chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiny bubbles near injection site; Hot to touch left arm; Headache; Redness; Itching; Injection site hardness left arm; Swelling "bullseye"; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), VACCINATION SITE WARMTH (Hot to touch left arm), VACCINATION SITE VESICLES (Tiny bubbles near injection site), VACCINATION SITE INDURATION (Injection site hardness left arm) and SWELLING (Swelling "bullseye") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRURITUS (Itching), VACCINATION SITE INDURATION (Injection site hardness left arm) and SWELLING (Swelling "bullseye"). On 04-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness). On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch left arm) and HEADACHE (Headache). On 06-Apr-2021, the patient experienced VACCINATION SITE VESICLES (Tiny bubbles near injection site). The patient was treated with IBUPROFEN at a dose of 2 doses. At the time of the report, PRURITUS (Itching), VACCINATION SITE WARMTH (Hot to touch left arm), VACCINATION SITE VESICLES (Tiny bubbles near injection site), VACCINATION SITE INDURATION (Injection site hardness left arm), SWELLING (Swelling "bullseye"), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported
Patient describes pain from shoulder to wrist. Advised to try Ibu or APAP.
12 days post vaccine I experienced nausea, headache, lightheadedness, blurred vision. I waited to see if it would go away. I had lab work done, went to multiple appointments with 2 different clinics and now I?m set for a CT scan to rule everything out. I live a healthy lifestyle. I exercise and eat healthy. I don?t do drugs. I drink seldomly. To date, all of my labs are normal and the symptoms are the same as when I used to get migraines, although instead of a 1 hour migraine this one is lasting  now 11 days and counting. I am miserable, I call in sick and lay in bed all day. The symptoms have not lessened.
After waiting 15 minutes after the shot, I started driving and about 5 minutes later, without warning I suddenly started to fall over to my side, as I almost fainted. That frightened me and boosted my adrenaline so I was able to drive to my home but the whole time I was fighting to stay conscious.
Congestion, runny nose, loss of sense of smell, some nausea (but that may be from the Paxlovid), and generally not feeling well. Also, not sure if it?s the Covid, but have been having random loud tinnitus (ringing) in my right ear, which I hope only remains random since I already have permanent tinnitus in my left ear which may be due to having Covid in April/May 2020.  Did Covid rapid test on 05/11/2022 and had a positive result.  Called doctor and was prescribed Paxlovid.   Am currently taking Paxlovid.
PATIENT REPORTED SWOLLEN EYE UNABLE TO OPEN FULLY, PIMPLES ON FOREHEAD, FOREHEAD SKIN ITCHY, HOT TO THE TOUCH, BURNING.
Vaccine triggered increased migraines. In addition to vomiting, diarrhea, nausea, headaches, fatigue. Migraines have not improved much. Migraines before covid shot were 1-2 events per month. After covid they were daily for the first three weeks after first covid dose. Now they are 3-5 times per week! Had to put patient back on a daily migraine medication.
I had the shot midafternoon on July 29. On July 30 I woke up with a sore arm and felt queasy and light headed. I went outside and gardened for a couple of hours until I was too fatigued to continue (around 11:00). (I read on the internet later that people who get the shot should be advised not to engage in strenuous activity for a few days after being vaccinated. Oh well.) After I came in I felt progressively worse with headache, muscle pains, stuffy nose, and increasing fatigue. I was also cold and had a slight fever, 99.8 degrees (my normal temp is around 97.5 or so). My injected arm was quite sore and had red blotches spread over several inches near the injection site. On July 31 I felt much better; I was slightly tired, still had a headache, and the arm still had red blotches. As the day continued I continued to feel better and now (late afternoon) am feeling pretty much myself again. I knew reactions to the vaccine were common so I wasn't disturbed by mine. A day or two of malaise beats having shingles. The only reaction I remember having to the first dose several months ago was a sore arm.
Patient appeared fine after vaccine. However, injection barrier bandage used and minor bleeding noted after injection and was absorbed via bandaid. Patient then sat in chair pharmacy lobby and moment later fell from chair and family noted patient passed out for a very brief moment. Upon observation, no signs of anaphylaxis and consciousness maintained. Ems called and transported patient to hospital and patient family was followed up and was doing better afterwards and received IV fluidsat hospital.
Patient came in for her 2nd dose and said her arm has shooting pain down to her wrist when I asked how her 1st dose went.  She said it started after she got her 1st dose.
