chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 63-year old female patient with pain in knees, asthma and right hip arthritis. The patient did not have any drug allergies/reactions. On 26-SEP-2018 the patient was vaccinated with PNEUMOVAX 23 (lot and expiry date not reported) subcutaneously for prophylaxis. Concomitant therapies included Etodolac, amlodipine, metformin, aspirin, PREMARIN, losartan, Irbesartan and vitamins (unspecified). It was reported that she experienced severe swelling, red, hot, arm pain" after receiving PNEUMOVAX 23. She had been in pain since she got the shot and nothing was helping her, TYLENOL did nothing. She couldn't cook and it was hard for her to get out of bed, she couldn't sleep and couldn't raise her arm overhead. On unspecified dates, she did visit her physician on an unspecified date and that "he couldn't even touch her arm it was so much pain and her blood pressure was 170 systolic when they checked it and it was never that high. Her physician did refer her to an orthopedic physician for evaluation. She reported that in addition that she was taking etodolac for arthritis and had been taking diclofenac which did no good on unspecified dates. Outcome of all the events was not recovered. Causality assessment was not reported for the events. Upon internal review, the event pain in arm which made her hard to get out of bed and affected her sleep was considered to be serious due to disability.
Pt hyperventilated, was dizzy and fell (according to witnesses) . Pt also vomited.  Pt sat for 20 minutes then departed store.
pt recv vax 16SEP98 & on 20SEP98 pt had spots on face, & spots on back @ shoulder's;face spots were bigger than others which looked like rubella;
vaccine was administered past the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered past the 30 day beyond use date) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Seizure, Obesity, Hyperlipidemia, Depression and Hypertension (HTN). Concomitant products included AMLODIPINE, LISINOPRIL, PRAVASTATIN, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) and METOPROLOL TARTRATE for an unknown indication.    On 07-Sep-2021 at 2:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021 at 2:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered past the 30 day beyond use date). On 07-Sep-2021 at 2:30 PM, EXPIRED PRODUCT ADMINISTERED (vaccine was administered past the 30 day beyond use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  It was reported that  the patient was not diagnosed or tested positive for COVID-19. It was also reported that the patient had no acute illnesses at the time of vaccination and up to one month before.
Shooting pains in lower right jaw starting day following injection. Pain progression from jaw to skull in 4 days. Intensity of pain from bearable to 10. Emergency room diagnosed Trigeminal Neuralgia on 5th day. Dr. prescribed Carbamazepine on 6th day. No change in pain level after second dose. No neurology appointment available until March 4.
Pt. reported "bottoming out" of blood pressure over the weekend.  Lowest recorded reading at home was 68/50mmHg.  Her medications for A. Fib were withheld during this time.  Pt reported dizziness, fainting and a fear to do anything but lay down during her low blood pressure event.
11/26 - left arm noticable red larger than 2 inches around shot site, normal soreness and warmth to touch. 11/27 - redness spread from shoulder to elbow and starting to wrap around arm; hot to touch arm noticeable swollen. 11/28 - entire upper arm red from elbow to shoulder and all they way around upper arm; hot to touch, swollen even more, less than double its original size.
This case was reported by a physician and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (details unknown) At an unspecified time after vaccination with KINRIX, the subject experienced rash, erythema and swelling. At the time of reporting the outcome of the events were unspecified.  There was no further information available at the time of reporting.
Optic neuritis-hospitalized for 5 day course of prednisone. Onset 5/13. Hospitalized 5/18/07 (headache, eye pain, papilledema) (color blind and visually severly impaired) 7/18/07-records received from facility for DOS 5/19-5/24/07- DC DX: Optic neuritis. One week piror to admission developed pain and vision loss in left eye accompanied by headache. Seen by ophthalmologist who diagnosed disk edema and afferent pupillary defect on left side.  Fatigue for 2 months since about the time she received her tetanus and HPV vaccines. No diplopia. No viual changes in right eye. PE: Pain on left eye with ocular movements. Tender globe in periorbital region on left side, afferent pupillary defect on left.
Four days after my second injection I developed,  at first on my right wrist to forearm,  a serious of blisters (which appeared to look like shingles) as well as bumps (mosquitoe bite size) on my head,  ring finger, and face.  Within three days thereafter the rash spread to my chest, abdomen,  left ankle, left wrist, and buttocks.  The size of those rashes varied from a few millimeters to over 100 millimeters.  Most were raised, and were discolored red.  Not all were itchy.   By happenstance my annual dermatology visit was scheduled two days after the first reaction.   My dermatologist PA looked at the site and told me she had seen  numerous patients who had reactions to the Moderna vaccine, including two of the staff.
1. Odd taste in mouth -metallic taste 5 minutes after the vaccine -still experiencing this symptom. No treatment has not call primary care provider.  2. Left eye started twitching and visual issues including blurry vision and seeing three images. Started 5 minutes after vaccine -still experiencing symptom. No treatment has not call primary care provider.  3. Left hand is numb, this started a couple days after the vaccine -not sure of date and is still experiencing this symptom. No treatment has not call primary care provider.
