chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Left eye jumping and twitching; bad knee; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 11Jun2021 (at the age of 67-years-old) as single dose for covid-19 immunization. Medical history included ongoing hypertension Diagnosed, ongoing diabetes mellitus, ongoing blood cholesterol, constipation from an unknown date and unknown if ongoing, sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medication includes that she took 3 different blood pressure medications, diabetic medication, cholesterol medication, medication for bowel problems constipation, and a medication for 21 days for sinus troubles. Caller does not provide any further information on these medications. Caller had stated she did not feel her medications or medical conditions were relevant to these events. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations and Relevant tests were reported as none. None of the additional Vaccines were administered on Same Date of the Pfizer Suspect. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 21May2021. Reporter stated that she had a headache since 22Jun2021, and it has not gone away and stated she was calling to see what the expected outcome is and how long may this last. Also said that her left eye has been jumping and twitching (on an unspecified date in Jun2021). Stated it has been doing it for a while. Reporter went downstairs to get her vaccination card. Stated it may take her a minute because she lives upstairs and had a bad knee. No further information related to her knee provided by the caller. The patient visited to Emergency Room and Physician Office. The outcome of events was not recovered where as bad knee was unknown.
Patient was administered with the vaccine after 30 days use by date; Patient was administered with the vaccine after 30 days use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with the vaccine after 30 days use by date) and PRODUCT STORAGE ERROR (Patient was administered with the vaccine after 30 days use by date) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with the vaccine after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered with the vaccine after 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with the vaccine after 30 days use by date) and PRODUCT STORAGE ERROR (Patient was administered with the vaccine after 30 days use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported the date the vial was initially stored in the refrigerator was on 22 Apr 2022. And the vial had not undergone any temperature excursions.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2022: Follow up received contains non significant information.
after injection - injection site instantly started to raise , I notified pt of the site reaction and got immediately got a cold compress to apply to site while holding compress to site I had the patient self administer 50mg or diphenhydramine solution.  after cold compress removed swelling and redness would come back.  pt complained of heat at site with cold compress.  I switched to frozen compress and after 10 minutes swelling did not come back as fast when frozen compress removed.  pt decided to leave sent diphenhydramine and frozen pack with patient to use as needed and with instructions to seek medical care if needed.  Patient returned on 9/17/21 a bruise at injection site was only remaining issue.
Patient said she start experiencing chest pain, shortness of breath, fatigue, nausea, and dizziness. Patient went to emergency room to get checked.
First 48 hours included muscle aches and cramping that cleared up as expected.   As those symptoms cleared, full body rash began on the evening of April 17 and is still worsening on April 23. Raised, red, and itchy small bumps all over body (including feet, ankles, legs, thighs, stomach, back, shoulders, arms). Some bumps open and weeping. Limited sleep for four consecutive nights even with oral Benadryl. Does not show much signs of improvement on Day 6.
Around 12:30/1pm on date of administration patient experienced numbness in arm that inhibited arm function. Patient took Tylenol and Advil to relieve, and applied witch hazel to area. Improved after 24 hours. Presented to clinic today for evaluation, motor function and numbness resolved. Pain was still present but improved.
Initial report received from a physician on 03 Jan 2011: This patient was vaccinated with MENVEO (batch number unknown) which had been exposed at -3 degree Celsius temperature for 24 hours on an unspecified date. It was unknown that adverse reaction had occurred following this administration of vaccine.
3 days p/the inject devel muscle pain in the back of neck, chills, vomitings & body aches;
This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with ROTATEQ lot # M041768, expiration date 25-JUN-2018, orally (dose unknown) and PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 (dose and route unknown) for prophylaxis. The vaccines were exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Administered dose more than 12 hours after vial  was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial  was punctured) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial  was punctured). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial  was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is not taking other medication, but is taking supplements.
Started feeling weak and headache and thirsty within 15 minutes. Then I felt like cold, low fever, back pain, hip pain and nausea. I wanted to vomit but nothing would come out. After that the headache is very very bad. The situation continued until Sunday around 07:00 pm and then I was better. After that, my hip pain and back pain and headache was still very bad. I went to my family doctor and they gave me to some medicine to help. They gave me a lotion to put on my hip to stop pain, and I had more rest. I am still getting the hip pain and back pain and the headache. Sometimes, I feel much better but sometimes when I feel tired my headache starts again. The headaches are only on the right side of my head.
