chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in legs and toes, She kept scratching and it kept moving to another location), INDURATION (Legs and feet feel hard) and PERIPHERAL SWELLING (heavy swelling in legs from feet up to thighs.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (Itching in legs and toes, She kept scratching and it kept moving to another location). On an unknown date, the patient experienced INDURATION (Legs and feet feel hard) and PERIPHERAL SWELLING (heavy swelling in legs from feet up to thighs.). At the time of the report, PRURITUS (Itching in legs and toes, She kept scratching and it kept moving to another location), INDURATION (Legs and feet feel hard) and PERIPHERAL SWELLING (heavy swelling in legs from feet up to thighs.) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient was wearing compression socks which did not work for the events. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant Followup received and 2 new events, second dose details,  patient's  contact details and date of birth updated.
Mild chest pain while breathing. Will not be treating. It's only been 24 hours so far.
Breakthrough COVID case. This patient completed pfizer series 1/8/21 and became positive 6/5/21
within 2minutes i felt my feet and toes get hot. whole body. thot it was just a reaction. later that day and  overnite feet very hot. now its 5days later its so much worse. very numb in whole leg, right foot the most, very tingly-painful, asleep type feeling, But Way Worse. im very scared. hands and fingers, and whole body feels real bad. . feels like dead nerves happening.
Instant Headache and feeling of Light headiness after admin of Vaccine. Then on 1/27/2021 at 1:30am I work with my left arm throbbing, hot to touch,  and very swollen. My Headache and Light headiness had gotten worse. Developed body aches and chills. Took 1,000mg Tylenol Q6h and 800mg of Ibuprofen TID.  Symptoms last for a total of 30 hours.
I had a little soreness at the injection in both arms for a day. I tested positive for COVID-19 on 01/05/2023. I contacted my doctor and got a prescription for Remdesivir.  I tolerated the medication without any difficult. The first time I tested positive COVID-19 was on 01/16/2022. I did not go to the doctor but I self-isolated and drank lots of fluid. I had shortness of breath, fatigue and a burning in my chest. As of today, I continue to have shortness of breath.
Approx 1/2 hour after receiving the vaccination I began to itch on my ears, arms, and feet.  I then notices small red bumps or hives in these areas.  It is now eight days after my shot and I am still experiencing hives and itching which is only relieved by taking benadryl.  After the benadryl wears off the symptoms return.
10/21/2014 - Severe headache, blur vision, light sensitive, dizziness, passed, out went to ER was diagnosed with Vertigo; 10/22/2014-Same symptoms as the above, went to ER and was diagnosed with Syncope; Same month 23/27/30/31- Had same symptoms as above, but this time didn't go to ER; Have more but running out of time to fill in all dates and events.
5cm long 3cm wide warm to touch.  Given 6-17-08 blotched noted by 6-18-08.
