chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: ER8733) at the age of 56 years as dose 1, single for COVID-19 immunization. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "Very sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. Other medications in two weeks included unspecified vitamins. No other vaccine was administered in four weeks. The first dose was administered at 01:00 PM. The patient has not been tested for COVID-19 post vaccination.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021439215 Same patient and product; different events and dose
Tachycardia and diaphoresis within 1/2 hour of vaccine administration, required ER eval where received IV beta blocker, IV fluids and started on oral beta blocker for persistent sinus tachycardia. Also had migrating burning sensation in chest, intermittent chest pain, mild paresthesia and intermittent diaphoresis. Aware of sensation of hypercontractility of heart. Remain on beta blocker with planned follow-up with cardiologist in April.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Additional Details: Patient was vaccinated with first dose of pfizer vaccine. Is expiriencing extreme fogginess, headache, and dizziness severely and is being refered to a neurologist for further evaluation.
I experienced severe fatigue, body aches, fever, chills, neuropathy in my feet and brain fog.
Within about 3 days post second vaccine; I've begun having sever Vertigo problems, having fallen several times. Some days are better than others. Required to have urine drug test at work.  Currently taking Dramamine to help. Contacted M.D., he said he has had patients report the same, but improve over time. I have appointment next  week with a different M.D. for consultation.
Vomiting; pt, a MD, experienced severe vomiting p/receiving Influenza Virus Vax; Pt was hospitalized & tx IV fluids
Fever 101 @ day 6 p/immunization; febrile seizure day 10 p/MMR;
This spontaneous report was received from a nurse refers to a 12-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 01-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045392, expiry date: 17-NOV-2018) for prophylaxis (incorrect product storage). The lot of M-M-R II were reconstituted with properly stored sterile diluent (DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054: Original Case : 1709USA000054.
Information was received on 30-JUN-2017 from a male consumer regarding  himself (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # N003997, exp 20-OCT-2018) (dose, route, and site of administration not reported). On an unknown date, the patient experienced redness from his elbow to his shoulder, a low grade fever, muscle aches, a severe headache and felt "fluish". The outcome of the events were unknown. The relationship between the event and PNEUMOVAX 23 was not provided. Additional information is not expected as no permission was given to contact physician.
Erythema multiform and pain. Treatment: Diphenhydramine 25 mg PRN, betamethasone Unknown.
I received my first Moderna vaccine on 3/10/21. I woke up at 7 am on 3/15/21 with a very itchy scalp. By mid-morning I had hives in my waist and thigh areas. By 3/16/21, my scalp felt somewhat better but I have large red, blotchy hives on my torso from my chest to my thighs. They are mostly along the sides of my torso and in my thigh area. They are dry hives, not painful but itchy. Some remain on my scalp and some on my back but not as bad as along my waist and thighs.  On 3/15 I took Benedryl during the day/night. I had a Computer visit with my doctor today (3/16) and she suggested I take Zyrtec.  I've not had exposure to anything new--no new detergent, clothing, food, etc. Given this, my doctor suggested I report this as a possible reaction to the vaccine.
Child under age 18 was given Moderna Vaccine at  on 3/22/21.  Patient came to site for second dose on 4/22/2021.  Parent is aware and requested dose be given to patient under age.
12 hours after receiving vaccine I woke up from a deep sleep because my tongue felt thick and too big for my mouth.  I am a RN so I assessed myself.  No tingling.  No numbness.  No difficulty breathing.  I could swallow my saliva.  Fell back asleep.  Soon after I woke up again and thought wow my tongue is huge and it is occupying my entire mouth.  I looked in the mirror and my tongue was huge.  Swollen and the knobs on the back of my tongue were huge too.  No other symptoms.  I grabbed my cell phone and was able to fall back asleep.  In the AM my tongue belt better and only the sides felt funny.  Visually, my tongue had decreased and I could again see the groves and marks in my tongue which were gone when it was swollen.  On AM of 2/19 it appeared to resolve completely.
Received  vaccine 1/13 at noon.  Woke up with a migraine level headache about 3am along with a fever of 101.6.  My right arm is very sore/tender.  I have generalized aches.
inadvertently administered to a 26yo patient instead of varicella vaccine; inadvertently administered to a 26yo patient instead of varicella vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number 42YY3, expiry date 28-MAY-2024) for prophylaxis.   On 24-MAY-2023, the patient received Shingrix. On 24-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered to a 26yo patient instead of varicella vaccine) and wrong vaccine administered (Verbatim: inadvertently administered to a 26yo patient instead of varicella vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 05-JUN-2023 The error was discovered on the day of reporting. The patient was fine, no harm done. The reporter did not want to provide email address. She said PV could follow up The reporter consented to follow up. 26year old patient was inadvertently administered Shingrix instead of varicella vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (concentration, dose, route and anatomical place of vaccination were not reported) which had the following lots # l040459, M014929 and m014929 with expirations dates of April 2017, 27-MAY-2017 and 27-APR-2017 respectively. Which were reported because a data logger and were exposed to 30.1F for 84.75 hours, 55.2F For 90 minutes, 31F for 124 Hours, 51.F 2 hours for 30 minutes and 28.2F for 28.25 hours. This is one of several reports from the same reporter. Additional information has been requested.
