chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm swelling with red circle area the size of a grapefruit , in center brusie appearance, very warm and itching hard and hurts to touch Applied cold pack several times daily , took Tylenol when it appeared  after 5 days still there  and called Doctor took Benydryl, Doctors advise.  Itching spread to back and neck very intense at times,  rash like reaction. Did get the chills fever dizziness the day after the shot and lasted until Monday, 03/01/2021 but then rash started on neck/head/back and arm still not back to normal.
tired/fatigued; arm was bruised/arm turned blue from the site of injection to elbow to under armpit; arm is red; arm is achy - still hurts; hematoma on arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired/fatigued), INJECTION SITE BRUISING (arm was bruised/arm turned blue from the site of injection to elbow to under armpit), ERYTHEMA (arm is red), PAIN IN EXTREMITY (arm is achy - still hurts) and HAEMATOMA (hematoma on arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired/fatigued), INJECTION SITE BRUISING (arm was bruised/arm turned blue from the site of injection to elbow to under armpit), ERYTHEMA (arm is red), PAIN IN EXTREMITY (arm is achy - still hurts) and HAEMATOMA (hematoma on arm). At the time of the report, FATIGUE (tired/fatigued), INJECTION SITE BRUISING (arm was bruised/arm turned blue from the site of injection to elbow to under armpit), ERYTHEMA (arm is red), PAIN IN EXTREMITY (arm is achy - still hurts) and HAEMATOMA (hematoma on arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not provided.  Action taken with mRNA-1273 in response to the event was not applicable
20-30 minutes after vaccination, slight dizziness followed by increased and pronounced heart beat, tightness in chest and throat, difficulty breathing. Returned to location where shot took place. Took 50mg BENADRYL and escorted to ER. 120mg I.M. BENADRYL over night symptoms continued despite more BENADRYL. Went to allergist, another ER for cardiac symptoms. Cardiologist Internist, multiple test and PREDNISONE prescribed.
Pfizer covid vaccine  diluted 0.2 ml instead of 2.2ml
Got shot at 1:30 pm.  at 1:45 started to have sensation of throat closing.  I took a benedryl.  Drove home, about an hour away.  During the drive home, experienced lip swelling and throat swelling.  Went directly to Hospital ER at 2:45 pm.  I was given dexAMETasone, diphenhydrAMINE, andfamotidine.  Swelling went down, and I went home about 4:00 pm.  I had no problems at home.  I saw my family doctor the next day.
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff). This case is linked to cases 2019SA088988 and 2019SA089011, same reporter. This case involves a 24 months old patient who received vaccine DAPTACEL. The patients past medical history and family history were not provided. Concomitant medications included HEPATITIS B VACCINE on 27-Mar-2019. On 27-Mar-2019, the patient received a 0.5ml dose of suspect DAPTACEL lot C5171AA, expiry date 23-Mar-2019 via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was reported that patient received expired dose of DAPTACEL vaccine on 27-Mar-2019 which got expired on 23-Mar-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Swelling, redness, left anterior thigh. Baby extremely fussy. TYLENOL administered as well a cool compress to affected area.
Received an incorrectly stored vaccine; A spontaneous report was received from a consumer concerning herself, 70 years old, female patient who received an incorrectly stored vaccine/Product storage error.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received the first of two planned doses of mRNA-1273 (Batch number: 025A21A) on 1 Mar 2021 at unknown injection site for prophylaxis of COVID-19 infection.    The patient received an incorrectly stored vaccine first Moderna vaccine 1 Mar 2021. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event received an incorrectly stored vaccine was not reported.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # 025A21A  with no associated AEs.; Sender's Comments:  MOD21-041814:Crosslinked same reporter MOD21-041815:Crosslinked same reporter
Injection site slightly stiff post injection.   06/12/2021     02:00pm.  experiencing extreme vertigo symptoms.   One hour later reclined for a 2 hour nap.  Awoke  feeling a small bit better.  Upon arising experienced chills, body aches, fatigue and extreme "over the toilet nausea".  BP slightly elevated
Received their third dose of ROT ATEQ at 9 months of age instead of 6 months of age; This spontaneous report as received from a nurse prescriber refers to a 9 month old patient of unknown gender. Medical history, concurrent conditions, and concomitant medications were not reported.  On unknown date in 2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally; and approximately in April 2020, the patient received second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ)orally (Dose, Lot number, and expiration date were not provided) prophylaxis.
Severe popular rash all over lower legs, tops of feet and trunk. Unable to stop itching.
Started with fever 08/04/2003 AM- 104 08/07/2003. 08/08/2003 AM started with rash and gradually spread over entire body.
persistent dysphonia since last yer (94-95 season) vax; evaluated by 8 different physicians;no on Klonopin w/ 50% improvement in voice quality;
Patient states that arm was hot to the touch, red area and swelling. It started the day after receiving vaccine.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 58 years old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown day in May 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date in 2016, the patient experienced herpes zoster (shingles). As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The outcome of the event of shingles was considered as not recovered. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX).