she felt her blood pressure was up and so she checked, it was at 179; her sugar was down; Dizziness; Weakness; Nausea/felt sick to her stomach; Diarrhea; Headache; Tiredness; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER VACCINE SHOT; lot number: EL3248; expiration date: unknown) at vaccination age of 84-year-old via an unspecified route of administration in the left arm on 29Jan2021 09:20 at a single dose for covid-19 immunization. Medical history included open heart surgery, diabetic/diabetes, high blood pressure, bone and joint problems, and her bones were already hurting for a long time before. She was calling because she was asked if she was allergic to anything, she is allergic to one medication, but she thinks they need to know more about her health conditions before giving this medication. Familial history included all of her family that has passed, died of diabetes or cancer. Concomitant medications included unspecified other blood pressure medication and nifedipine for blood pressure. The patient did not receive other vaccination within 4 weeks. The patient reported that she took the shot on 29Jan2021 and she stayed for the 15 minutes, but she didn't have any feeling about it. A little more than an hour later (29Jan2021), she had a slight headache, then she got tired and felt like she needed to lay down. She did lay down and slept 9 hours. The patient reported that she felt her blood pressure was up and so she checked, it was at 179 [unspecified unit]. It was at that point she called her children and told them she was not doing well. She does feel this is under control at this point. The next morning (30Jan2021), she had dizziness, weakness, felt sick to her stomach, and had a slight headache. She clarified that the sick to her stomach feeling was nausea and diarrhea both started on 30Jan2021. It had resolved as of 31Jan2021. She mentioned that she feels better but the tiredness is still going on today. It is explained that her blood pressure was up and her sugar was down on 30Jan2021, she is a diabetic. She takes blood pressure medication, but it wasn't bringing it down at first. She explained that when she took her blood sugar it was 70 [unspecified unit] something on 30Jan2021. Her normal is 120-121 [unspecified unit] (unspecified date) and that is where she likes to keep it so that was a problem. She has had to eat sweets to get it up, but it won't stay up. She reported that the tiredness, dizziness, and headache are still going on right now. She was calling because she was asked if she was allergic to anything, she is allergic to one medication, but she thinks they need to know more about her health conditions before giving this medication. She feels they should ask more questions or have the doctor send a recommendation over or information about a person. The outcome of the events headache was not recovered, as for the events dizziness and tiredness were recovering while the outcome of the events nausea and diarrhea were recovered on 31Jan2021. The outcome of the other events was unknown.
Constant pain in left arm at location of shot. More pain with movement and with lifting. Has been new and constant since the second shot. Has spread to chest, shoulder, and upper left back muscles. Ibuprofen reduces pain and mostly receded to arm muscle at injection area. Flares up to include other muscle groups without Ibuprofen.
This spontaneous report as received from a pharmacist refers to a 63 years old female patient. The patient was vaccinated with ZOSTAVAX on 26-OCT-2012, via injection in the back of the arm. The dosing regimen was not reported. The patient's medical history and past history were not reported. No other co-suspects were reported. No concomitant medications were reported. On 29-OCT-2012 the patient reported to the pharmacy that she experienced headache, furthermore the whole back of her arm was red. The patient had experienced a knot in her arm, from which she had recovered at the time when she reported the events. The onset dates were not reported. The outcome of the redness of the back of arm and the headache were unknown. No treatment information was reported. The reported relatedness for all reported events was unknown for ZOSTAVAX. Additional information has been requested.
Initial report received from a consumer (patient) on 20 September 2012. A 39-year-old female patient, with no illness at the time of vaccination and no known allergies whose concomitant medications were not reported, received first dose of FLUZONE ID (lot number: unknown) intradermally in the left deltoid area on 19 September 2012. On 19 September 2012, approximately 6 hours after vaccination, patient's arm became sore, warm to touch, red at site with a dime sized bump surrounded by a larger bump half dollar sized, and area was itching to underarm. The patient had returned to pharmacist on 20 September 2012; however the pharmacist did not offer any corrective treatment. As of 20 September 2012, the patient had not recovered from the events. List of documents held by sender: none. The follow-up information received from a healthcare professional on 22 October 2012. The pharmacist stated that the vaccine administered incorrectly so the nature of the report was considered as misuse. The patient received the FLUZONE ID vaccine with lot number UT4470AA. Corrective treatment was not offered. It was reported that, the patient received 2 intradermal injection and both caused patient more pain and discomfort than the prefilled and syringe.
right arm numbness, sensation of heat in the arm and neck, SOB, subjective feeling of throat constriction
Severe allergic reaction to a bee sting 4 months following vaccine.  No previous reaction to bee stings.  Resulted in an emergency room visit.
