chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the site of the injection for about 2-3 days), HEADACHE (slight headache that has persisted), ABDOMINAL DISCOMFORT (a little stomach upset), VACCINATION SITE ERYTHEMA (there was a big area, bright red) and VACCINATION SITE WARMTH (very hot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included DOXYCYCLINE (DOXYCYCLINE 3DDD). On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (there was a big area, bright red), VACCINATION SITE WARMTH (very hot), MALAISE (malaise), AXILLARY PAIN (the back towards the armpit is also sore), VACCINATION SITE PAIN (pain if you touch it) and FEELING ABNORMAL (general unease). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the site of the injection for about 2-3 days), HEADACHE (slight headache that has persisted) and ABDOMINAL DISCOMFORT (a little stomach upset). At the time of the report, VACCINATION SITE PAIN (pain in the site of the injection for about 2-3 days), HEADACHE (slight headache that has persisted), ABDOMINAL DISCOMFORT (a little stomach upset), VACCINATION SITE ERYTHEMA (there was a big area, bright red), VACCINATION SITE WARMTH (very hot), MALAISE (malaise), AXILLARY PAIN (the back towards the armpit is also sore), VACCINATION SITE PAIN (pain if you touch it) and FEELING ABNORMAL (general unease) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment include taking one dose of the doxycycline 100mg and has not started taking the Motrin 600mg.
her right arm started hurting; can't move her arm and Cant raise her arm higher than her elbow height; gradual but it has gotten worse over the last week; her arm is so sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her right arm started hurting), MOBILITY DECREASED (can't move her arm and Cant raise her arm higher than her elbow height), CONDITION AGGRAVATED (gradual but it has gotten worse over the last week) and MYALGIA (her arm is so sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (her right arm started hurting), MOBILITY DECREASED (can't move her arm and Cant raise her arm higher than her elbow height), CONDITION AGGRAVATED (gradual but it has gotten worse over the last week) and MYALGIA (her arm is so sore). The patient was treated with LIDOCAINE for Adverse event, at a dose of UNK dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her right arm started hurting), MOBILITY DECREASED (can't move her arm and Cant raise her arm higher than her elbow height), CONDITION AGGRAVATED (gradual but it has gotten worse over the last week) and MYALGIA (her arm is so sore) had not resolved.            Concomitant Medications were not provided by the reporter.
Patient reported to pharmacy that she had lots of redness and swelling in her arm and was very concerned because it had not gone away
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (dosing details were not reported) orally. There were several previous temperature excursions. Time frame and temperature excursion were not reported, but the reporter stated that the temperatures the vaccine were exposed were above the range and the range was back. There were prior excursion reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Intense erythema,  arthralgia, myalgia left shoulder and left deltoid. Shoulder injured in a jogging injury/ fall twenty years ago (subachromial impingement), but have had no problem with since, became "frozen" and extraordinarily painful (on pain scale its a 9). It is post-vaccine day 10 now and it appears to be showing no signs of abating. Only  relief is 400mg ibuprofen on a prn basis. Cannot lift left arm or extend left arm (abduction). Believe the  vaccine may have caused a vigorous immune response (great!), however it may be an "cytokine storm" which has caused an acute arthritis event. Concerned about immunization #2.
Patient is experiencing swelling and redness to the touch at and around the area of the injection site. Has been progressively getting worse since time of administration
Clinical Indications 62 year old male with progressive symptoms over weeks to months of leg > arm weakness, gait abnormality, dysarthria, dysphagia, fatigue with chewing, and double vision with onset ~3-4 weeks after his J&J vaccine in March 2021. He reached his nadir in late July, with ongoing symptoms with mild fluctuations. His examination shows subtle extraocular movement abnormalities with report of double vision, mild distal sensory loss, and gait ataxia.
hives w/in 24 hrs p/shot; lasted 4-5 days; pt a little more fussy than usual; no other sx talked w/MD on phone & pt was put on DPH;
Injection site reaction at site. Erythema, swelling pain, down to elbow.  Glaxo Smith Kline
chest pain; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 01May2021 10:30 (at the age of 59-years-old) as a single dose for covid-19 immunization. The vaccine was administered at the Pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The next day morning on 02May2021 05:00, the patient experienced chest pain. The event was considered as life-threatening. It was unknown if the patient received treatment for the event. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sore arm; Fever; Chills; Body ache; Joint soreness; Headache; Generally felt like a very bad flu for 2days so far; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 17Apr2021 at 10:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 12:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 17Apr2021 at 19:00, the patient experienced sore arm, fever, chills, body aches, joint soreness, headache and generally felt like a very bad flu for 2 days, but started to get better. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Therapeutic measures were not taken as result of the events. The clinical outcome of the events sore arm, fever, chills, body aches, joint soreness, headache and generally felt like a very bad flu for 2 days were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
At midnight that night she experienced a hemorrhagic stroke which led us to the ER and subsequently her being admitted to the stroke ICU for 19 days - where she had a brain surgery via angiogram to embolize the hemorrhage.  It was successful with lingering vision problems and headaches
24 hours after sore body headache neck very sore... 30 hours after sore body neck sore headache nauseous
so much body pain/ most painful thing; I though my bones were breaking in; spend 3 days in bed; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced general body pain, bedridden and bone pain. On an unknown date, the outcome of the general body pain, bedridden and bone pain were recovered/resolved.   It was unknown if the reporter considered the general body pain, bedridden and bone pain to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 21-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. When the patient got the vaccine, he/she had made the mistake by taking both the vaccine on same day, Shingles and flu shot and it was the most painful thing the patient had experienced.  The patient though his/her bones were breaking in.  The patient was in so much body pain and had spent 3 days in bed, and when it was time for his/her second shot of shingles it was fine. Additional supportive information: The follow-up would not possible as no contact details were available.
BODY ACHE; FEVER; This spontaneous report received from a vaccine facility concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced body ache. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body ache was not reported. This report was non-serious.
Pt complaining of the inability to move arm and it hurts. Pt does not state any swelling.
Varicella rash, approx 75-100 lesions. Temp 101.5
Feeling sick as hell after taking the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Feeling sick as hell after taking the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Feeling sick as hell after taking the vaccine). At the time of the report, ILLNESS (Feeling sick as hell after taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported   Reporter did not allow further contact
Injection site - severe itchy, swollen with "golf ball" size lump, redness, heavy "dead arm" with loss of sensation
patient received a flu vaccination and a Pfizer  covid vaccination.  Patient fainted after vaccination but quickly regained consiousness
It started with a headache that became of body aches and fever. 36 hours later, I lost my sense of taste and smell. I took 2 at-home COVID-19 tests on 10/28/2022 which both came back positive. I called my doctor who prescribed me PAXLOVID for treatment on 10/29/2022 which helped a lot. As of now, I'm doing much better but still have a lingering cough since catching COVID-19.
The adolescent and mother misrepresented patients age at time of vaccination. At an outreach clinic one dose of Pfizer was remaining. Vaccine coordinator for site/office asked if this individual could receive a the last dose to exhaust and not have a wastage. The coordinator was informed they could as long as the person was at least 16 y/o old.  He was reported as being 16 so mother brought him to site to receive vaccination. Before administering the vaccinator asked patient if he had just turned 16 and he reported "yes".  On the consent form his birthday was clearly written. Which would have made him 16 at time of administration.  Vaccine was given and individual had no issues on site.  While trying to document in patients online/electronic shot record staff could not locate him under the date of birth written and verified by mother and patient.  It was later verified by mother that his year was 2006 and not 2005. State immunization MD notified and was informed to administer the second dose when the 21 days is due and to file a Vaers report since adolescent was under 16.
Starting midday Sunday ( one day after vaccine) I started feeling nauseous and about 2:00 I started throwing up. I threw up until about midnight for a total of 7 times. The night before I had difficulty sleeping. The next morning I felt nauseous again and threw up about 10:00 a.m. I started having diarrhea which has lasted through today (Thursday) and I had lost over 5 pounds in just 3 days and my weight is still over 5 pounds less today because it is difficult to eat much. Sunday I was feeling pain around my lest breast where I had had my mastectomy in June of 2006. That eased up the next day.  Feeling stressed because I have bad tinnitus and was worried about a reaction.
Coughing blood; Nosebleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (Coughing blood) and EPISTAXIS (Nosebleed) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMOPTYSIS (Coughing blood) and EPISTAXIS (Nosebleed). At the time of the report, HAEMOPTYSIS (Coughing blood) and EPISTAXIS (Nosebleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
orthostatic dizziness began one week after vaccine.  eventually progressed into 2nd degree type 2 heart block.  Had v Tach.  Got a pacemaker.
Embolic appearing stroke of the right frontal lobe  acute deep veine thrombosis (DVT) of distal vein of left lower extremity (CMS/HCC) Small Bilateral pulmonary emboli Eliquis prescribed
Could not lift arm about 2-3 hours after shot was administered--have had chronic pain ever since, could not sleep for about a month and used heat wraps on upper arm. Reported my event to pharmacy three times. Pharmacist suggested that I see my family physician which I did. She ordered an MRI and referred me to an orthopedic surgeon. He said my shoulder/arm condition was not related at all to my degenerative disc problem and gave me a steroid shot to relieve the pain. The MRI showed fluid on my arm and the diagnosis was inflammation. I have since had open neck surgery to replace discs, and the surgeon at hospital also said my left shoulder and arm problem was not related to the disc problem and suggested I see a neurologist. I will see my family physician tomorrow who will refer me to a neurologist. Please note that the flu shot was injected on my shoulder rather than my upper arm which my doctor was concerned about. It has been six months since I received the high dose flu shot, and I need some answers as to why I am still having significant pain and lack of mobility, and am concerned about this condition being permanent.
A mother reported that her son received injections of Hib-Titer and DTaP vaccines from 5/5/00 through 10/25/00. She began to notice developmental delays at approximately 8 to 12 months of age. She stated that he has since been diagnosed with multi-system developmental disorder which she believes is due to mercury poisoning from his childhood vaccines. She reported that he has been seen by various specialists including speech and developmental specialists. These events were considered medically important (OMIC). No further information was available at the date of this report. Follow up info received from the physician on 1/7/03 provided his assessment. A mother initially reported that her son received injections of Hib-titer and DTaP (manuf unk) vaccines from 5/5/00 through 10/25/00. She began to notice developmental delays at approximately 8 to 12 months of age. She stated that he has since been diagnosed with "multi-system developmental disorder" which she believes is due to mercury poisoning from his childhood vaccines.She rported that he has been seen by various specialists including speech and developmental specialists. The physician reported the child "has always been developmentally on track with his fine and gross motor skills." On 4/24/02, the child underwent a developmental assessment. The evaluator concluded that the child is delayed in expressive and receptive speech. The physician feels that the child's only delay at this time is his language. These events were considered medically important.
made my period 3 weeks late; sunburn; injection site pain; swelling in arm; Pain when lifting arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 29Aug2021 as dose 1, single (Lot number: FC3184) at the age of 27 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS", start date: 2017 (ongoing); "Migraines", start date: 2020 (ongoing); "GERD", start date: 2018 (ongoing); "absence of periods", start date: Aug2021 (ongoing); "Flu", start date: 2014 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "not recovered", described as "made my period 3 weeks late"; SUNBURN (non-serious), outcome "not recovered"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "injection site pain"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "swelling in arm"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain when lifting arm". Therapeutic measures were taken as a result of menstruation delayed, sunburn, vaccination site pain, peripheral swelling, pain in extremity.  Additional information:  Prior to vaccination, the patient did not received any other vaccination within the four weeks of vaccination. Therapeutic measures were taken as a result of adverse event MENSTRUATION DELAYED and included treatment with Provera pills (Start Date: Jan2022; Stop Date: Jan2022), to reduce menstrual cycle. The patient did not undergo anu relevant lab relevant test for Thromboembolic Events with Thrombocytopenia. The adverse events required the initiation of new medication, other treatment or procedure that included medication to induce menstrual cycle. The patient had sunburn only at injection site pain and swelling in arm. Pain when lifting arm. Made my period 3 weeks late. Periods were normal until 1st shot. The patient had flu 5 times since 2014 and the side effects from the vaccine were worse than any flu the patient have had. for reference the patient had normal periods. Had a period 28Jul2021-31Jul2021. 1st shot on 29Aug2021. Period 3 weeks late came on 13Sep2021-17Sep2021. 2nd shot on 20Sep2021. no period since had a period on 20Feb2022-26Feb2022 with the help of medication. After that period the patient haven't had a period as of 31Jul2022. So have not had a period without medication, naturally since 28Jul2021.; Sender's Comments: Linked Report(s) : PV202200027324 same reporter/patient, different dose/AE.;
10/29/04 C/O site reaction and noted red edematous area where Flu shot given 10/28/04. States 1 week after site reaction had hive like ruddy rash from shoulders- ankles, follow by swelling of face, lips and hands. States went to ER and had injections. Follow by steriod dose pack.
Soreness at the site in injection.  Couldn't sleep that entire night.  Woke up with sweats and chills. Felt absolutely exhausted the  following day with little to no appetite.  Slept soundly (unusual for me) that night and felt absolutely fine the next day.
30SEP98 exp malaise, abd complaints, sleepiness;taken to ER dx benign rxn to flu vax;taken home later devel vomiting;mom found child unresponsive taken back to ER;child pronounced in ER;autopsy had acute hemorrhagic pancreatitis;
4/21 received DTaP on left deltoid, next morning small redness on left arm. 4/23 increased redness and swelling. 4/24 increased redness and swelling with pain, Tylenol po given. Benadryl cream applied; swelling and redness decreased after several days. 4/28 - bluish coloration still remains.
My arm hurt at the injection site for a day and it got better. I tested positive on 06/07/2022 for COVID-19 via PCR test. The home test showed that I was negative for COVID-19. Symptoms: runny nose, scratchy throat, cough and fatigue. I was switching my epilepsy medication at the time of vaccination which could contribute to the fatigue. I went to a COVID clinic for the PCR test. When I was diagnosed positive, I had a telehealth visit with my primary doctor and was given the prescription molnupiravir.
Violent chill/cold sweats, constant vomiting, body aches. Lasted about 16 hours.. then on to body aches, sluggishness,  still nausiated when I try to eat....
Size 10 cm X 8.5 cm red, warm, hard, itchy at injection site (R) arm.
8/8/21 She continues to be less responsive than normal and is sleeping more.  No noted fevers or chills at home.  No complaints of pain, nausea, dysuria or other urinary symptoms that they are aware of.  She does have a chronic cough which is unchanged from baseline.  Due to her continued decline, she was brought to the ED this afternoon for evaluation.  There, vitals were stable.  Labs were significant for Na 116, normal creatinine, WBC 5.3, lactate 0.8.  Repeat urinalysis was not suggestive of infection.  CXR was obtained due to cough and was clear.  Head CT was negative.  She received a 500 NS bolus and has been admitted to the Medicine team for further care.  Admitted on 8/8/2021
Left arm with severe swelling from elbow up, hot to touch, severe pain still present 24 hrs later.