chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After about 6 minutes of receiving second does of Pfizer, she complained of nausea, being lightheaded, dizzy, and had a headache. She also was cool and clammy. Patient nervous about getting second vaccine. After ask her some questions we found out she had not eaten. Gave her some Gatorade and a snack and she started feeling better. She left facility at about 10:45. After lunch her mother was called and she is doing good.
Tingling in 1st & 2nd finger & weakness rt hand. Pain in rt arm, shoulder upper & back eventually spreading to left shoulder, arm & hand.  Weakness and fatigue.
swelling under arm that was vaccinated (lymph nodes?); This is a spontaneous case from a contactable consumer (patient).A 76-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6200; Expiration Date: UNKNOWN) via an unspecified route of administration in arm left on 18Feb2021 at 14:00 as a single dose for covid-19 immunization. Medical history included 2X cancer survivor, osteoporosis. Concomitant medications included alendronate sodium (FOSAMAX), pravastatin (PRAVASTATIN), calcium (CALCIUM), pyridoxine hydrochloride (B6) taken for an unspecified indication. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 20Feb2021,The patient experienced swelling under arm that was vaccinated (lymph nodes?)  The outcome of the event was not recovered.
The 2nd dose of Moderna was given early by mistake, at day 15. No adverse reaction occured, but medication error reported.
Breakthrough case admission after 3 vaccines Moderna 2/3/21 Lot# 007M20A;  Moderna 3/3/21 Lot# 023M20A;  Moderna 12/17/21 Lot# 029H21B
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     The patient's past medical history included Epilepsy. Concurrent medical conditions included Thyroid disorder and High cholesterol. Concomitant products included CARBAMAZEPINE (TEGRETOL) and PHENOBARBITAL for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She did not take any medication as treatment. She was doing physical therapy for 3 months and the side effects are still ongoing. She was diagnosed with Vestibular neuritis.   This case was linked to MOD-2021-410049 (Patient Link).
Pt c/o scratchy, sore throat and voice sounding hoarse. Same situation occurred after receiving first dose of vaccine. She reported feeling this way to her primary doctor who instructed her to take Benadryl which alleviated the symptoms.  Benadryl 25mg po x 1 dose. Dose given at 1737. Vitals at 1748: BP 116/67, HR 77 and pulse ox 97% on room air. Patient reports improvement in symptoms. Husband present with patient. Pt left with husband at 18:20 with no complaints
Two events 8/26 daughter agitated fed then 90 mins later child found not breathing, pale, blue lips.  Picked up baby started rousing, then baby looked seizure-like. Eyes fixed upward, stiff back, limp limbs child was breathing when ambulance came and vitals all normal but child was extremely lethargic not responsive to environment.  Two weeks later it happened again only no blue lips as we were able to respond and call 911 faster.
I had a positive COVID test on 05/11/2020, My vaccine side effects were similar to the symptoms I had when I had COVID: body aches (initially worse with vaccine), temperature of about 101 (I run about 97 normally), headache, extreme fatigue. I was better on 03/01/2021, but not totally side effect free until 03/03/2021. Arm soreness lasted a couple more days,
mild sx HA ST covid after international travel from from DR.; mild sx HA ST covid after international travel from from DR.; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 23-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 18Feb2022 as dose 3 (booster), single (Lot number: FF2589) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "unknown" and all described as "mild sx HA ST covid after international travel from from DR.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Patient has had chest pain within days of the vaccine and went to a cardiologist, she had issues with anxiety in the months following. She has had severe menstrual excessive bleeding, she was put on progesterone to control bleeding. She was hospitalized for low hemoglobin of 6.8 with a low blood pressure and received three blood transfusion with no family history of blood disorders.
My right upper arm began aching  more than just from the initial injection a few days from getting the flu shot. I was told this was a better flu shot. The pain just kept getting worse and for the last two weeks I haven?t been able to sleep through the night. It?s been very hard to work as I have to lift some objects that are heavy and some that are not so heavy but now cause me very much pain. I had to leave work yesterday after two hours. Today is my day off, but I don?t know what I?m going to do about tomorrow. Working and  using my arm is excruciating and makes it worse. I have used Aleve in large doses and ice and heating pad for a little relief, but no change.
Urticaria s/p baths on 4/4 & 4/5, URI symptoms. No hx previous urticaria. No new foods or soaps recently. I doubt vaccines caused rash.
Pt recv vax on 7/21/98; approx 4 hr post vax pt exp swollen right thigh to knee & crying; tx=acetaminophen & cool compress
Information has been received from a RN concerning her 4 yr old son with no allergies or medical history who a year ago in approx Sep 2004, and on 16Sep05 was vaccinated with a first and second dose of varicella virus vaccine live. There was no concomitant medication. On 16Sep05, the pt started to experience lesions on the head, face, ear, neck, back, arms and legs. He currently had many more than 50 lesions. He also had a slight fever the first few days. He was seen by a physician and treated with mupirocin (Bactroban) cream. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Additional information has been requested.
