chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; sore arm; Did not feel well during the night; This is a spontaneous report from a non-contactable consumer (non-healthcare Professional reporting for a patient).   A 87-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number Unknown), via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 13:15 (at the age of 87-years-old)  as a single doe  for covid-19 immunization  The patient medical history and concomitant medications were not reported. The patient has no known allergies.  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 13Feb2021 The patient experienced chills,  sore arm and did not feel well. The clinical course is as follows the patient didn't feel good during the night and had chills during the night. Feels fine 24 hours later except for a sore arm. No treatment was given for the events. The clinical outcome of the event chills, and malaise were recovering while sore arm was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Body aches, generalized fatigue, hyperglycemia, 10lb weight loss, lightheadedness, headaches, swelling at the injection site.
101 -102 fever and rash from neck to extremities, tachycardia (144 pulse) for two days before seeking treatment at an urgent care facility.  Fever and rash more severe than what allergic reaction is described and I never have had any adverse reactions to vaccine in the past.
I was fully vaccinated in February 2021. I was exposed to COVID on July 30, and developed symptoms two days later. I tested positive for COVID on August 4.   It started off as an itchy throat and slight sinus pain. Within a couple days it had progressed to fever, extreme sinus/facial pain, loss of taste and smell, throbbing headache, sever congestions, plugged ears, and extreme fatigue. I was really sick for 8 days and developed a bad sinus infection after.  Three weeks after becoming sick, I went in to the doctor about my sinus pain and found out I also had a sinus infection.   It looks about 4 weeks to start to feel better, despite being fully vaccinated. A little over a month out, and I still tired and having an elevated heart rate when exercising that never existed before.
Information was received from a licensed practical nurse concerning a 7 month old patient of unknown gender. There was no information provided about the patient's past medical history, concurrent conditions, or concomitant medication. On 21-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017), orally. No symptoms were reported. The administered dose of ROTATEQ experienced a temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions and no further temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004967: US-009507513-1705USA004965: US-009507513-1705USA004952: US-009507513-1608USA012794: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004966: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004974: US-009507513-1705USA004975: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1705USA004946: US-009507513-1705USA004887: US-009507513-1705USA004888: US-009507513-1705USA004889: US-009507513-1705USA004890: US-009507513-1705USA004891: US-009507513-1705USA004892: US-009507513-1705USA004893: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899:
Received the first Moderna vaccine on 5-5-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the first Moderna vaccine on 5-5-2021) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first Moderna vaccine on 5-5-2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the first Moderna vaccine on 5-5-2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were not provided.
Information has been received from a health professional concerning a patient who on 27APR1999 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. On 09JAN2004 the patient broke out with shingles. Unspecified medical attention was sought. There was no laboratory or diagnostic studies performed. There was no product quality complaint involved. It was reported that therapy with varicella virus vaccine live was discontinued on 27APR1999. Additional information has been requested.
6 hours post injection, soreness started at injection site. Overnight I developed chills, fever, aches, and joint pain. Nausea by morning. Chills and aches have lasted more than 24 hours so far
FELT DIZZY; VERTIGO (COULD NOT GET OUT OF THE BED AND THE WHOLE ROOM  WAS SPINNING AROUND); JOINT PAIN IN SHOULDER RADIATED TO LEGS; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: type 2 diabetes. Patient was non smoker, and non alcohol user. The patient had no known allergies and no history of drug abuse or illicit drug usage. Concomitant medications included dulaglutide for type 2 diabetes, insulin aspart for type 2 diabetes, and insulin glargine for type 2 diabetes.  On 18-DEC-2020, Laboratory data included: SARS-CoV-2 test (NR: not provided) positive.  The patient was previously treated with paracetamol for body pain, dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride for body pain, dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol for body pain; and experienced dizziness, headache, joint pain and vertigo when treated with covid-19 vaccine ad26. cov2. s (Dose Number in Series: 1), administered on 06-MAY-2021 for prophylactic vaccination.  On 02-NOV-2021 the patient received booster dose and took paracetamol  (Tylenol PM). On 03-NOV-2021 patient experienced joint pain in the shoulder and radiated to his legs and felt dizzy. Joint pain was resolved on the same day.  On 04-NOV-2021 patient could not get out of the bed in the morning and the whole room was spinning around when he gets up. Patient reported that the dizziness went away by 11 AM on the same day. On 05-NOV-2021 the patient experienced the symptoms as the previous day, but the dizziness went away around 9 AM. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness and vertigo and recovered from joint pain and headache. This report was non-serious. This case, involving the same patient is linked to 20211122838.
Patient informed staff he is feeling hot, dizzy,c/o SOB.  Took patient to a room to cool down, ice pack given.  Patient placed in supine position.  Patient states he is feeling numbness around nose and mouth.  Breathing non-labored.  Patient's dizziness and SOB have resolved, but face numbness did not.  Patient transferred to hospital.   clinician ordered Solumederol 125mg IM, and patient given a Benadryl 25mg tablet. All symptoms resolved.
