chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within one hour of vaccine, pain at sight of injection.  Within three hours of receiving vaccine, body aches, joint aches.  Within 8 hours of vaccine, headache.
Fatigue approximately 4 hours after administration Body aches, chills, myalgia approximately 7 hours after administration Fever approximately 12 hours after administration (36 hours later still present)
Mild/moderate pain at the site of injection; This is a spontaneous report from a contactable consumer (patient himself). A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: not reported, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:00 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Feb2021, the patient experienced mild/moderate pain at the site of injection. Patient did not received any treatment. Clinical outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th September 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, injection site pain and chills. On 11th September 2018, the outcome of the influenza-like symptoms, general body pain, injection site pain and chills were recovered/resolved.  It was unknown if the reporter considered the influenza-like symptoms, general body pain, injection site pain and chills to be related to SHINGRIX. Additional details were reported as follows: The patient woke up dizzy, and was very ill on Tuesday and Wednesday. She reported that it felt like a train was going through her head, and that her head was pounding and the headache was severe. She also reported that she basically had flu-like symptoms, which included nausea, body aches, and a high fever. She was bedridden on Tuesday and Wednesday of that week, but stated that she was back to normal, but her arm at the injection site was still sore. The reporter suggested that she follow up with her healthcare professional. The patient had denied permission to contact their physician. This case has been linked with US2018167339, reported by same reporter.
ball formed by the clavicle; pain in her arm; Fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (ball formed by the clavicle), PAIN IN EXTREMITY (pain in her arm), FATIGUE (Fatigue) and MYALGIA (muscle pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. E31B21A and 004621A)) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included birth control pills for an unknown indication.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm), FATIGUE (Fatigue) and MYALGIA (muscle pain). On 07-Apr-2021, the patient experienced SWELLING (ball formed by the clavicle). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SWELLING (ball formed by the clavicle), PAIN IN EXTREMITY (pain in her arm), FATIGUE (Fatigue) and MYALGIA (muscle pain) outcome was unknown.            This case was linked to MOD-2021-114543 (Patient Link).
itchy back, still itchy 30 days later at time of 2nd dose appt; doctor advised me to cancel it; 4 zyrtec/day did not mitigate it; trying topicals now
developed angio edema; swelling in her face, lips; difficulty swallowing; weird feeling/feeling "down for the count"; feeling "down for the count"; Chills; fever; body aches; joint aches; muscle aches; diarrhea; upset stomach; started having injection site pain; started having injection site red /  red shoulder that extended to her elbow on the left side; This case was reported by a pharmacist via call center representative and described the occurrence of angioedema in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included shingles. Concurrent medical conditions included ra. Concomitant products included lisinopril.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 15 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, injection site erythema, facial swelling and swallowing difficult. The patient was treated with adalimumab (Humira) and methotrexate. On an unknown date, the outcome of the angioedema, feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, facial swelling and swallowing difficult were recovered/resolved and the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the angioedema, feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, injection site erythema, facial swelling and swallowing difficult to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about a half hour after experienced weird feeling that last 15 minutes and patient was fine. for the next 24 hours, then started feeling down for the count, chills, fever, body aches, muscle aches, joint aches, upset stomach, diarrhea that all lasted for 12 days.  The patient also experienced injection site pain and redness, and a red shoulder that extended to her elbow on the left side that started 24 hours after dose which was lasted for 9-10 days.  On an unknown date 15 days after dose patient developed angioedema, swelling in her face, lips. She states going to the Emergency room and being treated with prednisone and benadryl. After 16 days she had to go back to the Emergency room because she was having difficulty swallowing. She states her doctor things this may have been an allergic reaction to lisinopril and discontinued that medication. Reporter consented to follow up.
Patient called me about  4 and a half hours after his immunization. He stated his eyes have become sensitive to light .  He also stated that his bottom lip and chin started to tingle about fifteen minutes after the shot and then went away.  . I recommended that he immediately take a Benadryl tablet and wait a couple of hours I said he can take Benadryl every six hours if he needs to. If his symptoms don't go away  after two doses of Benadryl  I recommended he go to the Emergency Room and be checked out. Pre -immunization I counselled him  on the normal  run of the mill possible side effects and how to treat them.
Pediatric COVID vaccine booster was administered undiluted. Parent was informed of the error and to watch for any adverse effects
Patient did not have any adverse events.  Patient received the wrong dose of medication (administered 1ml instead of 0.5ml).
After I received the shot I started walking down an aisle at pharmacy and got a head rush and became lightheaded. Went and sat down by pharmacy till I felt somewhat better. Went on w/ the day but didn't really feel better till hours later. Next morning again felt lightheaded. Hours later, better.