Right arm was very sore and lymph node under arm swelled to the size of a golf ball and was hard for 2-3 days; Right arm was very sore and lymph node under arm swelled to the size of a golf ball and was hard for 2-3 days; This is a spontaneous report from a contactable Other Health Professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 08:15 as 1st dose, single dose for COVID-19 immunization. Medical history included hypothyroidism, metabolic syndrome, insulin resistance from an unknown date and unknown if ongoing. Patient was allergic to Latex and Mushrooms from an unknown date and unknown if ongoing. The patient previously took codeine and experienced allergy. Patient was received any other medications in two weeks (Prescription and over the counter meds). Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 30Jan2021 at 05:00, patient experienced right arm was very sore and lymph node under arm swelled to the size of a golf ball and was hard for 2-3 days. It has gone down now and less than the size of a almond and the soreness is subsiding. The treatment was not received for any event. The outcome of events was recovering.
Arm became red, swollen and hot to touch. Dizzy and fever for 24-48 hours.
Moderna COVID?19 Vaccine EUA no immediate impact; severe joint pain began ~ 8 hours after injection; rash on back of right leg a few hours later; rash expanded to left leg and chest, and inside of both elbows; slight temperature for a few hours, but gone now. still have the rash and it is expanding.  Saw a dermatologist, who said it is a typical "viral allergic rash." Told me he could not give me steroids, but gave me sample of cream to reduce itch and recommended OTC antihistamine seasonal allergy pills. He said I should not take the 2nd dose, but to follow the advice of Moderna and CDC re: that decision.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 26-APR-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # L038018, expiration date: 13-SEP-2017) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. The RECOMBIVAX HB was exposed to 49.7 degree Fahrenheit for 1 hour and 45 minutes; there was no previous temperature excursion reported. This is one of several reports received from the same source. Additional information has been requested.
feeling cold; achy joints; mild to moderate headache; patient received second dose of bnt162b2 on 09Jan2021; head and torso fever while extremities like ice; head and torso fever while extremities like ice; Sporatic sweats; chills; body ache; Lingering lethargy; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EJ1685), via an unspecified route of administration on 09Jan2021 07:00 at single dose at right arm for covid-19 immunization. Medical history included asthma, rheumatoid arthritis, raynaud's, known allergies: nickel and latex. Concomitant medications in two weeks included salbutamol (ALBUTEROL), fluticasone propionate (FLONASE), ascorbic acid (VIT C), ergocalciferol (VIT D) and multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient previously took erythromycin and experienced drug allergy, and received first dose of bnt162b2 on 23Dec2020 for covid-19 immunization and experienced splitting trident occipital headache/Dull ache in frontal skull region. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 2nd injection-15hrs post injection, patient began feeling cold and achy joints, mild to moderate headache on 09Jan2021 10:00 pm, by 3am head and torso fever while extremities like ice. Over several days ran fevers from 99.1 to 103.6 F. Sporatic sweats, chills, and body ache attacks. Symptoms gradually subsided in severity and duration until resolving one week post injection. Patient also had lingering lethargy in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of events lingering lethargy and 'patient received second dose of bnt162b2 on 09Jan2021' was unknown, and outcome of other events was recovering.
Patient called on 9/30/2015 and stated that she had a rash on her neck and nothing had changed in past couple of days other than getting a flu shot. No reaction at injection site.
Case number PHEH2013US06508, is an incomplete initial report received from a nurse on 02 Aug 2013 with a follow up information received from a nurse on 04 Sep 2013. This case was initially reported as a multiple patient case, but upon follow up receipt both the patients were identified. This report refers to a female patient. Her past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A11032), intramuscularly on 30 Jul 2013. MENVEO had experienced a one time temperature excursion of 9.0-9.5 C for maximum time of 18 minutes. No adverse event was reported following this administration error. Follow up information received from a nurse on 04 Sep 2013: Case category changed to spontaneous case the case became valid, patient demographics (patient initial and gender) and vaccination date updated.
34 hours post-vaccination, made visit to dr's office, bp was 200/110.  on 10th day post-vaccination, was treated in ER.  bp 200/110, complains of some chest tightness, has been treated in past for hypertension.
blacked out and loss consciousness twice; hit head and make a gauche on eyebrow needing stiches; hit head and make a gauche on eyebrow needing stiches; whole body was feverishly hot; This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 13Feb2021 10:30 (at 29-years-old) at single dose (Left arm) for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), on 23Jan2021 03:30 PM (at 29-years-old) on Left arm for COVID-19 immunization. Facility type vaccine was reported as Other. There were no other vaccine administered in four weeks. There were no other medications in two weeks. Approximately 12-24 hours after second dose, whole body was feverishly hot, blacked out and loss consciousness twice within 30mins of each other waking up on the floor from standing position, causing to hit head and make a gauche on eyebrow needing stiches. Events started on 14Feb2021 04:00. Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of hit head and make a gauche on eyebrow needing stiches. The outcome of the events was recovering.    No follow-up attempts are possible. No further information expected.
DTaP given sub Q instead of IM in right arm. 8/20/07 Pt doing well; no unusual swelling or problems.