Patient is younger than 50 yeras old; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   In April 2022, the patient received the 1st dose of Shingrix. In April 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's comments: The pharmacist stated that a patient who was younger than 50 years had received their 1st dose of Shingrix in April 2022. It was not known whether the patient was considered immunocompromised due to the patient's diabetes. Possible adverse event for younger than indicated age in immunocompetent patient. The reporter had declined to provide additional information. The reporter did not consent to follow-up. Additional supportive information: The patient who had received Shingrix was younger than 50 years which had led to inappropriate age at vaccine administration.
Passing out / same reaction that was on the paperwork his son received; tongue and lips swelled up; tongue and lips swelled up; eyes swelled up; This is a spontaneous report from a contactable consumer (patient's father). This consumer reported same events for two patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Stated that patient father's tongue and lips swelled up and he passed out. One of his eyes swelled up a little bit too, and he kept passing out. Stated that patient father was told it was from shrimp he ate, but it was the same reaction that was on the paperwork his son received when he got his shots so he thought that the reaction was from the vaccine. Outcome of events were unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100975963 same reporter/AE, different patient
This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient's pertinent medical history was unknown and drug allergies included penicillin. On 15-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # L044529 and expiry date: 09-FEB-2017). Concomitant medications included cholesterol and high blood pressure medicines (reporter did not provide names of medicines). Approximately in July 2016 (reported as after receiving vaccine), the patient experienced injection site reaction i.e., swelling (about size of fingertip) and redness around the injection site. The patient did not sought medical attention and no treatment was provided for the events. Patient visited the pharmacy on 19-JUL-2016 and the pharmacist reported that the swelling was gone little but injection site was still red. No causality was reported. No product quality complaint (PQC) was reported. Additional information has been requested.
3 AM this morning woke up with pain and swelling at injection site. States, "It's a little bit red. I have been putting ice. I could not sleep on it."  8AM: Nausea started. No vomitting able to hold down fluids and solid foods  1PM: Dizziness-- states,  "When you don't sleep for two days in a row, you just want to close your eyes."
According to records and patient, patient presented to get her 2nd shot.  Later health department called and stated she had received 2 shots at a clinic previously.
This spontaneous report as received from a healthcare worker refers to a 11 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 06-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient started to develop numbness around the upper body 2 weeks after the vaccine (mid-April).  Later the numbness and tingling progressed to lower extremities  (by July).  Patient later found to have transverse myelitis involving T4 spinal cord on MRI.  Strong suspicion that the transverse myelitis was triggered by immune reaction from Pfizer vaccine.
High PSA by lab draw 3 days after 1st Moderna shot; treated for bacterial infection; high PSA continued 1 month after initial shot; prostate biopsy revealed Gleason 3+3, Level 1 prostate cancer; treatment ongoing
I was notified by the Physicians Assistant that the patient reported to urgent care with trunk and arm pain. I later directly spoke to the patient who described an "achy, sore" pain throughout his trunk with occasional "sharp-shooting" pains in his whole trunk. He also reported a sore left arm and no pain in his right arm.
A Bivalent dose was given instead of a Monovalent for the 2nd dose.  No adverse events reported.
tested positive for covid on 17Apr2021; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable male consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN), via unspecified route of administration on 10Apr2021, as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 17Apr2021, the patient was tested positive for COVID-19. The caller wanted to know when he will be able to get second covid vaccine. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be required. No further information is expected.
Shingles twice; rash on an arm; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown 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 age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 1st dose of Shingrix, the patient experienced rash on an arm that had Shingles twice on it. The reporter did not consent to follow up.
several hours post vaccine patient is experiencing hives on the trunk of her body and redness and flushing of her face. Her temperature at home was 99.6 degrees but when we rechecked it was 98.6 here at the pharmacy at the time she was lodging her complaint
UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210413272.
delayed reaction  terrible inflammation in mouth, plus canker sore, inside of checks inflammed , small blisters all over tongue and some on lower lip , swollen lower lip for couple days  - have self treated with mouthwash, soothing foods and symptoms subsiding now,  canker sore not totally gone and some of small blisters remain
Immediate day after effects:   Fever up to 101 degrees, lungs felt inflamed and inflated, severe muscle aches, could not get out of bed in morning, had to call in sick  Long term continuing after effects:     Lungs get that same inflamed heavy feeling every few days for a few hours
2nd shot got really sick; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it when, he/she was 12) and pain (would never forget the pain).   On 8th September 2021, the patient received the 2nd dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the 2nd Shingles shot prior day of reporting and got really sick. But the patient would still advise everyone to take the vaccine.