Started feeling shortness of breath on 4/13/2021, got worse everyday. Went to clinic on 4/19/2021 and was diagnosed with pneumonia.
Inc temp taken to Hosp admitted; temp in hosp 104.7, WBC20,000 on adm, tx Augmentin & APAP; Mom stated had congestion;
Patient with the father was guided to Booster dose administration table and received booster dose when he was due for his second Pfizer dose in the primary series.  No adverse symptoms and sign noted at the time of vaccine administration and observation period.  Parent and MD were informed of this error.
Chills; Fever; Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received second 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 15:45 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, allergies and gout. The patient was allergic to penicillin, bees, and some blood pressure medicines. Concomitant medications included benazepril hcl (MANUFACTURER UNKNOWN) 40 (unspecified units) and allopurinol (MANUFACTURER UNKNOWN) 100 (unspecified units); both from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER6206), via unspecified route of administration in the left arm on 05Mar2021 at 16:45 (at the age of 66-years-old), as a single dose for COVID-19 immunisation and naproxen sodium (ALEVE) on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 27Mar2021 at 04:15, the patient experienced fever, chills and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcome of the events fever, chills and severe headache was recovered on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Body aches 101.8 temperature Started at 2:00 pm..took 2 Tylenol Fever receded to normal by 6:00 pm Went to bed at 8:00 pm Woke up the next day feeling fine, went on my Dailey 5 mile walk
allergic reaction; severe coughing; threw up; red spot on her left arm; This is a spontaneous report from a contactable consumer (Patient) reported for herself.  A 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL1283) dose 1 via an unspecified route of administration on 05Feb2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EM6202) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lung neoplasm malignant from an unknown date and unknown if ongoing. Consumer stated, "No, I just had lung cancer.", blood pressure measurement from an unknown date and unknown if ongoing, patient take blood pressure medicine and cholesterol medicine, blood cholesterol from an unknown date and unknown if ongoing I take blood pressure medicine and cholesterol medicine, lung operation from an unknown date and unknown if ongoing. It was reported that, on Feb2021, the patient has experienced allergic reaction (hypersensitivity), severe coughing (cough), threw up (vomiting) and red spot on her left arm (vaccination site erythema). Clinical course of events includes; she received the 1st and 2nd shot of covid vaccine. After she got the first dose, she had an allergic reaction, a severe coughing and she threw up and she had a red spot on her left arm. She encountered the same allergic reaction after she got her second dose of covid vaccine. Consumer stated, "What I want to do is I want to report a severe reaction to the vaccine." The first reaction I got was when I had the first shot. About 24 hours later, I was sick to my stomach and I was throwing up. At that time, I didn't think much about it because I thought first of all, I had just had lung cancer. So, I have been in the hospital and I was thinking - Okay, maybe it has something to do with that and also it started with like indigestion and my neighbor had fixed us dinner and I thought - Well maybe, I just didn't like the dinner, okay so I didn't think a lot about it. But then, last Friday when I got the second shot I had same deal where I was sick to my stomach and I am throwing up and coughing a lot and I am a little concerned about my lung surgery because I don't want to cough too much and tear any of that loose. Anyway, the other thing is that I also have a large red spot, you know like a, it's not really a rash, its just kind of a red area where they put the vaccine. Consumer stated that, yes, because it all happened with Pfizer both of my shots were from Pfizer. He also reported that, Yes and what they did is they removed a portion of my lung. The reason consumer reporting this is because she wanted others to be aware of it. The outcome for the events was unknown.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # L020015 expiry date 16-AUG-2017. On 09-FEB-2016 and 13-FEB-2016 the GARDASIL 9, was exposed to a lowest temperature of + 1.0U C for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, GARDASIL 9, was exposed to a lowest temperature of + 1.2 U C for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, GARDASIL 9, was exposed temperature of + 1.3U C for 21 minutes. On 15-FEB-2016, GARDASIL 9, was exposed to a lowest temperature of + 1.1U C for 25 minutes. On 17-FEB-2016, GARDASIL 9, was exposed temperature of + 0.0U C duration not reported. On 18-FEB-2016, GARDASIL 9, was exposed to a lowest temperature of - 1.0U C for 12 hours 29 minutes. On 19-FEB-2016, GARDASIL 9, was exposed to a lowest temperature of - 1.1U C for 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9, lot # L043213 with an expiry date of 28-AUG-2017, (incorrect product storage). Dosing details were not provided. 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.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. Since 28-JUL-2014, the patients were vaccinated with MMR II (dose, frequency, strength and lot number were not provided). Co-suspect or concomitant therapies were not provided. On approximately 2014, the dose that the patients received MMR II was improperly stored. No adverse effects were reported (also reported as no adverse effects were not reported). Additional information has been requested.
