chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX (batch number 4492P, expiry date unknown). Previously administered products included SHINGRIX (refer case US2018057021 for 1st dose). On 2nd April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 2nd April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and general body pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the general body pain was unknown. The reporter considered the pain in arm and general body pain to be almost certainly related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, she experienced body aches and her arm began hurting a couple hours after receiving the SHINGRIX in the left deltoid at 13:00 hours. The 2nd dose of SHINGRIX was given just under 8 weeks (1 day early). Expiration date was unknown. At the time of this report, the patient's arm was hurting, but it was not debilitating. The patient began taking TYLENOL on the vaccination date.
She developed an impressive localized allergic reaction to the injection, with swelling from shoulder to forearm. She had no pain to indicate infection, and has excoriation at the injection site. Her sister had a similar reaction which resolved within 48 hours.
This case is a cluster of 6 patients who tested positive for pertussis following administration of DTAP vaccines. The 5 other patient s are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 6-year-old male patient had received 4 previous injections of DTaP: Dose 1 of DTAP (manufacturer, lot number, route and site not reported) on 17 November 2005, dose 2 of PENTACEL, sanofi pasteur Ltd. lot number C2243AA (route and site not reported) on 14 December 2005 and doses 3 and 4 of DTAP (manufacturer, lot number, route and site not reported) on 20 February 2006 and 07 December 2006. The patient had received a 0.5ml dose 5 injection of DAPTACEL, sanofi pasteur Ltd. lot number C358AA (route and site not reported) on 01 November 2010. On the same date, the patient also received a 0.5ml dose 4 injection of POLIOMYELITIS vaccine inactivated, a 0.5 ml dose 2 injection of MMR, a 0.5ml dose 2 injection of VARIVAX, Merck and a 0.5ml dose 4 injection of INFLUENZA vaccine (manufacturer, lot numbers, routes and sites not reported). The patient was seen on 26 January 2012 with complaints of a barky cough, post-tussive vomiting five time over the past 3 days, fever on and off, shortness of breath (SOB), sore throat and cannot catch breath during coughing spasms. Upon examination, the patient had nasal congestion, mild erythema on right tonsil, no cervical lymphadenopathy and lungs were clear to auscultation. The physician's assessment was cough. A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 29 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was treated with azithromycin, fluids, increased humidity, honey and DELSYM. The patient had no known drug allergies and took DELSYM concomitantly. The patient had a past medical history of cryptorchidism repaired at 9 months, pharyngitis and strep. The patient was up-to-date on Hep B, hib, IPV/OPV, PREVNAR, MMR, varicella, hep A and flu vaccinations. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Extreme fatigue, muscle aches, headache, a little nausea, diarrhea.
after 12 hours that I took the Janssen vaccine, I woke up around 12 am and sweating a lot. my 2 hands and 2 feels are numb and even my tongue was numb and I can not control my body and my finger can not bend. My husband called 911 and sent me to the ER. After 20 mins my body went back to normal. the symptom is very similar to a mini stroke.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 04-MAR-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.77 Celsius Degrees for 336 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
SIGHT INFLAMMATION, SWELLING AND PAIN, PATIENT EXPERIENCED NECK PAIN, FEVER AND CHILLS.
11/28/21 pt was admitted to hospital with SOB, diarrhea, and fevers - pt confirmed pos for COVID pt treated with O2, Decadron and remdesivir 12/7/21 pt discharged to home on O2 12/14/21 pt feels she has improved ox readings arounf 95%
After receiving the vaccine I had been experiencing nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 14:30 hours (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV. Concomitant medications included rilpivirine hydrochloride, dolutegravir sodium (JULUCA) from an unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) on an unknown date and for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 after receiving the vaccine the patient had been experiencing nose bleeds. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nose bleeds was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Cellulitis; This is a spontaneous report received from contactable reporter (Nurse).  A 77-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), on 21Aug2023 as dose 1, single (Lot number: GT0538) at the age of 77 years, in right deltoid for immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Thyroid disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE CELLULITIS (non-serious) with onset 26Aug2023, outcome "recovering", described as "Cellulitis". Therapeutic measures were taken as a result of vaccination site cellulitis. Additional information: It was unknown if the patient received another vaccine within four weeks prior to the vaccine; or other medications within two weeks prior to the vaccine. The patient had no known drug allergies. The patient experienced pain, induration, redness, with possible cellulitis. The patient was treated with antibiotics.
Had extreme chills for approximately one half hour, then was okay until following night had a mild fever for a few hours, was fine after and since then.
