chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large ringing in his right ear; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248, Expiration Date: Apr2021), via an unspecified route of administration, administered in Arm Left on 15Feb2021 15:00 (at the age of 71-year-old) as dose 1, single for covid-19 immunisation at Hospital. Medical history included defibrillator was placed from Oct2020 to an unknown date (had a defibrillator so was seeing his Cardiologist and his heart was fine). Concomitant medication included on a series of holistic medication and prescribed medication. Other products were none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was reported as none. Family medical history relevant to event none. The caller reported that on 15Feb2021 18:00, he experienced large ringing in the right (R) ear and didn't know if this could be related. Caller stated that it has not gotten any better nor gotten any worse. He also stated he has had 12 in a row negative Covid tests. No emergency room/physician office visit. The patient underwent lab tests and procedures which included Covid tests: negative on an unspecified date (Stated he had 12 in a row negative Covid tests). Relevant tests none. Seriousness was reported as no by the reporter. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Intractable nausea and vomiting, body aches, weakness, headache, fever 101.9 started around 3:00 am the morning after the vaccination and lasted until the following day.   I had COVID illness diagnosed on 02/09/2021.
vertigo; Unable to stand; nausea; headache on the surface of her skull and behind her eyes/head pain; dry heaving; a painful headache on the surface of skull and behind eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (a painful headache on the surface of skull and behind eyes), VERTIGO (vertigo), RETCHING (dry heaving), DYSSTASIA (Unable to stand) and NAUSEA (nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis and Vertigo. Concurrent medical conditions included Drug allergy (Jenuvia.) and Type 2 diabetes mellitus. Concomitant products included METFORMIN and LIRAGLUTIDE (VICTOZA) for Type 2 diabetes mellitus, MULTI VITAMINS & MINERALS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced EYE PAIN (a painful headache on the surface of skull and behind eyes), RETCHING (dry heaving), NAUSEA (nausea) and HEADACHE (headache on the surface of her skull and behind her eyes/head pain). On 12-Apr-2021, the patient experienced VERTIGO (vertigo) and DYSSTASIA (Unable to stand). The patient was treated with PARACETAMOL at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, EYE PAIN (a painful headache on the surface of skull and behind eyes), RETCHING (dry heaving), DYSSTASIA (Unable to stand) and NAUSEA (nausea) outcome was unknown and VERTIGO (vertigo) and HEADACHE (headache on the surface of her skull and behind her eyes/head pain) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17 May 2021 contains significant information- updated height, weight, race, ethnic group, medical history, patient route of administration and indication of the concomitant drugs metformin and victoza. The onset date of event vertigo changed from 11 Apr 2021 to 12 Apr 2021 and outcome changed from unknown to recovered. The outcome of the event headache/head pain changed from unknown to recovered.
generalized pink discoloration near the injection site; covid arm; lump near the injection site; red patch on the injection upper arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (generalized pink discoloration near the injection site), TYPE IV HYPERSENSITIVITY REACTION (covid arm), INJECTION SITE SWELLING (lump near the injection site) and INJECTION SITE ERYTHEMA (red patch on the injection upper arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO historical condition reported.).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red patch on the injection upper arm). On 31-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (generalized pink discoloration near the injection site), TYPE IV HYPERSENSITIVITY REACTION (covid arm) and INJECTION SITE SWELLING (lump near the injection site). At the time of the report, INJECTION SITE DISCOLOURATION (generalized pink discoloration near the injection site), TYPE IV HYPERSENSITIVITY REACTION (covid arm), INJECTION SITE SWELLING (lump near the injection site) and INJECTION SITE ERYTHEMA (red patch on the injection upper arm) outcome was unknown. Related          Treatment details included Patient used Ice to treat the delayed injection site reaction. No relevant concomitant medications were reported For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable
arm was warm; has now knots around the injection site; Arm is red; she had chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE INDURATION (has now knots around the injection site), VACCINATION SITE ERYTHEMA (Arm is red) and CHILLS (she had chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement on 11-Mar-2021. Concomitant products included Pain meds for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE INDURATION (has now knots around the injection site), VACCINATION SITE ERYTHEMA (Arm is red) and CHILLS (she had chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE INDURATION (has now knots around the injection site), VACCINATION SITE ERYTHEMA (Arm is red) and CHILLS (she had chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that her symptoms went away for a while, however on an unreported date, she picked at the scab (on her arm) and the symptoms returned.
Started after 30 minutes. Bulging veins, light headedness, sore arm, pain that jumps around body in muscles, chest pain, baby bump discomfort, cramping
Case completed primary vaccine series in March 2021, then was hospitalized for Covid in July 2021. COVID-19 Assessment & Plan Symptoms onset 6/20 and tested + 6/23/2021. Has been released from quarantine - diarrhea is better, no other active covid symptoms, we are likely seeing the consequences of his recent illness
Pt had URI symptoms & fever 105 (ax). Tx'd w/Nebs, A Vent, Atrovent, O2, CPT, Tylenol, Rocephin inj. 2nd vax 12/29/99, had resp. sx's, 1/6/00, resulted in Viral Pnuemonia, requiring hospital stay.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on social media about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what's your take on who is to blame? This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.
This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Redness and itching around 10am, called ED for information and was told not to touch wait until seen by EHS on Monday morning per employee.
body aches; nasal congestion; dazedness; chills; headache; arm pain; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 03Nov2021 18:15 (Lot number: FD0810) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 14Oct2021; PANTOPRAZOLE; CARAFATE; MILK THISTLE; D3; B12-VITAMIIN. Past drug history included: Tetracycline, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EW0169, Location of injection: Arm Right), administration date: 16Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0183, Location of injection: Arm Right, Vaccine Administration Time: 10:15 AM), administration date: 08May2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 03Nov2021, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 03Nov2021, outcome "recovering", described as "nasal congestion"; FEELING ABNORMAL (non-serious) with onset 03Nov2021, outcome "recovering", described as "dazedness"; CHILLS (non-serious) with onset 03Nov2021, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 03Nov2021, outcome "recovering", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 03Nov2021, outcome "recovering", described as "arm pain"; FATIGUE (non-serious) with onset 03Nov2021, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of pain, nasal congestion, feeling abnormal, chills, headache, pain in extremity, fatigue.  Additional information: The patient did receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Approx 2 mo p/3rd immun, 6 mo old pt experienced a sterile abscess @ inject site. Seen in ER & referred to medicla ctr to rule out possible carcinoma. Abscess was aspirated, X-ray was negative; fluid was bloody.
Same day given vaccine I started to have heart irregular heart beats, difficulty breathing and a week later found a large skin rash on should blade area, along with red spots on both arms. Over time the heart and breathing issues continued and became worst which sent me to the ER.   The symptoms experienced were not Graves symptoms as I am very familiar with them. I now must take a beta blocker to control irregular heartbeat. This I did not have with Graves over the past 2.5 years.
No additional AEs; Caller reported vaccines administered after temperature excursio; the vaccines were administered IM (instead of SQ); This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 16-AUG-2022, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #U028164, expiration date: 09-SEP-2023 (vaccination schedule was not provided) and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 ml, lot #U006596, expiration date: 01-MAR-2023 (vaccination schedule was not provided), both administered intramuscularly instead of subcutaneously for prophylaxis (Product storage error, Incorrect route of product administration). The vaccines underwent temperature excursion in 32.9 degrees Fahrenheit (F) in a time frame of 28 hours and 39 minutes. It was reported measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) was stored within recommended temperature range, however the vaccines underwent previous temperature excursion, for which reporter was unable to provide data. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008668:dpoc# 02230999 US-009507513-2208USA008497: US-009507513-2208USA008558: US-009507513-2208USA008699:
highly milk allergic pt; pt recvd vax c/o diff breathing; pt given Epi, Ventolin, no wheezing, stridor, hypotension noted; later reported hives;
Had injection site reaction that became rash and grew larger over 2 days. Instructed patient to go to MD to double check and she did.
Evening p/receiving DTP inject mom called MD stating pt had swelling @ inject site, inconsolable screaming; refused to eat;
Spontaneous acute onset of several highly pruritic reddish rash on her upper abdomen noted the day after receiving flu shot.
I received the vaccine on Friday, Sept 29, I started having stomach sharp pains on Sunday morning 0800, Oct 1, 2017. The pains progressed to nausea then I began vomiting by 1600 on Sunday evening. I had episodes of nausea, vomiting, chills and fever and muscle soreness through the evening and the entire night. I did not sleep well, I woke up almost every hour vomiting and having muscle pains. I woke up Monday morning very weak, no vomiting today but have not eaten since Sunday, I have eaten some ice chip and a cup of hot tea.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hyperventilation-Mild, Additional Details: patient remained conscious. paramedics arrived and followed up with patient.
Client presented to the health department late afternoon of July 24, 2008.  States around 11:00 PM, July 23, she began to have pain in her right arm at the shot site.  States her right arm hurt throughtout the night, was warm to touch, itching, with a large, red, swollen area present.  She took a dose of Advil, placed and ice pack on the site for aproximately 15 minutes. She was able to sleep and worked today.  She states, today the site continues to itch and is larger.  On inspection, right are was found to have a large, red, swollen area surrounding the injection sites.  The area was warm and tender to touch.  Measurement of the area was 70mm x 65mm.  Client is taking Cipro for another illness.  Dr. called to inspect the site.  Instructed client to continue with Cipro from PMD, Advil, and ice.  Also, instructed to apply an OTC anti-itch cream, and to return to the health department on July 25 for re-inspection of the site.  July 25, 2008, client returned to health department as instructed.  States the right arm continues to have pain and itch; the site has increased in size but not redness.  She has been applying Cortisone cream with relief, applied ice times one for approximately 30 minutes.  Also, took Advil Q 6 hours; was able to sleep, and worked today.  Continues PMD prescribed Cipro.  States she also "chilled" last night and is "aching all over".  Temperature 98.9 orally.  Measurement of site 85mm X 100mm, with one longer area measuring 155mm in length.  Dr. called; verbally instructed client to continue treatment as she has been doing and to continue to watch area, that site should begin to show signs of improvement.  Client is off from work on Saturday, July 26, instructed to rest her arm, along with physician advise.  Diluent utilized for MMR vaccine, lot #5000X; expiration date:  May 2010.
I felt sick just minutes after receiving the meningococcal vaccine (and also a TB skin test), both of which are required by my college. I believe the vaccine is what made me sick though. My chest started hurting and feeling tight. I had to sit down in a chair and my mother says that I passed out (and that my eyes roll in the back of my head). I was extremely woozy and had to keep my eye closed. I was given my inhaler and that seemed to help slow down my breathing about 10 minutes later. When I was able to walk, I was taken back to the rooms to wait for an available doctor to come see me. At this point, the breathing was better, but my muscles ached, I felt extremely tired, and my stomach also cramped. About 10-20 minutes later, all my symptoms subsided but I still felt a little weak. The doctor just told me to rest for the rest of the day and that this happens commonly around my age.
Vaccinated with Pfizer vaccines for Covid on 4/1 and 4/30/2021.  Symptoms started on 12/10 - nasal congestion, cough, loss of taste and smell.  Reported as a case of breakthrough Covid in immunized person.  Rapid antigen + on 12/11/2021
About 15 to 20 mins after receiving shot, patient experienced difficulty breathing, brief blurry vision and difficulty hearing. Was given some water to drink, and EMT was called. After drinking some water patient felt better. Blood pressure and pulse were checked - both were within normal limits. Patient mentioned not having drank or eaten anything prior to appt. She felt better at the time when EMT arrived about 10 minutes later. EPIPEN administration was not necessary. Mother was present and helped patient home. Adviced patient to get something to eat.
right upper  arm with approx 10 x 10 cm area of erythema. warmth, mild itching and tenderness-worsening after second Moderna vaccine on 1/23/21
Complained of tingling and throat tighness.  Stretcher,v/s150/88,HR89, O2sat 100 on RA. Color, pink, warm and   dry.  reassurance offered. Discharged without issue.
Patient states that she is having some numbness at the location of vaccination in the deltoid muscle.  She also states that the numbness or "feeling funny" extends to the back of her scapula when she is driving.  Patient states that these symptoms started soon after vaccination on 10/4/16 and are continuing through today, 10/7/16.
Pruritos Hives on chest, back, stomach and upper arms; This is a spontaneous report from a contactable physician reporting for himself. This 33-year-old male patient received on 18Dec2020 11:00 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FJ1685) at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies. Prior to vaccination, the patient was not diagnosed with COVID 19. Post vaccination, the patient had not been tested for Covid-19. Concomitant medications were not reported. On 24Dec2020, the patient had pruritus hives on chest, back, stomach and upper arms. No fevers/chills, difficulty breathing, throat swelling or other symptoms. Outcome was not recovered.
Extreme itching several days after vaccination; red rash at vaccination site, spreading larger on day 8 through 10
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient Bled with both shots. First the Fluzone had a long drop of blood running down his arm about 5 inches, with the Pfizer Bivalent COVID shot hes had drop of blood about a 1/2 inch. After receiving both shot the patient passout briefly and was unresponsive for brief period of time. We then had him lay on the floor with his feet up on a chair. we called 911, ems came and evaluated the patient. no further action was necessary. pt was given water and apple juice to drink and the left the pharmac
Within 24 hours of the first dose of Moderna COVID-19 vaccine I developed a meibomian gland infection and injected conjunctiva in my  right eye.  This resolved within 5 days.  Within 24 hours of receipt of the second dose of Moderna vaccine I developed identical signs and symptoms in my right eye as well as a stye in my left eye and massive lymphadenopathy and swelling in my left axilla (the arm of vaccine administration for both vaccinations).  The eye conditions resolved within 10 days.  However, the lymphadenoapthy persisted for at least 4 months, with moderate resolution.  I continue to have some painless swelling in my left axilla.
Soft tissue swelling at injection site, without redness: Hives to trunk (macular rash).
Patient passed out immediately after being administered the vaccine as he walked to the  observation zone of the ware house. He was caught from behind by pharmacy technician on duty. He was able to respond to questions about his name, where he was and what he was there for. His blood pressure reading was showing "out" on the wrist cuff. Five minutes later the blood pressure was 127/68. Thirty minutes later his BP was 160/84. He called his dad who picked him up
Pt experienced Nausea and vomiting 1 - 1 1/2 hours after getting flu vaccine. Advised pt to see DR but pt went home, husband called and said she was better, probably car sick plus empty stomach.
Within 2 hours of shot, vomited x 3, extreme lethargy, slept 15 hours. Next 2 days listless, barely interactive. Seen by me today (2 days after shot). Listless, not happy. No apparent illness.
Sore stiff tender left arm. Left neck pain into temple. Right arm stiffness  right hand center palm  sore.  Weak grip.  Eye pain sensitivity to sun light. Rt leg numbness felt weak while walking. Generally feel unwell