chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Induced psychosis.  My daughter, a 32 year old female, healthy, non-smoker, no comorbidities, taking 200 mgs clozaphine for eight years. Stable during this time except for one incident (Rx downgrade) four years ago. Patient has taken dose appropriately and bloodwork considered normal. 30 Rx cycle. Psychotic event appeared about ten days after 3rd Covid booster shot. All three were Pfizer mRNA. Patient was hospitalized but would not remain beyond mandatory 3 day hold. She is presenting with delusions, paranoia, and anger related mania. Some limited research has been written and published that identifies potential interactions of mRNA vaccines and Clozaphine. In some individuals they report high serum counts which suggests lower metabolic conversion of Clozapine. This would explain patients relapse as Clozapine absorption likely reduced to below therapeutic thresholds and psychosis results. I have tried contacting Clozapine, but they refuse to accept my call, citing only Doctors can use this line. The ER doctor agreed to have hospital pharmacist research this information. Five days later is was assigned to a Pharmacy student. The Manufacturers help line told me they can only investigate if a doctor specifically ask them. I can forward the journal reports to you if it helps. Additionally, and unrelated to this patient, there are other journal reports that Covid 19 virus can downgrade white blood cells counts. This is a key marker for practitioners to then reduce Clozapine dosage. The journal report advises Drs to NOT reduce Clozapine dosage as a result of Covid infection related to WCC reduction. There appears to be an interaction between Covid 19 vaccines and Clozapine in some patients. There appears to be an impact on the immune system from Covid 19 that sends a false remediation action to Drs prescribing Clozapine. The normal systems are not open to investigating at this time.
Per CDC guidelines, Moderna vaccines are only recommended for 18 years or older patients. Technician accidently vaccinated this 12 year old patient without prior consent from pharmacist. Technician thought CDC guidelines allowed for Moderna vaccines to be vaccinated to 12 years or older. Technician was confused with Pfizer vaccines guidelines.   No adverse effects are noted and pharmacy is closely monitor patient daily for 2 weeks. If any adverse effects happen, we will notify VAERS of the change. Technician was reprimanded and re-educated for the guidelines and re-trained on vaccinations.
Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure
Upon arriving at pharmacy, patient was asked by the pharmacy technician, if she had received any covid vaccine previously. The patient said "no, this is my first dose." Prior to administration, I verified that the patient was here for her first dose of Pfizer vaccine and asked if the system allowed her to make her second dose appointment. The patient verified that this was her first dose and the second dose was scheduled for 3 weeks out. The patient also checked "No" on her consent form on the question "Have you had the vaccine(s) you are receiving today before?". After administration, I went to log her dose into system, which is when I saw that she got 2 doses of Pfizer in January/February of 2021. When I asked the patient if that was correct, she said "Yes, I received both doses, but after reading about it and seeing that other countries are allowing booster doses, I wanted to get a booster dose. I'm sorry I lied to you." I told the patient that this was not currently recommended by the CDC and that she would not be receiving a fourth dose from us. I also cancelled her 2nd dose appointment in system.
Dizziness TIGHTNESS IN HEAD, CHILLS, SWEATS, FATIGUE Narrative:
aches; fatigue; This is a spontaneous report from contactable consumer (patient) via Pfizer Sales Representative. A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. Patent previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced aches & fatigue same day that he received 2nd dose of vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Rash on ears and prickly feeling to back of neck after 7 days. Was evaluated at Urgent Care. Pt given a cream to apply to affected area BID. S/S resolved but came back a week later. Being evaluated again on 1/28/2021.
Patient states that within a day of getting her dose of Moderna vaccine she started experiencing nause/vomitin, diarrhea, and double vision. Her vision has since gotten better but she reports still experiencing nausea and diarrhea (now 14 days after her dose). Patient was advised to consult her doctor due to the length of symptoms and having her vision affected to determine the cause.
