chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cramping has been stronger and hurting more than usual.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included none. 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 COVID-19 vaccine. Concomitant medication included ethinylestradiol; drospirenone (YASMIN) from an unknown date for birth control. On 20Apr2021 at 12:00, the patient was currently on period, and experienced cramping had been stronger and hurting more than usual. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cramping which had been stronger and hurting more than usual was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Right thigh swollen, hard to the touch, 20% larger than normal and hot to the touch. No fever. Limping/redness at injection site. Tx: Hydrocortisone, cool cloths and Benadryl PRN. DX: DTAP reaction (possibly IPV).
Information has been received from a consumer concerning her daughter, a twin, who was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. The reporter indicated that the patient's speech is not clear and she takes speech class. It was noted that the patient was not tested by a neurologist. A product quality complaint was not involved. Additional information has been requested. The reporter also indicated that the patient's twin brother experienced an adverse event after therapy with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live.
GBS noted weakness of leg 17NOV92; admitted 23NOV; remains inpatient;
rapid, hard  beating heart, feeling out of breath, extreme anxiety, lasting for approx. 2 minutes
Seizure. I?ve been put on an anti-seizure medication. I?ve also been scheduled for an MRI and an EEG
At 8:30 am during the day following the vaccine I had a sudden blood pressure drop resulting in fainting. The next day I began to develop an itchy rash. Initially I thought it was bug bites, but it spread from my left arm to my trunk to my legs. I sought treatment at urgent care on 5/14/21 where they diagnosed it as a shingles rash as a result of the vaccine. They put me on Valtrex for 7 days.
Shingles (herpes zoster) first signs occured on 6/4/21 and diagnosed on 6/9/21. Prescribed Valacyclovir HCL 1 gram tablet twice a day for 7 days, and Prednisone 50mg tablet once per day for 5 days.
Patient received vaccine 6/8 and says soon after started having visual changes of a black line across her vision  right eye and later had fatigue, light flash in peripheral vision right eye, leg cramps that lasted a long time.  eventually developed right shoulder pain and difficulty moving shoulder and raising above her head.
SEVERE DIARRHEA, MUSCLE AND BONE PAIN, SEVERE HEADACHE 11/23/2009 OB-GYN records for visits 8/2009 to 11/16/2009. Records do state that 6 days post vaccine patient with c/o's dizziness, no other sx noted. no tx noted
Chills, nausea, vomiting, fever. Red, blotchy rash. Passed out. Back (between shoulders) and back of legs hurt.
Generalized aching, left sided neck stiffness, and left arm muscle soreness. Cold compress to left neck and at vp site.
tingling in legs; Numbness in legs; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling in legs) and HYPOAESTHESIA (Numbness in legs) 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 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 PARAESTHESIA (tingling in legs) and HYPOAESTHESIA (Numbness in legs). At the time of the report, PARAESTHESIA (tingling in legs) and HYPOAESTHESIA (Numbness in legs) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter reported that a patient received first Moderna COVID-19 vaccine 3 or 4 weeks ago and stated that stated the tingling and numbness was currently a bit better.  No concomitant medication was reported. No treatment information was provided.
Received shingle vaccine 4/28/16 (R) arm. 4/29/16 noticed sore red spot (R) arm. 4/30/26 fell fatigued and slept all day with decreased appetite and headache. 5/1/16 less soopy yellow drainage. Seen in office 5/2/16 3 cm area of area of bright pink erythema with surround of 20cm erythema. Rx KEFLEX 500 Q 10X 10dy. for cellulitis.
5 hours after vaccine: patient felt dizzy, lightheaded, shaking, fatigued, and sweaty. Was back to normal by the evening time (before bed).
Temp 103.5 temporal, myalgia, SOB, loss of balance, SpO2 85% RA lying down Symptoms appear to be resolving this AM.  Sp02 98% on 2L O2. Temp 98 temporal - at 7:45am
This spontaneous report as received from a physician refers to a 5 year old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions were provided. On an unknown date, the patient was vaccinated with the first dose of PROQUAD (Merck) injection (lot# reported as K011310, expiry date 14-FEB-2016; dose and route of administration were not reported). Then, 34 days later (date unspecified), the patient received the second dose of PROQUAD (Merck) injection (lot# reported as K011310, expiry date 14-FEB-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Information has been received from a physician's assistant concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a 0.5mL first dose of Gardasil.  Subsequently, the patient experienced a headache and nausea that lasted for one week.  The patient called the doctor's office.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Pt received HPV vaccine on 5-22-07 (lot # 0387U) and 7-17-2007 (lot # 0387U. VAERS report submitted due to pt receiving HPV vaccines beyond the recommended age range of 26 years.  No adverse events occured.