The vaccination uncovered an ongoing, hitherto silent infection: after a few days, my teeth started hurting, with the pain intensity increasing over two days to the point where I had to see a dentist. It turned out I had a molar that was infected and needed a root canal. The immune response from the vaccine probably caused my body to react to the tooth infection as well. I normally wouldn't put the two things together, but I had a very similar reaction a few days after my flu vaccine back in October: sensitive teeth, wandering pain in different parts of my head, neck, and shoulder area. At that time, the dentist didn't find anything (although we now know it was probably the start of that same tooth becoming infected and dying), and antibiotics took care of it.    The root canal specialist I saw, the dr, said she is seeing a number of similar cases in her patients, where vaccinations bring out undetected problems. I actually consider that a good thing - I wouldn't want to have a rotting tooth that goes unnoticed for a while.
No additional AE.; pediatric dose of RECOMBIVAX HB was given to an adult.; This spontaneous report has been received from a medical assistant referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported   On 17-OCT-2022, an adult patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 milliliter for prophylaxis (vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (incorrect dose administered).  No additional adverse events were reported.
Hyperpigmentation of the right hand near fingers. It is a little bit similar to freckles. I took the second dose on Thursday and the symptom of my hand started on Saturday and still is the same. Do not have another symptoms. I have not used any medication. After taking vaccine I experienced severe side effects including fever, chills, nausea, and fatigue which lasted up to 36 hours. I took 3 times Acetaminophen 500 and 3 time Ibuprofen 400 for fever and one Ondansetron for nausea.
Headache, NauseaVomiting, fatigue, light sensitivity Nausea, fatigue, headache with light sensitivity (hx migraines) within 48 hrs of vaccine, self resolved within 48 hrs.
Patient received Hep A vaccine and DTaP in Left deltoid on 04/18/2003.  Mother called health center and claims patient's left arm has been red and swollen for 4 days.
Bivalent vaccine administered instead of the second dose of monovalent.  Employee did not experience any problems.
Per patient; Pain in left arm right where she got the shot, went to the doctor...waited a little while thinking it would pass, finally saw the doctor on Feb 16, about two months after the vaccine,  and he told her she has capsulitis (inflammation in her shoulder) and the treatment is oral steroids and physical therapy which she started and if that doesnt help then she has to get US guided cortisone injection and then surgery if that doesn't work. MD was Dr. (Privacy) at Clinic.
102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headache, overwhelming fatigie, and diapohretic x 2days. Swelling of arm from elbow to axilla during same. Unable to work during symptoms. Moderate fatigue, body aches, headache, and site tenderness persist to date of reporting.
Swelling around injection site that I noticed the morning after vaccine. Pain in my arm is moderate and is comparable to the first two doses of Pfizer vaccines I received (last dose 2/4/21).
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On an unspecified date in 2013, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, exact dose and route of administration were not reported). On an unspecified date in August 2015, the patient got a very bad case of shingles. On an unspecified date in November 2015, the patient's physician prescribed a second vaccination with ZOSTAVAX, but at the time of report, the patient did not receive it yet. No PQC (product quality complaint) was involved. The outcome of the very bad case of shingles was unknown. The relatedness between this event and ZOSTAVAX was not provided. Additional information has been requested.
Rash on face that spread all over body.  Evaluated 8/17/16.
fever and headache 24 to 48 hours after,  72 hours after rash and itch at vaccine site,   5 days later no rash - itchy on and off - for over 2 weeks now - every day
had a reaction to Flublok; Initial information was received on 05-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who had a reaction to influenza quadrivalent recombinant vaccine [Flublok QIV] after receiving it.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in Sep-2022, the patient received 0.5 ml, total dose of suspect influenza quadrivalent recombinant vaccine (prefilled) (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization. The information on the batch number was requested.  On an unknown date the patient had a reaction to flublok (immunisation reaction) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  It was reported The health-care professional reported it but now the patient wants information on the inactive ingredients in the vaccine. Provided the inactive ingredients per the PI. The health-care professional wanted the ingredient information be emailed to her.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
This spontaneous report was received from a registered medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in April 2016 (healthcare worker stated that vaccinations occurred between 01-APR-2016 and 07-APR-2016), the patients were vaccinated with ROTATEQ oral solution, lot # L029617, expiry date 19-MAY-2017 (dose was not specified). Administered doses of ROTATEQ underwent temperature excursion at 50.5 Fahrenheit degrees for 2 hours and 42 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Started bleeding from what I assume is an early period?2 weeks early?within just hours after the vaccine. The blood is heavier than usual. I haven?t had an early period in over 5 years, since giving birth to my son. The blood is brighter and different from my typical period blood.  Concerned about what this means for my reproductive health. If worsens, will be calling my gynecologist.