Left axilllary lymphadenopathy with 2nd Pfizer on 05/12/21
mom reports p/vax pt had problems;pt exp fever, felt hot;did not know what temp was;relates high pitched screams & cried for hours;
Non traumatic insidious stroke right brain leaving left side paralysis; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 13:45 (lot number: EL9262) at 2nd dose, single for COVID-19 immunization. Medical history included coronary artery bypass grafting (CABG). Concomitant medications included metoprolol, atorvastatin (reported as 'atorvasten'), tamsulosin, and clopidogrel (reported as 'clopidigrol'), all taken for unspecified indications, start and stop dates were not reported, these medications were received by the patient within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in arm left on 07Jan2021 13:30 (lot number: EL3246) at 1st dose, single for COVID-19 immunization. The patient experienced non traumatic insidious stroke right brain leaving left side paralysis on 15Feb2021 12:30. The event reported assessed as serious which required hospitalization and resulted to disability. Hospitalization: 28 days. The event resulted to emergency room/department or urgent care. Treatment received included intensive care unit (ICU) care (1 week) and rehab hospital (3 weeks). The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination (unknown result on an unspecified date). The patient also underwent nasal swab on 22Feb2021 with negative result. The outcome of the event was recovering.  Follow-up information has been requested.
developed a lump on her leg, below her knee.; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (developed a lump on her leg, below her knee.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (developed a lump on her leg, below her knee.). At the time of the report, NODULE (developed a lump on her leg, below her knee.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment drugs were provided
Shakes; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
At night.  I got severe chills and muscle spasms, but they did not last for too long.
PT RECEIVED VACCINATIONS, WHILE PUTTING ON BLOUSE PT FELL TO FLOOR AND HIT HEAD. CODE BLUE IMMEDIATELY CALLED. ASSESSED AND DISPOSITIONED BY PROVIDER AND NURSE. PT WAS DISCHARGED BY NURSE.
Headache pain left side of her head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache pain left side of her head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0101421A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced HEADACHE (Headache pain left side of her head). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache pain left side of her head) had not resolved.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-036855 (Patient Link).
Local reaction R arm red, raised, warm, painful 12 cm by 7 cm. Flu like symptoms.
DID NOT COMPLETE VACCINATION COURSE PRIOR TO TRAVEL; TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1031) was received from a pharmacist on 29-Apr-2019. It describes a 23-year-old adult female consumer who "took unrefrigerated doses" and "did not complete vaccination course prior to travel". The consumer was receiving Vivotif (3003241) for an unknown indication.  Case report: The consumer took three unrefrigerated doses of Vivotif. The first dose was taken on 23-Apr-2019. She had a planned trip on 30-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the events "took unrefrigerated doses" and "did not complete vaccination course prior to travel" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" and "did not complete vaccination course prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" and "did not complete vaccination course prior to travel" was considered as not applicable.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of M-M-R II with a Lot # reported as L030162 with an expiration date of 11-AUG-2017 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that from 23-DEC-2016 to 31-DEC-2016, the vaccine was exposed to a temperature of 32 to 36 Fahrenheit degrees range (0 to 1 centigrade degrees) for a time frame of 177.5 hours (for 6 cycles); from 03-JAN-2017 to 31-JAN-2017, the vaccine was exposed to the same temperature for a time frame of 464.5 hours (for 21 cycles); from 02-FEB-2017 to 28-FEB-2017, the time frame was 409.5 hours (for 16 cycles) and from 01-MAR-2017 to 15-MAR-2017, the time frame was 61 hours (for 6 cycles). The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Lower left side abdominal pain; Acute abdominal pain; stiff arm; fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Acute abdominal pain), ABDOMINAL PAIN (Lower left side abdominal pain), MUSCLE SPASTICITY (stiff arm), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MUSCLE SPASTICITY (stiff arm), FATIGUE (fatigue) and MYALGIA (muscle pain). On 27-Feb-2021, the patient experienced ABDOMINAL PAIN (Acute abdominal pain). On 02-Mar-2021, the patient experienced ABDOMINAL PAIN (Lower left side abdominal pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Acute abdominal pain) outcome was unknown, ABDOMINAL PAIN (Lower left side abdominal pain) had not resolved and MUSCLE SPASTICITY (stiff arm), FATIGUE (fatigue) and MYALGIA (muscle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were none.
