after receiving both above vaccines. Patient was unconscious for only a few seconds. Once patient was helped to a chair they stated they felt a strange headache and then blacked out. Patients BP was 111/70, HR 68, and O2 98%. Patient was assessed by APRN-C. Patient stated that they had nothing to eat or drink for the day. Patient was given a juice box which they threw up shortly after. Patient was monitored for 15 minutes where no other adverse affects happened and was cleared to go home by APRN-C.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine NOS, Anxiety and Endometriosis. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), SERTRALINE HYDROCHLORIDE (ZOLOFT) and DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Oct-2020 and the estimated date of delivery was 30-Jul-2021. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Pregnancy test: positive (Positive) Positive.         Patient was reported to have 2 live full-term births previously with pregnancy end dates on 29-AUG-2015 and 21-FEB-2017 respectively. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Internal review conducted on 22jul2021 resulted in updates to pregnancy information
accidentally gave Shingrix subcutaneously; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter reported this case via interactive digital media. The patient accidentally received the dose of Shingrix subcutaneously. The reporter asked what would they need to watch the patient for. Additional supportive information: The patient accidentally received the dose of Shingrix subcutaneously, which led to Intramuscular formulation administered by other route.  The follow-up would not possible as no contact details were available.
On the morning of the seventh day after receiving my first COVID-19 vaccination, a red, hot, tender, and itchy red area appeared on my upper arm about 1.5 to 2 inches below the injection site.  I also observed a small bump that I interpreted as a possible bug bite on the outer rim of the red area, at "about 5 o'clock" - though the red area was not circular.  The entire red area was about 3 inches long and 1.5 inches wide.  I applied an over-the-counter cortisone ointment once that morning and again the following morning, and the irritation cleared within a week.
After receiving the vaccine, my daughter took me to my Cardiologist appointment (this was scheduled before I received the vaccine). When I got to my doctor my blood pressure was elevated, it was about 180/88. My blood pressure is never that high. It did go down before I left to 140/84. When we were walking in the elevator after leaving the appointment my gait was unsteady. I felt very weak. I also light headed, and dizzy.  It felt like the feeling of the sedation you have receive  before having surgery. When we made it home I couldn't even see straight.  This lasted about 2 hours. I feel much better today.
A non-serious spontaneous report of gave full dose in one nostril was received from a nurse concerning a 38-year old female. On 02-Sep-2009, the patient received the full 0.2ml dose in one nostril. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 12-Oct-2009: Follow-up received: confirmed patient had no adverse effects.
Fever (98.1 degrees fahrenheit); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (98.1 degrees fahrenheit)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 01-Jun-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 01-Jun-2021, the patient experienced PYREXIA (Fever (98.1 degrees fahrenheit)). The patient was treated with IBUPROFEN at a dose of 1 DF. At the time of the report, PYREXIA (Fever (98.1 degrees fahrenheit)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Body temperature: 98.1 (High) fever (98.1 degrees Fahrenheit)..         The patient took Ibuprofen as a treatment of the symptom.  Company Comment: Based on the 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.   This case was linked to MOD-2021-201926 (Patient Link).; Sender's Comments: Based on the 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.
Information has been received from a physician concerning a 16 year old female who on approximately 31-JAN-2008 was vaccinated with the first dose of Gardasil (lot number not reported). Concomitant therapy included MENACTRA. Subsequently the night of the injection the patient experienced hives. The patient was reported to be recovering. No further information is available. 07/08/08 Information has been received from a physician concerning a 14 year old female with an allergy to cats and SEPTRA, who on 25-Feb-2008 was IM vaccinated with the third dose of GARDASIL (lot number 659653/1448U) in the left deltoid. Original documentation indicated concomitant therapy included MENACTRA, however follow up information did not confirm this. Approximately 4 minutes after the vaccine injection the patient felt faint and fell to the floor hitting right side of her head on the hard floor. It last only a few seconds. Ice was applied to her head and the patient was seen by a physician. She complained of headache. Patient was monitored for 1.75 hours after incident. Patient was sent home with instructions to go to ER if condition worsened. The patient recovered on the same day. No further information is available.
pt exp dec vision in the rt eye;2wk s/p HepB Vax #2 dose;decrease was gradual;VEP showed inc latency consistent w/optic neuritis;still residual neuroretinitis;
Severed redness and swelling extending to from shoulder to elbow and circumferentially. Discomfort and limited range of movement. Redness and heat radiating from arm.
