chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen axillary lymph nodes on left side; fever; chills; muscle aches; This is a spontaneous report from a contactable nurse (patient).   A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:15 (at the age of 34-years-old) as dose 2, single for covid-19 immunization.  Medical history included , ventricular extrasystoles and Premature ventricular contractions (PVC's) and  VSD repair in 1991. Patient had known allergy of cherries, apples, melons, walnuts,  cauliflower. Concomitant medication included metoprolol (METOPROLOL), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), acetylsalicylic acid (BABY ASPIRIN) and magnesium (MAGNESIUM). Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EM9809), via an unspecified route of administration, administered in Left arm on 09Feb2021 10:00 as dose 1, single for covid-19 immunization. Prior to vaccination, patient the patient was not pregnant, did not receive any other vaccines within 4 weeks. The patient experienced swollen axillary lymph nodes on left side, fever, chills, muscle aches on 03Mar2021 02:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jul2020. No treatment was taken for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
the patient started not to fill well and started to sweat and get white. He had not eaten since the morning. We got him some water and crackers as well as putting some ice on his neck.
Vaccine was administered on 9/18/14, patient reported on 10/1/14 that 12 hours after he received the flu shot he had an anaphylactic reaction at home and had to call 911 and go to the hospital.
Started spotting during it even though it wasn't during my cycle. The same thing happened after each vaccine dose and is happening again after the booster.; Dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 08:30 (Lot number: FH8028) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "had covid", start date: Jan2021 (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: KARIVA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW1076, Location of injection: Arm Left), administration date: 03May2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Spotting menstrual"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW1062, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Spotting menstrual". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 08:30, outcome "unknown", described as "Dose received 3"; INTERMENSTRUAL BLEEDING (non-serious) with onset 17Dec2021, outcome "recovering", described as "Started spotting during it even though it wasn't during my cycle. The same thing happened after each vaccine dose and is happening again after the booster.". Therapeutic measures were not taken as a result of intermenstrual bleeding. Additional information: The patient did not receive any other vaccine within 4 weeks.  The patient was on tricycle birth control so, she only get her period once every three months. The patient had covid in Jan2021 and started spotting during it even though it wasn't during my cycle. The same thing happened after each vaccine dose and happened again after the booster. The patient informed the reason why she was reporting this was because when she contacted her gynecologist the last time it happened, they felt it was a coincidence and put her through lots of expensive tests and visits, all of which resulted in no answers. The patient wanted to report it so others can be aware before they make the same mistake as the patient did.  No follow-up attempts are possible. No further information is expected.
Lack of vaccine effect; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered", described as "Lack of vaccine effect"; ILLNESS (non-serious), outcome "recovered", described as "sick". The patient underwent the following laboratory tests and procedures: Antibody test: titer levels were very low, notes: the mother found a doctor who would do antibody testing, and the doctor saw that the child's titer levels were very low. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Immediately following vaccine symptoms started with short breathing, ichy, warm body, headache, dizzy, feeling hives. Then every 24 hours since vaccine have been having hives, fatigue, memory loss, hard to concentrate, today has been painful joints and muscle
his blood pressure is high; my son has had a fever; had chills and the shakes and he is cold (chills); had chills and the shakes and he is cold (chills); This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 11Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced fever, chills and the shakes and he is cold (chills), and he has high blood pressure too on Aug2021. Reporter stated she did not know if it's high because his fever is up or what. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Major back pain; sore muscles in lower half of body; constant vomiting; Cant eat and barely can breathe; Cant eat and barely can breathe; not able to rest without waking up repetitively; headache; This is a spontaneous report received from a contactable consumer. A 19-year-old non-pregnant female patient (consumer) reported for herself that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on 03May2021 09:00 (Age 19-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 Since the vaccination. The patient experienced major back pain, headache, sore muscles in lower half of body, constant vomiting, not able to rest without waking up repetitively on 03May2021 16:00. She could not eat and barely could breathe on 03May2021 16:00. The outcome of the events was reported as not recovered.  Follow-up attempts completed. No further information expected.