Moderna removed from freezer on 7/29/21 - stored in refrigerator starting on 7/29/21 - expiration date changed to 8/28/21 once stored in refrigerator.  Dose given on 9/22/21 - product expired 8/28/21. Contacted Moderna, awaiting response.
5 x 5 redness left thigh, mild swelling, Benadryl, Advil, return to office if worsens.
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical, drug and allergy history or concurrent conditions. On unknown dates, the patients received improperly stored doses of LIQUID PEDVAXHIB lot # M032149 (dose and route of administration were not reported) for prophylaxis. The doses of LIQUID PEDVAXHIB were exposed to a temperature excursion of 9 degrees Celsius (°C) to 25°C (20.9°C) during a time frame of 1 hour 27 minutes, which was detected by the data logger. There was no prior temperature excursion. Neither adverse events, nor product quality complaints were reported.
Turned red all over, and burning over head, neck, chest. Redness lasted 1.5 hours, heat lasted for 45 min. Nothing to treat symptoms
he has a friend who got two doses of Moderna Covid-19 Vaccine and then seven months later got a dose of the Pfizer BioNTech Covid-19 Vaccine; he has a friend who got two doses of Moderna Covid-19 Vaccine and then seven months later got a dose of the Pfizer BioNTech Covid-19 Vaccine; Reported states he believes he may have been injected with too large of a needle that may have hit a nerve; This is a spontaneous report from Medical Information Team. A contactable consumer reported for a patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter told a long story about being shorted cholesterol pills at PRIVACY pharmacy. Historical vaccine included two doses of moderna vaccine via unspecified route of administration on an unspecified date for COVID-19 immunisation. After receiving first booster dose of vaccine the patient experienced he has a friend who got two doses of moderna covid-19 vaccine and then seven months later got a dose of the pfizer biontech covid-19 vaccine reporter states he believes he may have been injected with too large of a needle that may have hit a nerve on an unspecified date. Reporter states he believes it is better to get a dose of Pfizer BioNTech Covid-19 Vaccine and also a dose of Moderna Covid-19 Vaccine instead of getting two doses of the same vaccine. He reports that he has heard of many people doing this. He also reports he has a friend who got two doses of Moderna Covid-19 Vaccine and then seven months later got a dose of the Pfizer BioNTech Covid-19 Vaccine. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected
At 14:00 given PPD and MCV4 at 14:05. Standing at counter, c/o weakness, dizziness. Became pale and diaphoretic. BP (supine) 110/58 58 14 - given juice. At 14:12 Sat increased, BP 110/70 88 18, states feels better, drinking juice. 14:15 laid back and stated she felt nauseated and weak, did eat today. 14:20 Still lying in supine position "clammy, weak". 14:27 Mom here states she felt weak and dizzy, herself yesterday. At 14:30 Pt walked out with mom. She is driving pt home. Color is better. Pt states she feels better.
Nausea, extremely tired, Headache. Started taking typhoid on 6/15
left arm sore at injection site and left arm "puffy" from elbow down to end of left arm Narrative:  Other Relevant History:
Right face/eye nerve inflammation; Right face/eye nerve inflammation; stapling symptoms of shingles; erythema/  Redness; This case was reported by a consumer via call center representative and described the occurrence of optic neuritis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced optic neuritis (serious criteria GSK medically significant), neuritis cranial (serious criteria GSK medically significant), shingles and red face. On an unknown date, the outcome of the optic neuritis, neuritis cranial, shingles and red face were unknown.   It was unknown if the reporter considered the optic neuritis, neuritis cranial, shingles and red face to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 61 years or 62 years. The week before the date of reporting, the patient received Shingrix. In the week of reporting date, the patient experienced stapling symptoms of shingles, right face or eye nerve inflammation and redness.