child was given Kinrix instead of Pediarix.  error found through billing on 2/10/2020.  Verification of documentation to ensure it was not a  clerical error. Once paper confirmed on 2/13/2020 . Parent was notified and  parent stated that child had been without any adverse  reactions post vaccine " maybe a fever but I do not think it was bad."  Mom wanted to know if vaccine would count towards  her series and  she  told yes, it would count, but  infant still needed to be given a Hep B since she had not yet recieved the  4 month dose. Mom  made appointment for daughter to get Hep B  on 2/18/2020.  All of this reported to Medical Director .
Bruise on left arm. Red/purple/reaction from injection site to elbow. Warm to touch.
01-10-06 Mom called the clinic this AM to report patient had been taken to the ER at hospital after having a seizure. Mom reported 3 hrs after immunization a fever of 104. Medical records state irritability, Rhonchi. msv
Beginning February 28, 2021 stroke, seizure, fever, headache and weakness.
Extreme discomfort in right shoulder following administration of Menactra vaccine lasting just over 3 weeks.
Facial Swelling, Head and Feet Itching, Air Way not compromised, Tretment of Benadryl 50 mg PO, and EMS Activated
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Nov-2021 at 11:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 11:29 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 72.40. No concomitant medications were reported. On 03-Nov-2021 at 10:00 Am the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 05-Oct-2021 and beyond use date was 05-Nov-2021. Product moved to clinic on 03-Nov-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Superficial Thrombosis in right leg began to present 2 weeks after first injection. Worsened over next two weeks until I visited my doctor who sent me for an ultrasound.
Breakthrough case admission after 4 vaccines Moderna 2/4/21 Lot# 007M20A;  Moderna 3/6/21 Lot# 015M20A;  Moderna 12/13/21 Lot# 041J21A;  Moderna 2/17/23 Lot# 023H22A
A male patient of about 56 years old, received Tice BCG series of 6 weekly instillations, from approximately 05/02/2002 until 06/06/2002.  On 06/13/2002, he reported he had been experiencing a fever up to 103 degrees F (39.4 degrees C), chills, and back and neck pain for the past few days.  He was being seen by his urologist on 06/13/2002.  FU: On 01/15/2003 information was received that the patient had the flu; there were no signs of a BCG reaction.
March 6th noticed right hand going numb but cleared up within 10 minutes.  March 7th right hand went numb again and had vision problems with right eye, cleared up in about 15 minutes.  March 9th right hand and right side of face went numb.  Went to hospital and was examined and told I was having a stroke.  I was admitted to hospital for two days.  MRI showed that I had a stroke and now have some brain tissue damage.  I and now going to occupational therapy to regain use of right hand.  The Doctors thought that it was pretty coincidental that my first stroke symptom (transient numb right hand on the 6th) started just a couple days after I got the second dose of the moderna vaccine.
Since waking up morning after vaccines, I have had lightheadedness and dizziness when moving my head to quickly.  Also ringing (sounds like Cicadas) in both ears.
Fever up to 101.7 degrees, body aches, chills, headache, armpit pain on side of injection, redness and pain at injection site, fatigue. Lasted 2 days. Took Tylenol for fever and slept alot.
After second dose of pfizer and 3rd dose of pfizer vaccines pt experienced whole body chills, tingling in extremities, muscle twitching, headache. Continues to have episodic chills, tingling, muscle twitches and head pressure 4 weeks after 3rd dose.
PATIENT DESCRIBED SEVERE MUSCLE TIGHTNESS ON LEFT SIDE OF NECK THAT PERSISTED AT THAT LEVEL THROUGH 5/9/2021 (NO RELIEF WITH MUSCLE RELAXER) AND IS STILL FEELING TO A SMALLER EXTENT AS OF TODAY.
