chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulty of breathing; first dose: a little nausea; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old female patient had received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, lot FA7485) via unknown route at the left arm on 07Aug2021.  Relevant medical history included lung disease ongoing and COVID-19 in Jan2021. She didn't have any reaction at first, and noticed after 4 days, on 11Aug2021 she had difficulty of breathing and after it got worse and a little nausea. The outcome of the event difficulty of breathing was reported as not recovered, the outcome of the event nausea was recovering.
DVT- developed leg pain and swelling  for several days. Presented to ED for evaluation.  Found to have RLE DVT
Pink circle spread down arm; Left arm sore at injection site; Left arm warm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 07Jul2021 at 15:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 16Jun2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jul2021, the patient experienced left arm sore and warm at injection site. On 09Jul2021, the patient noticed pink circle which spread down the arm and the arm was still warm at injection site all the way down to end of the pink area. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events left arm sore at injection site was unknown, while that of left arm warm at injection site and pink circle which spread down the arm were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
I started my period on August 19th, 2021, which was my first period after receiving the vaccine. My cramping was so abnormally intense and the bleeding was so excessively heavy that I almost went to the hospital.  I also had accompanying large blood clots during my period which were unusual.
Patient did not inform the pharmacy that he had previously received the Moderna Covid 19 vaccine. He filled out our questionnaire/screening checklist and indicated he had not received a vaccine. Prior to administering the vaccine the patient was informed he would be getting Janssen Covid 19 vaccine and that it was indicated for 1 dose. He did not inform us that he had received Moderna so Janssen was administered and documented. As of right now, I have not been informed of any adverse reactions that the patient has had.
Sore throat, coughing, mucous.  Started on monday patient called on tuesday. so duration for now was one day.
Mom states client has raised, red, bumps (several) on the lateral aspect of right leg. Client says her leg is sore, but the area is not warm to touch.
Eryth mac papules ~ 1/2cm size trunk pubic area few vesicular.
Dizziness diaphoretic Narrative: Employee had complaints of dizziness and was briefly diaphoretic as soon as the injection was given. The employee lied down on the exam table for 10 minutes and her symptoms resolved. No further treatment was needed.
pt was feeling nausea, dizziness and lightheadedness, 5 minutes after receiving vaccine. Bp was 120/75. HR was 65 . Pt waited for 25 minutes for nausea to resolve and was able to leave the store in good health.
Patient has been fussy and had a mild fever the past few days and today, 03/01/2013 I noticed a rash or small red bumps on her stomach. I bathed her and put her in new clothes etc. Now we've noticed the rash/red bumps have spread all over her stomach and chest and onto her back and around her hairline. We have no idea if this is normal/common or if we need to take her back in to the doctors but it is closed and will have to wait until the morning since she has not had any severe or serious life threatening reactions thus far.
PATIENT WAS SHAKY, DIFFICULTY BREATHING, ANXIOUS, GATORADE AND WATER TO HYDRATE,  V/S CHECKED, 132/71 86, 98%, THERAPRUTIC COMMUNICATION WAS ALSO USED TO CALM HER DOWN. PATIENT BREATHING NORMAL, STATED THAT SHE IS FEELING WELL, PATIENT STABLE AND WAS SEND HOME.
RA Fare; This is a spontaneous report from a contactable nurse and a contactable consumer.  A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as a single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR, strength: 11mg), orally from 2016 (Batch/Lot number and expiration date were not reported) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. The patient's medical history was not reported. Concomitant medications included MODERNA COVID-19 VACCINE taken for covid-19 immunisation; spironolactone (tablet); sertraline hydrochloride (ZOLOFT, tablet); rosuvastatin calcium (CRESTOR, tablet). The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as at age of 41 years old a single dose for covid-19 immunization. The patient experienced RA fare on an unspecified date. Clinical course: reported small RA flare after receiving the second covid vaccine that lasted one day. MD told patient to hold tofacitinib citrate (XELJANZ XR) for 1 week after covid vaccine. The action taken in response to the event for tofacitinib citrate was not applicable. The outcome of the event was recovered on an unspecified date.   The lot number for BNT162b2 was not provided and will be requested during follow up.
soreness in joints; severely sick; could not move and it  took 2 days to get out of her bed; very weird, different  and severe than normal flu symptoms; Chills; Fever with 100.9F; soreness in whole body- including joints, muscle.; weird headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (severely sick), DYSKINESIA (could not move and it  took 2 days to get out of her bed), INFLUENZA LIKE ILLNESS (very weird, different  and severe than normal flu symptoms), CHILLS (Chills) and PYREXIA (Fever with 100.9F) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced ILLNESS (severely sick), DYSKINESIA (could not move and it  took 2 days to get out of her bed), INFLUENZA LIKE ILLNESS (very weird, different  and severe than normal flu symptoms), CHILLS (Chills), PYREXIA (Fever with 100.9F), MYALGIA (soreness in whole body- including joints, muscle.) and HEADACHE (weird headache). On an unknown date, the patient experienced ARTHRALGIA (soreness in joints). At the time of the report, ILLNESS (severely sick), DYSKINESIA (could not move and it  took 2 days to get out of her bed), INFLUENZA LIKE ILLNESS (very weird, different  and severe than normal flu symptoms), CHILLS (Chills), PYREXIA (Fever with 100.9F), MYALGIA (soreness in whole body- including joints, muscle.), HEADACHE (weird headache) and ARTHRALGIA (soreness in joints) was resolving.            The patient was feeling better on 29-Aug-2021. No Concomitant medications were provided. No treatment medications were provided.    This case was linked to MOD-2021-302184 (Patient Link).