Arm hurt, body ached, lymph nodes on left side of body near neck were very swollen, headaches
Developed blood clots following COVID vaccination. Known history of DVT/PT and likely APS.
Bells Palsey Left side of face paralyzed for 3 to 4 weeks
she needed to report 3 more Vaccine Administration errors; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors).    No concomitant medications were reported. No treatment medications were reported.
PRESSURE IN HEAD; TREMENDOUS AMOUNT OF PAIN IN THE LOWER BACK; GENERALIZED PAIN OVER BODY; FATIGUE; HEADACHE WITH PRESSURE; INTERMITTENT HEART PALPITATIONS; VERTIGO; DIZZINESS; NUMBNESS/TINGLING IN  IN RIGHT HAND THEN SPREAD TO LEFT HAND.; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 129 pounds, and height was 68 inches. The patient's concurrent conditions included fibromyalgia, gluten allergy, casein allergy, alcohol consumption, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. patient was not pregnant at the time of the event.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced numbness/tingling in in right hand then spread to left hand. On 01-JUL-2021, the subject experienced intermittent heart palpitations. On 01-JUL-2021, the subject experienced vertigo. On 01-JUL-2021, the subject experienced dizziness. On 01-JUL-2021, the subject experienced couldn't sleep. On 01-JUL-2021, the subject experienced headache with pressure. On 02-JUL-2021, the subject experienced generalized pain over body. On 02-JUL-2021, the subject experienced tremendous amount of pain in the lower back. On 02-JUL-2021, the subject experienced fatigue. On 16-JUL-2021, the subject experienced pressure in head. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache with pressure on 03-JUL-2021, was recovering from generalized pain over body, and vertigo, had not recovered from numbness/tingling in in right hand then spread to left hand., fatigue, intermittent heart palpitations, dizziness, and pressure in head, and the outcome of tremendous amount of pain in the lower back and couldn't sleep was not reported. This report was non-serious.
swelled (at the injection site); The pharmacist told her that the Shingrix shot hurts more (than the flu shot); This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingles vaccine (live). Concurrent medical conditions included hard of hearing.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the injection site pain was unknown.   The reporter considered the injection site swelling to be related to Influenza vaccine Quadrivalent unspecified season. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: This case was reported by patient for herself. The age at vaccination was not reported. The had Flu shots that sometimes swelled (at the injection site). In September 2020, the patient received the flu shot and had no issues. The pharmacist told her that the Shingrix shot hurts more (than the flu shot). The reporter consented to follow up. Further tolerance to the dose of Shingrix refer case US2020211098, reported by same reporter. This case has been linked with the case US2020211096 (patient's husband), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211096:same reporter US-GLAXOSMITHKLINE-US2020211098:Same patient
fever; lymphadenopathy; couldn't move arm; got really sick; This is a spontaneous report from a contactable Physician. A 44 age (unit-unknown) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. After the second dose of the vaccine, the patient got really sick. He had a fever, lymphadenopathy, and couldn't move arm his arm. The reporter thought since he had this reaction he would have a high antibody level. The patient underwent lab tests and procedures which included blood immunoglobulin g: negative. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt called approx 1 hr after vaccine with complaint of itching (no rash and the itch was several inches below site) - told pt to call again or see MD if anything changed. Pt came in 11AM 10/14/13 with bruised and contused area 3 to 4 inches below injection site - injection site nicely healed with no redness/swelling or heat.
The day following the vaccination, pt. had a very red arm about the size of a tennis ball- the spot where the redness was was very hot and firm/swollen.  The 3rd and 4th day after the vaccination, he had red raised bumps on his shoulder and arm around the injection site.
Patient seen in the office with persistent fatigue, joint pain.  ANA +; Further workup shows Anti-DsNA antibody equivocal, histone Antibody positive, all other work up negative.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil without incident. On an unspecified date, the patient was vaccinated with the second dose of Gardasil. After the second dose (date unspecified), the patient experienced possible seizures. Unspecified medical attention was sought. Subsequently on an unspecified date, the patient recovered from possible seizures. No product quality complaint was involved. Upon internal review, possible seizures was considered to be an other important medical event. Additional information has been requested.
Pt w/hx of dementia p/w cough and fevers over the past few days and increased confusion.  Of note, his unvaccinated daughter who he recently interacted with was recently admitted to the hospital for COVID.  Pt had tested positive for COVID despite having received the Moderna vaccines (3/23 & 4/20). He was admitted for acute hypoxic respiratory failure associated with COVID-19 pneumonia d/t increased O2 requirements and was given steroids, remdisivir, and tocilizumab. He is still currently being managed and will ultimately be discharged home if continues to improve.
