chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dosing Interval Deviation. Patient received their 1st dose of Moderna on 08/18/2021. They self-scheduled themself for an appointment 3 weeks from the 1st dose instead of the recommended 4 week interval. Patient was vaccinated by a 4th year pharmacy student who did not catch the early administration even though the patient wrote on the consent form the date of their 1st dose. We consulted the CDC "Covid-19 Vaccine Administration Errors and Deviations" guideline and the interim recommendation is for a 2nd dose administered fewer that 24 days (Moderna) after the 1st dose, We do not need to repeat the dose.   Staff and interns have been verbally retrained on the recommended dosing intervals and the need to thoroughly review the consent forms PRIOR to administration.
Site edema, redness, and pain; Left shoulder swelling and Pain; Left anterior aspect of neck swelling, pain; General malaise, nausea, chills, and headache
Achy; Muscle aches; Flu like symptoms; Soreness at injection site; felt crummy/ felt like they were coming down with; This case was reported by a other health professional via call center representative and described the occurrence of pain in a male 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 pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad. On an unknown date, the outcome of the pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The veterinarian on the line reporting following the Shingrix vaccine the patient had 24-48 hours of feeling achy, had muscle aches, flu-like symptoms, soreness at the injection site, felt crummy and felt like they were coming down with something. Related to Patient. Adverse event filed for contact as well. No further information captured regarding husband. This case linked with US2019AMR125734 and US2019AMR125759, reported by same reporter.
pulmonary embolism despite of patient was coagulated  for A-fib. INR was 2.2 at that time
Persistent palpitating tinnitus in my left ear since  2nd dose. Has increased in the last 4 days to a buzzing.
HIT HARD; This spontaneous report received from a patient via a company representative concerned a female 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, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hit hard (coded as ill-defined disorder). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hit hard was not reported. This report was non-serious.
it was much worse and nausea; there was nothing in my stomach to throw up (dry heaving); I have a severe headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via unspecified route of administration on 23Feb2021 (reported as yesterday) as a single dose for COVID-19 immunisation. Patient's medical history included headaches occasionally. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation and had a little sore arm but no problem. Patient previously took paracetamol (TYLENOL) for headache, which doesn't work and ibuprofen for headache, which was didn't help. Patient reported that she received her second dose of the COVID vaccine yesterday. Also reported that at around 8 or 9 (date unspecified in 2021), it was much worse and nausea but there was nothing in my stomach to throw up (dry heaving). It was reported that after first dose, had a little sore arm but no problem. She had a severe headache and do get headaches occasionally. Asked about excedrin Migraine, is that ok to take for headache? Usually Tylenol doesn't work for me. Ibuprofen didn't help, didn't make it go away. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Bells Palsy event 5-27-21 - Emergency Room due to collapse, admitted for observation to Hospital, discharged 5-28-21.
Post third anthrax vax, pt developed joint and muscle soreness, insomnia, increased blood pressure, increased heart rate, shortness of breath and night sweats in addition to the previous and continuing symptoms of severe headaches, nausea, vomiting, diarrhea which developed with the first and second vaccinations.  Follow up on 05/17/2000: "Patient did not recover from adverse event."
This spontaneous report was received from a nurse and refers to a 18-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was inadvertently administered a dose of PROQUAD subcutaneously (dose, route of administration, lot# and expiration date were not provided) for prophylaxis.
Massive chills, shaking and shivering, fever, neuralgia, sleeplessness.
1/24/20211 unresponsive, sent to Hospital.  Admitted with diagnosis: Acute Ischemic left MCA stroke. 1/26/2021 Transferred to Hospice care. 01/30/2021 died.  I don't believe the hospital was aware of her vaccination date as it is not recorded in her records, therefore I assume that a previous VAERS report has not been submitted. My relationship to the patient is that I am her daughter.
strong headache, shivers, fever (101.7), joint and muscle aches, dizziness, weakness, dehydration
This spontaneous social media report was received from a physician and refers to a female patient of unknown age. There was no information concerning the patient's pertinent medical history, concomitant medications drug reactions or allergies provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided) or with GARDASIL (dose, route of administration, lot# and expiration date were not provided) for prophylaxis.  On an unknown date, the patient experienced Guillain-Barre syndrome and paralysis. The outcome of the events was unknown. The causality assessment was not provided. Upon internal review, the events of Guillain-Barre syndrome and paralysis were concerned to be medically significant.
