chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 59 year old female patient with acetaminophen, PERCOCET and SEPTRA allergy. On 02-FEB-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous in the left arm (deltoid) for vaccination (lot # J008128 is an invalid lot number for ZOSTAVAX, expiry date and dose unknown). Concomitant therapies included LIPITOR, pantoprazole and SYNTHROID. The pharmacist reported that the patient reported red, inflamed, swollen lymph nodes in the injection site arm. The red, inflamed, swollen lymph nodes were described as moving (creeping) from the armpit to the elbow and hand. The patient contacted the pharmacist. The pharmacist reported that the patient took BENADRYL as treatment and the inflamed lymph nodes were getting better. The patient was recovering. No rash was reported. Additional information has been requested.
NOTHING OCCURED TO CHILD, CHILD WAS GIVEN 0.1 ML OF PFIZER
PARTIAL DOSE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose was not reported. This report was non-serious.
pt recvd vax & noticed red bumps next am; were flat but raised sl later; only on face
Physician diagnosed patient with Shingles; Rash; This case was reported by a physician via sales rep and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included mycophenolic acid (Cellcept).   On 13th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed rash several days later. The patient was diagnosed patient with Shingles.
Dizzy & disoriented. face 7 neck spasms, Extreme pain to touch on skin all over the body, stabbing pains in organs, lips and tongue swollen, gasping for breath, wheezing, rapid heartbeat. No treatment was provided when she went back to the ER.
Patient to hospital with c/o SOB x 4 days; took an at home COVID test and it was positive; admitted to hospital with COVID PNA; given remdesivir, steroids, vitamins C, D3, and zinc; patient required intubation; multi-organ failure; AKI; acute liver failure; GI bleeding; shock; family changed patient's status to DNR/DNI; withdrew life support and patient died in the hospital.
Meningococcal disease in an Individual who had received 3 doses of Trumenba, Disease occurred 2 yrs after vaccination; Meningococcal disease; This is a spontaneous report from a contactable healthcare professional via Pfizer sales representative. A patient of unspecified age and gender received the first, second and third dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that Meningococcal disease in an Individual who had received 3 doses of Trumenba, Disease occurred 2 yrs after vaccination. Outcome of the event was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with TRUMENBA in this patient cannot be completely excluded. Further information like confirmative serotype results and vaccination schedule are needed for full medical assessment.
Sore arm (not as bad as 1st dose) Bad headache (not as bad as 1st dose) Extremely red and sore tongue,sore/chapped lips and mouth around inside of lips with a few small blisters.  It started first on the tip of my tongue and got worse as the week progressed.  Everything felt like it was on fire.  I called my Dr, who called in a prescription mouthwash to swish in mouth and spit out.  When I realized it might be related to the vaccine, I also took a Benedryl which seemed to help.  I?m on day two of the meds.  It?s not burning quite as badly, but still isn?t gone.
On 1/13/21 at about 1100 I felt a swollen lymph node in neck just above the midclavicular line. It is painful and feels hot to the touch. I currently put ice on node.
Around 4:30 pm April 6 I became very cold and my fingertips went numb and fingernails turned purple-ish. This lasted for 2 hours until I could soak in a warm bath  April 6 5:00pm- April 7 8:00 pm Slight loss of urinary control; leaking urine on the way to use toilet and very frequent trips to toilet  April 7. 12:30 am 103.8 fever. Reduced when I took 2 extra strength Tylenol
Information has been received from a physician concerning a 27 year old postpartum female who in May 2001, was vaccinated with a dose of rubella virus vaccine live (lot number not reported). The patient had delivered 3 days prior and was vaccinated due to a negative rubella titer. The patient was also administered Rho-gam. On 6/4/01, the patient developed symptoms of Guillain-Barre syndrome, ataxia, weakness in the lower extremities and face. The patient was subsequently hospitalized and underwent unspecified medical attention. The patient underwent an extensive r/o process including tests for campylobacter, HIV, and hepatitis. On 6/5/01, the patient was started on therapy with IVIG. At the time of this report, the patient had recovered fairly well but was noted to have some residual symptoms. Follow up 03/03/05: Per reporter lot number for vaccine not provided.
I had the normal symptoms of pain at injection site, headache, fatigue, chills, muscle aches.  I did get a fever for a short duration.  The main thing I wanted to report is that I feel my heart and blood flow had been compromised from the vaccine.  The reason I say this is that I have been getting pains in my chest and the blood flow in my body just feels not right.  Lastly, I do feel it affected my cognition but I hope this will resolve soon as the fatigue dissipates.   I also easily get skin reactions (skin reactivity increased such as redness and I got one red bump that looks like a hive but went away the next day).  Not sure, but I feel this vaccine may be a cause for a potential blood clot. I do wonder if it has any effect on the characteristics of the blood.  This is so far my experience and I hope as time goes on things become better.
