chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in right arm and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Treatment drug Paxlovid from 29Jul2022 to 02Aug2022 for COVID 19. Other medication in 2weeks: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Events occurred 24 hrs p/1st vax; tx antibiotics; Has been sick for 2 wks;
Information has been received from a nurse practioner concerning a 12 month old Caucasian male with no known drug allergies who on 04/15/2001 was vaccinated with MMRII SC in the thigh that expired 02/28/2001. Concomitant vaccinations included Varivax, that was received SC in the thigh. The nurse practitioner reported "finding 2 occipital non-tender lymph nodes post vaccination". Unspecified medical attention was sought. In FOLLOW- UP, the nurse practioner reported that following the injection of the MMRII, she  realized that the vaccine was outdated, 2/01. She reported that at a subsequent clinic visit on 04/30/01, "two non-tender "shotty" occipitalm nodes were noted. The nurse practitioner reported that the patient did have a scalp injury from hitting head under coffee table about the same time that the mother noticed occipital nodes. The scalp area became somewhat inflamed and scabbed over and was healed by the 04/30/01 visit. Axillary and inguinal nodes were also "shotty". In FOLLOW-UP , the nurse practitioner reported that the patient had a scalp laceration at the time of vaccination. The nurse practitioner reported that the patient  had 2 non tender occipital nodes one week after vaccination with MMRII and Varivax. The patient recovered from his experience. No further information is available.
Shoulder pain, Shoulder range of motion limited, Can be force, pops very painfully, full range is restored without pain for a short period of time. Injection site is tender when moving arm. Reduced strength in arm. ~30% Peak of pain was about 1 week post shot. Issues are slowly subsiding after two week, but persists. Number of times my shoulder gets stuck/ hurts or pops while in use has been reduced to under a 10 times a day from a peak of over 20. Ibuprofen, stretching and ice.
Pt. states she began mild itching over Friday night and woke up Sat. with patches of red rash on (L) side of face - Provider describes "diffusely spread patches of erythema with excoriations on neck, left cheek and chin with erythematous patches and scaling. Mild swelling over chin" on 1-14-14.
Pt. states on 4/4/19 when he awoke he noticed a mild rash over his torso, front and back, that was itchy. He states he believes it is a reaction to the vaccine due to literature he has read. He states rash better today.
Full body rash with itching; Swelling in my upper and lower eyelids; Urticaria; Soreness at site; Headache; Fatigue; This is a spontaneous report from a contactable other HCP (patient).  This 67-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1284), via an unknown route, on 13Jan2021 (at 15:00) at single dose on the left arm, for COVID-19 immunization, administered at hospital. Historical vaccine included the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899) on 24Dec2020 (at 10:00) administered at single dose on the left arm. Relevant medical history included hypertension, benign prostatic hyperplasia, and allergy to NAIDs. Past drug history included allergy to acetylsalicylic acid (ASPIRIN). Relevant concomitant medications included losartan, simvastatin, eszopiclone (LUNESTA), dutasteride (AVODART) and tamsulosin. On 14Jan2021 (at 10:00), the patient had soreness at site, headache, and fatigue. On 15Jan2021, same symptoms but lower intensity. On 16Jan2021, she woke up with full body rash with itching, and swelling in her upper and lower eyelids. She took cetirizine hydrochloride (ZYRTEC) and the urticaria resolved within 90 minutes. Pre-vaccination and post-vaccination COVID tests were not performed. No therapeutic measures were taken as result of the events 'soreness at site', 'headache', 'fatigue' and 'swelling of eyelid'. All the events resolved in Jan2021.
Patient reported 9-24-19 for a flu shot and showed her left arm which had a dime sized rash on it, about 2.5 to 3 inches from top of arm. She said it tingles for alittle bit and then it hurts in that area in what she calls a nerve type pain. It lasts around thirty minutes and goes away. When the tingling comes, the rash shows up. The dime size of rash never goes away but it gets redder when the tingling happens which is followed by the pain. It happens maybe once a month.
I felt dizzy so I grabbed the edge of the bathroom counter, the next thing I knew I was on the bathroom floor and couldn't move. My mom said I was out for 1-2 minutes before she found me. I have never fainted before ever. This only happened once. But the following week my heart rate when standing would reach 130-145 bpm.   The following weekend I experienced a longer than normal menstrual cycle with heavier bleeding than normal, even while I was still on my birth control.
