chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pimples or like pimples on neck back and left side near ear and surrounding area; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the right arm on 17May2021 at 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis C and other related pain issues. The patient had known allergies to unspecified medications, food, or other products. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN), oxycodone (MANUFACTURER UNKNOWN), tapentadol hydrochloride (NUCYNTA ER), diazepam (MANUFACTURER UNKNOWN) and vitamins; all taken from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 23Apr2021 at 09:45 (at the age of 67-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 20May2021 at 17:00, the patient experienced pimples or like pimples on neck back and left side near ear and surrounding area. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event pimples or like pimples on neck back and left side near ear and surrounding area was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
I experienced high fever 101 for two days after vaccine was given, severe body aches of joints, low blood pressure, and extreme fatigue.  I had dizziness that was later diagnosed as Vertigo.  Went to Hospital's ER and was put on IV for dehydration, given muscle relaxers, and pills for dizziness.  Now experiencing Vertigo and was recently diagnosed with  Vestibular Neuritis and Vestibular Unilateral Hypofunction  (right ear).  Currently, out on short term disability and FMLA.
Hallucinations; Anxiety; Paranoia; She was nervous; she wasn't feeling right; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, first dose on 25Jan2021, then second dose on 13Feb2021 both at single dose on the left arm, for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension, both from an unknown date. Concomitant medication includes taking an unspecified medication for years, pain pills or whatever and the doctor said that it can take up to 7 days to leave the system. On 27Jan2021 at 10:00 am, 2 days after the first dose, it was reported that patient began to have hallucinations, anxiety, and paranoia. On an unspecified date in Jan2021 after the first dose, the patient reported that she was nervous, she is not feeling the same. The events continued after the second dose. She went to the Emergency room on Valentine's day 14Feb2021, she was not admitted and went home the same day. They just told her don't drive and talk to her primary Care Doctor. She then made an appoint for the primary care doctor on 17Feb2021. She has no other vaccines on the same day or in the 4 weeks prior. She has no other family medical history to provide. The outcome of the events hallucinations, anxiety, and paranoia is slowly going down and recovering while for the rest of the events was unknown.  Information on lot number/batch number has been requested.
About a week later after receiving the shot, I got a rash on my neck the side and back of my head. It was very painful. I also got another rash on my chin that was itchy. My back of my head was very itchy too. I went to the doctors and she told me I had shingles. She gave prescribed me medicine for the infection and also to help the pain. She advised me not to get the second shot.
Extremely unusual menstrual cycle. Usually my menstrual cycle is 6 days long. First day is light, second day is heavy, and then it wains from there. After receiving the Covid shot I started my period and heavily bled for four days to the point that I was soaking through super plus tampons every hour to two hours and having to wear heavy night pads. It was similar to bleeding after birthing a child. Then after the four days my bleeding stopped. On the fifth day I had severe leg pain in the upper right hip area. Then on the sixth day I started bleeding again. I?m on day 8 of my period.  My period has never been this long.
PT COMPLAINS OF DIZZINESS NUMBNESS IN ARMS AND CLAIMS HEART FELT LIKE IT WAS RACING. PT WAS GIVEN WATER.
Patient came in for second dose of the Moderna series and was provided with a Pfizer vaccine by accident instead. Patient was kept in observation longer to check for any s/s of distress. None noted.
Tingling in tip of tongue.  Patient then informed us that she has burning tongue syndrome.  Then several mins. later gums in front teeth going numb tingling.  We gave her 50 mg liquid Benadryl.  Pt. then stated traversing jaw bone.  Not feeling well. I had patient stay longer then in a few mins. patient requested us to call 911. Tingling in arms and not good in chest area. Feeling some thing in back of throat. This weirdness traversing from one side of arm across the body to other arm.  Patient requested us to call 911.  Paramedics came out took it after this.
Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4526974-00.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown), on 16Aug2021 as dose 2, single (Batch/Lot number: unknown) and on 12Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1160031), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up". The action taken for upadacitinib was unknown.  Clinical course: The reporter considered "rheumatoid arthritis flare up" not related to BNT162b2. Rheumatoid arthritis flare up, out come not recovered/not resolved. Solicited report from the USA by a consumer of an adult female with an event of  non-serious rheumatoid arthritis flare ups periodically/got flare ups when took  covid booster shot with Rinvoq (Upadacitinib). There was no reported medical history. On an unknown date, the patient experienced rheumatoid arthritis flare ups periodically/got flare ups when took covid booster shot. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for the event(s) of Rheumatoid arthritis flare ups periodically/got flare ups when took covid booster shot was not provided. The reporter's causality with event and Rinvoq (Upadacitinib) was not reported.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
devel two maculopapular red, raised lesions @ inj site;warm to touch w/in 2wk of having recv varicella vax;tx westcort to area;
The Shingrix vaccine comes in a powder form that needs to be reconstituted with a diluent. When the vaccine arrives in the department the vial with the powdered vaccine and the vial with the diluent are banded together to remind staff to reconstitute prior to administration. An LPN was preparing give Shingrix to a member when she noted that the last vial coupling in the box was two vaccine powder vials banded together. Because this was the last of the vaccine, out of 10, left in the box, it can be assumed that two diluents were also banded together and it is likely that one of the 9 patients who received Shingrix vaccine from this box received a diluent only injection.
Patient is complaining about severely swollen and painful lymph nodes in the axilla in the arm that the vaccine was given. She also complained of fever that lasted about 24 hours, slight bruise at the injection sight and that her arm really hurts. She is taking acetaminophen and has iced the axilla. I suggested she take ibuprofen.
Two days after receiving the vaccine,  on Jan 28th, I noticed pain in my right lower back area.  It went away so I didn?t pay much attention to it.  On Jan 29th,   I woke up to stabbing pains in my right chest which continued to night of Jan 30th.  Morning of Jan 31st, I was very short of breath and could hardly get around.  I went to the ER in evening of Jan 31st.  I was admitted due to two pulmonary embolisms in my lungs.  Doctors were convinced I had Covid 19.   However, three tests came up negative.  I was put on a Heparin drip and then eventually on Eliquis.  I have always been healthy up to this point and never had any clotting issues.  I now am on Eliquis for at least six months (have to have a follow-on echocardiogram due to issues on right side of my heart.).  I am convinced the vaccine triggered the clots.
She reports the following day she felt fatigue. About 3 days later with fevers, chills, body aches, fatigue, runny nose, congestion, cough, and severe sore throat.
My period has been longer than normal. It started in the morning on the day I got my 2nd vaccine in the afternoon and has been going on for 9 days. my normal periods are 5-7 days.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 16:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included multivitamin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received nitroglycerin (MANUFACTURER UNKNOWN)and sulfamethoxazole-trimethoprim (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 14Apr2021, the patient noticed that her period had been longer than normal. It started in the morning on the day, of seecond vaccine in the afternoon and had been going on for 9 days and normal periods are 5-7 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event, period had been longer than normal was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Why did my resting heart rate go up to 146 BPM after your vaccine. I now have to take medication to help lower it; This spontaneous case was reported by an other health care professional and describes the occurrence of TACHYCARDIA (Why did my resting heart rate go up to 146 BPM after your vaccine. I now have to take medication to help lower it) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Why did my resting heart rate go up to 146 BPM after your vaccine. I now have to take medication to help lower it). At the time of the report, TACHYCARDIA (Why did my resting heart rate go up to 146 BPM after your vaccine. I now have to take medication to help lower it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 146 (High) Heart rate go up to 146 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient stated that they had to take medication (Unknown) to lower the heart rate.
Breakthrough case admission after 4 vaccines Moderna 2/3/21 Lot# 013M20A;  Moderna 3/3/21 Lot# 030A21A;  Moderna 11/16/21 Lot# 005C21A;  Moderna 4/19/22 Lot# 005M21A
Rash on left thigh and fever. Instructed to use warm compresses, Tylenol/Motrin, and push fluids.
Per patient's daughter the patient had severe flu like symptoms, shaking, extreme pain in wrists/fingers/feet. Patient collapsed at home and pronounced dead at scene.
Three days post vax child developed hives. Parents kept food diary x 2 days, thinking it was food allergy. Took child to MD on 5/15/00. No rash present. Mother states it comes and goes when he eats. No problem with breathing, wheezing, lips or tongue swelling. MD recommended Benadryl when hives appear. Has one swollen posterior cervical lymph node. Nose, throat and ears are clear. BP 90/50, P 60 and lungs clear.
Bad neck and lower spine pain, headache, and sinus pressure. No symptoms prior to the 29th. No redness or rash at the injection site but from elbow to wrist on arm used for the injection patient has a rash similar to a heat rash.
