chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has rash and peeling on her hands. Her hands were red and very irritated. When she applies some "cream" on her hands, it burned. Patient also stated she had been working in the yard.
Per doctor, I had increased activity of my auto immune condition, which means I have inflammation in the front of my eye. To me, it looks like decreased vision and presence of floaters. It happens overnight and then gets better during the day, then starts again. My doctor did imaging, like a CT scan for your eye. My eyes were dilated and a vision check, pressure check and exam was conducted.
Information has been received from a registered nurse concerning a 15 year old female who on an unspecified date was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was indicated by the nurse that the patient developed hearing loss after receiving measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). A product quality complaint was not reported. Additional information has been requested.
Redness within 2-inch in the area of the injection site; redness within 2-inch in the area of the injection site; rashes that grew in size and raised; rashes that grew in size and raised; Feverish but went away quickly.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 10:00 (Lot number: 30155BA) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hyperthyroidism" (unspecified if ongoing); "graves disease" (unspecified if ongoing); "soy" (unspecified if ongoing), notes: Verbatim; known allergy: soy; "Berries" (unspecified if ongoing), notes: Verbatim; known allergy: Berries. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL0140, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Jan2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 21Dec2020, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 08Oct2021, outcome "recovered with sequelae" (Oct2021), described as "Redness within 2-inch in the area of the injection site"; VACCINATION SITE REACTION (non-serious) with onset 08Oct2021, outcome "recovered with sequelae" (Oct2021), described as "redness within 2-inch in the area of the injection site"; RASH (non-serious), RASH PAPULAR (non-serious) all with onset 08Oct2021, outcome "recovered with sequelae" (Oct2021) and all described as "rashes that grew in size and raised"; PYREXIA (non-serious) with onset 08Oct2021, outcome "recovered with sequelae" (Oct2021), described as "Feverish but went away quickly.". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site reaction, rash, rash papular, pyrexia.  Additional information: It was reported that the most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Fever (102.8), body aches, fatigue that didn?t subside for almost 48-hours after shot Massive swollen lymph node in left armpit
After getting my COVID-19 shot I noticed that my eye was swollen and my cheek is up higher. Then I started noticing that my mouth is dropping and my mouth is feeling numb. I was supposed to go see my doctor again but had to reschedule due to a family health emergency and I am now going in November. This has not changed and it still occurring and I am concerned it is linked to the COVID-19 vaccine.
fatigue; headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (fatigue) and HEADACHE (headaches) 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 FATIGUE (fatigue) and HEADACHE (headaches). At the time of the report, FATIGUE (fatigue) and HEADACHE (headaches) outcome was unknown.        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.   Concomitant medication was not reported. Treatment information was not reported.
NO ADVERSE EVENT; 4 months old patient inadverently admninistered a dose of proquad; This spontaneous report was received from a other health professional refers to a 4 month old patient. Information about patient's concurrent condition, medical history, drug allergy/reaction, concomitant medication was not reported.  On 08-NOV-2019, a 4 months old patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) therapy type: rHA,  lot # S007074, expiration date: 06-SEP-2020 for prophylaxis (strength, dose number, route, anatomical location was not reported) (product administered to patient of inappropriate age). Other suspect therapy included sterile diluent. No adverse events were reported. No product quality complaint was involved.
She had a sore arm after the first dose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: EP6955) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She had a sore arm after the first dose".  Additional information: Caller reports that his fiancee/partner (name) 60 y/o female) received her Pfizer Covid vaccines the same dates he did. She had a sore arm after the first dose and had a 102-degree Fahrenheit temperature, migraine headache, and sore arm after the second dose.  No follow-up attempts are possible. No further information is expected.
Per protocol, Pfizer vaccine should be discarded 6 hours after having been taken out refrigeration.  Vaccine would have expired at 2:45 pm, and it was administered at 3:10 pm, 25 minutes passed the indicated expiration hour
Swelling at injection site.  183/99, HR 77, R. 70, 98.6.  Pt. observed with swelling at injection site.  Elevated BP has history.  Transported to a Hospital for further evaluation.
pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v, d who did not recv flu vax;this is one of 25 cases reported by a pharmacist;
Headache, joint pain, muscle ache,  Taking Tylenol ,  4 regular doses on 3/10/2021,   2 regular doses 3/11/2021 A.M.
can no longer tolerate carbs/sugar; can no longer tolerate carbs/sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: CARBOHYDRATE INTOLERANCE (non-serious), GLUCOSE TOLERANCE IMPAIRED (non-serious), outcome "unknown" and all described as "can no longer tolerate carbs/sugar". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient could control blood sugar with 2-500 mg tablets of metformin before 3 vaccinations for COVID 19 and could eat most carbs and a small amount of sugar in moderation. After booster dose that changed rapidly and patient was taking 2-1000 mg metformin. Patient was trying hard to make life changes but patient might need to start insulin soon.  The lot number for bnt162b2 was not provided and will be requested during follow up.
