chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was "asleep").  The sensation moved to shoulder, traps, and face after about 30-45 minutes; 30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was "asleep").  The sensation moved to shoulder, traps, and face after about 30-45 minutes.; numbness/tingling mostly right side (arm, shoulder, face); This is a spontaneous report from a contactable consumer, the patient. A 51 -year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, 0.3 mL, lot number: EL0140), via an unspecified route of administration on 05Jan2021 at 05:30 PM, (at the age of 51 years-old)  as a single dose in the right arm for COVID-19 vaccination. Medical history included Hashimoto's thyroiditis, hypertension and asthma. The patient was allergic to gadolinium MRI contrast, morphine (plus standard environmental allergies). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included allergy shots weekly, vitamin C, vitamin D3 and zinc quercetin. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 06:15 PM, (also reported as 30 min after injection), the patient's right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"). The sensation moved to the shoulder, traps, and face after about 30-45 minutes. The sensation started to subside after about 3-4 hours. There was never ever any weakness or sensation of throat, hives or rash, breathing issues or pain at injection site. Just a numbness/tingling mostly right side (arm, shoulder, face). The lower extremities or left side was not affected. The events were reported as non-serious. Laboratory data included a COVID-19 test (nasal swab) on 15Oct2020 which was negative. The patient was not treated for right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), the sensation moved to the shoulder, traps, and face. right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), sensation moved to the shoulder, traps, and face. The clinical outcome of right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), sensation moved to the shoulder, traps, and face was recovering. It was also reported that since the vaccination, the patient has been tested for COVID-19 (nasal swab) on 15Oct2020 .
Patient presents to pharmacy to pick up rx for steroidal agent and antihistamine. She tells me about a breakout of hives that she experienced a few days ago and how she presented to her physician for assistance. Vaccine was given 2+ weeks prior to breakout; however, patient is not sure where the reaction has come from.
Severe tinnitus in left ear; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 17:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as "na" (not applicable). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 09Apr2021 at 23:30, 30 hours after the first shot in the left arm the patient started suffering from severe tinnitus in the left ear. The patient reported that it was still ongoing 14 days after it started (at the time of this report). At the time of this report, the patient was contemplating not to take the second dose or only when the symptoms improved. The event resulted in doctor or other healthcare professional office/clinic visit. The patient saw an ENT (ear, nose and throat) doctor. Therapeutic measures were taken as a result of the event and included treatment with unspecified steroids but without result. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe tinnitus in left ear was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Uterine/pelvic cramping, nausea.  Third pregnancy, EDD 6/8/21, 16 weeks pregnant
four month old male patient received Adacel vaccine, no AE; four month old male received Adacel in error and not the prescribed DTap, no AE; Initial information received on 30-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who received a 0.5mL second dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) via an intramuscular route in the right thigh, on 25-Feb-2019 for prophylactic vaccination, instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included HIB VACCINE (HIB) for Immunisation.  It was actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. It was reported that 4- month old male received Adacel in error and not the prescribed DTap. Hence the patient received PediaRX for the Dtap in 6 months of age. The event was discovered while reviewing the chart when the patient came for 6 month vaccination.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
I had a reaction to the vaccine less then 5 minutes after getting it. I experience profuse sweating, arm concussions, vomiting & tunnel vision / fitness. This results in the EMTs being called on my behalf the pharmacist whom note a drop in blood pressure and heart rate. Please see attached for EMT report and vaccination card.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number K012919, dose, route of administration and expiration date were not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Allergic reaction to COVID-19 vaccine (rash on stomach - left side) Began 03/08/2021 cleared up and then reoccurred 03/11/2021 still evident 03/16/2021
Initial and follow up information has bee received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 12-OCT-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
high pitched cry lasting > 2 hrs; high fever; hot, hard, swollen leg;
Hypertension (BP of 150/100); Tachycardia (HR of 130); This spontaneous case was reported by a physician and describes the occurrence of HYPERTENSION (Hypertension (BP of 150/100)) and TACHYCARDIA (Tachycardia (HR of 130)) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced HYPERTENSION (Hypertension (BP of 150/100)) and TACHYCARDIA (Tachycardia (HR of 130)). At the time of the report, HYPERTENSION (Hypertension (BP of 150/100)) and TACHYCARDIA (Tachycardia (HR of 130)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Blood pressure measurement: 150/100 (Inconclusive) 150/100. On 04-Jan-2021, Heart rate: 130 (Inconclusive) 130.     The action taken with 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Arm started swelling and turning red below injection site several hours after injection given. By following day arm is red in approx 3 x 5 inch area below injection site, warm to touch.
By about 9:00 pm, the night the flu mist was given, I started throwing up, shaking, migraine headache, then hives showed up by next morning.  Hives lasted 3 days.