Fatigue; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) via an unspecified route of administration at left arm on 03Apr2021 at 16:30 (47-year-old and not pregnant at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included bronchitis, elevated blood pressure, seasonal allergies (dust and pollen allergies), muscle pain, and back pain. Prior to vaccination, the was not patient diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ALLER TEC, lot number: 9BE2641B, expiry date: Dec2020, patient says this is a Zyrtec generic) for seasonal allergies; naproxen sodium (ALEVE LIQUID GELS, lot number: 87167925, expiry date: May2022) for a couple years for her muscle pain and back pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 05Apr2021 at 12:00. The adverse event did not result in emergency room visit or physician office visit. Patient said she took both of cetirizine hydrochloride and naproxen sodium after getting her first dose of the vaccine since that was her normal night routine, and it didn't occur to her that it might interfere with the vaccine. She said she would like to know if she needs to stop taking these medications before her second dose on 24Apr2021. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, Fever, chills, soreness and swelling at injection site Narrative:  Other Relevant History:
pt recv vax; arm very sore, HA; lt leg starting cramping in calf; soon rt calf started cramping;p/ 25 min of inc cramping & pain, big spasm in rt calf and "threw pt to the ground"; pt felt like muscle was torn;limped for 3 days per pt;HA;
w/in past 6mo pt was immunized w/vax;pt presents to ER w/herpes zoster, lt thoracic, shingles;dx shingles on PE or vesicles in ER;
The first few days, I had flu-like symptoms. After I got the vaccine - my migraines became very severe - they would last for days. They became unmanageable and I had to go to ER.  I have asthma - it's a lot harder to breathe - this is on and off. It used to be once in awhile I need my inhaler but now I need to use it more. It feels like I'm catching my breath a lot more now.. My rashes went away - but I had had rashes (random places - arms/legs) that came and went for the first two weeks after the vaccine. I went to hospital ER on the 12th of April - because my migraines were so bad that my blood pressure went up to 200 something and they had to clear me to make sure I wasn't having a stroke. I have always had migraines but the only thing different that has changed the severity is the vaccine. I just finished off the steroids' - Progesterone that the neurologist (at ER)(the one that called the cold stroke) prescribed to me. But that didn't really help. I'm waiting for approval from insurance for another medication. Saw another neurologist - after the ER visit.
ADMINISTRATION OF PUNCTURED VIAL  AFTER 6 HOURS; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: 01-AUG-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced administration of punctured vial after 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of punctured vial after 6 hours was not reported. This report was non-serious.
Vaccination error: Pt was given MMRV and Varicella together during today's visit (01/26/2022) for immunizations.
Per patient, symptoms started at night on the day the shot was given. Started with a small bruise, swelling, a little tender, hot to the touch. Bruise spreads downward on the left arm, still hot to the touch; swelling has gone down; not much pain. Patient did not receive any treatment yet.
I have ehlors danlos syndrom and live in chronic pain. my pain is 100 time worse now that I have recived this vaccine- please take this pain away; I have ehlors danlos syndrom and live in chronic pain. my pain is 100 time worse now that I have recived this vaccine- please take this pain away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jun2021 04:30 (Lot number: EW0191) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "EDS" (unspecified if ongoing); "Turners" (unspecified if ongoing); "PVC" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Drug allregy: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Name : Covid-19 vaccine, Batch/lot number: EW0167,Anatomical Location: Arm Left    Dose Number: 1), administration date: 10May2021, for Covid-19 immunization. The following information was reported: PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Jul2021, outcome "not recovered" and all described as "I have ehlors danlos syndrom and live in chronic pain. my pain is 100 time worse now that I have recived this vaccine- please take this pain away". It was unknown if therapeutic measures were taken as a result of pain, condition aggravated.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Chills, shaking, aching joints the night I received vaccination. Joint pain and swelling became worse over time and ended up in Urgent Care with Prednisone. Symptoms to date have not resolved
