chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This is a spontaneous report from a contactable consumer. A patient of unknown age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced shingles. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event shingles was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives on wrists, torso. Anywhere clothing or watch band touched skin.  Very itchy. Relieved with benadryl.  Cannot attribute anything else to the hives (detergent, clothing, food, lotions, etc..)
Couldn't move my neck & had to lift my head with my arm to get out of bed. Shot was Mon - problems started Tues. Neck is better after a week, but still hurts.
Patient presented to the ED and was subsequently hospitalized for Acute pulmonary embolism without acute cor pulmonale within 6 weeks of receiving covid vaccination.
the day after vaccine i had a fever for a full day from morning until evening, 4 days after vaccine that night i had a large round dark red  mark on my left arm (slightly below vaccine site) which was uncomfortable & very hot. the following morning 5 days after the vaccine i had an issue where the veins in inner left wrist (same side as vaccine) began to feel painful, then became swollen, then the swelling went down & a large strange black bruise appeared with a red circular area in the center where main wrist veins are. my d-dimer levels were elevated when labs were done. no further issues thus far.
PEDIARIX given R thigh 4-1-09 per mom. Pt developed fever and "shakes" that same evening - she called 911 - fever decreased to 98 - mom called again 4-3-09 - fever of 104 - Dr on call told mom to alternate TYLENOL and ADVIL and not to have baby receive the same combo of shots together next time. Mom called again 4-4-09 - fever 104.7 x 3d. Spoke to Dr on call - we called mom 4-6-09 baby is doing better - T-102... CPT. go to ER if Sx's worsen. On 4-9-09 child was seen in office T-103.5 R labs done--- LFT's increase, WBC increase, positive UTI (see below - values) antibiotics started (OMNICEF) 4/11/09 mom called "stools are red". Labs ordered T-98.8.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 2:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 2:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 41.75.  Concomitant products were not provided.  On 13-Jan-2021, 30 vials were moved to clinic. On 09-Feb-2021, Vaccine moved to fridge.  On 13-Feb-2021 at 09:00 am, Temperature excursion reported as 32 and total doses given for the day was 152. Vaccine BUD date was reported as 10-Mar-2021  Condition of vaccine prior to administration was not frozen. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
pt calls ofc 2OCT95 w/c/o red, sore welt on buttocks where DT inj given;when seen by MD measured 8" x 4" w/central knot of 1 1/2" c 1 1/2";using warm compresses & oral ATB has f/u appt 5OCT95
No adverse effects; patient was administered improperly stored VARIVAX; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 14-MAY-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R023513 with an expiration date in 16-UAG-2020), for prophylaxis (strength, dose, frequency and route were not provided), that underwent multiples temperature excursions, from 6 degrees Fahrenheit to 14  degrees Fahrenheit during a time frame of 7 hours; from 15 degrees Fahrenheit to 46  degrees Fahrenheit during a time frame of 1 hour. Digital data logger was not involved. No adverse effects were reported.
approximately two weeks after the varicella vaccination, my son showed signs of irritability, fever, and loss of appetite.  A few days later he broke out in the chicken pox (about 20 lesions)
Pt had rash on chest 5 min after injection of seasonal flu. Had difficulty breathing c/o chest pain. After 5 more min rash was gone but pt c/o dizziness and clogged throat. EMT's called. Taken to hospital.
After the first inoculation (Pfizer - 7A6780), I noticed muscle cramping around the site of the inoculation and in my chest.  This would be particularly evident if I felt stressed or was exerting myself.  After the second dose, I continued to experience the same symptoms though they were worse than before.  Additionally, I became ill after the inoculation and needed to stay in bed.  The illness' symptoms included fatigue, pain in my chest and lungs, and flu-like symptoms.
Woke up the following day with  headache, fever, severe sore throat, generalized body aches, flu-like cold symptoms, fatigue.  Tested negative for COVID, negative for influenza, negative for strep throat. The headache, fever  and cold symptoms lasted 24-48 hrs, the sore throat lasted 3-4 months requiring at least two visits to ENT for a camera look down my throat as well as an MRI of my throat to r/o other reasons; the generalized body aches and fatigue still remain but have diminished in intensity over the past year.  If I get over-tired, I wake up feeling like I have the flu (no fever but headache, body aches) so I take ibuprofen and rest for a day before resuming my usual activities. .
rash devleoped under breast left hand side; sore arm; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash devleoped under breast left hand side), AXILLARY PAIN (sore arm), HEADACHE (headache) and FATIGUE (tiredness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ABATACEPT (ORENCIA) for Immunosuppressant drug therapy.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced AXILLARY PAIN (sore arm), HEADACHE (headache) and FATIGUE (tiredness). On 18-Feb-2021, the patient experienced RASH (rash devleoped under breast left hand side). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH (rash devleoped under breast left hand side), AXILLARY PAIN (sore arm), HEADACHE (headache) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was fine now and doesn't require further follow-ups. Didn't provide email address.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: TCR received.  Event outcome updated.