Vaccine given 10:15 A and by 12:00 MN 102 deg and 4:00 increased 103.7 vomiting and fever. Seen by Dr later in day 2 pm c/o  pain (R) shoulder, rash (hives) circular radiating into back and down arm and temp. increased 103.4 c/o leg weakness x2 days alternated TYLENOL & MOTRIN for elevated temp. Out of school 2 days. Day 2 no temp felt better. 4/25/09, sl . rash and swelling
Left upper arm from shoulder to elbow with erythema, swelling and warmth, tender to touch.
Vision changes: blurred vision Dizziness throughout the day Swelling and stiffness of knuckles  Passing blood clots similar to menstruation.
Patient in to clinic for Pfizer booster. Pfizer 1st dose received 6/20/21, 2nd dose received 7/11/2021. Booster administered prior to the recommended internal. No immediate adverse effects noted.
10 am seasonal flu shot right deltoid, H1N1 left deltoid 3 pm tingling and swelling of bottom lip, patient states that she feels like she has a bone in her throat, but no respiratory distress or localized reaction at injection sites.
pt recv vax 25FEB97 & exp fatigue, inability to think or focus, felt drunk, syncope-like rxn w/blacking out JUN97, staring into space, tinnitus, optical hallucinations, sleeping all the time & dizziness/vertigo;had bad stomach rxn;lethargy
On the first day, I had fever, chills, aches and pains , and a head ache.  Second day- swollen lymph nodes under the arm, aches and pains,.  Third day - head ache  and muscle fatigue   5th day- starting at 4am. I woke up with skin itching. I noticed a rash on my arm where injection was. It then spread to back, other arm, legs, neck , ankles and knees. Took Benadryl and Zyrtec by doctors orders. The rash went away- but then six hours later returned and has grown. I also have to take more Benadryl since the same amount has not helped the rash disappear.
flu like; dizziness; muscle pain; soreness in the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like), DIZZINESS (dizziness), MYALGIA (muscle pain) and VACCINATION SITE PAIN (soreness in the injected arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No reported medical history). Concomitant products included FINASTERIDE and TERAZOSIN for an unknown indication.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like), DIZZINESS (dizziness), MYALGIA (muscle pain) and VACCINATION SITE PAIN (soreness in the injected arm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like), DIZZINESS (dizziness), MYALGIA (muscle pain) and VACCINATION SITE PAIN (soreness in the injected arm) outcome was unknown.            No Treatment information  provided   This case was linked to MOD21-037913 (Patient Link).
Sudden hearing loss followed by severe vertigo and severe vomiting. General decline with A-fib alternating with extreme bradycardia, dangerously low blood pressure, 94 degree core body temperature, treatment for hypothermia, 4 day hospitalization. Pacemaker surgery shingles outbreak at same time. Patient condition one month later: All doctors consulted so far agreed that CT's/MRI's show no CVA, lesion, tumor, or other cause for sudden deafness. All suspect a virus, particularly shingles virus, caused damage since patient suffered serious outbreak in conjunction with this medical emergency, which also precipitated pacemaker surgery. I am 100% deaf in my left ear - permanently, irreversibly. It happened over 2 hours! Hearing has been replaced with constant, loud ringing and buzzing which makes hearing from other ear difficult. I have a constant headache as a result of this and of the vision distortion resulting from delayed vestibular-ocular reflex caused by this event as well. My balance is shaky; walking is affected, and I'm not allowed to drive at this point. In addition to this pain and inconvenience is the frustration of not being able to participate in favorite activities, such as reading, watching TV or movies, walking on beach, dancing, doing water aerobics despite daily vestibular rehabilitation exercises. Patient presented to the office on October 8, 2018. She reported sudden hearing loss, severe vertigo and difficulty with vision since having a recent herpes zoster vaccine. The comprehensive eye examination showed all structures of the eye to be normal and healthy. Extraocular muscles appear to track normally in all directions of gaze. The patient does have nuclear sclerotic cataracts, but this was not a reaction to the vaccine. It is my belief that the zoster vaccine could have caused patient's vestibular-ocular reflex difficulties - vertigo along with occasional double vision. Patient never showed any of these problems prior to the zoster vaccination.
Fever, chills, body and bone aches, toothache, lethargic, no energy. Lymph node swelling on the left side on the neck. Lasted 2 days