A 62-year-old female with a history of hypothyroid, had received an intramuscular left deltoid injection of TET TOX ADS USP (lot number not reported) on 31 January 2011 and about a week later on 07 February 2011 experienced pain at the left deltoid and could not put her arm behind her back without discomfort. She was referred to an arm specialist by her physician who diagnosed her with impingement in her arm. Treatment was physical therapy but included "working on (her) rotator cuff". Diagnostic tests included an x-ray where impingement was seen. Concomitant medication included Synthroid. Illness at the time of vaccination, other vaccines within four weeks of the suspect vaccine and adverse events following prior vaccinations were all reported as none. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 05 August 2011. The patient was referred to an orthopedic specialist and to physical therapy (PT). The lot number of the ADACEL was reported as Sanofi Pasteur Ltd. C3677 and Sanofi Pasteur Inc. U3553AA. The outcome was not recovered. Follow-up information was received from a health care professional on 22 September 2011. The patient has had no improvement in her shoulder. She is to follow-up with an orthopedic specialist for probable impingement. Follow-up information was received on 28 October 2011 from a health care professional. Contact information was provided for the patient's orthopedic specialist. No further information was available at the time of the report. Documents held by sender: none.
Patient received vaccine around noon on 6/7/14. That evening she said she felt a little achy and arm was red. Next day the redness/warmth on arm was a lot more noticeable. The area is slightly raised, red, bump and warm to touch, about 6 inches in diameter. Patient states it is getting better though and will not seek medical treatment for it.
Mother reports that 2 wks after imm he broke out in fine red rash. "He has eczema and I wasn't sure if it was that." States that rash was it's worst on 7/27. MD refered him to Hosp on 8/2/06 because he couldn't get the rash to improve. He feels it is due to varicella. States that the doctor told mother he is to have no further live vac. On 8/7 mother reports that he had a fever of 101 and dark red rash on abd and forehead. She took him to dermatologist who feels it is combination on varicella and his eczema.
Chest pain; Dizzy; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DIZZINESS (Dizzy) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain), DIZZINESS (Dizzy) and HEADACHE (Headache). At the time of the report, CHEST PAIN (Chest pain), DIZZINESS (Dizzy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    Reporter did not allow further contact
Information has been received from a woman in a physician's office concerning an 8 year old male who on 23-FEB-1999 was vaccinated in the left arm with a first dose of Varivax (lot # 628149/1325H). On 02-MAY-2006, the patient developed less than 50 lesions and recovered on an unspecified date. Additional information is not expected.
Patient was fine after immunization until he stood, then he became dizzy.  We had his sit down on pharmacy bench.  His skin appeared sweaty, however it was warm in the store. He said he was hot before the shot, but was now hotter. He stated he had not eatten since last night.  He was going to eat after the shot, because it was his lunchbreak here (stockman).  BP was 93/57 mmhg 10 min post-shot. Gave him cold bottle of water and pk crackers.  BP 114/83 mmhg 25 min post-shot. Gave 2nd water which he drank.  Also drank can of soda.  BP 121/82mmhg 20 min post-shot.  Felt some better, so went to the breakroom to eat lunch. Observed walking to back with no staggering.  He did not know what his normal BP was because he does not have PCP.
24hr p/vax pt devel hive-like rash on abd spreading to entire body-seen in ER-given DPH & steroids;
approx. 20 minutes after receiving the vaccine, client started c/o tingling in her hands, arms and legs.She was flushed and had a headache. She says she also had this reaction with her first vaccine. She continues to not feel well and went to her pcp today, bc she is c/o irreg heartbeat, tired, sore arm. Says her BP is normally low and it was high today and low grade fever. Her pcp did a rapid covid test. She is drinking large amounts of fluids to stay hydrated.
pt devel inject site rxn w/ a  lump and redness; one of three pt to exp rxn following vax
On day of administration (12/10/03)in the afternoon states having hives on inside of elbow.  On 12/11 in the AM states legs, feet, stomach and back with hives.  12/13/03 states having a cough that "hurts."  Denies dyspnea or tachycardia. Continues with pruritic hives.  Encouraged follow up call with physician.  States Benadryl did not help.  Physician prescribed Zyrtec and that relieved symptoms.  Developed pneumonia and was ill for 3 weeks after influenza vaccine.  Physician instructed her to not take the influenza vaccine in the future.
