chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling going to vomit or faint; Immense pain during menstrual cycle; feeling going to vomit; heaviness in pelvic area; unusual pain and heaviness in pelvic area; This is a spontaneous report from a contactable consumer. The reporter is the patient. A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Sep2021 (Lot number: FC3184) at the age of 32 years (not pregnant) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications included vitamins, OTC pain reliever. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number: FC3180, vaccine location: Left Arm), administration date: 06Aug2021, when the patient was 32 years old, for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. The following information was reported: PRESYNCOPE (medically significant) with onset 23Oct2021, outcome "unknown", described as "feeling going to vomit or faint"; DYSMENORRHOEA (non-serious) with onset 23Oct2021, outcome "unknown", described as "Immense pain during menstrual cycle"; NAUSEA (non-serious) with onset 23Oct2021, outcome "unknown", described as "feeling going to vomit"; PELVIC DISCOMFORT (non-serious) with onset 23Oct2021, outcome "unknown", described as "heaviness in pelvic area"; PELVIC PAIN (non-serious) with onset 23Oct2021, outcome "unknown", described as "unusual pain and heaviness in pelvic area". The events "feeling going to vomit or faint", "immense pain during menstrual cycle", "feeling going to vomit", "heaviness in pelvic area" and "unusual pain and heaviness in pelvic area" were evaluated at the physician office visit. Therapeutic measures were taken as a result of presyncope, dysmenorrhoea, nausea, pelvic discomfort, pelvic pain, which included Prescribed birth control, pain regimen. Covid was not tested post vaccination.  Follow-up attempts are completed. No further information is expected.
experiencing joint pain in hip and knees; 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 ARTHRALGIA (experiencing joint pain in hip and knees) 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 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (experiencing joint pain in hip and knees). At the time of the report, ARTHRALGIA (experiencing joint pain in hip and knees) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
The patient was tired the next day; Patient had a sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore injection site arm) and FATIGUE (The patient was tired the next day) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 026L20A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Patient had a sore injection site arm). On 03-Feb-2021, the patient experienced FATIGUE (The patient was tired the next day). In February 2022, FATIGUE (The patient was tired the next day) had resolved. At the time of the report, VACCINATION SITE PAIN (Patient had a sore injection site arm) outcome was unknown.            No concomitant medication was reported. The event tiredness lasted for 10 to 12 hours as reported. No treatment medication details were reported.   This case was linked to MOD-2022-543480, MOD-2022-543473 (Patient Link).
Nausea, vomiting, dizziness, weakness. Weak and dizzy, room is spinning. Admitted to hospital through emergency department for vertigo. Placed on scopolamine patch and given meclizine, admitted for IVF and monitoring, edemawear, PT/OT eval adn treat. Discharged 3/8
Received vaccines below on 9/27/05.  Experienced adverse event on 9/28/05.  Child had febrile seizure and diarrhea.  Awaiting ER report.  Follow-up phone call to father who states daughter is now doing well.
Extreme dizziness; Falling over; Inability to drive; Numbness in both arms and legs/ Couldn't feel legs from the calf down at one point; Arm weakness to pick things up; Involuntary left arm shaking; Memory issues, forgetting to complete tasks that I have started; Feeling of extreme itching inside my body; Crushing fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on an unknown date in Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included Nickel allergy and food sensitivities. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, 1 hour after the vaccination, the patient experienced numbness in both arms and legs, couldn't feel legs from the calf down at one point. On 08Apr2021, the patient experienced extreme dizziness, caused falling over and  inability to drive, arm weakness to pick things up, involuntary left arm shaking, memory issues, forgetting to complete tasks that the patient had started, feeling of extreme itching inside body and crushing fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events extreme dizziness, falling over and inability to drive were resolved on an unspecified date in Apr2021, after a duration of almost 2 weeks; while that of the events numbness in both arms and legs, couldn't feel legs from the calf down at one point, arm weakness to pick things up, involuntary left arm shaking, memory issues, forgetting to complete tasks that the patient had started, feeling of extreme itching inside my body and crushing fatigue were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Fever developed; Right arm red, swollen, hot from upper deltoid to mid humerus- started KEFLUX & ROCEPLIN 2gm 1mx 3 days -> improvement is WBC, SXS, arm redness & fever
The evening of the day of the shot I developed a sore arm at the injection site. My lymph nodes under that arm were extremely swollen and very painful. I woke up approx 4am the morning after the shot (12/30) in excruciating body pain. My joints and muscles hurt. On a scale of 1-10 with 10 being the most pain, I was at a 12. I ran a fever the day after, with a cough, running nose, extreme headache that lasted 2 days.  Headache is still present but not as bad. Finally feeling a little better on Jan 2. Today, Jan 4, still have a running nose, headache and persistent cough and fatigue.