No adverse reaction.  Patient indicated this was second Moderna vaccine AFTER she was vaccinated by the medic.  First dose was administered at vaccination site on 1/11/21-five days before the 28 day recommended period between doses. iIt is unknown whether or not she needs to be re-vaccinated with the second dose.  Please advise.
Myalgia, NIGHT SWEAT, CHILLS, HEADACHE,JOINT PAIN, BACKPAIN, FREQUENCY IN NIGHTIME URINATION Narrative:
T101 w/screaming fit lasted several hrs & into next day, fussy, good appetite, dec sleep;
I tested positive on 12/24/2022 for COVID-19.  I had a cough, runny nose and fever. I reached out to my provider and I did not qualify for Paxlovid. My symptoms were not that bad. Then on 02/01/2023 I was positive for COVID-19. My symptoms were congestions, pain on my face, sore throat, glands in my neck were painful, headache in the front of my head, my heart rate went up to mid 80's, joint pains everywhere and fatigue. I had those symptoms for 18 days. I still have minor symptoms. Also have pain in my right ear and pain in my ribs from congestion. I followed up with provider and I was told to come in for tests. I still have sinus pain and congestions.
Right away, within about 8 minutes, began to feel awful. Felt hot, like I would pass out. Could breath in but felt I couldn't breathe out. EpiPen given and taken by ambulance. In ambulance another EpiPen was administered as well as epinephrine shot. Went to ER, ran tests and lab work, x-rays of lungs, was on a breathing monitor, but does not remember much.
On the 7th day, my left arm where the injection site was developed itchy bumps that were swollen. I also experienced chills and low-grade fever that night. The swollen part of my arm was tender and hot to the touch.
I had basically a painful 5 day migraine beginning the Saturday after I received my vaccine. light intolerance, pain in my eye. I had fatigue, nausea and Diarrhea, I took migraine medicine on my 2nd dose. The first one I used ice compresses on my eye. I had mental fog that continued through 2nd dose. I had visual changes after 2nd dose. My migraines started with 1st dose. My doctor felt I had an inflammatory response due to vaccine.
13-year-old otherwise healthy female presents to ED by ambulance for chest pain. Patient received her second dose of the Pfizer vaccine on 6/18. The following day, patient had generalized fatigue, sore arm, and one episode of nonbloody nonbilious emesis. Yesterday, patient began to have intermittent midsternal chest pain which radiates to the back. Patient reports symptoms worsen with movement, walking, and deep inspiration. She denies any shortness of breath, or palpitations. She denies any headache, lightheadedness, fevers, chills, diarrhea, abdominal pain, or dysuria. No cardiac family history per mom. Patient did not have any symptoms after her first Pfizer vaccine. Differential Diagnosis: Chest pain, costochondritis, myocarditis secondary to vaccine.
ARM PAIN; FEVER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 19 year old female. 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced flu like symptoms. On 13-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and fever, and had not recovered from arm pain. This report was non-serious.
Around midnight had severe chills and shakes, severe headache. Woke up around 2:30 am and hot. Took temp 101.6. Took 2 Tylenol. Fever starting coming down. Gone by morning. General body aches. Woke up after 9 AM. All symptoms gone except headache, which subsided after I took over the counter migraine formula. First time ever had reaction. Also racing heartbeat (84bpm) compared to 70 normal. Subsided by morning.
Client received the COVID vaccine (Pfizer dose 2, lot #EW0179, expiration date 4/28/2021) at 1330. At 1345, the client reported right sided numbness and bilateral jaw tightness; RN, PHN; RN responded. Vital signs were as follows: blood pressure 140/75, heart rate 83, respiratory rate 14, O2 97%. The client stated that she has no allergies, takes lipitor, eliquis, and "colon medication," and she has a medical history of COPD, asthma, cardiac arrhythmia, and high cholesterol. At 1350, 50 mg of Benadryl PO was given and water was given. The client's color was within normal limits, she was neurologically intact (alert and oriented) and in no visible distress. The client denies shortness of breath and her lungs were clear to auscultation bilaterally. At 1355, the client's vital signs were: 96% O2, heart rate 89, temp 98.5, At 1401, the client stated that the numbness had decreased. Her blood pressure was 130/66, O2 99%, heart rate 92, respiratory rate 16. The client stated she did eat and drink today. At 1410, the client's blood pressure was 135/72, O2 96%, and heart rate 75. The client stated her symptoms had resolved at this time. Education provided regarding v-safe, emergency management, and AMR activation. At 1420, the client's vital signs were as follows: blood pressure 122/65, heart rate 72, and O2 96%. The client left at this time, ambulating to her car with a steady gait.
had all the same symptoms she did and "got really bad with her for a couple of days" after her first dose; headache; vomiting; diarrhoea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 70's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "had all the same symptoms she did and "got really bad with her for a couple of days" after her first dose"; HEADACHE (non-serious), outcome "unknown", described as "headache"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhoea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received adult pfizer (0.3mL) instead of pediatric pfizer (0.2mL)
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 17-NOV-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
pt recv vax 15AUG96 & 3SEP called & c/o pain/swelling rt knee then lt knee;2SEP pt contacted in 6SEP-16SEP-20SEP pain persisted & spread to feet;advised n 20SEP to see MD;
Daily headaches, dizziness, lightheadedness, head pressure, intermittent shortness of breath, intermittent chest pain, cognitive problems (difficulty putting words together) since vaccination.
