chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching on torso and back; Pins and needles on torso and back; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 11:30 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. 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 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 03Apr2021 at 01:00, the patient experienced itching on torso and back and pins and needles on torso and back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events itching on torso and back and pins and needles on torso and back was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-DEC-2018, the patient was vaccinated with a dose of ROTATEQ lot # R021055, expiration date on 01-APR-2020 (dose, anatomical location and administration route were not reported) for prophylaxis. The reporter stated that the patient received a dose of ROTATEQ that may have been invalid due to shipping issues. No adverse effects reported.
Received vaccine on 11/13/12. On 11/15/12 there was a dark red, hot, circular area around the injection site approximately 1 1/2 x 2 inches with swelling surrounding it. On 11/16/12 the vaccination site was larger, hotter & redness with severe swelling encircling the upper arm. Sent to ER.
lost all my balance; Feels very very hot to the touch; Cannot get out of bed; Cannot sit up; Cannot walk; feeling very bad; nauseous; joints hurt; Fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (lost all my balance), FEELING HOT (Feels very very hot to the touch), DYSSTASIA (Cannot get out of bed), HYPOKINESIA (Cannot sit up) and GAIT DISTURBANCE (Cannot walk) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010MZ0A and 010MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced GAIT DISTURBANCE (lost all my balance), FEELING HOT (Feels very very hot to the touch), DYSSTASIA (Cannot get out of bed), HYPOKINESIA (Cannot sit up), GAIT DISTURBANCE (Cannot walk), FEELING ABNORMAL (feeling very bad), NAUSEA (nauseous), ARTHRALGIA (joints hurt) and PYREXIA (Fever of 101). At the time of the report, GAIT DISTURBANCE (lost all my balance), FEELING HOT (Feels very very hot to the touch), DYSSTASIA (Cannot get out of bed), HYPOKINESIA (Cannot sit up), GAIT DISTURBANCE (Cannot walk), FEELING ABNORMAL (feeling very bad), NAUSEA (nauseous), ARTHRALGIA (joints hurt) and PYREXIA (Fever of 101) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants included blood pressure medications.  Treatment medications were not reported.   This case was linked to MOD21-028184 (E2B Linked Report).; Sender's Comments:  MOD21-028184:
Since the second dose of the COVID-19 vaccine, patient started to experience spontaneous episodes of urticaria and hives. She has 1-2 episodes of itchy hives involving bilateral legs, abdomen, chest and bilateral arms. These typically resolve spontaneously within 15 minutes. When they last longer, she is able to control them with OTC benedryl. She presented to the emergency department on 9/30/2021 for lip and throat swelling along with her usual hives. She took two OTC benedryl capsules which resolved the hives but her lip and throat swelling remained. On exam,  patient was breathing comfortably without stridor or drooling. She had visible edema of the uvula. Famotidine 20mg IV , solumedrol 125mg IV and epinephrine 0.3mg IM were administered due to ongoing subjective feelings of throat swelling. Plan is to observe the patient for several hours until the uvular swelling resolves.
This spontaneous report was received from a physician through email via healthcare worker refers to a patient of unknown demography. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # J009833 (Expiry: 25-JAN-2015) (dose, route and frequency was not reported). On an unknown date the patient experienced significant pain, redness and swelling at the injection site. The outcome of the event significant pain, redness and swelling at the injection site was unknown. The reporter did not provide the causality between the event of significant pain, redness and swelling at the injection site and the suspect drug. The case is linked to the case 1402USA007454, 1402USA007455 and 1402USA007456 (same reporter link). Additional information has been requested.
Large slightly raised rash about 2" below injection site, only moderate relief from over-the-counter anti-itch cream. Heavy breakthrough bleeding while on active pills for birth control.
blood clot; This is a spontaneous report from contactable consumer (patient) via Pfizer Sales Representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blood clot on an unspecified date. It was reported that the event took place after use of product. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mother reports that patient had Varicella, Tetanus, Hepatitis B, and flu vaccines though exact types are unknown. The next day patient was irritable and developed redness and swelling of his ears, hands, feet, and papular rash on his face, trunk, and in his armpits. No difficulty breathing, vomiting, diarrhea, facial or lip swelling, difficulty swallowing, or signs of anaphylaxis.