11/21/2005 hospitalized with heart attack, underwent angioplasty and stent placement discharged from hospital 11/23/2005.
Information has been received from an office manager concerning a patient, who was intended to received ZOSTAVAX but, on 17-OCT-2013, was inadvertently administered VARIVAX (Merck), 0.5 ml dose, subcutaneously (lot # not provided) due to a nursing error. No adverse effects were reported. Additional information has been requested.
June 12, 2002 received Hep B vaccine  #2. Severe fatigue, dizziness, headache for 2 weeks after. Continued dizziness in episodes with fatigue since shot to present day.
hallucinating x 2 days; seen in ER 31AUG94 1245AM; dx viral synd, dehydration; tx IV LR 300cc over 30 mins;
Fever 105 deg - ear "Crying all day" - > 3 hours.
Moderna booster shot given to 16yo patient  Only ae so far are the expected aches and headache
This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (patient had an anaphylactic reaction to the Moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (patient had an anaphylactic reaction to the Moderna shot) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (patient had an anaphylactic reaction to the Moderna shot) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (medically significant)expected event anaphylactic reaction, on an unknown date after receiving an unspecified dose of RNA-1273. Patient details, clinical course, diagnostic tests and treatment details were not provided. It was reported that the patient was tested at the allergist and could not have any injections that have PEG. Events seriousness captured as per local list. Further information is not expected. The benefit-risk relationship of mRNA-1273 is not affected by this report. Concomitant medication information was not provided by the reporter. It was reported that the patient was tested at the allergist and could not have any injections that have PEG. Treatment information was not provided by the reporter. Sender's Comments: Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (medically significant)expected event anaphylactic reaction, on an unknown date after receiving an unspecified dose of RNA-1273. Patient details, clinical course, diagnostic tests and treatment details were not provided. It was reported that the patient was tested at the allergist and could not have any injections that have PEG. Events seriousness captured as per local list. Further information is not expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Tooth fracture; Respiratory Infection; Rash on legs; Psoriasis on both shins in front; Strep Infection; Ear Infection; fever; Red bumps; This is a solicited report from a marketing program facilitated collect received from a contactable consumer (patient) based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4090412-00). A 58-year-old female patient received bnt162b2 (BNT162B2) dose 1 intramuscular on 01Jan2021 (at the age of 57 years old, Batch/Lot number was not reported) as dose 1, single and dose 2 intramuscular on 01Feb2021 (at the age of 58 years old, Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneous from an unspecified date (Batch/Lot number was not reported) at CF for psoriatic arthritis. Medical history included psoriatic arthropathy. The patient's concomitant medications were not reported. On unknown dates in 2021, the patient experienced rash on legs, strep infection, respiratory infection, ear infection, fever and red bumps that would had psoriasis on both shins in front. In Aug2021, the patient experienced cracked tooth. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. The action taken in response to the events for adalimumab was unknown. The outcome of event Tooth fracture was recovering and other events was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the events of tooth fracture, strep infection, respiratory infection, ear infection, fever, red bumps that would had psoriasis on both shins in front unknown onset for adalimumab was not provided. The reporters causality for the event of rash on legs with adalimumab was no reasonable possibility. The reporters causality for the events of rash on legs, strep infection, respiratory infection, ear infection, fever, red bumps that would had psoriasis on both shins in front unknown onset for BNT162B2 was Probable and for event Tooth fracture was not provided.  The reporter's assessment of the causal relationship of the event tooth fracture with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events Respiratory tract infection, fever, Rash on both legs, Streptococcal infection, ear infection, psoriasis, rash papular cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate Based on available information , event Tooth fracture is unrelated to BNT162B2
Lymphadenopathy on the neck; This is a spontaneous report from a contactable nurse. This 60-year-old male nurse reported. A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: unknown) via unknown route in left arm on 19Feb2021 at 08:15 as DOSE 1, SINGLE (at the age of 60 years old) for COVID-19 immunisation. The patient medical history included bipolar disorder and past drug event with Aspirin allergy. Concomitant medication included valproate semisodium (DIVALPROEX) 250 mg for an unknown indication from an unknown date. The patient did not receive other vaccine in four weeks. On 21Feb2021 at 11:00 AM, the patient experienced Lymphadenopathy on the neck. The patient did not receive the treatment. Patient did not have COVID prior vaccination and tested for COVID post vaccination. On 25Jan2021 the lab data included Nasal Swab and PCR with negative results. The outcome of the event was recovered.  Follow-up attempts completed. No further information expected.