On 6/22, the pt developed a progressive eruption of bright red pruritic 2-3 mm papules on face, scalp, and extensor surface of arms. On 6/19, 6/21, 6/23, and 6/24, she had brief seizure-like episodes.
Patient had redness, bruising and swelling at injection site. She saw her doctor. Told her to put heat on area. Saw Dr 11-11-13.
Rash on arms and legs. Cleared on arms after 2 days and cleared on legs after 5 days. No pain or itching. No treatment.
pt recvd vax;sore throat on 11nov;apap & flu pills given till 14nov;start n 15nov; sore lt shoulder & arm 13nov;11dec swollen lt wrist & dec tendon,cannot lift or hold a cup;no appetite strength;recovering 9dec94;
Pt. developed fever, malaise, whole body urticaria-like rash assoc. with generalized edema (increased in hands & feet) with 24 hour of vaccine. To ER 2-8-13 hospital. Worsening parasthesias of bilat LE, bilat UE with increased pain in (L) arm -> To ER 2-13-13. Pt. with loss of (L) hand function -> neuro eval.
I noticed a lot of pain in right arm up into armpit 24 hours after my Pfizer Booster shot that was given to me on 12/30. Today on 01/01 I was in the shower and noticed a very enlarged lymph node in my right arm pit, the same arm as I received my booster shot.  The size of the swollen area is about 4.5" inches long by 2.5" wide.  It is sore to the touch. I have never had an adverse reaction like this from my first two covid shots or any other vaccines I have received.
After recognizing the child was in need of dose 2 of Hep A per school requirement, it was inadvertently administered too early.
Fever 102.4 day after vaccine.  Joint and muscle aches, headache, fatigue and brain fog day after vaccine and continues.  Vaccination site pain for 4 days after vaccine.  Eyes burning, painful, sensitive to light, floaters and occasional blurriness from 3rd day after injection and continues; being treated for mild uveitis with Pred Forte 1% eye drops.   Slight onset of palmo-plantar psoriasis.
Pain started at injection site - next day moved to my mid arm like I was hit..next day moved to my elbow and has not left after 2 weeks. It is sometimes hard to pick things up with my arm - the muscles and elbow hurt
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was light headed after injection.  Pt passed out/lost consciousness for approx 20 sec.  Recovered completely after approx. 5 minutes.  Left store with grandparent afterwards.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Within a few seconds I felt very sleepy, my face became numb which began spreading to my mouth. Mentally spaced-out, weak and unable to drive my car even a few yards. Requested ambulance and was taken to emergency room. EMT administered Intravenous Benadryl. In hospital Pepcid was administered immediately. The numbness eventually spread throughout my body and I felt twitching/trembling, particularly my mouth and jaw. My feet felt like they were being pulled away from my body. After testing was complete, Solu-Medrol was administered and all symptoms disappeared immediately.
20 months old was administered with Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 20-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 27-OCT-2023, the patient received Kinrix (intramuscular, unknown thigh). On 27-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 20 months old was administered with Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 27-OCT-2023 The reporter reported that a Kinrix vaccine intended for a 4 year old patient was administered by error to his 20 months old brother which led to inappropriate age at vaccine administration. The vaccine was administered on day of reporting and it was injected in the thigh. It was unknown if it was the left thigh or the right thigh.  No additional information was provided. The reporter consented to follow up
Pt passed out immediately after administration of MCV4 Vaccine.  Pt came too within 30 sec.  Pt Pale, Diaphoretic, low BP 90/50. Offered orange juice, candy, cool compress.  At 200PM  BP 80/42 still pale,diaphoretic.  Pt A&Ox3.  Reassessed Right side of head which hit heat register, noted small bump - ice applied. Mom present.  At 225 pm, BP 104/60, skin pink, dry, A&Ox3. reassessed right side of head.  no bump noted pain level 1/10 per patient, noted pin head size eccymotic spot.
Vaccine given on 9/23 and vaccine expired on 9/21, one day prior.