The day after my first vaccine injection, my right eye was completely covered in yellow mucous.  The eyelid was swollen, but white of eye seemed unaffected at first. There were no previous eye issues prior to this day. The left eye had a very small amount of mucous. Allergy eye drops have offered the best relief, but the yellow mucous is intermittent and right eye continues to be irritated.
I woke up on 5/4/21 at 5:20 pm and everything was spinning. I was so scared I couldnt walk, I was moving from side to side. It wouldn't go away, everything was spinning. My friend took me to the ER. I had to use a wheelchair. I went into the ER, they ran tests, gave me mescaline, it helped but I had to rest because I was still dizzy. It took about a week to go away.
injection site warm /palm size warm; redness at injection site; rash at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injection site rash. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The health care professional stated that the patient experienced injection site reactions of a palm size warm, red rash.  The health care professional had no further details at the time of report. The health care professional declined to provide patient and vaccine information. The reporter did not consent to follow-up. The case has been linked with the case US2019GSK083546 and US2019079164 reported by same reporter.
Periods of tachycardia and diaphoresis started 7 hours after vaccine  Had 3 "spells" of it ending am of 1/14/21
Pt received MMR 6/26/03 with instructions not to get pregnant in the following 3 months. A UPT was negative on 6/26/03. LMP 6/23/03. On 8/13/03 her UPT was positive. Estimate she is 7 weeks pregnant. Referred to Ob/gyn.  Became pregnant on or about 6/30/03.
Approximately 2 hours after receiving her first covid vaccine, my 14 year old fainted. She was standing in our kitchen at home and became dizzy and started falling backwards. She said her vision was black, she was hot, her head hurt, I could see sweat on her face and chest, and she said she was having tightness in her chest/not able to get full breaths. She didn't totally lose consciousness, but she was disoriented. These symptoms lasted a few minutes, then she felt fine.
pt has not and did not have any reactions Mom, patient and provider all notified wrong immunization was given (should have been Meningoccal B). Next time we will triple check with a 3rd person to prevent form happening again
Moderna COVID-19 Vaccine EUA Immediately - first two days: Bruising at the injection site, whole-body fatigue significant Day 3-7 Redness increasing at the injection site with rash forming, injection site felt warm and itchy, continued whole-body fatigue Day 7 Developed a fever of 100.4 in evening time with diarrhea, headache, fatigue, whole body aches. Injection site redness increased into a big red oval shape, felt hot, texture of rash deepened. Day 8 Fever continued during the day ending at 100.6 in the evening time.  Diarrhea decreased with some residual sx.  Covid test was taken and was negative. Injection site redness continued Day 9 Fever broke and whole body sx reduced to general fatigue.  Inject site redness continued Day 10-16 Whole-body sx reduced and stopped, Injection site redness slowly reduced and dissipated.
THE PATIENT CAME IN FOR WHAT SHE STATED WAS HER FIRST DOSE OF PFIZER COVID 19 VACCINE.  WE WERE UNABLE TO GET INTO TO UPDATE HER RECORD WITH HER VACCINATION UNTIL THE 11TH.  AT THAT TIME, HER RECORD SHOWED A DOSE ALSO GIVEN ON THE SAME DAY.  THE PATIENT HAS NOT RETURNED PHONE CALLS.
Left arm posterior cellulitis with rubor, tumor, calor, hyposthesia, axillary LAD, within 1 day of vaccine administration.   Treated with Keflex (14 day course), Medrol dose-pack, Motrin.
