chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed an auto immune disease called bullous pemphigoid a week after receiving my fourth dose of the Pfizer Covid vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: 30145BA, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 14Sep2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 07Mar2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9266, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 14Feb2021, when the patient was 65-year-old, for Covid-19 Immunization. The following information was reported: PEMPHIGOID (medically significant) with onset Apr2022, outcome "not recovered", described as "I developed an auto immune disease called bullous pemphigoid a week after receiving my fourth dose of the Pfizer Covid vaccine.". The event "i developed an auto immune disease called bullous pemphigoid a week after receiving my fourth dose of the pfizer covid vaccine." required physician office visit. Therapeutic measures were taken as a result of pemphigoid.  Clinical summary: The patient had pemphigoid on an unspecified date in Apr2022 at 12:00. The patient was treated with prednisone and antibiotics for the event pemphigoid. The patient did not receive any other vaccine in four weeks prior to COVID-19 immunisation. The patient did not receive other medication in two weeks prior to COVID-19 immunisation. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not have any known allergies. Other medical history was none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt seen in office for rash which was dx'd at that time as chickenpox. She had approx. 30 of them. She was given the varicella vaccination on 4/9/97.
shot really hurt, it brought tears to my eyes; tears to my eyes; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingles vaccine. In January 2022, immediately after receiving Shingles vaccine, the patient experienced injection site pain and eyes tearing. On an unknown date, the outcome of the injection site pain and eyes tearing were unknown.   It was unknown if the reporter considered the injection site pain and eyes tearing to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age ta vaccination was not reported. The patient got the 1st part of Shingles vaccination on Wednesday the 13th. That shot really hurt, it brought tears to his/her eyes. But the patient promised that on one would regret getting it, because from what the patient heard about the pain from Shingles, the shot was no comparison.  The patient would take the next part in six months. Note - Discrepancy in reported dates as reported received vaccination Wednesday with date 13th but the date on Wednesday was 12th January 2022.
Rash appeared a few hours after vaccination; color of rash was dark red to blue; patient reports this lasted for about 1 week; did not seek treatment and did not use any OTC products for rash to resolve on its own; no itching per patient
Pt reported 11/8/16 to have painful arm, unable to lift baggage. Pain continued until pt saw a APRN 11/13/16. Xray and sonogram was done to see if any soft tissue damage - none was found. Pt was prescribed Diclofenac 100mg. 1/day. Pt took 1 tab daily x 2 days but made him dizzy, fell from bike and continued to have arm pain. He is still seeing a MD in regards.
Neck pain.; I felt a heartbeat in my head & neck; Have recurring migraines; Confusion/ My mind itself, it's moving/ I feel like my brain is moving.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt a heartbeat in my head & neck), MIGRAINE (Have recurring migraines), CONFUSIONAL STATE (Confusion/ My mind itself, it's moving/ I feel like my brain is moving.) and NECK PAIN (Neck pain.) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neck pain (Patient had neck problems back in 2020.). Concurrent medical conditions included Deaf.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced FEELING ABNORMAL (I felt a heartbeat in my head & neck), MIGRAINE (Have recurring migraines) and CONFUSIONAL STATE (Confusion/ My mind itself, it's moving/ I feel like my brain is moving.). On an unknown date, the patient experienced NECK PAIN (Neck pain.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Neck pain, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (I felt a heartbeat in my head & neck), MIGRAINE (Have recurring migraines) and CONFUSIONAL STATE (Confusion/ My mind itself, it's moving/ I feel like my brain is moving.) outcome was unknown and NECK PAIN (Neck pain.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Everything was fine and stable..         Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: It was reported that she misreported her adverse events, and it was a misunderstanding. She has not been sick since those events previously. Hence "I felt kinda sick" event was deleted.
Fever - 100.3; Body aches; Diarrhea; Headache; Irritability. Tx: fluids, ASA x3 days.
I started having heart palpitations and shortness of breath.   Several episodes of elevated heart rate.This has been accuring since my second vaccine.  I am still having the symptoms with multiple trips to EC for evaluations.  Most recent symptom now includes some numbness in face.