Mild dizziness; Mild pressure in my mid-chest (2 out of 10 in discomfort, felt like a bearing down/pressure, not a pain); Mild fatigued; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route in the left arm on 21Apr2021 at 10:00 (at the age of 49-years-old) as single dose for COVID-19 immunisation. Medical history included allergy to adhesive. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within four weeks of COVID vaccine. Concomitant medications included ascorbic acid (ESTER C) and colecalciferol (VITAMIN D3); both for unknown indication from unknown date and unknown if ongoing. The patient previously received tetracycline and experienced drug allergy. On 21Apr2021 at 10:15, the patient experienced mild dizziness within first 15 minutes of vaccine and mild pressure in mid-chest (2 out of 10 in discomfort, felt like a bearing down/pressure, not a pain). These lasted for several days (approximately five days), but did not worsen. The patient experienced no other symptoms other than mild fatigued. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of mild dizziness and mild pressure in mid-chest (2 out of 10 in discomfort, felt like a bearing down/pressure, not a pain) was resolved on an unknown date Apr2021; while that of the event of mild fatigued was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
1-21-21 7-Days- after shot - swollen, Red Arm, itchy - Area - 2"x4", hot to touch - Took Benadryl after noticing. Irritation- Now - 1-25-21 - minimal Redness 50 cent piece size Tender to touch -
July 25 : sore throat July 26 - July 30 :Nasal congestion, sore throat
Vaccination site has developed gray hard scab with a "knot" under skin. No redness, itching, or blisters. Patient does not complain of pain or any other symptoms only complains scab will not come off. Suggested cool compress and notify if any further complaint.
Syncope approx. 10 minutes after vaccinations. Observed in treatment room for 1 hr. Vital signs, observed for head injury.
Pain at the injection site; Swelling at the injection site; Redness at the injection site; slight arthralgia; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), ARTHRALGIA (slight arthralgia) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ARTHRALGIA (slight arthralgia) and FATIGUE (tiredness). On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 07-Apr-2021, ARTHRALGIA (slight arthralgia) and FATIGUE (tiredness) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient concerned about a blood clot.  Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment : Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Injection site pain, injection site redness,  injection site swelling, fatigue and arthralgia are consistent with the product known safety profile   This case was linked to MOD-2021-101007 (Patient Link).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Injection site pain, injection site redness,  injection site swelling, fatigue and arthralgia are consistent with the product known safety profile
Information has been received from a licensed visiting nurse concerning a 13 month old male with no past medical history record who on 03/23/2001 at 10am was vaccinated with the first dose of varicella vaccine SC in the left upper arm. There was no illness at the time of vaccination. On 05/13/2001 the pt developed lesions with watery blisters, described as itchy. It was noted that the pt or sibling did not experience an adverse event following previous vaccinations. There was no further info provided. No further info is expected.
approx 2hr p/vax pt exp fever 101, chills, aching & bone pain;acute phase lasted approx 2hr;
Hospitalized for 29 days  Heart failure Kidney failure  3 heart attacks  Flat line Dialysis
Constant moderate tinnitus started about 1 week after vaccine.  Never had tinnitus or hearing loss before this.  Did test COVID positive in September 2020 and lost sense of smell and taste but that has since recovered. Tinnitus is new and constant....just since vaccine. Not going to get second dose.
On 12/6/17 pt showed RN photo of her arm 2 days after Flu vaccine given on 11/7/17.  Local reaction and bruising noted. Pt says reaction started 1-2 days after injection and lasted several days. Noted at site of injection bruised area, size of a quarter coin. Approx 2" below injection site, red area covered 1/3 of upper outer arm - pt said it was swollen and felt hot.
No additional AE or PQCs; VARlVAX was reconstituted using the STERILE DILUENT that came with the MMR II and administered; This spontaneous report was received from a nurse practitioner, referring to a 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 12-FEB-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 1 time dose (lot number T025946 which has been verified to be valid, expiration date reported and validated as 30-JUL-2022) (vaccination scheme, route of administration, and anatomical site of injection were not reported) as prophylaxis. The administered dose was reconstituted using the sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported) that came with the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (product preparation issue). No additional adverse events were reported in the patient.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA007358: