chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can't lift arm; Shoulder pain - right arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Can't lift arm) and ARTHRALGIA (Shoulder pain - right arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Can't lift arm) and ARTHRALGIA (Shoulder pain - right arm). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, INJECTED LIMB MOBILITY DECREASED (Can't lift arm) and ARTHRALGIA (Shoulder pain - right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
pt recvd vax & MAY94 pt dx w/autoimmune hepatitis; liver biopsy done by MD; wor\-up neg for viral hepatitis & other causes also r/o? relationship between vaccine & hepatitis;
'covid arm'  - (2") hard/warm/itchy/red welt about 1/2" below where I got my vax
Patient vaccinated and then later developed urticaria to bilateral lower forearms with erythema from scratching. Given 10mg Zyrtec. After about 10 minutes urticaria improved, but 10 minutes later, erythema streaks appeared to bilateral upper arms, without scratching either area. EMT's and MD assessed patient, but patient refused to go to ED. Patient did state she has gotten hives from anxiety. Before leaving urticaria and erythema resolved. Patient ambulated out with husband without difficulty.
None at time of administration. Medical staff forgot to dilute vaccine as instructed by manufacturer and subsequently patient received a more highly concentrated dose than recommended (approximately double strength). Patient remained in office for approximately 45 minutes to one hour after administration and was not observed to have any local site or systemic adverse reactions.
Pain, redness and swelling at the site of injection (upper posterior left arm) progressed to a larger area with more pain and warmth over the two days following the injection. central area (2x3cm of induration with spreading redness about 6x10cm).  Warmth at site and pain.  Treated for possible cellulitis with clindamycin for 7 days.
I woke up the next day and my arm ached, my fingers and my wrist on my left arm felt like I had arthritis.  My left ankle and foot also felt like I had arthritis.  My legs were very weak and my knees also ached.  I could hardly stand up and the pain in my left foot and ankle hindered my ability to walk.  By the next day I was able to walk with only minor pain but my left arm, wrist and fingers were still extremely sore.  The pain in my arm did not completely go away for six weeks.  Now after five months I still have some trouble with my left wrist and fingers.
hyporesponsive episode assoc w/fever lasting approx 20 mins; fever up to 104; vomiting total of 7 times through noc; back to nl since 15APR94;
Red area, hot to touch started 5 days after shot MD prescribed MEDROL dospk.
entire arm painful, swollen to twice nl size;area around inj site a little red;sx w/in 1 day when pt called 330PM 30JAN98 states swelling below elbow has dec but upper arm still painful to move & quite swollen;
Later the in evening of the day I received the vaccination, I developed a fever over 101 degrees with severe chills, aches, and pains that lasted through the night and into the following day. I started to feel better by late the next night. I took aspirin and later notified my doctor who recommended that I report the reaction.
Small Rash on tops of hands. Started with left hand on day 1, then right hand on day 2. Took Benadryl which helped but Zyrtec helped more. Rash consistent for at least 10 days. continues to flare up periodically. Going for 2nd shot tomorrow.
Knot detected in lymph node under right arm; Redness continues to spread after 6 days after receiving shot along with fever on this area; Redness continues to spread after 6 days after receiving shot along with fever on this area; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 05Mar2021 at 11:00 (Lot Number: EN6206) (at the age of 67-year-old) as single dose for COVID-19 immunisation.  Medical history included leukemia and penicillin allergy, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 06Mar2021, the patient experienced knot detected in lymph node under right arm and redness continues to spread after 6 days after receiving shot along with fever on this area. No therapeutic measures were taken as a result of the events. The patient outcome of the events was unknown.
Same day-severe muscle soreness in arm, dizziness/lightheaded, fast pulse, flushed, headache Next day-fever, full body muscle and joint ache and stiffness, tiredness, migraine
2/1/08 - Left arm 3x3 cm bullae, hot, ruptured - yais morning with surrounding small vesicles.  Placed on Keflex 375 mg po 2x daily for 7 days.
The next morning as soon as waking. Besides the usual mild effects. Had increased anxiety for 1st time in awhile. And heart flutters or premature beats
This is in follow-up to report(s) previously submitted on 3/14/2007; 4/6/2007. Information has been received from a registered nurse, for the Pregnancy registry for Gardasil, concerning a 19 year old female with no previous pregnancies, no known drug allergies, and a history of anxiety who on 03-NOV-2006 was vaccinated with first dose of Gardasil (lot # 653938/0954F) 0.5 ml in the left deltoid. Concomitant therapy included promethazine hydrochloride. On 05-JAN-2007, the patient was vaccinated with second dose of GARDASIL (lot # 655165/1425) 0.5 ml. There was no concomitant medication. The patient sought medical attention. Her last menstrual period was on 05-DEC-2006. On 29-JAN-2007, the patient's primary physician performed a quantitative beta blood test at the physician's office which was positive for pregnancy. Estimate date of delivery is 11-SEP-2007. On 08-FEB-2007, the patient experienced abdominal discomfort and was sent to the hospital for an ultrasound which was positive for pregnancy. The patient was not hospitalized. At the time of reporting, the patient no longer had abdominal discomfort. Additional information was received from the registered nurse. On 08-FEB-2007, an ultrasound was performed for pain that revealed intrauterine pregnancy of 6 weeks and 5 days and subchorionic hemorrhage. On 16-MAY-2007, an ultrasound was performed that revealed normal anatomy scan. The estimated date of delivery was calculated as 30-SEP-2007. Additional information was received from the registered nurse. The patient's LMP was on 25-DEC-2006. On 09-OCT-2007, 40 weeks from LMP, the patient delivered a female baby weighing 7 pounds 10 ounces. Apgar scale 8/9. The infant was reported as normal and healthy, no congenital anomalies and no complications. Additional information is not expected. 07/08/08 Follow-up information was obtained from a health professional in the physician's office via voice mail. It was reported that they did see the baby one time in the hospital, but it was not their patient. They do not have any medical records for this patient. Additional information is not expected.