After getting the vaccine, patient's tongue started to tingle.  @1015 diphenydramine 50 mg po x1 lot # 2029906 exp 09/2023
high blood pressure; tachicardia/she already had this problem and was taking medication before receiving the vaccines/she was doing fine until the vaccine flurred it up; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (high blood pressure) and TACHYCARDIA (tachicardia/she already had this problem and was taking medication before receiving the vaccines/she was doing fine until the vaccine flurred it up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 013A21A, 017F21A and 033K21-2A) for COVID-19 prophylaxis.     It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Tachycardia (treated with low dose (25mg) of Metoprolol ) and Cataract. Concomitant products included METOPROLOL for Tachycardia.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced HYPERTENSION (high blood pressure) and TACHYCARDIA (tachicardia/she already had this problem and was taking medication before receiving the vaccines/she was doing fine until the vaccine flurred it up). At the time of the report, HYPERTENSION (high blood pressure) and TACHYCARDIA (tachicardia/she already had this problem and was taking medication before receiving the vaccines/she was doing fine until the vaccine flurred it up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood pressure measurement: high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had the 5th dose of moderna bivalent vaccine (AS714413) on 09-Sep-2022 and also 6th dose (057H22A).  It was reported that the patient already had this problem and was taking medication before receiving the vaccines. But the patient thought  that the shots made it worth, and was having a breakthrough. It was also reported that the patient went to the ER about a year ago for tachycardia and high blood pressure. The patient was fine before this. The patient was doing fine until the vaccine flurred it up. No treatment medication was reported.
having nightmares; having trouble falling asleep; This is a spontaneous report from the Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously had an BNT162b2 (First dose) for COVID-19 immunization. Patient stated that she received her 2nd dose of 06Mar2021 then started having nightmares and having trouble falling asleep. Outcome of both events were unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Father called 9/4 at 9:30 a.m. PST to report patient had fever to 105F, chills, harsh breathing. Advised father to bring to pt to office for eval. for rx to Flu Mist (MedImmune) given 9/3 at 4:30 p.m. PST. Physical exam: HEENT WNL, Lungs CTA, no abnl findings.
Three hours after injection, I began to feel flu symptom (weak, fatigue, achy, chills, sweats, all-around unwell.)  Six hours post injection, flu symptoms  worsened along with explosive headache.  Nine hours post injection, severe sensitivity and pain with any contact along with burning sensation of entire body.  Pain felt in extremities.  Twenty-four hours post injection, symptoms continued along with excruciating, sharp stabbing pain of shoulder, shoulder blade, wrist, hand of injection arm.  The pain has almost caused me to pass out.  NSAIDs nor acetaminophen  has decreased discomfort or excruciating pain.  Heat nor ice pack has made any improvement.  My skin has felt extremely hot to the touch but I have not had a fever.  It is now over seventy-two hours since receiving the injection.  The pain continues to be unbearable.  The pain I am experiencing in my arm/shoulder/wrist/hand/shoulder blade is unbearable.  I would rather risk contracting COVID-19, then experiencing these side effects again.
been vaccinated, but still a little outbreak/Suspected vaccination failure; little outbreak on face; painful, hurt; itched; crusted; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: been vaccinated, but still a little outbreak/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: little outbreak on face), pain (Verbatim: painful, hurt), pruritus (Verbatim: itched) and crust (Verbatim: crusted). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain, pruritus and crust were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus and crust to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, pruritus and crust to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Mar-2023 The case was received from the patient via interactive digital media. The patient stated painful, had been vaccinated years ago against shingles, but still managed a little outbreak on his or her face. Talk about surprised that it hurt, itched, oozed, crusted and was so freaking ugly. The patient stated that anyone who knew him or her knows how vane he or she was about his or her appearance so  the patient was very thankful to be wearing his or her mask. The patient stated that imagine how much worse it could have been if I had not been vaccinated. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Within 2 hours, I became nauseous; I had a lot of nausea. I had three times of vomiting; loss of appetite; chills and a very sore throat; very swollen glands and chest pain. They were so severe I doubled over. I made an appt with - myocarditis and pericarditis. I was sent to get a heart Catherization  - femoral artery - right side that week. At a medical center.  It showed no blockages but helped to diagnose me. I am on medications for this now. Midodrine and I'm also getting a med but they have to determine what it will be:  I have a lot of doctors and they are trying to decided  how to proceed. Hospital did one part of it and the saliva collections was mailed to me for this test:  Amalodyis genetic thing  I have been tested for this and results have not come back yet. They would be me on something else besides  Humira  if I test positive but if I don't they may put me on Humira. I also am on Salt tablets because I dehydrate easily. Naproxen - I take once a day and that is 500 mg.  