No adverse affects; improperly stored MMR II was administered on 8/15/2019; This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status rHa, subcutaneously, lot # R027063, expiration date 20-SEP-2020 (dose was not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 70 degrees Fahrenheit for 4 days. There were no previous excursions reported. The data logger was involved.
Treatment of COVID-19; Treatment of COVID-19; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 at 11:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She describes immediate burning pain throughout her left upper arm/shoulder as the vaccine was being injected. Points to fullest area of mid-deltoid as injection site. Pain has not resolved, she thinks it might actually be a little worse since she tried to do some stretches thinking it might help. Pain is worst when she reaches across her body and up to grab her seatbelt, also hurts to lift or pull, and aches when she sleeps on her left side.
This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 26-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Began having shotness of breath, tightness in chest. Went to emergency room as worried her throat may be closing. Was given prednisone and released. Three days later still having symptoms and seen at her clinic where she was given inhaler, cough med and antibiotic.
On 6/6/21 I had a red bump appear on the left side of my back, similar to a pimple. It was sore and itchy, but I assumed it was a pimple. By 6/10/21, the bump spread to multiple bumps in the same area and they were very itchy and sore. I had fatigue and general feelings of unwellness. By 6/12/21 the lymph nodes in my left armpit were swollen and sore. I went to the doctor on Monday, 6/14/21, and was diagnosed with shingles. The shingles symptoms spread around my left side. The rash only appeared on my back, but the burning and itch spread from my back to the front under my left breast. Felt fatigue and headaches throughout the course. Was prescribed antiviral drug, valacyclovir 1gram 3x/daily for 7 days. The diagnosis occurred at that start of my menstrual cycle and I know of two other women in their early 30's who also got shingles after their covid vaccine and during their menstrual cycle. The symptoms have decreased, but as of 6/21/21, the rash remains.
Incredible arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-health care professional). The reporter is the patient.  A 42-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 10:30 (Lot number: Ew 0171) at the age of 42 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15May2021, outcome "not recovered", described as "Incredible arm pain". The event "incredible arm pain" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had incredible arm pain for four months. No sign of injury or damage from MRI or X-ray. The patient had no known allergies and no other medical history. He did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, he was not diagnosed with COVID-19. Since the vaccination, he had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Below report to Manufacturer: Possible side effect with SHINGRIX vaccine: I will BRIEFLY outline. I am writing to you as a patient. I'm an 87 year old retired pharmacist and believe I have a serious side effect from the first dose of SHINGRIX vaccine. One day after receiving the vaccine at Pharmacy I lost most of my vision in my left eye. I have a history of glaucoma and blepharitis (Rosacea) so I treated the symptoms as I previously did for the itchy, scratchy symptoms expecting the symptoms to disappear. However, the symptoms only got worse. My left eye became painful and extremely uncomfortable. I went to see my ophthalmologist. He was on vacation at the time, so I saw the optometrist who did not know why my vision was so blurry. I couldn't read the largest letter on the chart with the left eye. I reported that I got the SHINGRIX vaccine--after that I saw another ophthalmologist, and other eyes doctors until regular Dr. returned from vacation and I saw him several times. He did not know what caused my condition. I reported that the SHINGRIX was the only change in my medication. He referred me to a cornea specialist. He saw me three times--once with the swollen cornea, another time when I was off my glaucoma drops for a week as recommended by my regular eye doctor and Dr. said I needed a cornea transplant. I agreed and saw him a third time. He examined me and reconsidered. He said a transplant would not help me and may make my glaucoma worse. I went back to my regular eye doctor who disagreed somewhat and referred me to another cornea specialist. I have an appointment with him on 30 July. I would like to know if you have any reported side effects with SHINGRIX that relate to my condition. I don't believe any signs of herpes or rosacea was seen in my eyes when examined with a slit lamp. I spoke to one of my primary care doctors who was concerned and he added that I wouldn't be protected from Shingles without the second shot. I only briefly outlined the circumstances here. All this transpired over the past few months beginning the day after my SHINGRIX vaccine. My left eye doesn't appear to be getting worse at this time but I can't see through it. If you have any questions please contact me. I'll report my experience to other agencies in the event my symptoms may have been reported by others.
Patient reported redness for a few days. This progressed into pain and tingling in arm, like "ants crawling on my arms". Still itching, but was told my MD not to scratch (pt saw MD for routine appointment/exam). MD thinks the vaccine hit a nerve and it will just take time for the patient's symptoms to resolve. Patient says arm still tingles, but not constantly.