Has happened 6 times so far, first time being in January, most recently happened end of March  Face starts to tingle, then it turns red (see pictures). Then my neck/chest starts to get itchy along with my lips but they do not turn red. My elbows and hands will turn red and be mildly itchy as well. Sometimes my face/nose will feel tight? and hot and sometimes I feel a pulse in the bridge of my nose. All these things happen every time this happens. This has always happened in the morning after eating breakfast.
PATIENT REFERRED SHE DEVELOPED GENERALIZED SKIN RASH 15 MINUTES AFTER VACCINATION PLUS CHEST AND RIGHT SHOULDER PAIN. SHE ALSO COMPLAINED OF UPPER EXTREMITIES WEAKNESS. PATIENT IS ADMITTED TO THE HOSPITAL.
RED RASH, WARM TO TOUCH, SORE AT INJECTION SITE WITHIN 3 WEEKS LARGE BUMP APPEARED AND MORE TENDER A WEEK AFTER THAT BUMP GREW LARGER AND EVEN MORE TENDER/SORE.
Two days after receiving the vaccine, the patient fainted at the home.  Has had intermittent shortness of breath, and dizziness
Pt developed fever and was tested for COVID which was positive.  Due to history of leukemia on chemo she was admitted to the hospital
friends who got the Moderna vaccine had pain in the arm of the injection for 2 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (friends who got the Moderna vaccine had pain in the arm of the injection for 2 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (friends who got the Moderna vaccine had pain in the arm of the injection for 2 days). At the time of the report, PAIN IN EXTREMITY (friends who got the Moderna vaccine had pain in the arm of the injection for 2 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Pt received an injection in one right deltoid on 3/14/06. That night her arm swelled to one point where she could not move it. She took advil and returned to one office and received (on 3/17) and received Benadryl 2.5 and Prednisone 50 mg. Came to office on 3/21 with tarchcollis. Rx flexeril 10 mg Ibuprofen. Still under Rx.
No additional AE reported; PNEUMOVAX 23 was administered to the patient after the excursion occured; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-MAR-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U022819, expiration date: 14-JAN-2023) for prophylaxis (strength, dose and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposure to a temperature of 0.8 degree Celsius for a time frame of 24 hours. There was previous temperature excursion. No additional adverse event was reported.   This is one of the several reports reported by the same reporter. ; Sender's Comments:  US-009507513-2206USA006770: US-009507513-2206USA006587: US-009507513-2206USA007094: US-009507513-2206USA006674: US-009507513-2206USA007098: US-009507513-2206USA007068:
Information has been received from a healthcare worker (office manager) concerning a 72 year old female patient with no drug reactions or allergies and no pertinent medical history who on 09-MAY-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (lot# 668009/1174Z, exp. 10-MAR-2011). Concomitant therapy included NEXIUM, LIPITOR, DYAZIDE and ECOTRIN. On 10-MAY-2011 the patient developed severe swelling, redness and pain in her right arm that extended to her elbow. The patient was seen in the office on 10-MAY-2011 and then again on 11-MAY-2011. No laboratory diagnostics studies were performed. The patient was prescribed and unspecified dose of AUGMENTIN. At the time of reporting, the patient was recovering. Additional information has been requested.
improper storage; Based on information previously received with CSD: 22-AUG-2018, the following information [Reporter's State was updated to ASKU] have been amended.   Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 14 years old male patient who received vaccine which was improperly stored (improper storage), while he received vaccine Influenza Quadrival A-B Multidose Vaccine Preserved (Fluzone).  This is actual medication error case due to patient received vaccine which was stored improperly (product storage error).  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2018, the patient received a dose of 0.5 ml of suspect Influenza Quadrival A-B Multidose Vaccine Preserved lot UI982AC, exp date: 30-June-2019, in the left arm.   It was not reported if the patient experienced any adverse event.  Lab test and corrective treatment: not applicable  Outcome: not applicable.  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 sender: none.  Addendum: Based on information previously received with CSD: 22-AUG-2018, the following information [Reporter's State was updated to ASKU] have been amended.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, chills/ fatigue Narrative:
On April 7, 7 days after receipt of my second dose my heart rate started going up.  at the time of the second dose my resting heart rate had been in the mid 50s for many years.  On May 27 my blood work came back with a signal of hyperthyroidism and my doctor put me on atenolol to control my heart rate.   Diagnosis is presumed to be graves disease (all symptoms are consistent and new), ultrasound is planned for June 17
pt recv vax 26JUL96 & was tired, very weak & exp severe sweating & nausea;
17 days post smallpox primary inoculation, post 7 day post take check with event to medical complaining of large weeping smallpox site and erupting rash consistent with band-aid pattern.
patient was less than 18 years of age when vaccine was administered.  patient contacted and no adverse drug reactions were reported.
screaming started about 1 hr p/shots & cont til 11PM that noc; unconsolable, sl temp, legs did not appear to be sore; took bottle 2 1/2-3 hrs; only time was quiet fell asleep a few minutes but awoke up if put down & screaming resumed;
Pt called reporting pain in left arm at injection area. Pt stated she couldn't lift her arms out straight w/out pain, or behind her back. Arm is achy and throbbing.