Patient had a vaccine on 3/19/21, right deltoid at 2:35pm. At 2:45pm, patient experience sternal chest pressure 3 out of 10, headache and diaphoresis. Has a history of heart failure and anxiety. VS#1 160/90, 98% & 62. At 3pm, sternal chest pressure 2 out of 10 & still with headache. VS#2 160/98, 63 & 99%. Advised patient to we need to call EMS to have him check out. Patient is refusing to seek higher level of care. Patient were given education about the sign & symptoms of heart attack and call 911 if any symptoms occur. Patient verbalized understanding.
60x60mm reddened area to left arm. Onset 24 hours after vaccine. By 48-72 hours baseball sized, red, and indurated. Treated at home with warm compresses, resolved in 7 days.
swelling arm; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient had the arm swollen (peripheral swelling).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.
Patient complained of pain when lifting left arm above head. Started when she received flu shot one week later, no treatment. She is not sure if she just injured it before flu vaccine.
First shot of Moderna 1/30/21. Had rash on chest and left arm a month. Second Moderna shot on 2/29/21. By end of March had severe hives from head to toe covering whole body including face, eyes and scalp.. Multiple trips to urgent care prescribed multiple medications that did not help. Hospitalized 4/1/21 for sever hives, chest pain and abnormal labs. I have had the hives ever since. Can not work or go out due to hives. I can not wear shoes or clothes for long period of time ie more than an hour. These things cause more hives to erupt especially with heat. I have to ice down every night and take a multitude of medications to try and help. Nothing works. I have to cover myself head to toe with calomine lotion every night and cream. They are on eyes which causes vision obstruction and lips as well. They have already lasted 4 months and no sign of it disapeering any time soon.
Severe headache, fever, chills, nausea, vomiting for 18 hours following shot.
Red Spotted rash on feet, legs, trunk, arms, neck and scalp; Red Spotted rash on feet, legs, trunk, arms, neck and scalp; Red Spotted rash on feet, legs, trunk, arms, neck and scalp; Red Spotted rash on feet, legs, trunk, arms, neck and scalp; Red Spotted rash on feet, legs, trunk, arms, neck and scalp; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8737) via an unspecified route, administered in Left arm on 08Apr2021 at 08:15 (62-year-old at vaccination) as Dose 2, Single for Covid-19 immunization.  The patient's medical history included hypothyroidism, Allergies to medications, food, or other products such as Amoxicillin. The patient's concomitant medications included sulfamethoxazole, trimethoprim oral tablet within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior vaccination, the patient was not diagnosed with Covid-19 and since the vaccination the patient had not been tested for Covid-19.  The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EN6208) via an unspecified route administered in left arm on 18Mar2021 at 07:45 (62-year-old at vaccination) as Dose 1, Single for COVID-19 immunization. On 08Apr2021, patient experienced red spotted rash on feet, legs, trunk, arms, neck and scalp. The patient did not receive any treatment medication for the adverse event. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information was expected.
Administered 0.1 ml IPV intradermally. NO adverse reactions. No skin reactions or problems.
AFIB; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced AFIB in Feb2021 with outcome of unknown. The patient was hospitalized for event in Feb2021 to an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache; It hurts and ache all over; If I bump it(injection site) or roll over on it, it hurts; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 at 09:00 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, she got shot yesterday morning on 28Jan2021 about 9 o'clock 23 hours ago. And yesterday she felt fine right before she went to bed, started getting a headache. The injection site, if she bump it or roll over on it, it hurts otherwise it was okay, but she was just achy all over and she was wondering what she could take for it. The patient experienced headache, it hurts and ache all over and if i bump it (injection site) or roll over on it, it hurts on 28Jan2021. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Muscle twitches; This is a spontaneous report from a contactable consumer (Patient) and received from a Pfizer sponsored. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscle twitches on an unspecified date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Crying began around noon, cried for 2 hours, when baby was touch she would have a high pitch scream. Baby brought back into office at 15:20 crying had settled down no redness at injection site. Cried 2 more hrs after office visit, no redness or swelling at site, no fever.