45 minutes, post vax, the pt developed acute shortness of breath, wheezing, a cough and facial swelling. The pt was treated with albuterol nebulizer, Prednisone, Benadryl and Pepcid and was admitted.
Employee stated that approx. 1hrs after, she felt mild chest tightness and wheezing.. Has a hx of asthma-  Used Albuterol 1 puff and Benadryl. Denies sob. Called Nurse number and Followed up with doctor1 hr later. Prescribed Qvar.
Approximately 1 hour after vaccine, severe headache, erratic breathing, racing pulse, in/out of conscience.  No treatment given - nothing to counter act the vaccine available.  Monitored 3 hours by medical, 24 hour watch by family/friends.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 30-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
The patient called stating she experienced severe back pain after receiving the Moderna COVID-19 vaccine. She went to the hospital and was prescribed Flexeril and Prednisone. She was told at the hospital it was most likely related to arthritis.
did not receive 2nd dose of Shingrix for greater than 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018 with batch number m77b4 and expiry date 2nd October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, the patient did not receive 2nd dose of Shingrix for more than 6 months after 1st dose, which led to incomplete course of vaccination. The reporter consented to follow up.
pt to ED with hypoxia - on 2.5L O2 with O2 saturation 80s%; positive for COVID; CT of chest showed bilateral pneumonia, severe emphysema with bronchitis and mucous plugging; gave ABX, Dexamethasone, Remdesivir; started on BiPAP; bronchodilators; DNR/DNI; pt went into asystole and passed away
discomfort in his arm after doses 1 and 2; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort in his arm after doses 1 and 2) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke (derrame) in 2016.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (discomfort in his arm after doses 1 and 2). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort in his arm after doses 1 and 2) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2021-378301, MOD-2021-378284 (Patient Link).
Around midnight, patient explained arm was itchy.  She felt arm and felt small bumps.  Area of injection was very red and swollen.  Area around injection was also swollen, not red, just looked like a halo.  Arm was very itchy.  Since date of injection, symptoms have been subsiding.  As of 8/28/13, area of injection still red.
07/19/2000 pt sought medical treatment. Complained of vomiting, weight loss since yellow fever vax. Was prescribed Reglan. 07/20 pt states Reglan not helping. Prescribed Compazine. At the time of this report she was still under treatment.
no adverse effect; improperly stored vaccine administered; possibly administered outside of the guidelines of the prescribing information/ 18 month dose; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 07-OCT-2019, the patient was vaccinated with one dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, lot # S000351, expiration date 10-OCT-2021 (injection site and route of administration were not reported) for prophylaxis. The nurse reported that it was the "18 month dose" and the vaccine was possibly administered outside of the guidelines of the prescribing information. Administered dose of vaccine experienced the temperature excursion of 56.0 degrees Fahrenheit for 8 hours and 30 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There was no adverse effect reported.
This spontaneous report as received from an office manager refers to a 5 years old girl was inadvertently vaccinated with a 0.65ml dose of ZOSTAVAX (lot#batch# unspecified), subcutaneous injection at unspecified location instead of VARIVAX (Merck) on 15-JUL-2013. No adverse effects reported. Additional information has been requested.
area adjacent to injection site was tender, red, hot to touch, itchy and progressed in size to about 2 inches diameter for 5 days.  On 4/8 (date of this report) the redness is receding, but is still tender to touch.  Used ice to area daily as needed for comfort.
After each vaccine (4/6/2021), (5/4/2021) and (12/7/2021), I began experiencing breakthrough bleeding despite taking active birth control pills. I did not miss any pills or take anything else that would decrease their effectiveness. In addition to the breakthrough bleeding, I developed menorrhagia, with extremely heavy bleeding and blood clots, which I have never experienced in my life. This lasted approximately 2 days, then everything was back to normal. I became borderline anemic after this experience right after the 2nd shot. I will now be tested again after the third experience of this. This extreme bleeding occurred only after the 2nd and 3rd shots.
I experienced extreme abdominal pain, syncopal episode and collapse on 3/30/21, and was taken to the hospital ER. The pain subsided in a few hours and was determined by the hospital doctor and my primary care doctor to be extreme ovulation pain, which I had never experienced before.   I received my 2nd COVID Pfizer vaccine on 4/7/21.  My menstrual period was then 1 week late, beginning 4/22/21, with four full days of extreme menstrual/abdominal cramps. The pain level and duration was at least twice that of my regular cycle pain.