Headache, Myalgia & Arthralgia  Narrative:  Other Relevant History:
Patients arm turned a bright yellow jaundice color from the shoulder to the elbow. Arm also severely bruised a tennis-ball size bruise around the injection site. Patient complained of pain for whole top of arm.
Patient received Tdap October 31, 2006 and received again on Sept. 25, 2007. Received 2 doses within 1 year.
arm pain (severe) immed past inject 20-30mins p/inject; felt weak, dizzy about to past out; began running t101 about 630PM; arm was swollen & red, felt nauseous, itching @ site over body; seen by MD;
9 cm x 12 cm area of erythema left arm at site of deltoid IM injection. Area is warm, non tender.
Tiredness; Chills; Fever; Nauseous; Vomiting; This is a spontaneous report received from a contactable reporter (consumer).  A male patient received BNT162B2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), on 20Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 20Oct2023, outcome "not recovered", described as "Tiredness"; CHILLS (non-serious) with onset 20Oct2023, outcome "not recovered"; PYREXIA (non-serious) with onset 20Oct2023, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 20Oct2023, outcome "not recovered", described as "Nauseous";  VOMITING (non-serious) with onset 20Oct2023, outcome "not recovered". Additional information: The reporter stated, "my boyfriend had a the Pfizer shot yesterday, COVID shot yesterday but he also had a shingles shot too but he has had tiredness, he has chills, fever, nauseous, vomiting and it still has not gone away. Is there anything that I can do? It has been 24 hours. Is there anything we can do?" He also has a fever and vomiting really yesterday and chills. Product details (LOT#, NDC#, UPC# and expiration date) and pharmacy details could not be probed as the reporter hung up the call abruptly. Thus, limited information was available over the call.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 has been requested and will be submitted if and when received.
reports that his left arm where he had the shot is pretty sore; soreness to his left calf muscle as well; 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 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "reports that his left arm where he had the shot is pretty sore"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness to his left calf muscle as well".  Additional information: Consumer was asking if his symptom following his first vaccine dose is normal. Caller reports that he received his first vaccine dose yesterday and reports that his left arm where he had the shot is pretty sore, but he also reports soreness to his left calf muscle as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
red spot in the middle of her forehead/red spot the size of a quarter; chills; fever of 101 Fahrenheit; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (red spot in the middle of her forehead/red spot the size of a quarter), CHILLS (chills) and PYREXIA (fever of 101 Fahrenheit) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 004D21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (high blood pressure). Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced ERYTHEMA (red spot in the middle of her forehead/red spot the size of a quarter), CHILLS (chills) and PYREXIA (fever of 101 Fahrenheit). At the time of the report, ERYTHEMA (red spot in the middle of her forehead/red spot the size of a quarter), CHILLS (chills) and PYREXIA (fever of 101 Fahrenheit) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Body temperature: 101 (High) fever of 101 Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: No new information
Injection site sireness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site sireness) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site sireness). At the time of the report, VACCINATION SITE PAIN (Injection site sireness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT AND TREATMENT MEDICATION WERE USED   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-MAY-2021. Nonsignificant Follow-up; Reporter's Comments: NA; Sender's Comments: NA
Side effects of the moderna; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects of the moderna) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 20-May-2021, the patient experienced ADVERSE EVENT (Side effects of the moderna). At the time of the report, ADVERSE EVENT (Side effects of the moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Body aches, chills, fever, mild swelling in extremities following 2nd dose persisting for 2-3 days. Symptoms subsided, however intermittent fever and headache continued, along with swelling which gradually worsened, polyarthritis, Raynaud-like symptoms of lower extremities, chest pain, decrease in concentration and cognitive function. Continue to meet with PCP and referred to rheumatology specialist.
Injection given on 01/13/09 in arm. Mom gave child Tylenol after injection at home. At 4:00Am (1-14-09) mom noticed rash on child all over body. Seen MD today at 9:15 AM
Guest L. deltoid is extremely swollen and red from shoulder to elbow since receiveing both Fluzone hd and Pneumovax on same arm. Guest is concerned. Seems feels fine, but concerned since he has never reacted like this before.