So hungry after returning this morning she ate again after eating breakfast before going.; A little dizzy for a second; 98.1 Fever; A little headache; Is tired; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED APPETITE (So hungry after returning this morning she ate again after eating breakfast before going.), DIZZINESS (A little dizzy for a second), PYREXIA (98.1 Fever), HEADACHE (A little headache) and FATIGUE (Is tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced INCREASED APPETITE (So hungry after returning this morning she ate again after eating breakfast before going.), DIZZINESS (A little dizzy for a second), PYREXIA (98.1 Fever), HEADACHE (A little headache) and FATIGUE (Is tired). At the time of the report, INCREASED APPETITE (So hungry after returning this morning she ate again after eating breakfast before going.), DIZZINESS (A little dizzy for a second), PYREXIA (98.1 Fever), HEADACHE (A little headache) and FATIGUE (Is tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Body temperature: 98.1 (High) 98.1 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Reporter did not allow further contact
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 042B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Acute myeloid leukemia (started clinical trial drug in February 2021) since 2013. Concomitant products included AMLODIPINE from 2013 to an unknown date for Blood pressure management, VALACYCLOVIR [VALACICLOVIR] from 2013 to an unknown date and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 2013 to an unknown date for Cancer, FLUCONAZOLE from 2013 to an unknown date for Pneumonia fungal.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products used included Belumosudil 200mg bid as clinical trial drug since ??-Feb-2021,No treatment medication was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient received both doses in deltoid. Capped vaccine was kept refrigerated according to storage guidelines of between 36-46 degrees F and was only uncapped and removed from refrigeration prior to vaccination.   This case was linked to MOD-2021-215651 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added patient demographics, added medical history and concomitant medications, Added first dose details, updated event description, added event stop date and outcome.
Erythema Multiform and swelling, firmness, pain. Ibuprofen.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.   No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.
Received her 2nd shot at 16:00 yesterday (7/10/2021) *first shot was June 18, 2021  She started experiencing chest pain last night, also complained of shortness of breath when going up stairs She took 1/2 apap tab (strength not specified) for injection site pain (After first shot, she had anxious at the time of the shot; her BP was checked and was within normal limits. Only issue beyond that was redness of her arm).  Follow Up call to parent on July 11, 2021: Spoke with mom.  She took daughter to the emergency room last night.  EKG and chest x ray were both normal,  She was  given a muscle relaxer in ER with improvement of pain.  Child is sleeping but when mom checked on her she said her pain was minimal this morning.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments: US-009507513-1801USA005992:
noticed age spots on the back of his hand and a big one on his forehead and ever since the first shot these spots have been removed; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, lot number: EN5318, Expiration date: Unknown) via an unspecified route in the left arm (about an inch or so away from shoulder) on 27Jan2021 (21 days ago; at the age of 91-years) around at 13:30 or 14:00, as a single dose for covid-19 immunization. Medical history included pacemaker in 2015 (four years before the shot), prostate removed in Jun2020, blood pressure, age spots on the back of his hand and a big one on his forehead. Concomitant medications included metoprolol tartrate, 50 mg tablet twice a day with food for blood pressure (ongoing). The patient's cardiologist checked on 25Jan2021 and said it was okay to take the shot. Pacemaker was working. He still has 4 years before it has to be replaced. The patient received his first shot on 27Jan2021 and had no side effects or anything at all. Prior to the vaccine he noticed age spots on the back of his hand and a big one on his forehead and ever since the first shot these spots have been removed on an unspecified date in 2021. He had a few on his hand, a number of them on the back of his hand. He started to notice about a week or so ago, the age spots were disappearing. He had one that was half an inch in diameter on the front of his forehead and it has disappeared. These have all mostly disappeared. He was scheduled for the second dose on 16Feb2021 (this afternoon) at 14:45. He took his blood pressure medication this morning, has a pacemaker. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Swelling upper and lower left arm, severe erythema, heat, chills, myalgias. Mostly gone after 2 days. No treatment.
Information has been received from a physician concerning a female who in the end of June 2007, was vaccinated with a dose of Gardasil.  In approximately JUN-2007 the patient developed a very small bump under the skin at the injection site and pain.  On an unspecified date a Magnetic Resonance Imaging was performed, results were not reported. Unspecified medical attention was sought.  At the time of the report the patient had  not recovered from the pain.  It is unknown if the patient recovered from the bump.  Additional information has been requested.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with, oral, ROTATEQ (dose numbers, route, lot numbers and expiration date were not provided). Concomitant therapy information was not provided. On unknown dates, the patients experienced incorrect product storage as, oral, ROTATEQ was improperly stored and unspecified doses were administered. No adverse effects were reported. It was unknown if the patients sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
patient received pentacel which was excused at low temperature/no AE; patient received pentacel which was excused at low temperature/no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2020SA032086 and 2020SA032094 (same reporter).  This case involves a patient of unknown demographics who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ64BA, expiry date: 03-Feb-2021 via unknown route in unknown administration site) on 03-Feb-2020 which was excursed at low temperature and was not suitable for use (Poor quality product administered, Product storage error).  The patient medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.   It was of actual medication error due to incorrect product storage (Product storage error) and Poor quality vaccine administered (Poor quality product administered).  It was reported that patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.