Patient felt dizzy, vision changed, then she fainted. MA alerted me that she fainted. Patient became alert within 5 seconds/as I was walking back into the exam room. She was disoriented, was re-oriented & became pale & then vomited.  She had some water, a cool compress, she rested & her vitals were re-taken. She was stable. I discussed with her parent. She remained resting & then went back to school
Less than 5 minutes after receiving IZ, pt noticed a redness on his left arm at injection site.  Erythema was a round are of 2 cm,  No swelling.  25 mg of diphenhydramine given and ice applied.  Moc advised to continue with ice and Benadryl OTC as directed on label.  RTC here or to ER if symptoms become more concerning or worsen
Information has been received from a 78 year old male with an arthritic knee and no reported drug reactions/allergies who on 23-JUL-2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot # 656606/0033U). Concomitant therapy included diclofenac. On 26-AUG-2007 the patient experienced rashes and clusters of blisters on his feet, hands, forearms, thighs, and buttocks. The patient reported that these areas itched a great deal. On 27-AUG-2007, within twenty four hours all of the rashes and blisters went away and there are no residual marks or remnants of them on his body. Because they went away so fast there was no opportunity for a physician to observe them or to take specimens for testing. Follow up information has been received from the physisican who reported there was no information to report and that "he believed this was not vaccine". No further information available.
Terrible soreness at injection site. Shoulder makes noises. Elbow sore too. Shoulder clicks with motion. Painful after months. I had chills and fever 3 nights. Shoulder and arm pain followed. Feels like fibromyalgia. Whole arm affected.  Shoulder worst. Elbows were sore in BOTH arms. Now only on right.  I hope it goes away. But now it persists.
This spontaneous report was received from a medical assistant regarding unknown patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown dates, the unknown patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004883 and expiry date 31-OCT-2017) (dose, frequency and route were unknown). No concomitant medications were reported. On unspecified dates the vaccine was exposed to temperature excursions of 1 Celsius for 176 hours and 9 Celsius for 32 hours. There were no prior excursions and a data logger was not used. No adverse effects were reported. No product quality complaint (PQC) was filed. Additional information has been requested.
This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 73-year-old patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. In April 2018, less than a year after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, mobility decreased and myalgia. On an unknown date, the outcome of the pain in arm, swelling arm, mobility decreased and myalgia were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, swelling arm, mobility decreased and myalgia to be related to SHINGRIX. Additional information was received as follows: The age at vaccination could be 72 years or 73 years or 74 years. The pharmacist said that it could take 7 days to feel better to the patient because of the patient's age. The patient was looking at two weeks of myalgia so far.
Information has been received from a registered nurse concerning a 5-year-old female with no pre-existing allergies, birth defects, or medical conditions who on 10-SEP-2001 was vaccinated SC with a second dose of Varivax (Lot # 638811/0498L). There was no concomitant medication. There was no illness at the time of vaccination. On 25-APR-2006 the patient developed skin eruptions "looking like chickenpox". There were less than 50 lesions. No fever was noted. The patient recovered on 28-APR-2006. There were no relevant diagnostic tests or laboratory data. No additional information is expected.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a covid-19 vaccine trial   No concomitant medication and treatment information was provided.  The reporter's causality for the event of covid-19 with Humira was reported as reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
This spontaneous prospective pregnancy report as received from a physician refers to a 24 year old female patient. On 12-FEB-2015 the patient was vaccinated with GARDASIL lot # K007828, expiration date was unknown, third dose, intramuscularly. First dose was administered on 07-AUG-2014, dose number 2 administered 18-NOV-2014. Lot numbers and expiration dates not available for doses 1 and 2. The patient became pregnant on unknown date. No treatment was given for adverse event. The LMP and EDD was not known. The pregnancy outcome was pending. Additional information has been requested.
This case was reported by a healthcare professional (nurse) and described the occurrence of overdose in a 14-year-old female subject who was vaccinated with HAVRIX ADULT (GlaxoSmithKline). On 20 May 2013 at 17:57 the subject received a dose of HAVRIX ADULT (1.0ml, left arm) and experienced overdose. The nurse reported that a "14 year old patient received an adult dose of HAVRIX." No adverse events were reported at the time of reporting. Follow up was received from nurse on 18 June 2013. The nurse documented that on 21 May 2013, 1 day after vaccination with the 1st dose of HAVRIX ADULT, the subject also experienced injection site soreness. The event resolved on 21 May 2013 and was probably related to HAVRIX ADULT. The nurse did not consider this case to be serious. The nurse documented that erroneous administration of HAVRIX ADULT to be adolescent could have been associated with the event. The subject was also vaccinated with a booster dose of "Tdap" (0.5ml, intramuscularly) on 20 May 2013. The nurse documented that the subject's mother was notified and a "variance incident report form" was completed. Per the nurse, the immunization series was not delayed or discontinued. It was unknown if the symptoms recurred following subsequent administration. The subject had not experienced any adverse events following previous vaccinations.
Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case is linked to case 2019SA010565 (same reporter). This case involves a 18 years old female patient who was vaccinated with an 0.5 ml expired dose of MENACTRA (Batch number: U5746AC and expiry date: 14-Oct-2018) (dose in series and route of administration were not reported) in the right arm on 10-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included patient was received flu vaccine on an unspecified date. It was a case of actual medication error due to expired vaccine used. No reported symptoms. 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. Documents held by the sender: none.