chills; headache; fatigue; stabbing pain in my kidneys; acute sensation in my left sciatic nerve; tenderness; The stabbing pain in my kidneys eventually subsided and it felt very tender, almost like it was bruised around that area; This is a spontaneous report from a contactable consumer. A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EWO161), dose 2 via an unspecified route of administration, administered in left arm on 10May2021 at 11:00 (at the age of 53-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical was not reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EWO161) as dose 1, single administered in left arm on 15Apr2021 at 10:00AM (at the age of 53-years-old) for COVID-19 immunization. Concomitant medication included vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported received other medications in two weeks. No other vaccine in four weeks. Patient was very healthy with no prior health issues. No COVID prior vaccination. Patient did not have allergies. Other medical history reported as no. Facility type vaccine: other. On receiving the second dose, the day after on 11May2021 at 14:00 PM, patient had the common symptoms such as chills, headache, fatigue. However, throughout that day patient also had stabbing pain in kidneys for what felt like several hours, along with an acute sensation in left sciatic nerve. The stabbing pain in kidneys eventually subsided and it felt very tender and patient was unsure of what test should have to check if there has been any kidney damage. Almost like it was bruised around that area. 2 weeks on, there was still a tenderness there, so patient was a bit concerned that there may have been some damage. Patient had a concerned that there may have been some sort of damage to Kidneys. COVID tested post vaccination reported as no. Adverse event resulted in: Doctor or other health care professional office/clinic visit. The event was not treated. If patient recovered: Recovered with lasting effects. The outcome of the events were recovered on 2021.  Follow-up attempts are completed. No further information is expected.
This spontaneous case was reported by a patient and describes the occurrence of ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE (since the Moderna vaccines surprising to see how high my CCP went up. anti-citrullinated peptide antibody test (anti-CCP antibody test) is at 200. RF factor that was high is now way down) and RHEUMATOID FACTOR DECREASED (RF factor that was high is now way down) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 013M20A, 029A21A and 058E21A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis since February 2020. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE (since the Moderna vaccines surprising to see how high my CCP went up. anti-citrullinated peptide antibody test (anti-CCP antibody test) is at 200. RF factor that was high is now way down) and RHEUMATOID FACTOR DECREASED (RF factor that was high is now way down). At the time of the report, ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE (since the Moderna vaccines surprising to see how high my CCP went up. anti-citrullinated peptide antibody test(anti-CCP antibody test) is at 200. RF factor that was high is now way down) and RHEUMATOID FACTOR DECREASED (RF factor that was high is now way down) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2020, Anti-cyclic citrullinated peptide antibody: 24 24. In February 2020, Rheumatoid factor: positive (Positive) Positive. In June 2022, Anti-cyclic citrullinated peptide antibody: 200 now 200. In June 2022, Rheumatoid factor: now way down now way down. Patient had flare up in February 2020. It was reported that patient was unsure whether they had COVID and no flare ups during recent investigations. Patient reported that no medications were taken. No concomitant medication was reported. No treatment medication was reported.
Patient begin experiencing nausea, vomiting, headache, and swelling of arm that has lasted until today (2 days later). Symptoms began approximately 4-5 hours after vaccination.  Patient has not taken OTC pain or stomach medicines to alleviate symptoms.  Vomiting subsided today (10/7), but still feels nauseous and in pain. Counseled on hydration and possible OTC products to alleviate symptoms. As of 8:00pm on 10/7, she has taken 2 Tylenol without relief.
Started with a fever Fri the 11th of June through June 21 so far.....Fever starts higher in the Am and usually calms more in the afternoon and evening.  Fatigue along with headache.    Have been to the doctor 3 times with many many tests done with no results.
PATIENT WHO IS 10 YRS AND 4 MONTHS RECEIVED THE COVID VACCINE FOR 12YRS AND OLDER. THE PATIENT RESPONDED WELL TO THE VACCINE, WAITED 15 MINS PRIORTO LEAVING AND  PATIENT WAS FINE.
extreme fatigue, very low heart rate 30-35 BPM on and off for ten days. Lump in left arm at injection site and feeling like something is wrong with the shoulder joint continuing to date on and off.
Patient returned to the vaccine room on 15MAR21 at 0315 complaining of fatigue and dizziness.  Patient stayed for approximately 20 minutes before going home at 0335.  He will follow-up with our onsite nurse as needed.
mom states pt began crying about 1230PM; could not be comforted & cried uncontrollably @ about 4;00 began running fever of 105 ax;
pt recvd vax & exp pounding & racing heart & felt nervous & jittery; exp insomnia, lack of appetite & sl nausea; 4SEP93-6SEP93 was extremely tired, exp nervous feeling, could not concentrate, had h/a, overheated & a bit faint;
Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient did not take any treatment medication ( not applicable).    This case was linked to MOD-2021-222874, MOD-2021-223023 (Patient Link).
Started with vertigo, dizziness, blurry vision and problems with memory April-May. Then by beginning of June, I had high BP over 225 and could not lift head off the couch. I went to the ER. Diagnosed with multiple mini-strokes over the previous months. Left permanently disabled, with need to use walker just to get around the house. Can no longer write or drive. I need help from others with cooking, cleaning and caring for myself; including basic OT activities. BP drops from sit or laying down to stand dramatically.
SOB, anxiety, pain in neck that radiated to head, intermittent numbness in lips; vomited at 0925. BP 130/84, HR 64; breath sounds clear. Medics on site at 0932. Signed out AMA.