Pt recv vax on 11/17/98; on 11/18/98 pt exp fever, red/hot/swollen LA; tx=Advil; dx=allergic rx to MMR
When she gave him the shot he said his arm went numb imm after than it was numb for 4 days hardly could move it. So he had to go to the doctor 3 days in a row. It still hurts.
Upon review for patient's second dose of Moderna, she explained that for her first dose she experienced a tingling sensation on her throat area as similar as when she experienced anaphylactic reactions due to Aspirin an Penicillin allergies. This happened during the 30 mins observation period and she did not report it. She says that the tingling sensation subsided while she was at the store and then  went home and took a dose of Benadryl.  I proceeded to contact her PCP for consultation since the patient did not report the incident to her doctor. The doctor could not be reached and the patient was instructed to discuss the risk vs benefit of receiving a second  dose. Patient went to her doctor's office and he approved the second dose with a previous 24hr period of pre-medication with Benadryl 25mg every 6 hrs as indicated in a letter provided by the doctor. Patient was then re-scheduled for Health Clinic on 05/12/21.
After my first shot of the Pfizer vaccine, I experienced severe reduction of visual acuity and a reduction of my visual field. My first shot was on Friday 10/29/21. I woke up on Monday 11/1/21 and my right eye was extremely blurry to the extent that I could not navigate around my house if I were to close my left eye. This only lasted 1 day. Additionally, starting on Tuesday 11/2/21 my distance vision was impaired in both eyes for the next 7 days. Everything was blurry beyond about 70 feet. It resolved itself after 7 days, and my vision is back to normal now. I have no history of any visual issues. Additionally, I am not planning to take my 2nd does. Please advise how I should proceed from here.
Administered her Shingrix vaccine into her right deltoid, and patient felt the prick and you could see the mark where the vaccine was given, but as it was being administered, it looked like the majority of the dose ran down her arm. We believe the hub of the needle was loose, as the dose clearly did not go into her arm. I called the Manufacturer of Shingrix (GSK) and was informed that anything less than 0.45 ml is not considered a valid dose and should be repeated. Based on what I saw, the majority of the dose ran down her arm, and she thought so as well (she is an MD herself). Based on the guidance of GSK, I administered a new, full dose to her which was successful.
Pt requested to receive a COVID-19 vaccine. Pt received 0.5mL of Janssen COVID-19 vaccine in rt deltoid without issue. Upon logging pt's vaccine in alert system it was noted that pt had already received a Janssen COVID-19 vaccine on 6/16/21, pt failed to inform nurses of this. On call providers, Facility and public health notified. Upon asking about his previous vaccine pt reports he was unsure if he was actually given a "real" vaccine on 6/16/21 .
tooth pain; This is a spontaneous report from a Pfizer sponsored program via medical information team. A contactable consumer (patient's husband) reported that a 60-year-old female patient (reporter's wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was developing tooth pain in Apr2021 and went to the dentist. She was prescribed amoxicillin 500mg capsules yesterday (22Apr2021), and she already took 1000mg last night. She was taking Amoxicillin 500mg three times daily. Patient was scheduled for the second dose this coming Wednesday, 28Apr2021. Reporter asked if it is okay for her to receive the second dose. Event required physician office visit. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was given his first dose of Moderna COVID-19 vaccine at 9:47am and was waiting 15 minutes for observation when he fell out of his chair onto the floor at 9:54am. He was turned onto his back and he regained consciousness within a couple seconds. He was alert and aware of everything that had happened. EMS was called and they arrived about 15 minutes later. They monitored the patient's vitals for about 10 minutes and the patient declined to be taken to the hospital. A family member was called to come get him and take him home where they would observe him.
extreme arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received first dose of Shingles vaccine and experienced extreme pain in arm which lasted for over a month. The patient didn't experience any event after second dose. Consent to follow up was not possible as no contact details were available.