MMR given 19MAY92 & 30 mins post vax pt devel a grapefruit size reddened area w/approx 4" induration; ice apply for approx 5 mins; size inc; MD contacted advised DPH;
2.5in red raised lesion at injection site. There is additional swelling around the red lesion that extends about 2 additional inches. Firm and hot to the touch. Painful as well
Today I tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Today I tested positive) 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.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced COVID-19 (Today I tested positive). At the time of the report, COVID-19 (Today I tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medications were not reported. No treatment medications were not provided.
pt recvd vax 30DEC92 & between 30DEC92 & 5JAN93 exp swelling @ inject site, blotchiness on entire arm (rt) & chest pain; seen in ER x-ray taken; fluid around heart; no treatment; 5JAN93 pt doing better;
5hrs  after flu shot got tactile fever.  Then, 24 h  after flu shot got upper lip swelling (lasted 24h), sore throat, HA, abd pain, vomit x 1.  Dx strep in ER and given prednisone for possible "allergic reaction to flu shot"
Abnormal mammogram at my yearly mammogram 09/2021. Had biopsy 10/2021. Diagnosed with HER2+  Breast cancer. Bilateral mastectomy 11/4/2021. Currently receiving chemotherapy.
Swelling at injection site immediately after giving vaccination.  Place ice on area for 15 minutes.  Swelling subsided but since it was still present patient opted to take 600mg of ibuprofen.  15 minutes later swelling went down and a bruise remained. Patient reported no pain or itching at the area. Followed up with patient a few hours later and she stated she did not have any more swelling.
headaches; sore arms where the injection had taken place; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (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: HEADACHE (non-serious), outcome "unknown", described as "headaches"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arms where the injection had taken place".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 9- Redness at the injection site, continued  lump in arm at injection site some ichy-ness at injection site; aches and stiffness in back and neck Day 10- More redness spreading down my arm about one inch longer than Day 9 , hives on both forearms on waking and then on both legs about an hour after waking (which could be from vaccine or my urticaria due to cold--our outside temp was 38 this morning)
pt recvd vax 30NOV93; pt seen in office 8DEC93 w/?abscess rt thigh; also seen 9DEC in office-placed on ATB; seen in ER 10DEC w/I&D of abscess; f/u visits to MD office; 13DEC, 15DEC, 17DEC, 20DEC, 22DEC, 23DEC & 27DEC for f/u & care of I&D;
After I had my first vaccine I got COVID; I got COVID; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE), Dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, after she had her first vaccine, she got COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. Outcome of the events was Unknown.  No follow-up attempts are needed. No further information is expected.
One day after vaccine developed fever, nasal congestion, cough, post-tussive emesis and then on 11/13 conjunctival injection and red, cracked lips and cervical Lymphadenopathy
mom reported infant was extremely fussy following vax, vomited x2;no fever or redness @ vax site;stated pt given APAP;1230PM but this did not help mom presented @ hlth dept 4PM;
Information has been received from a consumer concerning her 10 month old male baby with no pertinent medical history, drug reactions or allergies who on 19-JUN-2008 was accidentally vaccinated with a dose of GARDASIL vaccine (yeast). There was no concomitant medication. A nurse at the office accidently mixed up the vials and the mother received diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid which was meant for her baby and her baby received the third dose of GARDASIL vaccine (yeast) that was meant for her. A couple of days later, on 21-JUN-2008 the baby broke out in a rash and had been constantly been crying. "2-3 days after receiving GARDASIL vaccine (yeast)", the baby experienced purple lips. At the time of the report, the baby had not recovered from the events. No medical attention was sought. Additional information has been requested.
ITCHINESS; RASH TO ARMS, LEGS AND SHOULDERS THAT WAS SPREADING; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included: rash. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 01-MAR-2021 for covid-19 vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced itchiness, and rash to arms, legs and shoulders that was spreading. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from itchiness, and had not recovered from rash to arms, legs and shoulders that was spreading. This report was non-serious.
At 12 midnight Patient states that she experienced body aches and chills.  She stated that she was exhausted and her temp rose to 101 degrees Fahrenheit starting at 1 am on 2/2/2021. The fever lasted until 3pm.  She did not got to work on the 2nd due to extreme exhaustion.  She stated that she took advil for her fever.