Child received immunizations on 12/2/02. On 12/3/02, child broke out with rash on entire body. On 12/5/02, was taken to MD and told it was an allergic reaction and to give Benadryl and to report it to Health Dept. Still has rash.
multiple bilateral Pulmonary emboli; pulmonary hypertension; short of breath; right heart strain; This is a spontaneous report from a contactable nurse. A 68-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number=EH9899), via an unspecified route of administration at right arm on 22Dec2020 08:00 AM at single dose for COVID-19 immunisation.  Medical history included uveitis, arthritis and known allergies: pine nuts. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. The patient was not pregnant. Concomitant medication included prednisone (eye gtt), naproxen as needed (PRN) less than weekly.  The patient previously took theophylline and experienced allergies. The day after getting the first dose of vaccine the patient worked all day in another (clinic withheld). She felt well all day, but at 6 pm when she left to go to her car she was so short of breath she had to stop twice to get there. Subsequent work up has shown that she had multiple bilateral Pulmonary emboli resulting in pulmonary hypertension and right heart strain. Adverse event start date was 23Dec2020. Adverse event start time was 06:00 PM. The adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 1 day, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events included Lovenox and Eliquis. The outcome of the event was recovering.; Sender's Comments: Based on available information and known drug profile the reported events are unlikely related to bnt162b2 .  These are probably intercurrent medical condition.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: patient started having pain in armpit and redness and swelling in deltoid 1 week after the vaccination-Medium, Systemic: Lymph Node Swelling-Mild, Additional Details: paitent received the vaccination on the 18th. on the the 25th, she stated complaining of armpit swelling and pain and rash and pain in the deltoid.
Very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today; pain and pressure in head through today; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 20Jan2021 07:45 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines weeks prior to receiving bnt162b2. The patient was not pregnant. Prior vaccination, the patient was not diagnosed with covid. Medical history included prone to headaches. She had no known allergies. Concomitant medications included clarithromycin (CLARITIN), dextroamphetamine [dexamfetamine], fish oil, and "Olly multivit". On 20Jan2021 02:00 PM, the patient experienced very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today, Day 6 after vaccine, and counting. No corrective treatment was received. Outcome of the events was not recovered. The patient was not tested for covid post vaccination.   Information on the lot/batch number has been requested.
Rash around area where vaccine was administered.  1 puss like dot. Treatmant with Atarax.
This spontaneous report was received from a registered nurse and refers to an 11 month old male patient. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The registered nurse informed that on an unknown date, one day before the the patient's first birthday, he was vaccinated with a dose of VARIVAX, subcutaneously for prophylaxis (strength, dose number, dose, lot # and expiration date were not reported). No adverse effects were reported in the patient.
burning instanly in shoulder. after couple hours severe shoulder pain. Immobility of the arm, nerve sensation and excruciating pain. Pain has persisted in its 5th day as of report. Seen in an ER. DIagnosed as muscle nerve pain
10/21/2010 - at 8pm started not feeling well (bad headache, dostinex). 10/22/2010 - fever of 105 degrees F, achy, headache, neck ache. 10/23/2010 - fever of 105 degrees F, achy, headache, neck ache; went to ED. 10/24/2010 fever of 102 degrees F, achy, headache, neck ache till 5pm had IV fluids in ED; TORADOL & had blood work done. Had been alternating between TYLENOL and Ibuprofen.
Narrative: 72y.o. male patient who received dose #1 of Moderna COVID vaccine (Lot #013A21A, exp 8/20/21) on 3/5/21 and dose #2 of Moderna COVID vaccine (Lot #018B21A, exp 9/16/21) on 4/2/21. Patient has a PMH of CVA in 2018 and nonverbal since, diabetes mellitus (daily insulin), A Fib (on apixaban), essential hypertension, Alzheimer dementia diagnosed 7 years ago. Patient presented to ED on 4/2/21 for worsening weakness over the 1 week. A CT at facility showed a chronic subdural hematoma he was subsequently transferred to Hospital for neurosurgical evaluation. Provider was consulted and recommended nonsurgical management. CT scan showed Right subdural hematoma 1.7 cm with a right to left midline shift. The patient was placed on comfort care and passed on the morning of 4/13/21.
Sore arm; swollen and red arm; Red blotches, red arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (swollen and red arm) and ERYTHEMA (Red blotches, red arm) 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) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (swollen and red arm) and ERYTHEMA (Red blotches, red arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (swollen and red arm) and ERYTHEMA (Red blotches, red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (MANUFACTURER UNKNOWN)), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 22Apr2021, outcome "recovered" (Apr2021), described as "Chills". Therapeutic measures were taken as a result of chills. Additional information: The patient had his heater on to help with his chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was required to be re-vaccinated for Hep B for school. I did not have any adverse reactions to the first 2 vaccines but the 3rd vaccine of the series caused severe side effects. A couple hours after receiving the vaccine, I started to feel dizzy and my vision became very blurred. Later that evening, a headache set in as well. All I could do for the next few days was sleep. I did not feel safe driving and had a lot of difficulty with reading. Five days later, the headache and dizziness have subsided but my vision is still a bit blurry.