103 fever from 10:30 pm-7 am. Low grade fever 100 from 7am-3pm. Headache(24 hrs), nausea(during high fever period), chills(during high fever period), fatigue (34 hours)
Starting on 04/17/2022, I developed a sore throat. It kind of went away so I didn't think much about it. When I woke up in the AM, I had a head cold and a sore throat. I knew I had been exposed the previous week so I got tested for COVID-19 via an antigen test and it was positive. The head cold got worse (more like a sinus infection) and by day 3-4 I started developing severe fatigue. By day 5 the head cold had mostly gone away and the fatigue was gone. I tested again on 04/25/2022 and I was negative.
spotted bruises on my dorsal left arm; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EL283), via an unspecified route of administration, administered in left deltoid on 29Jan2021 (at the age of 28-year-old) at a single dose for covid-19 immunisation. The patient had no medical history and was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication (received within 2 weeks) included Ibuprofen (ADVIL). Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient was not tested for COVID-19. On 04Feb2021, the patient noticed spotted bruises on her dorsal left arm. Patient did not receive any treatment for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
slept from 9 pm on 11-4 to noon the next day, chills/fever, lower BP than normal for me, woozy/groggy, headache, diarrhea, nausea, pain in shoulder radiating to right chest area,
Information has been received from a physician concerning a 12 month old male with no pertinent medical history, drug reactions or allergies who on 03-APR-2008 was vaccinated with 0.5 ml of MMRII (lot # "04284").  There was no concomitant medication.  On 6 APR 2008 the patient developed a measles like rash throughout his body and some redness in the mouth.  On 16 APR 2008 the patient went to the emergency room (ER) and was released.  On 18 APR 2008 the patient was seen "in the office" for a "typical measles rash".  It was noted that no treatment was required.  At the time of reporting the patient had not yet recovered.  There was no product quality complaint.  Follow-up information has been received from a physician concerning this 12 month old male child who on 03-APR-2008 was vaccinated IM with MMRII (lot # 656915/0428U).  Suspect vaccination included IM VARIVAX (Merck) (lot # 658374/1117U) on the same date.  Subsequently, on 06-APR-2008 the patient developed a morbilliform rash.  The rash started on the patient's face and within 2-3 days the rash had spread to the patient's legs and arms.  Otherwise the patient was well.  It was also reported that the patient recovered on 28-APR-2008.  Additional information is not expected.
Information has been received from a physician concerning a 17 month old white male pt who on 6/24/99 was vaccinated SC with 1 dose of varicella virus vaccine live in the left arm. On 12/17/99, the pt presented with shingles described as a classic dermatomal pattern with lesions on the pt's upper right abdomen around to the right side of his back. A VZV specimen was obtained and the results indicated vaccine strain VZV. The pt reported pain but had no other symptoms. On an unspecified date the pt recovered. Follow-up information received indicated that the pt "now has thrush." Additional information has been requested. Follow up information received on 04/04/2000 indicates the patient recovered from otitis media. In addition, it was noted that the results of the patient's immunologic work-up were not yet available. No further information is available.
Trouble walking; severe pain in right knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Trouble walking) and ARTHRALGIA (severe pain in right knee) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Total knee replacement on 15-Jan-2021. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ARTHRALGIA (severe pain in right knee) (seriousness criterion disability). On an unknown date, the patient experienced GAIT DISTURBANCE (Trouble walking) (seriousness criterion disability). At the time of the report, GAIT DISTURBANCE (Trouble walking) and ARTHRALGIA (severe pain in right knee) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included prednisone and Celecoxib. The patient's physician believed that her knee pain was related to Moderna vaccine because of the timeline and would give her a cortisone injection today, 13 May 2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Causality is also confounded by the patient's past medical history of total knee replacement.   This case was linked to MOD-2021-097847 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-May-2021 upgraded the case to serious with seriousness criteria (disabling/incapacitating), newevent, event start date, outcome of event, and treatment information updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Causality is also confounded by the patient's past medical history of total knee replacement.
Noticed headache bottom left back of head before bed.  Woke up at 2:30am with right leg fully asleep.  Attempted to wake leg up, lost equilibrium, stumbled, lost hearing, couldn't put words together to tell wife what was going on and ended up on the floor to regain composure.  Had difficulty putting on clothes to go to hospital.  Went to ER, had severe diarrhea there, they did blood work and EKG, sent me home saying maybe I feinted.  Had high blood pressure at ER, 150/86.  Felt weak and 'off' sense the event, felt tightness in chest and odd limb pain past 72 hours.  Woke up at 3:30am on 4/15 with left arm asleep, went back to bed fine.  Never had these symptoms before.
patient experienced mild redness and swelling about injection site, physician was consulted and antibiotic was prescribed
Typical sore arm for first two days. On 10/22/2020 patient reports a red blotch close to bicep (not injection site), sore arm, sore neck, chills, no fever
Patient began experiencing throat/tongue swelling.  1 mL Benadryl given IM.