Pt came in with two kids, I thought they were all getting COVID and flu turned out this pt had the covid vaccine already
Papular rash on neck, chest, back and face. Was seen in ER for Otitis Media on 2/6/2000 and placed on amoxicilin. Came to clinic on 2/8/2000.
Case number PHEH2012US005260 is an initial spontaneous report received from a physician on 02 Mar 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not provided. This patient was administered MENVEO MenA lyophilized conjugate component (batch number: not reported) diluted with another diluent, without being reconstituted with MenCWY, intramuscularly on to unspecified site on an unspecified date. No adverse reaction was reported after this administration error.
hives with itching/ bump on chest below the left breast and small raised swelling on the shoulder of right arm; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot no: EN 6207) via unspecified route of administration as a single dose for COVID-19 immunisation on 18Mar2021 (at the age of 53-year-old). The medical history reported are mild depression, allergies and allergies to penicillin. The concomitant medications included zoloft (MANUFACTURER UNKNOWN) and zyrtec (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 19Mar2021, the patient experienced hives and itching around 2:00, approximately 14 hours after receiving the first shot. The patient reported that there was a small bump on her chest below the left breast as well as a small raised swelling on the shoulder of my right arm and both the bumps were itchy. There was no treatment received for the reported events. The clinical outcome of hives with itching/ bump on chest below the left breast and small raised swelling on the shoulder of right arm was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shot and 3 years later now had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
I received the Moderna COVID vaccine on 2/3/2021 (lot 012M20A), 3/3/2021 (lot 002A21A), and 8/18/2021 (lot 032C21A). I experienced diffuse hair loss approximately 8-12 weeks after each shot, which continued for about 8 weeks. This side effect was temporary and has resolved as of February 2022 and I am now  seeing a regrowth of my hair. I also experienced menstrual  disruption after the first and second shot in the form heavy bleeding, a temporarily shorter cycle, and excessive cramping, which returned to normal after June 2021 and did not recur with the third shot in the series. I also experienced lymph node swelling in the breast after the second shot which presented as a lump in the breast on the injection side and led to my doctor sending me for a mammogram. The third shot in the series had a different series of side effects, which were vomiting, fever, and generalized stinging pain on the side of the injection which began abruptly 12 hours after the shot, and resolved as abruptly 48 hours after the shot. I did not have any similar side effects from the first or second shot. I have not to my knowledge been infected with COVID-19 at any point in the pandemic.
My left arm is extremely painful to use in the muscle around the injection site, i can't even raise my arm above my head without it severely hurting. Cant move arm behind my back to remove a jacket or shirt. The right arm is in pain from time to time depending on what I'm doing with it on a scale from 0-10 I would say 2. However my left arm is at a 10 everyday 24/7.
within 2 hours after having shot, extreme exhaustion, flue like feeling. first night, fever, extreme sweating, body pain, heart would alternate from regular to fast pounding heartbeats. felt like it would pound out of my chest, extreme nadeau, weakness. Day 2 all that continued, couldn't get out of bed, chills, sweating heartbeat fast would come and go. Right side of face was numb, and droopy, feet were on fire for 2-3 weeks soaked in buckets of ice water.  Was in bed unable had to crawl to bathroom due to feeling weak, and flu like and body pain for 4 days. couldn't think clearly for about a month. day 1 to day 8 my limbs had tingling then numbness and my face would feel be the same odd look on one side.  nausea went away after day 4.  A raised red rash spread around the shot area and across my chest spreading to other shoulder-Lasted 4 days.  My right shoulder, thigh and face/cheek would twitch and move uncontrollable off and on and for no reason from day 3 and lasted for 3 months after the shot. The intensity of the sickness went on for a few weeks.  The racing heart off and on continued for 3 weeks off and on. The fatigue took 6  weeks to get over.
There was no adverse outcome to date. Employee is aware.  The pfizer vial was reconstituted incorrectly with 0.18ml rather than 1.8 ml and employee was given 0 .3cc
Experienced a situation after receiving the second dose vaccination in feb, which i still suffering still today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experienced a situation after receiving the second dose vaccination in feb, which i still suffering still today) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced a situation after receiving the second dose vaccination in feb, which i still suffering still today). At the time of the report, VACCINATION COMPLICATION (Experienced a situation after receiving the second dose vaccination in feb, which i still suffering still today) outcome was unknown.            No relevant concomitant medications reported. Treatment information were not provided. The action taken with mRNA-1273 with the events was considered as not applicable.