The usual as described but severe and longer lasting: Muscle aches -- several muscle pain overnight Severe arm pain Raised pink rash or welt, hot to the touch, which expanded over 3 days to cover the area from just below my left shoulder to just above my inner elbow, 8 to 10 inches. General malaise and irritability for 3 to 5 days Sore and tender left arm for 5 to 7 days Rash started itching around day 4 or 5, rash began to subside on day 5 or 6, itching persisted with gradual improvement over the next 7 days. Basically, I had a mild case of shingles that resolved without medication.
Patient presented approximately 5 days after receiving immunization. He reported what he described as a canker sore that developed about 24-48 hours after receipt of immunization. At the time of his report the symptoms had improved but had not yet fully resolved. He did not consider it serious but wanted to mention as he was picking up a prescription anyhow.
fainted; 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), administration date Apr2020 (Batch/Lot number: unknown) 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: SYNCOPE (medically significant) with onset 2020, outcome "unknown", described as "fainted".  Clinical Course: Patient got 1st dose of vaccination on Apr2020. After receiving the 1st dose patient fainted and primary care doctor told to contact to Pfizer before taking the 2nd shot. So patient wanted to know was this common phenomenon or it was a rare case. The 2nd dose was very important to the patient's job and for future travel so patient was seeking advise. The patient took the vaccine in the evening around 6PM and drank spinach juice in morning and ate 1/2 lb chicken breast in afternoon.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I woke up early the next morning after the Moderna vaccination unable to use my muscles to stand or walk. I slowly slipped to the floor, and it took me about an hour to crawl to the bathroom even with my husband helping me. I felt like none of  my muscles were working. By late afternoon, I was better and able to stand and walk.
I developed hives on arms, torso and  legs. I was given prednisone for the condition and it has immediately improved.
This spontaneous report as received from a registered nurse refers to a 5 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012663 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent.; Sender's Comments:  US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Aching joints, coughing, listless, sore throat, headache, earache, eyes itching and mucous in eyes stuck closed in AM.
Suspected vaccination failure; Shingles twice; This case was reported by a consumer via interactive digital mediaand described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (five flare ups).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient got Shingles vaccine after having five flare ups.  After receiving Shingles vaccine, the patient had shingles twice. The patient stated that, as with any virus you could get it again and suggested to not get stressed out. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Severe headache, temperature beginning at 99.8 and then going to 102.5 and lasting three days and continuing to fluctuate.  Fluids, rest and Motrin to control fever.
Headache; fever; exhaustion; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date 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. It was unknown whether the patient receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced headache, fever and exhaustion. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events headache, fever and exhaustion was resolved on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee On Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. This child was vaccinated completely as per schedule. This child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
Several hours after receiving the vaccine, pt developed myalgia and temp to 99.6 (not unusual for a vaccine), but then developed a 1.5cm vesicle which ruptured and became an ulceration, then had surrounding 3 other areas of erythema. It has not been nearly a week and she is improving but the ulceration has not totally resolved.
Patient stated that she felt hot, internally. She then felt faint, dizzy. Her BP was elevated (115/99 mmHg) but pulse was normal (65 bpm). It did continue to change throughout her waiting/observation period (highest BP 158/110 mmHg and pulse 78 bpm). We observed her for 40 minutes when she stated that she felt ok to go home and rest. At that time her BP had normalized.
patient became nauseated light headed approximately 8 minutes after vaccine administratioin.   Patient was provided water and and a granola bar.  Patient said she was better,  She was able to stand up and walk on her own
Swelling noted  in axilla and left chest wall same side of injection.  was not over the arm but along the rib cage had a fluid wave no overlying redness self resolved in 7 days slowing improving
pt recvd vax; 24 hrs later fever 101;shaking of hands & feet;tingling sensation;weakness,inability to walk;unable to grasp w/ hands;polyneuroparhy;aches ; no ha,no v,no d;no URI;DTR ok;slow recovering over a period of 6 wks w/ 90%return;
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 21-JUN-2016, the patient was treated by a physician for a persistent vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Found unresponsive by parents just after midnight 6/30/12, transported to local hospital with external CPR by EMS.  ER able to intubate and establish HR, then transferred to another hospital.  Died at 2148 on 6/30/12.