Moderna COVID-19 Vaccine EUA Fever (101.5), headache, chills, body aches, rash
Information has been received from a physician concerning a 14-16 year old female who was vaccinated with her first dose of GARDASIL. On approximately 13-FEB-2008, one day after receiving the vaccine, the patient experienced bilateral numbness and tingling in hands and feet. The patient's bilateral numbness and tingling in hands and feet persisted. The physician reporting is not the administering physician. The patient sought unspecified medical treatment with an office visit. An unspecified CT scan was performed, results were within normal limits. Also an unspecified MRI was performed, results were within  normal limits. Additional information has been requested.
Patient reported 1st dose gave her jaw tingling on her way home after her 15 minute obs.  She states on arriving home it had dissappeared.  Today we agreed with charge nurse we would keep her additional 15 minutes.  As   first dose at the 15 min mark she reported tingling in jaw at 20 minutes she reported the tip of her tongue was tingling.  She states some times when eating hard candies she has the same sensation with her tongue.  At 10:14 she states vaccine side effects have resolved bp 156/86 HR 80 OX 100 %  We agreed she would stay 15 minutes   longer.  We discussed any oral itching of throat itching any airway sensations she will seek medical attention.
Within hours of receiving the vaccine, I was in agony with muscle spams that kept me awake until approximately 4:00 a.m. I was in so much pain and could not control all of the muscle spasms that were occurring throughout my body. I remained in a great deal of physical, muscular pain for approximately a month with my underlying health problems all greatly magnified and exaggerated. My normal neck pain became unbearable. What was even worse is that my neurological problems also amplified and became unbearable. My left leg had pre-existing nerve damage from the shingles (Post-Herpetic Neuralgia) and I had developed ideopathic peripherial neuropathy in my hands and feet. After receiving the vaccine, the neurological pain in my leg also became unbearable. In addition, I essentially lost all feeling in my feet, which was alarming.
Continued light headiness; Foggy brain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day at the age of 17 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Continued light headiness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Foggy brain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine administered at 5:17pm. Patient went to chair in waiting area to wait 15 minutes. At 5:20pm the patient fell off the chair/fainted.  I went to assist the patient and put pressure on his head wound. His parents we there also. 911 was called. EMS came and assessed the patient. The parents decided not to transport to the hospital. The parents decided to take him to the ER for stitches on his eyebrow.
Patient started feeling faint 5 to 10 minutes after getting the shot. Upon seeing the patient she felt nauseous and short of breath. Breathing rate became more rapid we moved her to a supine position on a cot. She complained of shortness of breath and tingling in extremities.  We took her blood pressure at 2:05 PM which gave an initial reading of 119/51. After that patient began to shiver and complained of numbness in the arm where we did the blood pressure. Her O2 sats were at 100 with a HR of 81. 10 minutes later we took a follow up blood pressure at 2:19 PM which gave a reading of 118/88. After she began experiencing muscle weakness and fatigue we called EMS and they took her at 2:35 PM
48 hrs w/o receiving MMR; mom calls & states rt leg where vax given is red, warm, swollen; advised appt-seen by MD that day; dx erythematous eruption following MMR local reaction;
After first vaccination, about 6 hours later had low grade fever, muscle aches and intense fatigue, lasting about 12 hours. After second vaccination, about 8 hours later had fever of 100.7, muscle aches, intense fatigue. Fever and muscle aches went away after 24 hours. Intense fatigue was absent just sitting still after 24 hours, but returned easily with any exertion for another 36 hours.
muscle cramps; Nausea; Muscle Pain; Tiredness; Soreness at Injection Site; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2019, several hours after receiving Shingrix, the patient experienced nausea, muscle pain, tiredness and injection site pain. On an unknown date, the patient experienced muscle cramp. On an unknown date, the outcome of the nausea, muscle pain, tiredness, injection site pain and muscle cramp were not recovered/not resolved.   It was unknown if the reporter considered the nausea, muscle pain, tiredness, injection site pain and muscle cramp to be related to Shingrix.  Additional information received were as follows: On Wednesday afternoon, the patient received Shingrix on left arm. Immediately, the patient experienced  soreness at the injection site.  The patient's upper half of left arm still sore. In the evening at unspecified hours, the patient experienced nausea, tiredness and muscle pain. The caller described muscle pain occurs in her left leg that felt similar to muscle cramps and a Charlie Horse. All symptoms were unresolved. The reporter did not consent to follow-up. The outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).