Can't do much. in the day I am in bed by 07:00 pm. I have a lot of fatigue. They symptoms are definitely interfering with my life. I get occasional nausea and I get occasional chest pain when I exert myself. I get breathless when I am lying down. I have been to ER twice - For the chest pain and feeling like I am going to pass out - it's hard to describe - it feels like my body is electrical and I get breathless and I can't feel my body. I get dissociation and I had that symptoms immediately after both vaccines and lasted a whole wee after both vaccines: the feeling of not being in reality. I want to get the Booster.  Note: I had chest pains with the Arava when I was on that Feb. and then I got off of it on March 16th - because the side affects were so severe. I had a terrible pain in my back. And neck pain. And then the COVID vaccines - severe muscle aches and very fatigued. I couldn't do anything I was on the sofa. And then those symptoms subsided. But the fatigue ahs continued.  It's hard to tell. A week after my vaccines (both) when my initial side affects were gone - I had complete relief from my autoimmune symptoms - it almost like it had rebooted my body. I had no pain. At all! No fatigue and my joints and my hands - they visibly had reduced swelling. I had a liaison on vaccine that had started to fade away. It felt like I had gotten a treatment for my autoimmune disease of some sort because my symptoms for that window of time after each vaccine (COVID PFIZER) were alleviated.
Pt received 1st dose of Moderna on 4/16/21 and had no immediate adverse reaction. However, patient went to medical facility on 5/3/2021 with c/o chest pain and SOB. That ER did an EKG and full work-up and diagnosed patient with New onset A-Fib. Patient denies any family history of Heart Conditions. Patient was advised by the ER to not get the second dose and he suspected it was r/t COVID-19 vaccine. After some investigating it was determined that a VEARS report had not been filed by the ER, so as the patient's PCP, we are filing the report today.
Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  nausea and vomiting.   Assessment : Time of assessment 1005. Alert and oriented, Anxious, Tachycardia, Nausea, Emesis and left hand tingling. As soon as patient received vaccine and was getting ready to sit for his 15 minute observation, he started vomiting x 1 in the floor. He says he felt nauseated, lightheaded, and his left hand was tingling. He was assisted in the wheelchair and taken to the triage area.  1012: BP 148/100, P 110, denies nausea, lightheaded, but still has the tingling to the left hand. 1017: BP 138/100, P 102, denies hand tingling or any other symptoms. 1026 standing BP 120/88, P 108.    Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN. Ambulated prior to discharge home without symptoms.   There were no vitals filed for this visit.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 20 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
The menstrual cycle as being "normal at first".However, the patient continued bleeding and is still bleeding at the time of the report The patient reported that the bleeding is "mainly at night with some clotting"; The patient does not normally have a menstrual cycle that lasts 2.5 weeks; This spontaneous report was received from the medical assistant, referring to a 25-year-old female patient. The patient's pertinent history was not provided, it was reported that the patient did not have previously drug reactions or allergies. The patient's concurrent conditions included genital herpes, and his concomitant therapies included acyclovir, anxiety, depression, and acid reflux medications.   On 18-JUN-2019 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot number and expiration date were not reported), and on 19-AUG-2019 the patient received the second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot number 1602283 has been verified to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast); expiration date 16-AUG-2019); both vaccines were administered intramuscularly, in left deltoid, as disease prevention. On 19-AUG-2019, the patient began her menstrual cycle which was on time, the patient reported that the menstrual cycle as being normal as first, however the patient continued bleeding, and the bleeding was mainly at night with some clotting (menorrhagia). The patient's menstrual cycle had lasts 2.5 weeks (menstrual disorder). It was reported that the patient did not received any treatment for the events, and neither laboratory diagnostics or studies were performed to the patient, however it was reported that the patient called to the physician for sought medical attention.   At the time of this report, the outcome of the events menorrhagia and menstrual disorder was reported as not recovered.  The relatedness between the aforementioned events and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  was not reported.
This spontaneous report as received from a physician (ophthalmologist) via a company representative refers to a multiple patients of unknown age. On an unknown date the patients were vaccinated with ZOSTAVAX (doses, routes, lot numbers were not reported). The ophthalmologist informed the company representative that an unspecified number of patients previously vaccinated with ZOSTAVAX were seen in his office and were diagnosed with ocular shingles. The ophthalmologist noted also that the patients had redness and eye pain that was herpes zoster but that "it was frequently misdiagnosed". No further information was provided. The outcome of events was unknown and the relatedness between the suspect: ZOSTAVAX and the events was unknown. Additional information has been requested.