Within one minute post vax the pt experienced a wheal and flare reaction at the injection site. The pt was treated with diphenydramine and topical steroid cream. Follow up states the patient was observed an additional twenty minutes without any additional event. The patient recovered. No further information is available.
Sore left arm, muscle soreness, fatigue waking up the next day. Around 24 hrs after vaccination, headache started, and lasted for ~8 hours. I took some advil around an hour before the headache stopped (really wish I'd taken it when I first felt the headache). I could feel the muscle soreness go away before the headache did. The headache felt like it moved from behind my eyes to the back of my head. I decided to only eat bits and pieces of stuff when I was feeling my worst because I was concerned that would make me feel nauseated (never did feel that way, so no idea if that made a difference). I drank probably 200oz of liquid throughout the day, but still felt dehydrated, even though I wasn't sweating. Did pee a lot though. Generally it was what I expected, but a friend who works at a hospital said I should report the info.
On September 23, 2022, I had a very bad headache followed by body aches, cough, and runny nose. Most of my pain is in my back area near my lungs and shoulders.  I have breathing issues.  I now must use my inhaler almost 4 hours a day.  My cough has gotten better but I still have the runny nose.  I have not had a fever, but I did experience chills and sweaty spells mostly at night.  Since September 20th, I have seen my asthma doctor and my regular doctor.
Upper respiratory infection. Bloody nose. Runny nose. Productive Coughing. Coughing up phlem. Vomiting,  diarrhea. Bloody nose, wheezing and short of breath,
This case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a 23-year-old patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.  On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, immediately after receiving Meningococcal B vaccine, the patient experienced meningitis (serious criteria hospitalization and GSK medically significant), near death experience (serious criteria hospitalization and GSK medically significant) and weakness. On an unknown date, the outcome of the meningitis, near death experience and weakness were unknown. It was unknown if the reporter considered the meningitis, near death experience and weakness to be related to Meningococcal B vaccine. Additional details were provided as follows: The patient received meningitis shot a week before he was supposed to be deployed in the navy. The patient was fine before the shot, but within hours of getting it he was shipped to intensive care unit and was there for a week. He got out and was very weak and within 3 days went right back into the meningitis, and had to be shipped by ambulance to emergency room. He contracted meningitis and nearly died, not once, but twice. He ended up having to get a medical discharge from the navy, and had permanent damage.
Patient received vaccine and seemed fine. Had a seat in the waiting area. About 5 minutes later the patient stood up to tell the staff that she felt dizzy. She then collapsed. A by-standing patient protected her head from the floor. Patient laid down on the floor and remained there until she felt better. She had some water and crackers and slowly felt better. Patients dad picked her up from the pharmacy and no other events were reported.
Received Pfizer vaccines on 2/5/21 and 2/26/21. Tested Positive for COVID 19 by PCR on 4/19/21. Patient asymptomatic for COVID.  Previously positive for COVID in 7/2020 and 11/2020. Immunocompromised d/t transplant status, on prednisone, Sirolimus, Cellcept.
Pt came to ER c/o generalized weakness, incontinence and confusion.  Noted to have fever.
This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received BOOSTRIX (batch number P39A2, expiry date 15th February 2015). On 16th February 2015, the patient received BOOSTRIX .5 ml. On 16th February 2015, an unkonwn time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
This spontaneous prospective pregnancy report as received from a pharmacist refers to a 29 year old female patient. There were no patient's concurrent conditions, drug reactions/allergies nor medical history. On 22-JUL-2016, the patient was vaccinated with a dose of VARIVAX subcutaneously (strength and dose were unknown). The lot number was L023587 with expiration date of 26-JUN-2016. Concomitant therapies included CEFDINIR. Subsequently, the patient performed a pregnancy test before a X-ray and, on 26-JUL-2016, she reported to her pharmacist that she was pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) were not known. No product quality complaint was involved. Additional information has been requested.
After BOTH vaccines, experienced flare ups related to my medical condition. The second vaccine caused a much worse reaction than the first but started at the exact same number of days as the first.
Mom noticed swelling day after shots were given. Mom used cool compresses and Tylenol. Pt was examined and had swelling, slight redness, feverish, semi-hard area on left deltoid. This area measures 2.5 inches by 1.5 inches.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.   This case involves an adult of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Erythema multiforme started day after immunization given; still going on x 5 days. BENADRYL given.