chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received her first does of pfizer 6:50pm today. HCP administering IMZ with RP. Immediately after the immunization, the patient bled a little and had syncope immediately where she fainted for approximately 5 seconds in the chair. Pt woke up again talking but feeling a bit nausous. Pt was given water to drink and offered a cold compress. Father was there and sat with her. After waking up, pt vomited. RP made her sit for 45 mins in the IMZ booth. Management notified immediately by RP. According to the father when she felt better she was monitored got up and was ok. Syncope/nausea reported promptly to VAERS by RP
HEART FAILURE; VOMITING; PASSED OUT; This spontaneous report received from a patient concerned female unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: HPA secondary hypothalamic- pituitary adrenal insufficiency (since she was a kid). On an unspecified date, The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 063A21A  expiry: UNKNOWN) dose was not reported, 1 total for covid-19 prophylaxis.  The patient experienced pain in arm when treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 29-DEC-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On DEC-2021, since she received the booster, she passed out, 3 times in total (Dose number in series 2). On an unspecified date, the patient experienced vomiting for 3 months since 4AM-5AM in the morning until 2PM-3PM in the afternoon about 2-3 times a day, every hours. She also mentioned having trouble breathing, she saw her doctor and they did a blood work and find out that she had a heart problem, early stage of heart failure. Heart failure was worst around March and April 2022. Her doctor explained to her that her enzymes were really low and they were causing her heartbeat to be slower (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and the outcome of heart failure and passed out was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20221024078.; Sender's Comments: V0: 20221022922-COVID-19 VACCINE AD26.COV2.S- Heart failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY- HPA secondary hypothalamic- pituitary adrenal insufficiency. Therefore, this event(s) is considered not related.  V0: 20221022922-COVID-19 VACCINE AD26.COV2.S- Passed Out. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Headache that is increasing in intensity and in frequency; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (COMIRNATY), administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 04Oct2021, when the patient was 12 years old, for COVID-19 immunization, reaction(s): "arm soreness and swelling", "arm soreness and swelling". The following information was reported: HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "Headache that is increasing in intensity and in frequency". The event "headache that is increasing in intensity and in frequency" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional information: Reporter stated that her daughter had a headache which predated with the vaccine that was not disabling at that time and her daughter was not back to school since the second dose due to the headache that was increasing in intensity and in frequency. It was much severe. She had seen peds neurology. The pediatric neurologist put patient on Beta blockers and it doesn't help. It doesn't respond to anything. She was a child prior to this and a year ago she had never been sick. She had never been on an antibiotic. They would joke that her immune system was something they wanted to clone. Her immune system is far greater than others. She would be getting an MRI and going to headache clinic.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml).    No concomitant product reported by reporter.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So, they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. Patient received under dose of 0.25 ml of Moderna Bivalent Booster.  It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-646512:Master case.
This report involves the Pfizer booster shot, which I received 8.5 months after my second Pfizer dose.  My symptoms, which started the morning following the booster shot and have gradually gotten worse, are runny nose, sore throat, slight cough, nasal congestion, slight chest congestion, and headache. It has been four days since my booster shot, and today (11/24/2021) is the worst day for my symptoms. It's like I have a bad cold.
Lip Swelling; Mild Sore Arm; A spontaneous report was received from a nurse concerning a 32-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced a mild sore arm (pain in extremity) and lip swelling.  The patient's medical history was not provided. Concomitant medications reported included certolizumab pegol.  On 29 Dec 2020 at 0800AM, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026-L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     The patient reported to be symptom free for 2 days after receiving the vaccine. However, she developed a mild sore arm and lip swelling on an unknown date.  Treatment for the event included 2 diphenhydramine tablets.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, a mild sore arm and lip, were not provided.  The reporter's assessment of causality for the events was not reported.; Reporter'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.
pt recv vax 29OCT96 & 29OCT96 pt exp lightheadedness w/in hr of vax;pt finished work day, but could not wait to ge home & get into bed;pt stayed in bed the following day;
Full Body Chills - 3/15 - 3/16 Lightheadedness - 3/16 Fatigue/Tiredness 3/15 - 3/16 Elevated Heart Rate 3/15 - 3/16 (94 bpm resting avg as opposed to 68 bpm normal resting avg)
This is a spontaneous report from a contactable consumer or other non health- care professional.  A 93-year-old patient of an unspecified gender received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Left Arm on 30Mar2021 (at 92-year-old age)  as dose 1, single for covid-19 immunization.  Patients Medical history included Atrial fibrillation, Thyroid, anxiety, COVID-19 from Jan2021 to an unknown date. Concomitant medication(s) included apixaban (ELIQUIS) taken for atrial fibrillation, levothyroxine sodium taken for hypothyroidism, lorazepam taken for anxiety, start and stop date were not reported.  The patient experienced chills, fever, nausea on an unspecified date. Patient stated he/she was afraid and worried about getting the second shot because patient was on blood thinner Eliquis, Patient asks is that going to make any difference? can patient get the second vaccine?  The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on Jan2021. Outcome of events was unknown.    No follow-up attempts needed or possible. No further information expected.
The patient described a redness and swelling around the upper arm starting the evening he received the vaccine. He had a standing doctor's appointment in the next 2 days in which an antibiotic was prescribed and the issue resolved.
Family reported patient had fatigue,  temp of 100 F, nausea, vomiting, and a seizure within 24 hours
Patient received her second Pfizer covid vaccine and when waiting  she lost her vision and became very pale. Her eyes were open and her pupils were at maximum dilation. She could answer question in a very slow and robotic pace. She said later it seemed to her she had ear muffs on. The EMT peaople arrived and she was treated and then taken to the local hospital for observation and to see a doctor.
Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle aches). At the time of the report, MYALGIA (Muscle aches) had not resolved. Not Provided
No additional AE/PQC reported.; Caller reports an expired vaccine was administered.; This spontaneous report was received from a registered nurse and refers to an 18-year-old patient of unknown gender. There was no information regarding patient's medical history, concurrent conditions or concomitant therapies provided.  On 14-APR-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, lot # S026372, expiration date: 01-APR-2022 (dose number, dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events reported (no adverse event).
I had the shot and I've gotten it four more times / suspected vaccination failure; I had the shot and I've gotten it four more times; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the shot and I've gotten it four more times / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the shot and I've gotten it four more times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 01-AUG-2023 This case was reported by patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored VAQTA (lot # M003011, expiration date 15-NOV-2017; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed a chicken pox like syndrome with multiple truncal & a few arm lesions. The vaccination site was very profound and he also had a headache.
Fever of 104.2 off and on, muscle aches, nausea, headache
He is asking if he can have the steroid antibiotic today because of his sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (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: SINUSITIS (non-serious) with onset 28Apr2021, outcome "unknown", described as "He is asking if he can have the steroid antibiotic today because of his sinus infection". Therapeutic measures were not taken as a result of sinusitis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) 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 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication was not reported. Treatment medication was not reported.
- First dose of phzier vaccine, on April 21, 2021 no severe symptoms.  - Second dose of Phizer on May 18, 2021,  gradually felt increasing fatigue, which became severe enough that I was unable to move or work as I normally do.  I was sleeping more than 11 hours per night and napping during the day without feeling rested. I am full time engineer and life-long endurance athlete, my resting HR is 30-40 bpm.  - June 27, I was experiencing weakness and fatigued and collapsed at home.  - June 28, I went to urgent care with shortness of breath and chest pain and weakness, near fainting.  I was brought to the hospital and saw MD who did ultrasound of my heart and found some pericardial effusion. No other issues we found at hospital with blood tests and examinations.  - June 28, I was dismissed from ER and told to return if I have more issue -June 29-July 11 continued to have extreme fatigue, shortness of breath, chest pain near my heart, heart palpitations, ongoing headaches and
Chills, dizziness, flu like symptoms, achy joints, soreness at injection site, tired.
still have pain / in that arm from my shoulder all the way down to my middle finger; nerve damage in that arm from my shoulder all the way down to my middle finger; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult 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 pain in arm and nerve damage. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and nerve damage were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and nerve damage to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient's reaction was so severe, his/her Doctor advised not to get the second Shingrix shot.  The patient still had pain and nerve damage in that arm from his/her shoulder all the way down to his/her middle finger.
This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a medical assistant concerning her patients who were vaccinated with a dose of GARDASIL.  Subsequently the patients experienced pain.  The patient recovered.  Additional information is not expected.
Sore arm started 6 hours after injection  Headache, fatigue, low grade fever started in the middle of the night lasted 3 days
Expired doses administered to 13 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Number of doses/vials was 13 doses from 2 vials. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. It was unknown if the patient experienced any symptoms.  No treatment medication information provided
Fever of 101, extreme tiredness 3-4 days with continued tiredness for 2 1/2 weeks, severe chills by 3 AM June 9 2018 (lasted off and on for 2 days).  Arm swollen 3 inches diameter at shot location for 5 days.
Pt developed lightheadedness and severe respiratory distress 10-15 minutes after vaccine administration tight wheezing noted in all living fields. Treated with Epinephrine 0.3 mg x 2 dose SC, diphenhydramine 50 mg IV, methylprednisolone one gram IV, Albuterol nebulizer, O2, one liter of normal saline IV 1/7/08-records received for DOS 8/23-8/24/07-DC DX: Anaphylactic reaction. Presented to ED after second shot of anthrax vaccination. Reports SOB started after the injection which progressed quickly to wheezing and difficulty breathing.
vial was not shipped frozen; The dose was given beyound 30days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vial was not shipped frozen) and EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 939906) for COVID-19 vaccination.     The patient's past medical history included Syncope on 21-Jan-2016, Testicular disorder on 20-May-2009, Esophageal reflux on 11-Feb-2008, Aortic valve replacement on 17-Feb-2016 and Anticoagulant therapy on 11-Aug-2016. Concurrent medical conditions included Allergy to antibiotic, Sulfonamide allergy, Blood pressure high on 28-Jun-2016, Hypercholesteremia on 28-Jun-2016, Morbid obesity on 28-Jun-2016 and Type 2 diabetes mellitus on 26-Jun-2020.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial was not shipped frozen). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vial was not shipped frozen) and EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Delivery of Moderna vial at refrigerator temp. on 16-Jun-2021. Office was unaware that the vial was not shipped frozen, staff put vial back into freezer when arrived morning of 16-Jun-2021. Transport temperature between 2-8C for a couple of hours. Vial was then set out on 27-Aug-2021 to thaw for one hour to room temperature. The dose was then administered. Per Moderna one re-freeze was ok, but can not be given beyond 30 days that time. Patient had no signs and symptoms of any adverse reaction to the injection given.   No treatment medications were reported.
She presented with bilateral carotid artery dissections approximately 4 weeks after receiving this Pfizer vaccine dose.  Whether there is a connection between her vaccination and carotid dissection is unknown.
Pt. received flu shot, within 24 hrs. her left arm felt very sore. Within 5 days of the shot, patient cannot move her arm due to extreme pain. Pt. took some Ibuprofen 600 mg with no relief, went to see Dr. but nothing was resolved. Pt. had been having difficulty sleeping due to pain. Pt. had seen also orthopedic surgeon, physical therapist. Pt. just received MRI 1/12/12, still awaiting result. Pt. also takes some VICODIN w/ little relief. Pt. to start FLEXERIL to see if she will get relief.