? site has lg red circle -> Advised to apply cool compress and make take TYLENOL for discomfort
A sales representative reported that a pt received an injection of Prevnar and subsequently developed a "pen-sized" lump at the injection site. The lump resolved after approximately 24 hours. No further information was available at the date of this report.
Chills; Fever; Headache; Vomiting; Diarrhea; Dizziness; This is a spontaneous report from a contactable consumer. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0169) via an unspecified route of administration in the arm left on 22Apr2021 at 11:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication taken within two weeks of vaccination was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 23:30, the patient experienced chills, fever, headache, vomiting, diarrhea and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever, headache, vomiting, diarrhea and dizziness was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
After receiving my first dose of Pfizer vaccine 2 days later I had severe  lymphadenopathy of my neck involving  my entire neck down to  cervical area of my neck .Huge lymph nodes causing extreme pain of my entire neck . After going to 4 doctors there  was no specific reason given except vaccine. The swelling lasted 4 months and was very painful..
Hip Joint and leg pain; Hip Joint and leg pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was Er8733 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Apr2021 at 16:45 (Age at vaccination was 48 years) as dose 1, single for covid-19 immunisation. Medical history included hip surgery. Patient did not have known allergies. The patient did not diagnosed covid prior to vaccination. The patient's concomitant medications were not reported. The patient previously took microgestin. The patient did not took other vaccine in four weeks. On 24Apr2021 at 18:00 the patient experienced hip joint and leg pain. The patient did not tested covid post vaccination. The patient did not receive any treatment. The outcome of event was not resolved.  No follow-up attempts are needed. No further information is expected.
tachycardia; This is a spontaneous report from a non-contactable pharmacist. A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via intramuscular route of administration in the left arm on 02Mar2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced tachycardia which was elevated for an hour and went away after 20 minutes. It was reported that the patient was 17 weeks pregnant. Therapeutic measures were not taken as a result of the event. It was unknown if since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event tachycardia was resolved on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
It was reported that a pt (5 of 7) received Fluzone 98-99 between 10/3/98 and 10/6/98. Reportedly the pt experienced vomiting and diarrhea.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
tested positive for Covid-19; Loss of taste; Loss of smell; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration in right arm on 11Mar2021(at the age of 25 years old) as 1st dose, single dose for covid-19 immunization. Medical history and concomitant medications were none. It was stated that they have not had any other recent vaccinations or started any new medications. On 12Mar2021 the patient had tested positive for covid-19 and experienced loss of taste, and loss of smell. Reporter stated as he got the COVID-19 vaccine, his first shot a day before he tested positive for Covid, he would like to know if there is any possibility that it could have triggered a false positive for a COVID test. He said he just tested positive, and he had lost taste and smell. It was reported that the COVID test that was positive was a rapid test that (name) is doing, specific test name unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Mar2021. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
10 hours after shot, I had pain all over my body - joints, muscular pains, needles.  Diagnostic: Guillain-Barre syndrome, frozen shoulders, tendinitis, bursitis, arthritis.  Recommendation for physical therapy. 9/18/08-records received for DOS 11/16/06-C/O feeling sick for 3 days. Returned to office for uric acid results 5.2. Neurology consult 2/21/07-C/O pain in left arm diagnosed as tendonitis pain increased in intensity in right shoulder spread to left shoulder with some weakness. DX:bilateral shoulder sprain, rule out adhesive capsulitis or impingement syndrome.   6/18/09 Consultant medical records received DOS 2/21/09. Previously included with primary care provided records - no new codes.
Headache, low grade fever, body aches, muscle aches/treated with ibuprofen mid-afternoon on day of occurrence/ felt better within 24 hours of occurrence.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     Patient was not tested positive for COVID-19.     On 30-Mar-2022 at 10:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (expired vaccine used) to be not related.    No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
This spontaneous report as received from a physician refers to a female patient of unknown age. On 02-OCT-2012, the patient was vaccinated with a dose of M-M-R II. No concomitant medications were reported. On 13-NOV-2012 (reported as 6 weeks later), serological testing for titer against measles was done and the patient was found to have negative titers against measles. The patient sought medical attention for the event. The outcome of the event was unknown. No further information is available. Additional information is not expected.