This spontaneous report as received from a consumer refers to his brother of unknown age. Medical history and concurrent conditions were not reported. On 22-MAR-2014 (reported as about 10 days ago), the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route, lot number and expiration date was not reported). Secondary and concomitant therapies were not reported. Reporter stated that "my brother went to ER because he had trouble breathing and had the flu after he received PNEUMOVAX 23 vaccine). Additional information is not expected.
Case number PHEH2013US011155 is an initial spontaneous report received from nurse on 20 May 2013. This case refers to a 23-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated inadvertently with expired MENVEO vaccine (batch number: A10133 and expiry date: 13 Feb 2013) intramuscularly on 15 May 2013. No adverse event was reported following this administration error.
Rapid heart rate, dizziness within 10 mins after injection. Severe migraines day 2-4 after vaccine. Loss of appetite day after vaccine (4/26/2021 -current 5/4/2021)
Injection was in the left arm on 04/15/2021.   The next evening,04/16/2021, the pain in my left arm traveled down to my left chest and lower.   The pain was a 3 or 4 out of 10, so it wasn't extreme.  It lessened over time, and after a week it was gone.
MENVEO vaccine given AM 5/19/15. Onset of headache and hypersomnolence that evening. 5/20/15 developed fever 102.9 with associated headache and neck stiffness. Seen in the ER with negative lab workup.
SHAKING; SINUS PAIN; BACK PAIN; BURNING SKIN ON AND OFF; PAIN IN PELVIS AREA; VOMITING; NAUSEA; SORENESS AT THE INJECTION SITE; MUSCLE ACHE; HEADACHE; FATIGUE; METALLIC TASTE; WARMTH IN BODY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 23:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced metallic taste. On 06-MAR-2021, the subject experienced warmth in body. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced sinus pain. On 07-MAR-2021, the subject experienced back pain. On 07-MAR-2021, the subject experienced burning skin on and off. On 07-MAR-2021, the subject experienced pain in pelvis area. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced soreness at the injection site. On 07-MAR-2021, the subject experienced muscle ache. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste on 06-MAR-2021, was recovering from back pain, and warmth in body, had not recovered from fatigue, shaking, nausea, headache, sinus pain, soreness at the injection site, burning skin on and off, pain in pelvis area, and vomiting, and the outcome of muscle ache was not reported. This report was non-serious.
24 hours, post vax, pt developed cough and difficulty breathing (angioedema). Improved by Monday, 9/18/00. Later, on 9/22/00, pt developed bronchitis.
Joint pain started in left ring finger with swollen knuckle.  Joint pain/numbness in both elbows.  Most recently (last week), acute pain in knees, restless legs, numbness in legs, pain walking.  Being tested for osteoarthritis.  Increased pain in neck (prior auto accident left some pain in neck)--increased since May.
There was no adverse event, the patient was given a third dose of HPV at an invalid interval. There was not 12 weeks between the second and the third dose even though there was 24 weeks between dose one and three.
Patient states severe pain in his shoulder with tenderness all the way down to the elbow and tingling down to his fingers.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 45-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Patient reported fever max of 99.8, fatigue, and muscle pain after receiving her second Covid 19 vaccine.  She received the BioNTech Pfizer vaccine.
This spontaneous report has been received from a physician, referring to a 14 years old female patient. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medication was unknown by the physician. On an unspecified day in February 2018 (reported as "a year ago") the patient was vaccinated with one dosage form of GARDASIL 9 injection, as prevention of human papillomavirus (HPV) (dose number and frequency in vaccine series was not reported; route and anatomical location of vaccination, lot number and expiration date were unknown by the physician). The physician reported that, since an unspecified date after vaccination with GARDASIL 9 the patient began to experience panic attacks. The physician described the panic attacks as happening at random times during the unspecified days and stated that when they happened, the patient did not know where she was and seemed confused, like if she did not know what she should do. In addition, the physician mentioned that the panic attacks scared the patient, as she started to breathe fast and sometimes got dizzy. The patient was reported to be extremely tired after the panic attacks happened. According to the physician, the patient had had 2 to 3 episodes over the 2018 summer (reported as "past summer") which lasted from 30 minutes to several hours. On 04-JAN-2019 (reported as "6 weeks ago") the patient sought for medical attention and visited a neurologist who performed her a 24 hour electroencephalogram (EEG) and an unspecified bloodwork as diagnostic studies; however, both resulted normal. The patient was prescribed topiramate 25 milligrams (mg), once daily in the evening, as treatment. On an unspecified date, the patient also visited an endocrinologist, who informed her that her panic attacks were caused by GARDASIL 9. The physician reported that, since November 2018 (reported as "in the past 3 months") the patient had not had any panic attacks and, by reporting time, she had not needed to take topiramate anymore. However; on an unspecified date in February 2019 (reported as "over the past week") the panic attacks had gotten worse and more frequent as the physician described that, on 14-FEB-2019 (reported as "yesterday") the patient was sitting in class and she felt like someone "had pressed a slow-motion button" and she felt very weird. It was reported that she walked to her next class, where she felt like she and other people were moving slow and she felt like she should not be there. Finally, the physician also reported that since an unspecified date after administration of GARDASIL 9 the patient had constantly had a sore throat. By reporting time, the patient had not recovered from panic reaction, fatigue and oropharyngeal pain. The physician causality assessment between the occurred events and vaccination with GARDASIL 9 was not reported.