Angioedema; Hives all over body; Crazy itching; skin peeling; Difficulty swelling; Red spots around injection site; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), URTICARIA (Hives all over body), PRURITUS (Crazy itching), SKIN EXFOLIATION (skin peeling), SWELLING (Difficulty swelling) and VACCINATION SITE ERYTHEMA (Red spots around injection site). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (Angioedema), URTICARIA (Hives all over body), PRURITUS (Crazy itching), SKIN EXFOLIATION (skin peeling) and VACCINATION SITE ERYTHEMA (Red spots around injection site) had not resolved and SWELLING (Difficulty swelling) had resolved.            No pre-existing or allergy was reported  It was reported that the patient experienced similar side effects from second dose but not as severe as booster side effects.  No Concomitant medication information was reported.  Company Comment: This case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected serious (medically significant) event of Angioedema, the unexpected non-serious events of Urticaria, Pruritus, Skin exfoliation, Swelling and the expected event of Vaccination site erythema. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was treated with Prednisone and Diphenhydramine. At the time of the report the outcome of the events was not resolved except for Swelling which had resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-460640 (Patient Link).; Sender's Comments: This case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected serious (medically significant) event of Angioedema, the unexpected non-serious events of Urticaria, Pruritus, Skin exfoliation, Swelling and the expected event of Vaccination site erythema. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was treated with Prednisone and Diphenhydramine. At the time of the report the outcome of the events was not resolved except for Swelling which had resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Received pfizer vaccine on 5/21/21 and 8/6/21. COVID positive on 2/21/22. Presented to ER on 2/21/22.  admitted on 2/21/2022 presented with worsening shortness of breath leg swelling, dizziness.Weight gain, missed Lasix. Vaccinated patient, screening COVID test positive 2/21/22.  Developed acute hypoxic respiratory failure from CHF exacerbation, required high-flow oxygen-resolved.  Remain on Lasix. Discharged on 3/4/22.
This is a spontaneous report from a contactable consumer and from a contactable physician. An 81-year-old female consumer received PREVNAR 13 at 0.5 ml single in the left arm at top of his shoulder at near vertical angle, on 16Nov2015 at 09:00. Medical history included ongoing rheumatoid arthritis (diagnosed a long time ago), problem with neck and rotator cuff on right side, fall in 1990, herniated 3 discs but has recovered from vertebrae problems, surgery. Concomitant medications included RITUXAN from 2014 and ongoing (2 in 2 weeks, then 2 more after 6 months, they had extended transfusion time to 3 hours) for rheumatoid arthritis and influenza vaccine in early Oct2015, at 1 DF single, (without any adverse effects). On 16Nov2015, the patient experienced frozen shoulder with pain/hurt at first and right away the pain spread from her neck to her wrist on her left side. She went to the ER and was hospitalized on 20Nov2015. The physician diagnosed it as frozen shoulder and gave her naproxen, hydrocodone and surgery physical therapy meds. The medications worked for pain, but she still could not use her arm or shoulder very much. After exercising and physical therapy she was a little better. On an unknown date the patient experienced also torn rotator cuff and shoulder disabled. On 07Jan2016 MRI of left shoulder joint without contrast (Long-and short-axis fat- and water weighted images) performed: AC arthropathy was mild, subacromial spur. Partial thickness interstitial and bursal surface supraspinatus insertional tendon tear was 1.07 cm. Tear greater than 50% of the tendon depth. Infraspinatus insertion moderately tendinopathic and frayed. Mild to moderate peritendinobursitis. Biceps arcuate segment tendinopathic. Mild glenohumeral arthropathy. Small SLAP type 2A tear. No intraarticular loose body. Supraspinatus muscle was small. Mild fatty atrophy. No soft tissue mass. Cysts and osteoedema within the greater tuberosity. No macrofracture. Final Diagnosis was: Incomplete rotator cuff tear or rupture of left shoulder, not specified as traumatic; impingement syndrome of left shoulder; primary osteoarthritis, left shoulder. Physical therapy (left shoulder push gently) and stretching done. Patient still experiencing frozen shoulder with pain/hurt at first and right away the pain spread from the neck to her wrist on her left side. Outcome of torn rotator cuff and shoulder disabled was unknown. The physician was not provided with the information regarding the adverse events by the patient. The physician was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (05Feb2016): New information from the same contactable consumer includes: additional event "torn rotator cuff". Follow up (28Mar2016): New information received from a contactable Physician included: reporter informed regarding the adverse events; reporter further contactability. Follow-up (15Apr2016): New information received from a contactable consumer includes: vaccination date, event onset, seriousness criteria, lab tests, products updated.