Fever; Body aches; Chills; Swollen lymph nodes under armpit; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and penicillin allergy. 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 COVID vaccine. Concomitant medications included sulfasalazine (MANUFACTURER UNKNOWN) and ethinylestradiol, etonogestrel (NUVARING); both for unspecified indication and unknown date. On 18Apr2021 at 19:00, the patient experienced fever, body aches, chills and swollen lymph nodes under armpit. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches, chills and swollen lymph nodes under armpit were resolved on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained;No further information is expected.
Patient came to the pharmacy requesting for the Prevnar 13 vaccine. The vaccine was administered by 09/17/19 without any observed complication or adverse event neither during or following administration. Patient came to the pharmacy 6 days later (09/23/19) indicating that the previous saturday (09/21/19) he woke up at 4:00 am with his arm swollen, warm and painful in his elbow and wrist. He inform the pharmacists that he went to the emergency room by 9:00 am that same day (09/21/19) and visits the orthopedic physician who told him that the vaccine exacerbated pre-existing arthritis in the patient and  prescribed Diclofenac sodium 1% gel and Aspercreme patch. The patient then arrange a visit to his primary physician who told him he was thinking about the possibility of a gout attack. Uric acid labs were ordered and a new prescription for Colchicine 0.6mg and Prednisone 5mg  was written. Follow up consults were given to the patient and is currently stable and improving.
I am currently 13 weeks and 2 pregnant and decided to get the booster vaccine. Interestingly- I received my first two doses in December and January and had no side effects - other than a sore arm.  Since my shot on Monday I have experienced fevers, headaches, neck stiffness, photo and auditory sensitivity. My fevers have responded to Tylenol q4-6 hours for the first 48 hours. I no longer have a fever.  However- my headaches with photo and auditory sensitivity have persisted and I?ve been waking up at night with headache. Since then I was advised to check my BPs which diastolic have been consistent elevated ranging in mid 80-90s. Prior to this I have not had elevated BPs. I?m also experiencing greater fatigue with walking etc.  I will be checking in with my OB today as well since my headache is now on day 5.
Circular bruise, light blue/yellow discoloration of the site. No pain or discomfort.
This spontaneous report as received from a pharmacist refers to a female patient "in her 70's". The patient was vaccinated with ZOSTAVAX (lot # not reported) on 05-JUN-2012. On 24-JUN-2012 the patient experienced rash after the vaccination and the patient had spots that itch but do not blister. Per the pharmacist, the rash was all over the patient's body. The patient prescribed her an oral steroid to take but as of 2 days before the time of report (09-JUL-2012) it was still not helping the rash. And the patient sought for medical attention by seeing her physician. It was reported that the pharmacist did not believe this is due to ZOSTAVAX but the patient did feel it was due to the vaccine. The outcome was not recovered. Additional information is not expected.
LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, sulfa drug allergy, peanut and shell fish allergy, tree nuts allergy, mango allergy, chocolate allergy, allergic to color, allergic to flowers/ allergic to soil, allergic to horses, allergic to cats and dogs, and pecan tree allergy, and other pre-existing medical conditions included patient carries an epipen patient was tested for 48 things. The patient was previously treated with . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included azelastine for allergy, cetirizine hydrochloride for allergy, fluticasone propionate for allergy, and rosuvastatin calcium for high cholesterol. On 02-APR-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheadedness. This report was non-serious.