This spontaneous report as received from a physician as part of a marketing research program conducted by Research Group refers to a 75 year old female patient with diabetes and hypertension. In approximately September 2003 (reported as 10 years ago) the patient was vaccinated intramuscularly (IM) with a 0.5 ml once dose of PNEUMOVAX23 (lot # was not reported). Concomitant therapies included bisoprolol and metformin. On 28-AUG-2013 the patient had pneumonia. On 28-AUG-2013 chest X-ray was performed and result was pneumonia. The outcome of the event was reported as recovered on 05-SEP-2013. The reporter considered the event to be not related to PNEUMOVAX23. Additional information has been requested.
Patient reported experiencing arm swelling, redness, warmth, and soreness around the area of injection site after receiving the 2nd dose of Moderna vaccine. Photo showed picture of deltoid area, redness around the deltoid , extending approximately half-way down to elbow. Patient developed a bruise at injection site but reported the bruise is fading, and the swelling has gone down. She experienced fever and fatigue after the injection, but reported not having to seek medical attention. She said fever escalated to over 103 deg. F. She used OTC treatment to help with fever and arm pain. She said she has recovered from all fever/fatigue symptoms as on 8/31/21. Arm swelling has gone down and redness around injection site is decreasing. She added that she experienced a similar local injection site reaction after first dose, but it was smaller and not to the extent of the reaction she experienced after the 2nd dose. She reported having no systemic symptoms after the first dose.
Patient described chest pain (pain scale of 6.5, from 0-10 with 10 being the highest) located centrally near the heart, extreme headache and sore arm. The chest pain lasted about 24hrs until patient took acetaminophen.
A few hours after getting the shot, I had swelling of the injection site, soreness, and light body aches the next morning. On 4/8/2021 I noticed that I had a swollen lymph node above my collar bone that was noticeable. After getting it looked over by medical professionals, they stated that I should monitor it for 6 weeks to see if the swelling goes down.  It was also advised that go forward with my second shot on 4/24/2021
Itchy rash at site of injection - did not show up until a week later.1/2 inch tall, 2 inches wide. Minor, I have not called a doctor just treating it with Benadryl cream
Pt felt like her face was itchy, she reported that she felt like her throat was closing up.
I had a little infection in my uterus; spitting up phlegm; she has been throwing up; dizzy; her appetite has changed; rash; too mild infections; had a itching, Burning sensation; sleepy; had a itching, Burning sensation; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 26Mar2021 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she was difficult to understand but from her, what she got, she had first dose of the COVID-19 vaccine and was supposed to go for her 2nd dose, and she did not give her any dates or notes but, she has been spitting up Phlegm, has seen her healthcare provider so, she going to go back and tested again (Unspecified test) but she has been throwing up, dizzy and has had a change in her appetite. She said that they checked her urine but have not found any infection. She said that she had a rash, too mild infections and she said that one doctor told her, might be from the vaccine. She did not have any questions. She just wants to report those side effects. Consumer stated, "See I'm starting to get the COVID Shot. I got the first one and anyhow, but I had a little infection in my uterus. I had an itching, burning sensation. Something else and doctor said, I have more rash in my arm". Consumer stated, "What was the last thing you said? I am a little sleepy". Consumer stated, "I do not know my email address. I am making a new email address for my friends, tomorrow so, she was trying to do tonight but I grow from a disability". Consumer stated, "I am on birth control right now so, where would you like to give my child, but I have general wards too something in my room and then trying. "Where it would be? 32612. Is that it or is it # 4606? The number is 4606 # or it be 82621. I am sorry. Two numbers, Which I never can decide 193". Consumer stated, "No, I just took one shot right now and I was on in and doctor told me to quit to one pill (Further clarification Unknown) today so, I am on a double check with the clinic. My family doctors. There is another one on 16Sep2021, that actually, When I was on my appointment". The patient received unknown treatment for all the events. The patient underwent lab tests and procedures which included urine analysis: have not found an infection on an unknown date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.