The symptoms started 2-3 days after the flu vaccine. Patient went to ER, her MRI revealed 3 areas of white matter change in the brainstem and 2 areas of white matter change in another area of the brain. She has Acute Demyelinating (or Disseminated) Encephalomyelitis secondary to the flu vaccine.
I did not have an adverse reaction to the vaccine. In 02/2023, I developed a cold with a cough. I contacted my doctor and got a prescription for cough medicine with codeine. In 04/2023, my seasonal allergies started to bother me.  The cough started up again and I used the cough medicine with codeine.
pt recvd 2nd dose of vax & devel burning sensation upon inject as well as soreness & or an aching sensation in the arm; pt feeling heaviness in the arm;
Within 10 minutes of receiving the shot, I got a headache from center to left side, front of head. Slight muscle ache in going from base of neck into top of shoulders.
Developed localized skin reaction - redness and swelling noted approximately 4x3in in size on right  deltoid.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number, dose, route not reported) on 18-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was getting a prescription for prednisone in the pharmacy on 19-SEP-2102 and was not in the pharmacy to provide information about the reason why this medication was prescribed. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Medication error; incorrect interval between doses 1 and 2.   Given 22 days apart.   No adverse reactions reported.  Error discovered when client requested updated vaccination card.
Spotting between menses after vaccine.  Also patient (with known migraines) has noticed that migraines have been more severe in the last two to three months . Was advised to return for follow up appt on breakthrough bleeding  and headaches.
Papulovesicular rash to body (knees first) then spreading to legs, arms, upper chest, and face. Diagnosed as probably Gianotti-Crosti Syndrome.
8 Days after getting my second dose, I started my period two weeks early with heavy flow and terrible cramps. I don't think over ever started my period two weeks early before in my life.
sore throat with a clear mucus, and nausea; sore throat with a clear mucus, and nausea; a pinch in the injection site; fatigue; worsening on her off balance; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (fatigue), BALANCE DISORDER (worsening on her off balance), VACCINATION SITE DISCOMFORT (a pinch in the injection site), OROPHARYNGEAL PAIN (sore throat with a clear mucus, and nausea) and NAUSEA (sore throat with a clear mucus, and nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included THYROID and CRATAEGUS LAEVIGATA, MAGNESIUM CITRATE, PLECTRANTHUS HADIENSIS, THEANINE, THEOBROMA CACAO (HIGH BLOOD PRESSURURE) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced BALANCE DISORDER (worsening on her off balance). On 31-Mar-2021, the patient experienced FATIGUE (fatigue). On 07-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat with a clear mucus, and nausea). In April 2021, the patient experienced VACCINATION SITE DISCOMFORT (a pinch in the injection site). On an unknown date, the patient experienced NAUSEA (sore throat with a clear mucus, and nausea). On 30-Mar-2021, BALANCE DISORDER (worsening on her off balance) outcome was unknown. In April 2021, VACCINATION SITE DISCOMFORT (a pinch in the injection site) outcome was unknown. At the time of the report, FATIGUE (fatigue), OROPHARYNGEAL PAIN (sore throat with a clear mucus, and nausea) and NAUSEA (sore throat with a clear mucus, and nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Holy water (on the injection site) that cured the pinch
LOC <10 SECONDS IMMEDIATELY AFTER INJECTION. RIGIDITY, EYES ROLLING TO BACK OF HEAD, PALLOR, NAUSEA, VOMITING, SWEATING AFTER DONOR CAME TO. REDNESS TO ARMS AND UPPER TORSO, IMMEDIATELY. FANNED DONOR, CALLED EMS. DONOR REFUSED EMS TRANSPORT AFTER THEY ARRIVED. B/P 129/88 PULSE 112.