3 patients reported on the document who received ROTATEQ after an excursion was reported/Temperature 48F Time frame 17 minutes; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions and allergies and concomitant medications were not reported.   On 17-JUL-2020, at the age of 10-weeks-old the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered at a dose of 2 milliliters, by oral route (formulation, strength, vaccination scheme were not reported; lot number S004400, which has been verified to be valid, expiration date was not reported, but upon internal review was established as 14-NOV-2020) as prophylaxis. The vaccine administered experienced a temperature excursion of 48 degrees Fahrenheit for a time frame of 17 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA006635: US-009507513-2009USA006229: US-009507513-2009USA007900:
Pt received Tdap vaccine instead of Dtap.  No adverse event reported by patient or parent.
migraines; have a stomach bug; having a mild illness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 11Oct2021 (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: MIGRAINE (non-serious) with onset Oct2021, outcome "unknown", described as "migraines"; ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "have a stomach bug"; ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "having a mild illness". Therapeutic measures were taken as a result of migraine.  Additional Information: Caller states she initiated treatment with Aimovig for migraines on 16Oct2021. Caller states she has already been on a daily steroid regimen for a while. The event stomach bug required frequent trips to the bathroom.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of a tightness in her throat and feeling short of breath within minutes following vaccination.  She also felt dizzy and light headed.  She was immediately taken to an exam room and vital signs were taken. Vital signs were stable. Sa02 was 99%.  Several minutes later she developed a rash on the left side of her neck. Benadryl 25 mg po was given. Patient remained in exam room and monitored for 1 hour. About 15-20 minutes after injection the shortness of breath and throat discomfort resolved. 1 hour after vaccine all symptoms were resolved.
Pt. return to flu clinic with complaints of tongue "thickening" and tingling sensation. Pt. was given 25MG of BENADRYL (liquid) at 3:01PM and then given 25MG of BENADRYL at 3:05PM also liquid. Pt. was observed for 1 hour with watching pt. oxygen and pulse rate and observing pt. breathing. Pt. denied any SOB. We consult via telephone with our medical director who advised us to administer BENADRYL and observe pt. At time 4:00PM pt. was stated that she was feeling better. Pt. was advised that if symptoms return to call 911 and to contact her PCP. Pt. voiced understanding. I spoke to pt. today (10/05/17) via telephone and she states that she woke up with headache this morning, still has tingling in the corner of her mouth, and fingertips are a little numb. Pt. states that she has contacted her PCP and he advised to not get flu vaccine anymore and to start taking ALLEGRA and stop ZYRTEC.
After eating food she has started some rashes on her face and ears and again after eating the dinner she started again with some rashes on her face and the ears; After eating food she has started some rashes on her face and ears and again after eating the dinner she started again with some rashes on her face and the ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 27Nov2021 11:30 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), RASH (non-serious) all with onset 27Nov2021, outcome "not recovered" and all described as "After eating food she has started some rashes on her face and ears and again after eating the dinner she started again with some rashes on her face and the ears".   Follow-up (03Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Three days after second vaccine, began having low grade fever, malaise, R-arm redness and swelling, fatigue. On Feb.6th woke up from napping with extreme neck-ache and very loud, intrusive tinnitus. Panic attach on Feb. 6th, Feb. 8th, and several instances afterward coupled with anxiety. As of 4/2/2021 had one day of low to no tinnitus on 4/1/2021.
This spontaneous report as received from a healthcare worker refers to an unspecified number orf patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates in2015 (reported as "on or after 13-OCT-2015"), the patients were vaccinated with improperly stored doses of (Oka/Merck) PROQUAD (lot # L032761 with expiry date 30-DEC-2016, lot # L030586 with expiry date 10-FEB-2017, lot # L031602 with expiry date 18-FEB-2017, lot # L032421 with expiry date 24-FEB-2017 and lot # L032759 with expiry date 24-FEB-2017 and albumin status of recombinant human albumin (rHA); dose and route were not reported). The patient's experienced no adverse event. This is one of two reports received from the same reporter. Additional information has been requested.
HEADACHE; UPSET STOMACH; FEVER; This spontaneous report received from a vaccine facility concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 25-MAR-2021, the subject experienced upset stomach. On 25-MAR-2021, the  subject experienced fever. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of fever and upset stomach was not reported. This report was non-serious.
soreness on the left arm; metallic taste in mouth; slight tingling on top of her tongue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on the left arm), DYSGEUSIA (metallic taste in mouth), PARAESTHESIA ORAL (slight tingling on top of her tongue) and NAUSEA (Nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness on the left arm), DYSGEUSIA (metallic taste in mouth), PARAESTHESIA ORAL (slight tingling on top of her tongue) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (soreness on the left arm), DYSGEUSIA (metallic taste in mouth), PARAESTHESIA ORAL (slight tingling on top of her tongue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Pt had no previous seizure hx and while with friends they said she appeared to have a grand mal seizure. Pt was incontinent of urine.
injection areas starting hurting; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (injection areas starting hurting) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection areas starting hurting). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection areas starting hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pt developed vesicles approx 6 days following vaccination with varicella, along with viral prodrome. Symptomatic care.
After administration of vaccine, we were notified that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of guidelines that recommend revaccination.  Patient declined revaccination.  Letter sent.