Information has been received from a physician concerning a 16 month old male with no pre-existing allergies, birth defects, or medical conditions who on 18, Oct 2006 at 3:30 pm was vaccinated SC in the left arm with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 655141/0833F). On 23, Feb 2007 at 11:00 am the patient experienced an adverse event. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/4/2007. Follow up information received from a nurse manager indicated that the adverse event was chickenpox. Additional information has been requested.
out came breakfast out of both ends; every part of body ached from head to toe; dizzy; horrible horrible pain; freezing, could not get warm; fingers red and swollen; feverish; fever for a few hours; out came breakfast out of both ends; kept vomitting; shivering like crazy; left arm was hurting so bad; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (out came breakfast out of both ends), PAIN (every part of body ached from head to toe), DIZZINESS (dizzy), PAIN (horrible horrible pain) and FEELING COLD (freezing, could not get warm) in a 53-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.     No Medical History information was reported.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced DIARRHOEA (out came breakfast out of both ends), PAIN (every part of body ached from head to toe), DIZZINESS (dizzy), PAIN (horrible horrible pain), FEELING COLD (freezing, could not get warm), PERIPHERAL SWELLING (fingers red and swollen), PYREXIA (feverish), PYREXIA (fever for a few hours), VOMITING (out came breakfast out of both ends), VOMITING (kept vomitting), CHILLS (shivering like crazy) and INJECTION SITE PAIN (left arm was hurting so bad). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, DIARRHOEA (out came breakfast out of both ends), PAIN (every part of body ached from head to toe), DIZZINESS (dizzy), PAIN (horrible horrible pain), FEELING COLD (freezing, could not get warm), PERIPHERAL SWELLING (fingers red and swollen), PYREXIA (feverish), PYREXIA (fever for a few hours), VOMITING (out came breakfast out of both ends), VOMITING (kept vomitting), CHILLS (shivering like crazy) and INJECTION SITE PAIN (left arm was hurting so bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: high (High) High 101.7 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Nausea, muscle weakness, tingling sensation in fingers hands, forearms, and elbows. Unable to grasp items with fingers. No strength in fingers to open Gatorade bottle. Fingers could move slowly but could not make a fist. Symptoms with hands and arms passed by 11:30 am. Headache and muscle tenses back of neck continued.as of this writing. 7;00 p.m. Ibuprofen had little to no effect. Nausea relievesby ondansetron I had on hand 3;00 p.m. light headedness in morning. Crawled to bathroom and fell off commode. Required assistance to return to bed.
Within 2 hours of getting vaccinated, I had severe arm pain at the vaccination site. Approximately 6-7 hours after getting vaccinated I began feeling body aches and chills and had trouble sleeping. When I got up the next morning at 8am (~12 hours post vaccination) I had a horrible headache (most painful I've ever had), body aches, and exhaustion. My headache was at a pain level 10 so I took one Excedrin Migraine around 11am and napped for a few hours. The Excedrin helped to slightly lessen the headache for ~8 hours. I ate soup with dumplings for dinner around 7pm on 4/9 and two hours later began feeling extremely nauseous with severe stomach pains. Around 10pm I had a severe case of the chills and a low fever around 99.8 degrees. At 10:45pm I threw up for the first time. My headache came back quite strong and my fever began to spike. My nausea got better for an hour then came back along with the chills and cold sweats. I had severe aches and body pains along with the nausea and fever until throwing up again around 3 or 4am on 4/10. I continued to have a severe headache, body pains, nausea, and a fever of up to 101.8 for the rest of the night into the morning. I was able to sleep around 7am until 12pm on 4/10. On 4/10 I was able to eat some food, but still felt very nauseous and had a bad headache with a fever, although both had decreased slightly. I took advil around 1pm that day to help with the fever and it reduced from 101.8 to 99.5 in the evening. I still had body aches, a headache, and nausea at night on the 10th, although I was able to sleep a little better. When I woke up on the 11th my headache was much better and my stomach was less upset. The body aches and exhaustion were still present on the 11th all day, although a lot less severe than the days prior. I woke up this morning 4/12 feeling much better, with a very mild headache and body aches. The pain at the injection site began to lessen on 4/11 and is minimal today (4/12).
Had a headache within 10 mins. After 30 mins of shot -had  bottom lip numbness and loss of taste then swelling of throat and left side of face. Anaphylactic  symptom and all other symptom were worsening until decreased when Benadryl and Pepcid AC which was taken an hour later due driving en route to destination. Within 2 hrs all symptoms were gone except for throat tenderness. Continued Benadryl and Pepcid AC for 2 days now.
Second dose of Shingrix in Nov 2019 and in Jan 2020 she developed outbreak of shingles; Outbreak of shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (3 times prior to vaccination).   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, unknown after receiving Shingrix and between 2 and 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received Shingrix in Nov 2019 and in Jan 2020 she developed outbreak of shingles. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation for shingles were not provided.
Numbness in fingers and arms for 5 days. Left arm, arm remains numb as of 7/9/03.