No additional AE/PQC involved; Nurse called to report expired dose of MMR II given to patient; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 03-FEB-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) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). No additional Adverse Event (AE)/Product Quality Complaint (PQC) was involved.
Have been having ocular migraines beginning couple hours after first dose regularly 2 to 3 times a week where as before I would have one every 2 or 3 years. Also mild headache comes and goes throughout the weeks.
Patient received her second Covid shot IM right arm. She said she felt hot. I told her to stay seated until she felt better. She fell out out the chair and hit her forehead on the floor. I helped her back up to the chair and she said she still felt hot. She had a bump on her forehead. She said she was thirsty so I got her some water and an ice pack for her head. We called management  and they arrived in a few minutes and brought a fan to keep her cool. She called her boyfriend to come pick her up. She stayed here until he got here and she said she was feeling fine. She didnt want to go to ER.
My POTS went from well controlled to debilitating.  Chest pressure, out of breath, shaky, brain fog, severe fatigue, nausea, headache. Resting heart rate went from 55-65 to 75-90. Unable to work
At the end of June, I started have cloudy eyes and "sleep" in my eyes. I would have to wipe crusty stuff out of my eyes. My eyes went from this to over producing and having "wet" eyes. I went to see and eye doctor on 07/12/21 who gave me steroid eye drops. I went to see an optometrist who gave me cyclosporine eye drops. On 07/16/21, I had an itchy bump on my scalp. My face became swollen from the bump two days later. It looked like a pocket of water coming from my hairline down to the bridge of my nose on the left. I went to the walk-in medical clinic on 07/20/21, they told me that I had shingles. They gave me valacyclovir and prednisone to help clear up the shingles. The next day I went to my regular doctor who confirmed the shingles diagnosis. The shingles have cleared up, I am currently still using the eye drops and trying to find if there are other things that can help keep my eyes from being so dry other than the eye drops.
09:04 AM-Turned to find patient lying on her side/back-unresponsive with arms jerking, lasted approximately 4 seconds. Pt. sat up immediately and was AAO x 3.
Severe angioedema of tongue, upper lip and face, primarily on the right side. Required ER admission. Treated with IV Benadryl and Dexamethasone, and nebulized Epinephrine.
new onset of redness at the injection site; swelling of the injection arm; fever; arm soreness which was quite bad; injection arm is tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness which was quite bad), TENDERNESS (injection arm is tender), ERYTHEMA (new onset of redness at the injection site), VACCINATION SITE SWELLING (swelling of the injection arm) and PYREXIA (fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Hypertension.   On 05-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm soreness which was quite bad), TENDERNESS (injection arm is tender), VACCINATION SITE SWELLING (swelling of the injection arm) and PYREXIA (fever). On 08-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (new onset of redness at the injection site). The patient was treated with IBUPROFEN at a dose of 1 UNK and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 UNK. At the time of the report, PAIN IN EXTREMITY (arm soreness which was quite bad), TENDERNESS (injection arm is tender), ERYTHEMA (new onset of redness at the injection site), VACCINATION SITE SWELLING (swelling of the injection arm) and PYREXIA (fever) outcome was unknown.
Patient seen for followup appt on 5/19/11 and stated that the day after her vaccines given she experienced headache, cold sweats, weakness & itchiness when cold. These symptoms are on & off throughout the day. No complaints of respiratory distress. Seen by MD 5/19/11.
This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age with no pertinent medical history and drug allergies reported, who on unspecified date (mid-1990's), was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse stated that a patient received an unspecified hepatitis B vaccine (recombinant) (manufacturer unknown) and completed series in the mid-1990's but recently was tested on an unspecified date and was not showing any titers. Since the hepatitis B vaccine (recombinant) (manufacturer unknown) reported was unknown, it could possibly have been RECOMBIVAX and therefore AE was reported as a Merck product. The patient sought medical attention. No further information is available. The outcome of anti-hbs antibody negative was unknown. The relatedness for anti-hbs negative was unknown for hepatitis B vaccine (Recombinant) (manufacturer unknown). Additional information has been requested.
Splotchy-looking rash at and slightly around injection site - no pain or itchiness
Immunizations Friday 8-23-13. Monday 27, 13, pt presented with localized 3-4 cm round reaction at injection site (L) deltoid. Afebrile, no c/o pain or change in health status pt observed. No tx other than supportive care was needed.