The patient is a 46-year-old male who was hospitalized 06/28 through 06/29 for nonspecific chest pain and shortness of breath.  He was admitted at that time for a stress test.  The stress test was normal, and the patient was actually feeling pretty well at the time of discharge, but when he left here, he felt a little heavy in the head, but nothing specifically headache per se.  He went home and by the late evening was feeling lousy.  He did state that the only thing that was abnormal was that he got a pneumococcal vaccination in the right upper extremity and is very tender, even from the very beginning, and only became more red and tender over the 24 hours after the vaccination, so he presented to the emergency department. He had fevers associated with delirium in the night, and he had severe shaking chills.  He also has sweats and normally he just has the sweats sort of chronically, but never has recalled having fever, chills, or delirium recently.  He thinks maybe 3 times in the last 10 years he has had that, and last night was one of those times.  He called his PCP, and told him that he came in the emergency department and came in as a consequence of this illness and was trying to schedule a followup when the PCP told him that he had better get back to the emergency department and get checked out.  While here, he was noted to have the fever and tachycardia.  As a consequence, there was noted to have the fever and tachycardia.  As a consequence, there was a question as to whether he had meningitis because of the severe headache.  A lumbar puncture was done with a traumatic tap and was basically unremarkable, other than blood, a small amount of leukocytosis was noted, but the micro at the time of admission does not show any evidence of organisms on the CSF.  There were rare WBCs , and many RBCs noted.  The influenza testing was negative.  Blood cultures are pending.  A throat swab for group A strep was negative as well.
CROHNS DISEASE AGGRAVATED; This spontaneous report received from a patient via other company concerned a 28 year old male of an unspecified race and ethnicity.   The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Humira (adalimumab) (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. Concomitant medications included prednisone.  On an unspecified date in 2022, the patient experienced Crohns disease aggravated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of Crohns disease aggravated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220901987-covid-19 vaccine ad26.cov2.s-Crohns disease aggravated. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:  UNDERLYING DISEASE (Crohn's disease). Therefore, this event(s) is considered not related.
Began developing rash on both arms with severe itching. Initially appeared as typical hives/Swollen skin. Now has progressed to entire body. Looks somewhat like chicken pox. Has crusty top in mornings and leaks fluid when scratched. Provider gave me topical cream but no positive results.
My shot is what gave them to me/Suspected Vaccination Failure; gave them to me; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My shot is what gave them to me/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: gave them to me). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-MAR-2023 The case was received from the patient interactive digital media. The patient stated that his/her Shingles shot what gave them (shingles). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
FACIAL FLUSH, SWELLING OF HANDS, RAPID HEART RATE, BLOOD PRESSURE INCREASE.
No additional AEs; patient was administered MMRlI that expired; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. Concomitant therapies included sterile diluent  On 07-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) Recombinant Human Albumin (rHA) (lot number S015284, expiration date 19-MAY-2021) 0.5 milliliter for prophylaxis  (strength and route were not reported).    The vaccine had not had a temperature excursion. No additional adverse events reported.
Approx. 15-20 minutes after my son received the Menactra vaccine he had a seizure. It lasted about 15 seconds. He has never had a seizure before. He was then taken to the closest Emergency Room. They checked him over and couldn't find anything wrong with him. He was extremely tired and went home and slept the rest of the day.
Patient presented for 2nd COVID-19 Pfizer dose today. Patient was asked to stay for 30 minutes since she endorsed reaction to 1st Pfizer dose of red rash at site and some shortness of breath. Today, patient got 2nd dose and see below for chronological details.  10:30 am Pfizer dose given 10:40 am Pt c/o feeling trouble breathing, throat tightness, numb fingers and weakness. Patient seated and monitored while team got RN. 10:42 am Pt c/o shortness of breath and diaphoretic. This RN administered Epinephrine Injection x 1 to patient's left outer thigh and called 911 while other RN monitored patientin exam room with head of bed elevated.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMh significant for CKD, Glaucoma, bradycardia, vitamin d deficiency, hyperlipidemia, basal cell carcinoma of skin, peripheral vascular disease. Diabetes Mellitus. Carotid Artery stenosis, HTN, advanced age. Per note, patient deceased on 5/3/2021. No cause of death noted.
3 hours after vaccination started crying: becoming completely inconsolable - refused to breast feed, couldn't hold her, lay down, etc. Taken to ER- was told she had colic (no prior history) - given 120 mg tylenol suppository; sent home. Fell asleep after 4.5 hours of screaming - Woke up the next day and was ok. " Legs where she got the 2 shots" seemed to be really sore.
I have had constant back pain starting the day after my shot. The pain is across my upper back between my shoulders and up to my neck. I can't even carry my purse for more then 5 minutes without pain and strain across my back.; I can't even carry my purse for more then 5 minutes without pain and strain across my back; The pain is across my upper back between my shoulders and up to my neck. I can't even carry my purse for more then 5 minutes without pain and strain across my back.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the left arm on 21Oct2021 at 17:00 (at the age of 47-years-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 vaccination. The patient did not receive any medication within two weeks of vaccination. On 22Oct2021 at 07:00, the day after her shot, the patient had constant back pain. The pain was across her upper back between her shoulders and up to her neck. She could not even carry her purse for more than 5 minutes without pain and strain across her back. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events constant back pain/ pain across upper back between shoulders and up to neck and could not even carry purse for more than 5 minutes without pain and strain across back were not resolved at the time of this report.
Initial extremely sore and swollen arm  8 days after injection, red, swollen, hot rash at injection site 1? x 2.5? in length