Given the booster shot within the 6 months window. 2nd shot - 09/02/2021 3rd shot - 10/01/2021
The day after receiving vaccines I woke up with dizziness and it continued until I went to ER about two days later, I was feeling pressure on my chest and my blood pressure was elevated even though I take Nitro Slow caps and Maxide for BP. I was at the ER from 5:45pm to 9:45pm being administered to with drugs to put me to sleep. I had a reaction to the drugs. I felt like all my nerves were screaming and about to burst (for lack of a better word) and wanted to get up and walk because of this creepy crawly feeling in my entire body. the more drugs I was given the worse it got until I was finally knocked out, so my ex husband who was with me told me. He drove me home and I was still dizzy and passed out on the bed at home. The doctor at Emergency prescribed meclizine 25 for the dizziness. since he diagnosed middle ear infection or a virus, we filled only the meclizine which didn't help to control the dizziness. On Friday June 30 I went to my primary care Dr. I feared leaving the country July 6th and asked him to check me out, he prescribed a patch for the dizziness which lasted 3 days. I took those until I boarded the plane, July 5 which finally controlled the problem, Thank God. We were I sincerely hope this report I have given will help your dept in better understanding vaccines and possible side effects.
ability to bleed and bruise more easily; Heavier than normally menstrual cycle with blood not clumping; ability to bleed and bruise more easily; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm right on 15Apr2021 12:30 at age of 26-year-old (Batch/Lot Number: EW0162) at single dose for COVID-19 immunization. Medical history included asthma, diabetes, polycystic ovary syndrome. The patient is not pregnant. The patient had known allergies to latex, berries and seasonal. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 12:00, the patient experienced heavier than normally menstrual cycle with blood not clumping, and ability to bleed and bruise more easily. The events were reported as non-serious. The events did not resulted in hospitalization prolonged. Treatment was received for the events which included tranexamic acid 650mg for 5 days. The patient received second dose on 08May2021 (Batch/lot number: EW0167) in arm right for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.   No follow-up attempts are needed. further information is expected
Paralysis of both legs resulting with inability to walk, doctor treated with steroids, out of hospital 01/11/2013, ongoing therapy, still cannot walk.
Developed 101.1 fever starting 12 hours after injection. Went from 99.9 at first onset. Next day grew to 101.1 degrees. Finally fever broke in early morning hours after 1-1/2 days of feeling ill. Stayed hydrated with 7-up and water every hour or so, no food. Slight bit of nausea. Normal temperature is 97.6. Some aches in neck area, slight hurt at injection site.
I had fever, chills, shivers, head pain for 48 hrs after. Both legs became extremely cramped feeling (charlie horse and tingling) for about 14 days after. My right leg still has episodes of this problem.
Woke in the night feeling like the flu -- fever, body aches, headache. It's now near 12 noon the next day, took ibuprofen for headache & fever, symptoms subsiding. Fever was 99.7
R shoulder/upper arm pain that began suddenly, gradually worsened from 7/10 - 10/10. Pain radiated to middle upper back. Nausea. Anxiety.
pt reports received Vaccine on 1/7/21.  she did have a biopsy on scalp 1/6/21 for possible basal cell.   Woke up 1/10/21 with some swelling noted around both eyes and forehead.  She has no other symptoms.  She did take some OTC benadryl last night before bed and woke up this am with no change in swelling noted.   she was unsure related to vaccine or related to the scalp biopsy.
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of varicella virus vaccine live. On approximately 23-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/12/2006. Information has been received from a registered nurse concerning an elementary school-aged child who on 12-FEB-1999 was vaccinated with a dose of VARIVAX (Merck). On 21-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Patient developed scattered erythematous maculopapular rash to bilateral arms 20 minutes post vaccination. Denies itching, lip/ throat swelling, dizziness, shortness of breath. Patient appears comfortable and talking in complete sentences.   Vitals: BP: 135/69 BP Location: LA-LEFT ARM Pulse: 78 Resp: 16 SpO2: 99%   Benadryl 25 mg po administered.  15 minutes post Benadryl administration: patient remains comfortable, no distress. Rash stable, not worse. Denies itching, lip/ throat swelling, dizziness, shortness of breath. BP 141/79, pulse 68, O2 sat 99%. Patient discharged in no distress. Ambulated out of observation area. Advised to follow up with primary care physician. Go to ED for life-threatening events.
This spontaneous report was received from a healthcare worker (also reported as secretary) regarding multiple unspecified male patients of unknown age. The reporter stated that on an unknown dates multiple unspecified male patients were vaccinated with GARDASIL (dose, frequency, product lot/expiry date not reported) in their office and have passed out after receiving the dose. The causality and outcome of the event was unknown. Additional information has been requested. This is one of report received from the same source.
Pt became diaphoretic, blurred vision and shaky. Pt was brought to tent. Laid on cot in trendelenburg psotion. Symptoms resolved, as pt was able to drink, stand up and walk well. Released at 1:13pm.