This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a 47-year-old male subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject completed the hepatitis B vaccine series.  When tested in 2007, the subject's titers came back showing non-protective levels for hepatitis B.  No additional details were provided.
fever of 105 on 5th day p/vax; rash on trunk x 3 days; seen by MD;
31 y/o F pt presented to clinic on 9 Nov 2022 with allergic reaction 1 hour after getting flu vaccine(approx 1030) . Pt presented with hives on torso and back that spread to neck and face, flushing on skin and redness/tingling on/around lips. Pt states she took additional dose of Xyzol when she first noticed hives on chest. Pt states she returned to clinic and was seen by PCM at 1230 as sx worsened. Pt did not have any medications administered in clinic. Pt was given rx for EpiPen and Benadryl with active sx. Pt took 50mg of Benadryl at 1400. Pt did not need to use EpiPen. Pt was given 24 hour qtrs and returned for duty at 0730 hrs on 10 Nov 2022.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 12:48 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.
Patient reported injection-site reaction (redness and soreness of injection site which is warm to touch).
"pt recv vax 12DEC95 & 27JAN97 pt devel a varicella-like rash, number of lesions unk, p/exposure to wild type varicella @ school;the nurse reports that the pt is also a little itchy;"
Patient stated she went to the ER with a 103 degree fever and rash at the injection site of the Heplisav
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 24-MAY-2016, the patient was vaccinated with improperly stored dose GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017 (strength, dosing details and anatomical location were not reported) (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-OCT-2016, the patient inadvertently received one dose of PROQUAD lot# M017335 with expiration date: 05-OCT-2017 (dose and route of administration were not reported) and one dose of M-M-R II lot# M002418 with expiration date: 12-JAN-2018 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Neck swelling; sore arm; Headache; fever; A spontaneous report was received from a consumer concerning a 58-year-old,female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache,fever,sore arm and neck swelling.  The patient's medical history, was not reported. Concomitant medications was not reported.  On 22 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Feb2021, the patient felt headache,fever and sore arm.On 24 Feb21, she had swollen of her gland on the right side of her neck.   No laboratory details was provided.  Treatment information - Dr advice to take Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report,the outcome of the events,headache,fever,sore arm and neck swelling , were considered unknown
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received SHINGRIX. Previously administered products included PREVNAR (experienced a reaction that lasted two days). On 3rd March 2018 10:00, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain and local reaction. On an unknown date, the outcome of the influenza-like symptoms, pain and local reaction were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, pain and local reaction to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The age at vaccination was not reported but could be 72 or 73 years. The patient experienced severe flu-like symptoms and severe local symptoms. The patient went to see her physician on 6th March 2018, and her symptoms were unchanged at the time of reporting. The patient required the emergency room visit. Additional information was not provided.
Gave 5th dose of moderna 1 month after receiving 4th dose. No symptoms noted
This spontaneous report as received from certified medical assistant (also reported as healthcare worker) refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 17-FEB-2016 the patient was inadvertently vaccinated with expired dose of M-M-R II (dosing details were not reported) lot # K00738 with an expiry date of 16-JAN-2016. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
mom said child rt leg red & swollen from knee to upper thigh 5MAR98 afternoon approx 130PM;no redness or tenderness today 6MAR98;minimal swelling if any;
shingles; bumps on his neck; This spontaneous case was reported by a health care professional and describes the occurrence of HERPES ZOSTER (shingles) and RASH (bumps on his neck) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis of neck (lower back and neck arthritis). Concomitant products included VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles). 26-Feb-2021, the patient experienced RASH (bumps on his neck). On 05-Mar-2021, HERPES ZOSTER (shingles) had resolved. At the time of the report, RASH (bumps on his neck) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   medical history of lower back and neck arthritis was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Treatment drug (Valcyclovir) was prescribed and medical history was reported.
lower lip was swollen and lasted about 1 week. swelling at injection site in the arm ( size of golf ball)  lasted for 3 to 4 days.
anaphylactic reaction; lung producing bloody phlegm (when waking up in morning); sore muscle (deltoid) / muscle pain; abdomen pain (lower left); diarrhea; fatigue; joint pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received dose 3 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Oct2021 10:00 (Batch/Lot Number: FF2590) (at the age of 50 years old) as dose 3 (booster), single for Covid-19 immunisation. Medical history included asthma, hypertension, degenerative disc degeneration (DDD), attention deficit hyperactivity disorder (ADHD), and bee sting allergy. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for immunization, start and stop date were not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 16Mar2021 10:00am in left arm (Batch/Lot No: GN6206) (at the age of 50 years old); and second dose on 06Apr2021 10:00am in left arm (Batch/Lot No: FR8730) (at the age of 50 years old); for COVID-19 immunization. The patient previously took metformin and levothyroxine and experienced allergy. After the third dose, on 29Oct2021 at 16:00, the patient experienced anaphylactic reaction, lung producing bloody phlegm, sore muscle (deltoid), abdomen pain (lower left), diarrhea, fatigue, and muscle and joint pain. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse (school nurse) concerning a 7 year old male who in approximately 2008, about 1 year ago, was vaccinated with VARIVAX. In February 2009, the patient was diagnosed with shingles. At the time of this report, the patient was recovered. The patient sought medical attention in physician's office. No further information is available.