36 hours post vax, the pt developed hives:rash on child's arms and legs. Mother called pediatrician who recommended Benadryl or Claritin.
Administration error: 17y/o F given Moderna vaccine instead of Pfizer by mistake. Tolerated vaccination well without adverse events.
Information has been received from a registered nurse concerning an unspecified patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not informed. On an unknown dates, the patients were administered improperly stored doses of ROTATEQ lots # M016238, M022371 and M031553 with expiration dates 07-DEC-2017, 18-FEB-2018 and 19-MAR-2018 respectively, orally, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of ROTATEQ were exposed to a temperature > 46°F but < 77°F and were out of range for 24 hours. A data logger was not used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001060: US-009507513-1702USA003013.
A nurse reported that a 6 year old child experienced nausea, vomiting and stomach pain. Three days after receiving FluMist on Oct 28 2005. the patient is being taken cared of at home. The patients clinical outcome is unknown. The reporter causality is not provided. No other information was available at the time of the report. Additional information has been requested. Follow up information - Patient DOB and vaccine lot number received.
pt recvd vax & 6 months later lab eval revealed anti-HBs; pt was found to have pos core antibody in the borderline range; It was felt pt was a indeterminate clinical picture;
pt recv vax; cellulitis 15cmx17cm lt arm; dicloxicillin x 10 days; motrin given;
Patient described redness down entire right arm and states it is sore to touch. Started the evening of her vaccination. Patient taking diphenhydramine 50 mg PO Q4-6hr until improved. Reports that the redness is gone today (2/1/17) when reporting the reaction to me.
Patient presented to the ED and was subsequently hospitalized for injury of globe of eye within 6 weeks of receiving COVID vaccination.
Client received Twinrix vaccination on 5-26-09. Clt's wife called Health Department 6-9-09 inquiring about services she received and mentioned in passing that her husband passed away on 5-28-09. "No one knows what happened" was quoted by the wife.  7/7/09 Autopsy report received. Cause of death is Diphenhydramine intoxication.
Consistent pain in the lower back sacral area feels deep in the bone/the lower  back pain became much worse constant ache worsened with movement; pain burning sensation and her left hip left shoulder and left wrist.; pain in the hip and shoulder/pain in left wrist; cold like symptoms; nasal congestion; running nose; 1st dose: 26Dec2020; 2nd dose: 01Jan2021; 1st dose: 26Dec2020; 2nd dose: 01Jan2021; This is a spontaneous report from a contactable other HCP (patient herself). A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 36 years, at single dose in right arm on 01Jan2021 (Lot number: unknown) for COVID-19 immunisation. Medical history included chronic migraines, muscle spasms and allergies to some topical antibiotics. The patient was not pregnant at the time of vaccination. Concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 36 years at single dose in left arm on 26Dec2020 at 14:15 for COVID-19 immunisation. The patient experienced consistent pain in the lower back sacral area feels deep in the bone Day of second shot she had pain burning sensation and her left hip left shoulder and left wrist. The pain in the hip and shoulder went away within two days the left wrist was persisting still and the lower back didn't start until about two weeks ago. She had cold like symptoms nasal congestion running nose this past Wednesday on that same day the lower back pain became much worse constant ache worsened with movement. She asked "are these things that I should be still seeing after the second covid vaccine I'm now almost a month and a half out from my second vaccine date". Adverse events start date on 12Jan2021 at 20:00. The patient had no Covid prior to vaccination. She had Covid test with type of Nasal Swab post vaccination, separately on 24Feb2021 with a result of negative and on 25Feb2021 with pending result. There was no treatment received. Events outcome for Back pain, Pain burning, Arthralgia, Cold symptoms, Nasal congestion and Runny nose was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 16 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
NO ADVERSE EVENT REPORTED - PATIENT UNDER 18 WAS ADMINISTERED MODERNA VACCINE BY MISTAKE WHILE TRYING TO SAVE A DOSE OF THE VACCINE
Breakthrough COVID-19 infection. Tested positive on 06/30/2021. Patient fully vaccinated on 02/20/2021.
Injection received in left arm. 1-2 hours later I experienced  swelling of throat on the left side, swollen tongue, difficulty swallowing, headache, extreme fatigue
Patient received his first dose of the Pfizer vaccine, roughly 3 seconds following administration, this patient's upper body fell to the back of the chair he was sitting in, he then preceded to mildly shake, along with jerking movements in the upper limbs. He also appeared very pale in color. His father had supported him until the event was over. This event lasted roughly 5 seconds. Immediately following the event, the patient reported feeling "blurry", but within roughly 2 minutes following the event, the patient was asked his age and name, which he answered correctly -- he was alert by this point, but appeared tired and off-standish. We then offered him a ginger-ale which he accepted and drank. The patient along with his father and younger sister agreed to stay for 15-20 minutes following the event. The patient was not very talkative, but did not experience any other events during this time besides experiencing "goosebumps". After the 20 minutes passed, the patient and his family had left.
