chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blowing sensation in the right ear.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (blowing sensation in the right ear.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TINNITUS (blowing sensation in the right ear.). At the time of the report, TINNITUS (blowing sensation in the right ear.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   As treatment the patient applied some oil in the right ear.
Flare of her psoriatic arthritis which had been quiescent for a number of years. She is a bit vague about the time course, started having swelling of several fingers and a toe that started late March or early April she thinks.  She did have covid infection in December but was recovered and had no persistent sxs.  Physical exam showed marked swelling and synovitis of several DIP joints on hand and toe. She was treated with methotrexate and had had improvment in her symptoms
Moderna covid 19 vaccine EUA  - 12 hours post vaccine - sore arm lasted for 24 hours  - 48 hours post vaccine- severe migraine  - 7 days post vaccine- severe migraine as well as soreness at vaccine site , tingling and pain going down left arm and tingling in feet and legs.
pain at injection site, body aches, headache, fatigue, and mild chills for about 28 hours post vaccination.  Treated with Tylenol and rest.
Evening of vaccine, pt began getting scattered, itchy hives on body. Pt using topical hydrocortisone. Instructed to use Benadryl 25mg PO q 4-6hrs for itching. Pt verbalized understanding. Resolved by 5/17/06 AM.
A report was received from a health care professional on 12/15/03 concerning a 15 month old male vaccinee who inadvertently received two doses of Fluvirin on an unknown date in 2003. On an unknown date in 2003 the vaccinee inadvertently received two doses of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Metallic taste after shot. Pins/Needles on left side of face - continually near eye, every few hours rest of face.
Burning and tingling immediately after injection; burning and tingling immediately after injection/ tingling throughout the right arm and fingers; developed redness and swelling; developed redness and swelling; Patient received Shingrix back of right arm, maybe subcutaneous; This case was reported by a other health professional via sales rep and described the occurrence of burning sensation in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2020, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, immediately after receiving Shingrix, the patient experienced burning sensation, tingling of extremity, erythema, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the burning sensation, erythema, swelling and intramuscular formulation administered by other route were unknown and the outcome of the tingling of extremity was not recovered/not resolved.   The reporter considered the burning sensation, tingling of extremity, erythema and swelling to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix back of right arm, maybe subcutaneous, which led to intramuscular formulation administered by other route. The patient complained of burning and tingling immediately after injection, also developed redness and swelling. After 2 week follow up patient was still experiencing tingling throughout the right arm and fingers. The reporter consented to follow up.
Waking up; Discomfort on the left side of my head, jaw, and side; Frequent headaches, nearly every day; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Waking up), DISCOMFORT (Discomfort on the left side of my head, jaw, and side) and HEADACHE (Frequent headaches, nearly every day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced SLEEP DISORDER (Waking up), DISCOMFORT (Discomfort on the left side of my head, jaw, and side) and HEADACHE (Frequent headaches, nearly every day). At the time of the report, SLEEP DISORDER (Waking up), DISCOMFORT (Discomfort on the left side of my head, jaw, and side) and HEADACHE (Frequent headaches, nearly every day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  On 10-Mar-2021, the patient reported that for the past three weeks, she had had frequent headaches, nearly every day. The nature of them was as follows. They were shooting pains in the back of the head and behind the right ear; one-sided pain, both left and right, most nights when she was going to bed; and was waking up with a severe headache in the middle of the night; and had an experience of discomfort on the left side of my head, jaw, and side. As per the patient she had decided to skip the second dose, which was due on 13-Mar-2021. No treatment information was provided.
Change in menstrual cycle. Delayed. Development of right ovarian  fibroids,and cysts in uterus.  Painful irregular menses.
bumps and rash, subsequently diagnosed as PLEVA by biopsy (pityriasis leichenoides et varioforma acuta)
3 days after the first dose of the Pfizer vaccine I got some mild swelling, pain, and redness in my left breast. I am breastfeeding, so I thought it was a clogged duct or mastitis but it cleared on its own in 3 days. 3 days after my second dose of the vaccine I got severe swelling, redness, and pain in my left breast. The swelling and redness are so severe my Arreola has almost doubled in size. The pain is still very bad after 3 days and has not subsided yet
On May 5th I felt extreme fatigue. I didn't want to do anything, very lethargic. Paxlovid was prescribed to me. The fatigue and lethargy lasted about 2 days. On the second day the medication kicked in.
L thigh at site of vaccine with red mildly swollen, warm to touch, mild tenderness, a little hard to touch.
I experienced a breakthrough case of COVID-19 with congestion, coughing, tiredness, nausea and no appetite.
Constipated; physical and emotional breakdown; physical and emotional breakdown; Vomiting; Pain; pain specially on her left side, from left shoulder to her neck and up into the skull; pain specially on her left side, from left shoulder to her neck and up into the skull; pain specially on her left side, from left shoulder to her neck and up into the skull; suicidal thoughts; I got violently hit with reaction that put me on wheelchair; I had muscle cramping all over my body whenever I would move my muscle I would be crying out with pain/ muscles were cramping; I had extreme edema; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on [11Nov2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report  received from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot Number: EN6200) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing autoimmune illness, ongoing Hashimoto's disease, ongoing comorbidities: endocrinologist diabetes, ongoing fibromyalgia , ongoing high blood pressure, ongoing blood triglycerides, fatty liver from an unknown date, ongoing incontinence, ongoing episodes of bursitis pain, multiple chemical sensibility from an unknown date. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (Lot: EN5318) 1st dose on Jan2021 for COVID-19 Immunization. Patient, after about one week from second dose (Feb2021) got violently hit with reaction that put her on wheelchair (Further clarifications unknown hence event captured as per verbatim). She had muscle cramping all over her body whenever she would move her muscle she would be crying out with pain. She had extreme edema and other reactions (Further clarifications unknown) and the reason she am calling is she just find out she felt that since she had a extreme reaction she had really good antibodies but when she went to her Doctor She was concerned about getting a booster shot and she asked her if she can check my antibodies and it turns out she had zero antibodies and she was concerned because she was taking care of my 84 years old husband who is currently disabled and 2 old children who are on the autism spectrum. So she needs to protect herself but she was afraid that if she took the booster it is going to kill her so is there any way to test. She had a violent reaction a week after the covid vaccine; all her muscles were cramping, and she ended up in a wheelchair. She was also constipated and had to take a laxative, she had a physical and emotional breakdown, vomiting, excruciating pain specially on her left side, from left shoulder to her neck and up into the skull, and suicidal thoughts. She went to ER with her husband. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had immediate onset of swelling at injection site. Looked like a bubble inside the arm. By the time patient left, swelling was less
chills, fever 99.1 day of, severe headache, pain at site and hot to touch, muscle fatigue in neck, back, arms and all over, night sweats, nausea, diarehea, no appetite day after, pain at injection site, lower back pain, fatigue 2 days after.
Pt complained of "mild" shortness of breath and dizziness. Went to E.R. was given BENADRYL and discharged to home. F/u next day pt states completely resolved.
Muscle aches that spread slowly from Lower back to extremities-started around 6:30, has lessened about 24 hours after injection  headache-started next morning  joint pain-started approximately 12 hours after shot  sore throat-started next morning  Queasiness-started about 2 hours after injection, stopped after about 6 hours post-injection
Fatigue, chills, headache, muscle ache. Noon to midnight on 4/3.  Took Tylenol and symptoms subsided.
Developed itching at injection site scratching it noticed rash distal to injection site and deltoid next morning 10/12/2005. Red dot non blanching, appears petechial 10/13 no longer itching scabbing at rash sites.
I had no symptoms right after vaccine. Recent health event: I fainted and was taken to the ER. All tests looked okay. Seven second pause of my heart rhythm and they had to arouse me and I would feel dizzy and nauseous at the onset of the fainting and heart pauses. But I was unable to push a call light. I had another heart pause and they admitted me to ICU and I had two more pauses in ICU and the longest one being 21 seconds. That evening and night, I slept hooked up to crash cart and heart rhythm was in 20's at time and it was determined I needed a heart pacemaker due to being diagnosed with heart bradycardia and multiple heart pauses within the past 12 hours. The pacemaker was inserted then on the 13th of April. I was discharged from the hospital on the 14th. I eat very well, I teach aerobics and I'm very healthy so this was out of the ordinary. No other treatment besides the pacemaker.
SWOLLEN NECK; SWOLLEN RIGHT ARM; 6 BLOOD CLOTS; SICK; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included surgery. There was no history or family history of blood clots. Prior to vaccination, the patient had several physicals performed due to other health concerns and CAT-scans and MRIs were performed that showed his body was totally without any blood clots.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic indication. Batch number was not reported and has been requested.  No concomitant medications were reported. After getting the vaccine patient was sick for 3 days. On an unspecified date, the patient woke with a with swollen neck, swollen right arm that was twice its normal size. The patient went to the hospital and they were concerned it was a blood clot further so he was then sent to hospital where they performed an ultrasound which revealed 6 blood clots. The patient was hospitalized and underwent surgery on his arm to "open up the vein that was causing the swelling". The patient reported he was scheduled for several more surgeries of this kind.  Corrective treatment included intravenous blood thinners.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen neck, swollen right arm, 6 blood clots, and sick. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This male patient of unspecified age noted swelling of righ arm and neck that the ultrasound showed 6 blood clots after an unspecified duration from receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. The patient was hospitalized and underwent corrective surgery and was started on unspecified blood thinners.  No other details was reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (I had a sore arm). At the time of the report, VACCINATION SITE PAIN (I had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-279435 (Patient Link).
LIGHT HEADED, HEART PALPITATIONS, BLURRED VISION, FATIGUE. VITALS WERE TAKEN AND WNL, BP 129/80, TEMP 98.3, PULSE 85. @ 1:55PM ON 04/21/2020
COVID vaccine breakthrough case. Pfizer EL9261 1/21/21 and EM9810 2/11/21 and boosted with Moderna Lot 012F 10/28/21.
1 inch blister right lower leg, and 1/2 inch blister center upper back
Slight fever, MD visit, congested x 2 days; LOM; pharyngitis; bronchitis;
Chills, headache, body aches, fatigue for about 14 hours starting  about 12 hours after my second dse
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cefaclor, reaction: "Drug allergy". Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (booster), Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
*Unexplained increases in heart rate (up to 165 bpm) over next 4-5 days following injection.  During sudden heart rate increases , I would feel sweaty and weak. *I also experienced  mild fever, chills, and body aches for about 36 hours beginning about 6 hours after injection.
1st.  vaccination no adverse rxn, 2nd  swollen arm at vaccination site in left arm, tightness in throat, sweating, tiredness
Pt stated they felt lightheaded and sweaty when injected. Pt stated they ate a rice cake at around 11:30 am. Pt was brought to Med. Obs. 1 and placed into t-berg position and given crackers and water. Pt began to feel better (slightly) in t-berg position within a few minutes. Vital signs as follows: Laying Down- 1:11 pm: BP-157/85, HR- 85, SPO2-100% 1:16 pm: BP-148/82, HR-85, SPO2-100% 1:22 pm: BP-132/87, HR-85,  SPO2-100% Sitting Up- 1:27 pm: BP-155/95, HR-93, SPO2- 100% 1:58 pm: BP-162/111, HR-83, SPO2- 100% 2:06 pm: BP-106/79, HR- 85, SPO2-100% Standing Up- 2:11 pm: 157/100, HR- 85, SPO2- 100%
little dizzy; felt really fatigue; cold; chills; trembling; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little dizzy), FATIGUE (felt really fatigue), NASOPHARYNGITIS (cold), CHILLS (chills) and TREMOR (trembling) in a 24-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced DIZZINESS (little dizzy), FATIGUE (felt really fatigue), NASOPHARYNGITIS (cold), CHILLS (chills), TREMOR (trembling) and PYREXIA (fever). At the time of the report, DIZZINESS (little dizzy), FATIGUE (felt really fatigue), NASOPHARYNGITIS (cold), CHILLS (chills), TREMOR (trembling) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not provided. Treatment information was not provided.