Pt lost conciousness x1-2 minutes, Diaphorectic, pale.  Moved to w/c to resting area. Has HX of Vagal Syncope.  BP 92/62 P72 R18   1:15 Resting color pink 1:30 BP 104/72 Left with boyfriend w/o assistance.
12/02/05 flu vaccine administered noticed swelling to both hands and at injection site. 12/07/05 office visit, DX mild myalgia, local swelling right deltoid. 12/09/05 return visit symptoms improved states much better. Ache left hand is all that remained. Negative exam. 01/09/06 office visit c/o cough, sob, swelling lower extremities, referred to ER and left AMA. 01/10/06 office visit increased sob, dizziness, 3x tibial edema, increased jugular venous distention, irregular heart beat, weight increase 238, went via ambulance to hospital.
migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208416.
Woke up with severe fever and cold chills, only at night time after sleeping for several hours. Body ache to go along with that symptom. Taking an acetaminophen remedied these symptoms.
HEADACHE; FLU-LIKE SYMPTOMS; BODY ACHES; This spontaneous report received from 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 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flu-like symptoms. On MAR-2021, the subject experienced body aches. On 09-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 flu-like symptoms, headache, and body aches. This report was non-serious.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.  No Concomitant medication was reported.  No lab data was provided.   This case was linked to MOD-2021-313106 (Patient Link).
pain in my lymph nodes under my left arm pit.; Slight numbness in face and arm on side where shot was given; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 16:00 (Lot number: FH8027) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 01Apr2021, when the patient was 33 years old, for COVID-19 immunization, reaction(s): "common side effects"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 11Mar2021, when the patient was 33 years old, for COVID-19 immunization, reaction(s): "common side effects". The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 16:00, outcome "unknown", described as "Booster"; LYMPH NODE PAIN (non-serious) with onset 27Nov2021 18:00, outcome "not recovered", described as "pain in my lymph nodes under my left arm pit."; HYPOAESTHESIA (non-serious) with onset 27Nov2021 18:00, outcome "not recovered", described as "Slight numbness in face and arm on side where shot was given". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, hypoaesthesia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient had no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.Device Date :29Nov2021.   No follow-up attempts are possible. No further information is expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Hives (chronic hives). Concomitant products included DOXEPIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.    Treatment medications included,Tylenol ,An Antihistamine.   This case was linked to MOD-2021-056113 (E2B Linked Report).; Sender's Comments:  MOD-2021-056113:SECOND DOSE CASE
chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any Cardiac history; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; irregular heart rate and am going to have to more cardiac work up; extreme shortness of breath with minimal exertion; weakness; dizziness; very tired; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:15 (at 68 years old, not pregnant), single dose for covid-19 immunisation. Medical history included hypothyroidism, arthritis, all from an unknown date. The patient had her first dose of bnt162b2 for Covid-19 Immunization on Mar2021. The patient was taking unspecified concomitant medicines. The patient experienced within 5 minutes after receiving her second injection, she began having chest pain and palpitations. The paramedics ran a 4 lead EKG and she was experiencing consistent PVC's which is abnormal because she does not have any Cardiac history. She went to the emergency room and was noted to have a D-Dimer lab result of 758ng/ml as well as other abnormal labs. Still continue having PVC's and irregular heart rate and was going to have to more cardiac work up. Also have experienced other symptoms associated with actual COVID such as extreme shortness of breath with minimal exertion, weakness, dizziness, very tired. And muscle aches 2 days as of Friday 09Apr2021. All the events also reported as started 07Apr2021 14:15. The outcome of the events was not recovered. Treatment for the events was observation and medication. Patient was hospitalized due to the events for 1 day. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.
This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received BEXSERO for prophylaxis. Co-suspect products included BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO and BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO and BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that she had a patient that had received 2 doses of BEXSERO and later experienced meningococcal disease which was confirmed as serogroup B, by the local hospital. The physician stated that the patient did not experience any serious complications or consequences. This case was considered as suspected vaccination failure as time to onset for the event for targeted disease was unknown. Lab Comments: On an unknown date, laboratory test confirmed serogroup B for meningococcal infection by the local hospital.
Chills (shaking), Nausea, diarrhea, numbness tingling in fingers, weakness, some loss of taste, pressure in both ears, dry cough