RespDepression, Shortness of Breath Narrative: Employee states he went to his PCP and to a cardiologist
booster; Pain in arm/Under that area is all red around I got the injection; red around the injection/Under that area is all red around I got the injection, I have like a red mark or the injection mark on my arm and it's kind of hurt; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 (Lot number: FH8028, Expiration Date: 28Feb2022) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE taken for anxiety. Vaccination history included: Covid-19 vaccine (Dose 1st , Lot# of First shot: EW0161., Anatomical site of administration: Left), administration date: 06May2021, when the patient was 47 years old, for COVID-19 immunization; Covid-19 vaccine (Dose 2nd, Lot# of second shot: EW0182, Anatomical site of administration: Left), administration date: 06Jun2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2021, outcome "unknown", described as "Pain in arm/Under that area is all red around I got the injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 21Dec2021, outcome "unknown", described as "red around the injection/Under that area is all red around I got the injection, I have like a red mark or the injection mark on my arm and it's kind of hurt". Therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema.  No follow-up attempts are possible. No further information is expected.
Within 1.5 hours of receiving the vaccine, pt. was tired and quiet. Personality was changed.  He also had a red swelling on his left arm (not at injection site but same arm. )A few hours later I noticed the red swellings on his legs at well.  The next day  (Thursday) he was lethargic and weepy.  Friday  he woke up very pale and lethargic, he also had severe congestion. This went on a few days . Monday he  had a severe heartburn like pain and threw up. Wednesday he seemed to feel better but was still tired. The following monday he began developing ulcer like lesions on his left elbow. They were about penny sized, oozing and rapidly spreading. By the following week they began to appear on his right elbow. He was taken to both his Doctor and dermatologist,, The Dermotologist said it was inflammatory reaction. He prescribed a steriod.
got this vaccine & had shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter stated that lots of friends had this vaccine and still had shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR182894 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR182894:same reporter
Swollen lymph node in arm pit 2 days after shot.  4 days after vaccine, swollen testicle and tube (Epididymis). It has now been 6 days since vaccine and still swollen testicle and tube.  Armpit gland swelling has gone away.
Tingling in extremities, numbness in legs. Progressed to temporary paralysis of legs.
This case was received from a health professional on 22 July 2008. A 66-year-old male patient, with a history of aortic valve replacement and benign prostatic hypertrophy, received the following vaccinations on 02 July 2008: YF-VAX, TYPHIM VI, DIPHTHERIA and TETANUS TOXOID (manufacturer unknown), Hepatitis A (manufacturer unknown), and Hepatitis B (manufacturer unknown). Lot numbers, routes/sites of administration, and number of previous doses was unknown. The patient was admitted to the hospital on 21 July 2008, 19 days after vaccination, with delirium, confusion, and a temperature of 102 degrees. He had reportedly complained of a frontal headache two days prior to admission. White blood count on admission was 16.7, and 14.0 the following day. A CT of the head showed thickness of the sinuses, and a chest x-ray revealed patchy pneumonitis at the left base. Treatment included Augmentin, and temperature had decreased to 99 degrees the day after admission. Concomitant medications included Flonase, aspirin, Nexium, lorazepam, and hydrochlorothiazide. The patient remained in the hospital at the time of the report, and had not yet recovered.  9/16/08 Reviewed hospital medical records of 7/21-7/26/2008. FINAL DX: aseptic meningoencephalitis, suspect yellow fever vaccine Records reveal patient experienced increasing confusion & abnormal behavior with staring spells & inappropriate questions.  Neuro & cardio consults done.  Tx w/IV & oral antibiotics.  LP done.  Gradually improved & d/c home.  9/16/08 Reviewed PCP medical records of 7/21/08. FINAL DX: none provided Records reveal patient experienced intermittent HA & intermittent fever x 2 weeks with behavioral change & mild disorientation.
Morning after at 3AM severe body aches and pain in major joints, hot stabbing knife feeling, hips, shoulders, knees. Fever about 100.2. Heavy aches and severe exhaustion. A little bit of nausea. Pain so bad I did not feel well enough to get out of bed to get pain medication.
Spoke with the grandmother this morning the incident yesterday regarding the peds pfizer booster 5-11 yrs was not diluted and the signs and symptoms the family should watch out for grandmother stated Patient did stay home because she was complaining of a stomach ache and headache. I also explained if she feels the need to bring them in for further evaluation she is welcome to. I also explain I will check back tomorrow and Saturday to see if there are changes