Began feeling as if someone had punched me in the upper arm terribly around 11:30pm. Hurt arm to lift it. NO redness, NO swelling, just intense muscle pain.  Had pain following day, so took Advil to help alleviate tense feeling in muscle. Also rubbed painful area to try to "work out" the stiffness. It seemed to help somewhat. Now around 35 hours later,  the muscle is still feeling a bit "stiff", but much better. I'm sure I'll be back to normal two days after my vaccine.
2nd dose-During the moment of the vaccine, my child complained of the shot feeling to go deeper than usual. Hours later she felt soreness increasing. By that evening she complained of throbbing pain in the left arm it was administered. The next day the soreness and pain seemed to continue. During days 3 and 4 the pain and swelling continued and extended to the shoulder and collar/neck area and the back of her arm. The site was warm to touch. She applied ice as treatment day 2 thru now. Anti-inflammatory was prescribed by Dr.
Fairly sudden onset red rash that had appearance of hive, red outside with white inside, itchy.  Sites were on feet, lower legs, around waist, lower back and ears.
This spontaneous report as received from a physician via a company representative refers to a female non-pregnant patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were unknown. On an unknown date, the patient was vaccinated intramuscularly with an unknown dose of GARDASIL (3 dose series; lot # and expiry date were not reported), which was stored under potentially out of range temperature. The patient did not seek medical attention and no treatment was given. Additional information has been requested.
Patient did not experience any adverse events from this vaccine administration.  A newborn infant was mistakenly given a Tdap vaccination instead of a Hepatitis B vaccination.
Angioedema (swelling of hands and Mouth)  / Skin Rash & Hives
Woke up with tingling in right foot; This is a spontaneous report from a contactable nurse, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 12:30 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. On 04Aug2021, the next day of vaccination, the patient woke up with tingling in right foot and every day since then, the patient woken up with tingling. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event woke up with tingling in right foot was not recovered at the time of this report.
pt recv vax 8AUG97 & ran a fever to 101.6 less than 24hr later was readmitted to hosp;
On February 11, 2021 my left arm and hand and shoulder began hurting. the next day my arm experienced constant tingling pain and into my  left hand.  I went to the Primary doctor, and he prescribed several pain killers to combat the pain, didn't help much , then went to the ER because I thought something happened. Had an MRI , which diagnosed I have pinched nerve in my spinal column in three places. Several doctors don't think this is related to the Covid shot, but maybe  a coincidence. As of today I am still taking nerve pain killers.
Received DTaP  4/25/02-no fever, no redness until 5/1/02. At this time, site became red, had small blisters in area. called 7 am -no problems. Today 5/3/02. area is clear of blisters-No redness.
Intermittent heart palpitations  -  no treatment - for three or four days; no pattern to it.
Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vomiting.  Patient became unconscious and EMS was called, found patient on floor and she was brought to ED where CT revealed intracranial hemorrhage.  Patient was admitted and supportive care given.  She had worsening status on 2/17/21 with pupillary reflexes no longer present and withdrawal of care was performed on 2/21/21.  Patient expired on 2/22/21.
Pt was given PEDIARIX as a catch up vaccine. Pt is over the age of licensure for PEDIARIX.
Mild to moderate arm pain for first 2 weeks. Progressed to severe arm and shoulder discomfort with decreased mobility during 3rd week.
Vaccine error: An MA accidentally administered a Pfizer COVID vaccine 6M- 4Y (a multiple dose vial, which makes 3 doses after dilution) to a 5-year-old patient.
Pea sized, hard lump at injection site that lasted ~1.5 weeks. It seemed to go away or I stopped noticing it. But on July 16 there was bump at injection site that was much larger and softer, about 2 inches in diameter. It was very sore, i could not sleep on my arm, and it was warm to the touch. This lasted ~1 week and the bump slowly got smaller and less warm. As of July 25, there is a pea sized hard lump at the injection site but is no longer warm or sore.
Dizziness and loss of balance upon waking; ER doc determined vertigo due to allergy symptoms
Bright red rash on face, neck and chest moments following injection. Increased heart rate and elevated BP 188/120