35 y/o pt reports allergic reaction to Typhoid ViCPS vaccine x 2. His immunization records have been lost, but he states that the 1st allergic reaction occurred in Jan 2001, prior to his deployment on 16 SEP 2001. He received Typhoid ViCPS, MMR, & Hepatitis (can't remember if A or B) at the same time and denies any difficulty breathing or swallowing, hives, angioedema in the first 3 hours after immunization. He reports local soreness, erythema the size of a nickel and itching at the injection site at 24 hrs post vaccination. He reports chills, body ache and a fever of 104F x 48-72 hrs. He went to Sick Call and was given TYLENOL and MOTRIN. His second, and more concerning allergic reaction to Typhoid ViCPS occurred in JAN of 2003. He did not received any other vaccines at the same time, as with his first episode. He denies febrile or viral illness (GI- no N, V, D- or respiratory sx) up to 6 weeks prior to receipt of his second Typhoid ViCPS. He remembers getting the vaccine around 3PM in the afternoon and had an early dinner and went to bed. He woke up around 04:00AM and noticed that his face was swollen and his eyes were swollen, itchy, & tearing; he also was having difficulty breathing. His wife told him he had hives, but he does not remember where. By that afternoon he developed a fever of 104F, which lasted x 6-7 days, despite three visits to the ER, where they initially treated him with (2) doses of IM BENADRYL 50 mg, with mild relief of his facial & periorbital swelling. The drew blood (CBC w/diff ?); but he does not think that blood cx were drawn. They gave him MOTRIN & TYLENOL for fever, which would go down, but come back up to 104F. He was referred to another ER after (3) visits to his local ER. He says that the whole process was repeated at 2nd ER. They drew blood, but he doubts that blood cx were drawn. They treated his fever with high dose MOTRIN, alternated with TYLENOL 1000mg every 4-6 hours and made him bathe in a cool tub of water. He continued taking MOTRIN and TYLENOL at home, as well as cold showers. His fever eventually broke after 6 or 7 days. To his knowledge no other infectious source was identified for his high fevers. The pt is now preparing to deploy on 15JAN10 and he is required to receive another Typhoid ViCPS vaccine. SRC referred himto Vaccine Healthcare Center for Vaccine Causality Assessment and Recommendations regarding receipt of continued doses of the Typhoid ViCPS.
Dizziness, nausea, seeing black spots, loss of hearing, having difficulty speaking, neurological disorientation for roughly 25 minutes. (Unable to answer nurses questions or understand the questions being asked)
COVID Breakthrough. Patient began with symptoms on 3/4/22. Presented to the ED on 3/5/22 and tested positive. He is experiencing some shortness of breath.
Extreme swelling of upper arm and shoulder extending to forearm . Redness and pain entire shoulder and arm. Temperature elevation to 102.4  lasting 5 days.  Lethargic and no appetite. Contacted Md/oncologist on day two....tylenol and ice.  Started  amoxicillin-clav 875-125 mg 02/22. Saw dr.on 02/24 at hospital.. continuing to monitor.
Allergic reaction post vaccine; rash and hives to bilateral legs, back, and face. Client complained of mild shortness of breath.
It impacted my pituitary gland which adversely affected my thyroid. I now have elevated BP, heart races, and made my hormones shift back into menopause.
scattered papular, itchy, dry rash on thigh at the site initially, progressive over 1 month from lower torso to knee not responsive to emollients or hydrocortisone
This is a spontaneous report from a contactable consumer. A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3249), dose 1 via an unspecified route of administration, administered in arm left on 18Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, hyperlipidemia and iodine allergy. The patient received other medications in two weeks. The patient did not had COVID-19 prior to vaccination and did not tested for COVID post vaccination. The patient experienced low grade headache and slight soreness at the injection site on 18Jan2021. The patient did not receive any treatment for the events. The outcome of the events was recovered in 2021. Follow-up attempts completed. No further information expected.
Moderate hive like rash which began 30 hours after vaccine. Severe itching and local swelling
Fever, chills, congestion, cough, SOB, fatigue, headache, loss of smell/taste, gastric sxs, (+) COVID, worsening COPD, rectal bleeding after mAb treatment
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Contrast dye" (unspecified if ongoing), notes: known allergies: Contrast dye. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness and tenderness left arm with fever. Onset of symptoms within 24 hours of receiving immunization. Both immunizations were given in the left arm according to the patient. Documentation lists the pneumococcal vaccine being given in the right deltoid, and the influenza vaccine being given in the left deltoid.
Reaction at injection site - red, warm, swollen, approximately 4.5 inches by 2.5 inches in diameter.  Pt also c/o general aches the evening of the injection.