Patient received vaccine at approximately 8:55 am, patient says she called her sister, and then her husband.  After she got off the phone, about 7 minutes after her injection, she started to feel like she was going to faint,  she then put her head between her knees like she normally does when she gets that feeling, and then when she came to, she felt better. The patient had blown her horn, so an EMT and nurses were able to assist her right away. EMS was called to check patient for her syncopal episode.
1-19-21: Arm at vaccine site became swollen, red, itchy, painful, and sore, developed a rash Emailed doctor, said it was an allergic reaction, and advised me to take Zyrtec Also took tylenol
My periods have always been between 3 and 6 weeks apart.  They lasted no more than 5 days with relatively light bleeding.  On 9/24/21, after not having a period for 3 and a half months, I started a period that lasted three full weeks and was characterized by unpredictable and excessive bleeding.  On at least two occasions I missed work and considered going to the ER, because I was soaking overnight pads every half hour to two hours.  After about three hours on each of those occasions, the bleeding was not quite as heavy, so I opted to call my gynecologist instead.  In October of 2021, I had an endometrial biopsy and trans-vaginal ultrasound with normal results.  My "period" returned on 1/5/22, with the same pattern of unpredictable and excessive bleeding.  At the end of January, I called my doctor and made another appointment.  I missed at least one day of work during this time due to the excessive bleeding.  The doctor ordered another trans-vaginal ultrasound (to re-check), another abdominal ultrasound (I had to fill my bladder prior to having that ultrasound), and bloodwork.  Bloodwork came back normal.  Ultrasound results showed possible polyp (s) and the endometrium had grown by 1 cm over the past month.  The doctor was concerned about the endometrial thickening and we scheduled a D and C to test the tissue and try to stop the bleeding.  I was prescribed Prevara for one month leading up to the surgery, but it did not completely stop the bleeding and prior to surgery I was bleeding heavily again.  I had a D and C on 2/24/22 and will get the pathology report from the tissue that was removed by 2/14/22.   I am still bleeding three days post surgery but not as heavily as before the surgery.  Outcome is not certain at this time.
Within a couple of days from receiving the vaccine, I had worsening heart palpitations. I called my PCP to schedule an appointment and was seen on April 9th, 2021. She referred me to a cardiologist. He ordered a holter monitor but the same night as my cardiology appointment, I went to the hospital for worsening palpitations, shortness of breath, fatigue, and sweating. I was found to be in second degree heart block and unknown cause. I have had autoimmune testing, extensive lab testing, MRI's, echo's and genetic testing. They are unable to find an alternate cause of worsening heart block.
Acute on chronic diastolic congestive heart failure. She was started on midodrine, octreotide, and albumin however no improvement. Upon further evaluation likely had ATN 2/2 iatrogenic hypotension with recent introduction of propanolol vs cardiorenal with diastolic heart failure. Midodrine was continued for BP support and she was eventually started on diuresis. Her BP improved and midodrine stopped. She also had low cortisol during evaluation for her hypotension. ACTH stim test was abnormal. Endocrinology was consulted and stress steroids started with eventual taper to maintenance. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Stomach Ache on the right side; Fever 101F; Injection Site Pain; Blood Pressure was increased 140/96; High Pulse 101; Body Pain all over the body; This spontaneous case was reported by a nurse and describes the occurrence of BLOOD PRESSURE INCREASED (Blood Pressure was increased 140/96), HEART RATE INCREASED (High Pulse 101), PAIN (Body Pain all over the body), ABDOMINAL PAIN UPPER (Stomach Ache on the right side) and PYREXIA (Fever 101F) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood Pressure was increased 140/96), HEART RATE INCREASED (High Pulse 101), PAIN (Body Pain all over the body), PYREXIA (Fever 101F) and VACCINATION SITE PAIN (Injection Site Pain). On 07-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Ache on the right side). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Fever, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (Blood Pressure was increased 140/96), HEART RATE INCREASED (High Pulse 101), PAIN (Body Pain all over the body), ABDOMINAL PAIN UPPER (Stomach Ache on the right side), PYREXIA (Fever 101F) and VACCINATION SITE PAIN (Injection Site Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: increase (High) 140/96. On 05-Feb-2021, Body temperature: high (High) Fever 101F. On 05-Feb-2021, Heart rate: high (High) pulse rate 101. On 06-Feb-2021, Body temperature: high (High) went up again Fever 99.6 F.     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.   patient has applied heat on the stomach and taken 2 advil tablets   This case was linked to MOD-2021-022908, MOD-2021-022912 (Patient Link).