Ringing in ears started within 2 weeks of the shot.  I already reported it on this website BUT, in follow ups, reported it subsided.  BUT, I want to give an update becasue it had returned, and my hearing in the affected ear (left) has some hearing loss as well and ringing in ears has been constant (more pronounced)  all winter and while it subsides at times, has always been there.
Vaccine given in Right deltoid.  Next day hot to touch, redness, and swelling measuring 40 X 19 cm
A 2 month old, female patient had inconsolable crying for 4-5 hours, after she received Daptacel (lot number C2605AA, route of administration not reported) in the gluteus (side not reported), IPOL (lot number Z0548-2, route of administration not reported) in the gluteus (side not reported), and ActHIB (lot number UE975AA, route of administration not reported) in the gluteus (side not reported). She also received PCV7 (lot number B36258C) in the gluteus (side not reported) and Rotavirus (lot number 0023U/908VR) in the gluteus (side not reported). The parent treated with patient with Tylenol and the patient recovered. This case has the same reporter as case 2007-01629.
I had a mammogram done. They said my lymph nodes were inflamed. They said it was because from the vaccine. I also had a lump under my arm pit. I was also swollen and tinder as well. My left breast is also tender and swollen as well. I am having another mammogram done. My blood pressure went extremely low.
Pt one week after shot had erythema with circular macular rash at site of shot. Temp 99.2. Rash was pruritic (-) N/V (-) fatigue (-) SOB (-) dysphagia. Antihistamines, cool compresses.
Patient received flu vaccine on 11/23/2004 and was diagnosed with influenza on 01/08/05 using CLIA waived flu test.
Patient called the pharmacy today that after receiving the two vaccines last Saturday she is unable to breathe and that she feels sick. I recommended her to sick medical help.
Monday, March 10, 2003, I received the Tetanus vaccine at my doctor's office around 2:30 p.m. It was sore and had typical results, however as the evening approached, the pain began to intensify.  Tuesday, March 11, 2003, the pain was becoming severe and swelling around the needle/vaccination entrance was very noticible.  By evening the pain caused interference from moving and lifting, the (left) arm  and was terribly uncomfortable even when not moving.  The severe pain prevented me from laying on that side at bedtime and the whole arm including fingers, shoulder, left side of neck were not comfortable.  The swelling had also increased with redness, and was hot to the touch.  By morning, Wednesday, March 12, 2003, a large bright red area was produced approximately one and a half inches in diameter over the inflamed area.  The pain was continuous.  Movement was extremely painful.  I called my family doctor to make an appointment and was able to get in with the immediate care provider around 5:00 p.m.  I was seen byMD who prescribed Cephalexin 500 mg. four times per day for seven days, Benadryl, and Tylenol or Advil. That evening I put a hot pack on the arm at bedtime, it was extremely sore.  Thursday, March 13, 2003, The red area was approximately two inches in diameter and hot to the touch.  Even wearing the seatbelt in my car was painful to have on.  My upper arm was still swollen and painful, although by evening the pain had lessened some.  Friday, March 14, 2003, the area around the vaccination site is lighter red to pink, still warm and sore but less swollen.
Woke up in AM with Swelling of upper lip, patient is a nurse at the hospital where she received the vaccine.  Took a Claritin 10mg & Benadryl 12.5mg and also applied topical hydrocortisone cream to affected area which had little effect.  One hour later repeated Benadryl 25mg and Zantac 150mg. Decreased swelling after, however still swelling 15 hours later, repeated Benadryl 25 mg & Zantac 150mg.