First period following vaccine in July more bleeding with stronger cramping. Second period following vaccine I did not have normal cramping they felt like contractions, I could not perform my daily tasks, I had heavier bleeding  and ended up passing two blood clots the size of cookies. My second period was also 9 days late and it is never late and there is no chance I?m pregnant.  Awaiting my 3 rd period  that is supposed to start tomorrow (Sept 13) . I will notify cdc again to inform you guys if it worsens even more.
This initial serious spontaneous case, was received on 03-Nov-2017, reported by other non-health professional and concerns a 32-year-old adult female patient. The patient's historical drug included SINGULAIR for an unknown indication. It was reported that, the patient stopped oral contraceptive pills on an unspecified date in May 2017. The patient did not have any maternal medical history and paternal medical history (hereditary disease). The patient's last menstrual period date was 02-Aug-2017 and estimated date of delivery was 09-May-2018. There was no evidence of defect/adverse finding from a prenatal test. It was reported that, no medications were taken by father prior to conception. The patient's concomitant medications included Acyclovir for cold sores. On 03-Nov-2017, at gestational age of 13-weeks (first trimester), the patient was administered with FLUCELVAX QIV (dosage: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). It was reported that no adverse event was reported in the patient and fetus. The reporter assessed the report as serious (medically significant).
husband got the shot, didn't stop from getting them\ suspected vaccination failure; shingles, not a bad case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's Wife. The age at vaccination was not reported. The reporter stated got Shingles shot but shot did not stop him from getting them shingles, the patient did but not a bad case. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Extreme fatigue, sore arm, fever, chills, headache, lack of appetite.  Took Tylenol.  Everything went away except for the fatigue.  Fatigue continued through the second dose, and got worse during  the following months.  I had a fever and a rapid heartbeat event in April 2021.  Tested negative for COVID.  Went to the ER in May thinking I was having a heart attack.  They sent me home saying it was pneumonia. Fatigue got worse.  I asked to be referred to a cardiologist in June.  Dr., cardiologist, diagnosed me with SVT (supra ventricular tachycardia) in September.  I later found out from other family members that my mother (deceased in 2017) was also diagnosed with SVT two years before she died.   I didn't think the vaccine was responsible, but V-safe wanted me to report it.
pt stated she received booster dose moderna.  the next day her arm was swollen, red, and warm.  she said it has been getting worse.  I referred her to PCP
45 min after vaccination pt felt she had some tightness in the throat and chest. Unable to differentiate if was caused by her anxiety or the vaccine. After exam in clinic felt improved but still given Benadryl and monitored , no worsening symptoms felt all sx had resolved at the time of discharge
Chills; Feeling tired, fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, FATIGUE, and NAUSEA in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS, FATIGUE, and NAUSEA. The patient was treated with TYLENOL at a dose of Unknown dosage form. At the time of the report, Chills, FATIGUE, and NAUSEA outcome was unknown. Not Provided
I had a rash on my torso with each vaccine, progressively worse each time.  All were 24 to 30 hours after the vaccine.  All were all on my torso front, a little towards my back, and a little under my armpits.  Took either Benadryl or Zyrtec each time and they faded overnight and disappeared within a couple of days.
Mild intermittent chest pain, left and right sides at different times.  Started within a day or so of receiving vaccine, lasted approximately 3 weeks.  Advised by clinic to go to ER.  EKG, X-ray and blood draw results were all normal.
This spontaneous report as received from a certified medical assistant (CMA) refers to a 3 year old male patient. The patient has no relevant medical history or concomitant medications. On 13-JUL-2017 the patient was vaccinated with VARIVAX, (lot# reported as M046926, expiration date 28-NOV-2018) 0.5 ml, intramuscularly to the left arm for routine vaccination. Other suspect therapies included sterile diluent (STERILE DILUENT) (lot # M015993, expiration date 03-DEC-2018). The VARIVAX had undergone a temperature excursion. The vaccine was stored between -14 Celsius degree to -10 Celsius degree for 5 hours on 12-JUL-2017. The CMA reports she believed that patient had not experienced an adverse reaction, as the facility had not received a call from the patient's family. There was no relevant laboratory data. As of 15-JUL-2017, it was unknown if the patient continued to receive VARIVAX, it is believed that the patient did not experience an adverse reaction, and the outcome of receiving VARIVAX that had undergone a temperature excursion was unknown. This is one of two reports received from the same reporter.
Fever; Chills / Shivering; Headache; Muscle aches; Nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, chills, headache, muscle pain and nausea. On an unknown date, the outcome of the fever, chills, headache, muscle pain and nausea were unknown.   It was unknown if the reporter considered the fever, chills, headache, muscle pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving dose of Shingrix, the patient experienced fever, chills, shivering, headache, muscle aches, and nausea. The patient was upset at me because I could not provide medical guidance on how to manage the events when referred to her HCP and abruptly hung up on me. No further adverse event details. The reporter did not consent to follow up.
Got the shot, then got a bad case/Suspected vaccination failure; Got a bad case of shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's Comments: The patient self-reported this case via interactive digital media and described the occurrence of suspected vaccination failure. The reporters friend got the shot, then got a bad case of shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.