blister; Expiration date was in 25JUN2023, dose administered on 17AUG2023; This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (blister) and EXPIRED PRODUCT ADMINISTERED (Expiration date was in 25JUN2023, dose administered on 17AUG2023) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Aug-2023, the patient experienced BLISTER (blister) and EXPIRED PRODUCT ADMINISTERED (Expiration date was in 25JUN2023, dose administered on 17AUG2023). At the time of the report, BLISTER (blister) had not resolved and EXPIRED PRODUCT ADMINISTERED (Expiration date was in 25JUN2023, dose administered on 17AUG2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received historical drug as Pneumonia 20. Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 16-AUG-2023. Vial did not undergo temperature excursion. Treatment details was not reported by the reporter.
Severe chronic fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Severe chronic fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Severe chronic fatigue). At the time of the report, FATIGUE (Severe chronic fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment included antibiotic injection.  After the second vaccination which was in June, the patient had severe chronic fatigue. After treating with antibiotic injection, she got better.
I have COVID-19, I got it even after I got the vaccine; I have COVID-19, I got it even after I got the vaccine; This is a spontaneous report from a contactable nurse and consumer (patient). A 54-year-old female patient (unknown if pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis. Concomitant medications included tofacitinib citrate (XELJANZ XR) taken for rheumatoid arthritis from 01Feb2021 to Feb2021, adalimumab (HUMIRA), celecoxib (CELEBREX), calcium carbonate, colecalciferol (VITAMIN D 400), magnesium oxide, pyridoxine hydrochloride (MAGNESIUM + B6), methotrexate, ospemifene (OSPHENA), estrogens conjugated (PREMARIN), prednisone, and sulfasalazine (SULFASALAZINE (ENTERIC COATED)); all taken for unspecified indications, start and stop dates were not reported. The patient reported "My Dr took me off the Xeljanz for 2 weeks I have COVID-19, I got it even after I got the vaccine." MD aware. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date. The outcome of the event was unknown. The event was considered as serious (medically significant).  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events COVID-19 and Drug Ineffective and the suspect bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).
This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. In October 2018, the patient was vaccinated with a dose of VARIVAX (strength, dose detail, lot # and expiration date were not reported), subcutaneously for prophylaxis during her first month of pregnancy (the patient was pregnant with last menstrual period (LMP) approximately in September 2018) (exposure during pregnancy). The pregnancy outcome was pending. No adverse effects were reported. The outcome of exposure during pregnancy was unknown.
WITHIN 2 MINS OF INJECTIONS ADMINISTERED PT FELT FAINT, AND VOMITTED B/P WAS CHECKED 80/40. 10 MINS LATER B/P WAS CHECKED 91/71 PATIENT WALKED OUT, NO PROBLEMS
armpain (hurts like it was punched when lifting up); mild fever; severe headache; fatigue; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, 2-3 hours after second vaccination, the patient experienced armpain (hurts like it was punched when lifting up), mild fever, severe or bad headache and tiredness or fatigue for 2 days. On the 3rd day, in the noon all events were almost completely disappeared. Although the patient was reporting it to the CDC every day, for two weeks after the vaccination. The outcome of the events was recovered on an unspecified date.  No Follow-up attempts are possible. No information is expected further.
Information has been received from a consumer referring to her 67 year old male fiancé. The patient's medical history and concurrent conditions were not provided. In appropriately February 2009 ("about seven years ago at 60 years of age"), the patient was vaccinated with ZOSTAVAX (dose, route and lot number not provided). The patient had an outbreak of a sporadic rash around 12-FEB-2016. His symptoms included blisters and pain on his left side, which also affected his upper back, hairline, chest and neck. The patient's fiancé said he was also experiencing headaches. The patient went to urgent care place where his condition was diagnosed as Shingles and was given famciclovir for his symptoms. The outcome of events was reported as recovering/resolving. This is one of several reports received from the same source. Additional information has been requested.
onset 630PM 10APR95 w/shaking or arms & rapid blinking of eyes & then shut eyes real tightly closed; episode last 20mins; 8AM 11APR95 aunt reported same type of episode lasting about 20 mins per grandma