chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 4/6/04 from a health care professional regarding an adverse event, it was reported that a female patient, age approximately 18 years old, received an IMOVAX RABIES vaccination, lot number W1419-3, route and site of administration unknown, on 2/25/04. The reporter stated that within 24 hours the patient experienced a seizure and would not provide any further information. The physician reporter did not have the patient's file at the time of the report, therefore had limited information. It is unknown whether the patient recovered. Additional information was obtained from the reporting physician regarding the patient's medical history, number of dose and latency. This reporter will have a staff member complete the VAERS after contacting the patient. This information will be forwarded when available. Required intervention was ticked due to the internal system requirement. At this time it is unknown what intervention was performed. Additional information received 16Apr04: It was discovered that duplicate/multiple information had been received and that two cases had been created for this same SAE. All information is being merged into 2004-01408, which shall become the case of reference.  From information received on 14Apr04 from a field representative, the pt is 19 years old. She received IMOVAX rabies, administered IM in the left arm on 25Feb2004 at 08:30AM. At 7:00AM the following morning, the pt had a grand mal seizure.  The pt is an animal handler and was starting a pre-exposure series. The pt had a history of juvenile epilepsy since age 13, and was taking phenytoin. She had been seizure free for six months prior. Her last known seizure was 12Apr04. From a telephone conversation with a reporter on 16Apr04, it was learned that the pt did contact her physician, but it was not known if she was examined by him. The pt had a known seizure disorder with monthly seizure episodes since the age of 13 years. She had been seizure free for the last six months since starting on phenytoin. She then had a seizure on 26Feb2004 and again on 12Apr04. It was initially decided that she would not continue the pre-exposure series, but now the physician does not think that the seizure was related to the vaccine. The pt will continue the series starting again next week while under physician observation. The pt has recovered from the initial event.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Other- diagnosed with cellulitis on arm of injection-Medium
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Approximately 45 minutes after the vaccine, patient reported "feeling itchy all over". Patches of skin were red from scratching, although no specific raised or patterned rash was visible. She was given a 25mg dose of Benadryl. Symptoms persisted through her bedtime but were resolved in the morning. Redness and significant pain (more than her previous injection) were observed at the injection site for a few days.
Headache (4/1 - 4/2) Swollen glands in neck (4/1-4/2)  I skipped one night of sleep on 3/30/2021 (39 hours without sleep due to a work deadline).
I experienced chills; mild headache; fever ranging from 100.8 - 101.8; Mild body aches; This is Spontaneous report from a contactable consumer.  A 64-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 08Jan2021 at 01:00 PM at single dose for COVID-19 immunization. The patient had a medical history of Rheumatoid Arthritis, Sjogren's Syndrome, Osteoarthritis and known allergies to penicillin, Valium, ketamine. Concomitant drug included Synthroid and Humira - Abbvie on 31Dec2020 (lot number 1136949). On 09Jan2021 approximately 24 hours after BNT162B2 administration, the patient experienced chills, mild headache and fever ranging from 100.8 - 101.8 and mild body aches. 48 hours later she still had fever ranging 100-101. No treatment was received. The patient did not have Covid prior vaccination and was not covid tested post vaccination. At the time of reporting the patient was recovering.
Intense chest pains,, first intermittent, then fairly constant, accompanied by weakness.   Doctor's office sent me to ER, where many tests were performed, as below, but no cause determined.   ER Doctor listed PVC.  Reactions to vaccines not well known at the time.  Chest pains and weakness continued for 3 weeks then subsided.
Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 21-JAN-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-JUN-2016, patient was treated by physician for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages.  Additional information has been requested.
I had fatigue, sweats, chills, shoulder pains stabbing me in my right shoulder blade, stabbing pains in the left side of my pelvis, and terrible back pain in my lower back & nausea
Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-SEP-2016, the patient was treated at medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
Period started after i received the shot and has not stopped; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via intramuscular route of administration in the left arm on 22Sep2021 at 10:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via intramuscular route of administration in the left arm on 01Sep2021 at 10:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 22Sep2021, the patient's period started after she received the shot and has not stopped. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period started after she received the shot and has not stopped was unknown at the time of this report.
Beginning approximately 6 hours after the injection, pain at injection site and low-grade fever (~100 degrees). Overnight, higher fever and extreme pain throughout my body, particularly at joints. Unsure whether shaking was due to chills or reaction to pain, but breathing was impacted by level of pain. (My husband thought I was having trouble breathing - it was more that I was taking shallow breaths because of the pain level).  Fever continued intermittently for approximately 48 hours, with fatigue associated with it.  Pain at injection site was enough to wake me up at night for 4 nights.
Chills, high fever (106.4), pain and lump at base of neck on left side, extreme fatigue and Covid headache
Shortness of breath starting about 1-2 hours after injection Headache Extreme Fatigue Dry heaving for 24 hours Auditory/visual changes-patient felt "like she was outside of her body"
multiple bruising to right hip, left arm and left leg a few hours after injection, followed by 24 hours later a diffuse hive like rash that resolved after two days.
Patient called on 1/24/2022.  She stated she had a bruised, swollen, raised and hot injection site.  She also was concerned about the depth and location of the injection (too deep and too high) on the phone.  She came in later the same day and the pharmacist looked at the site.  The pharmacist stated that it was swollen, red, and bruised, but appeared to be in a normal position and a common response to a vaccination in their opinion.  Patient also saw her doctor later that day about the reaction, and per the patient, the doctor said to watch it and see if it improves.
onset of gen papular eruption 2wk p/vax 5SEP97;
Slight Diaherra began about 2 hours after injection.  Continued on for approximately 14 days.  It was worse around 10 -12 days after injection. Took probiotics but diaherra persisted for 14 days.
Sickness; Ear discomfort; Psoriasis flare-up; Joint tightness; Cold; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), JOINT STIFFNESS (Joint tightness), PSORIASIS (Psoriasis flare-up), EAR DISCOMFORT (Ear discomfort) and NASOPHARYNGITIS (Cold) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. In September 2020, the patient experienced NASOPHARYNGITIS (Cold). In 2021, the patient experienced JOINT STIFFNESS (Joint tightness). In August 2021, the patient experienced PSORIASIS (Psoriasis flare-up). In September 2021, the patient experienced EAR DISCOMFORT (Ear discomfort). On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness), JOINT STIFFNESS (Joint tightness), PSORIASIS (Psoriasis flare-up), EAR DISCOMFORT (Ear discomfort) and NASOPHARYNGITIS (Cold) outcome was unknown.            Concomitant medications and treatment medications were not provided.  On an unknown date, the patient experienced sick. In September 2020, the patient experienced lingering cold. In 2021, the patient experienced joint tightness after Covid vaccine. In August 2021, the patient experienced flare/ couple small psoriasis spots on skin. In September 2021, the patient experienced stopped up ears.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event of sick and stopped up ears was not provided. The reporter's causality for the events of joint tightness after covid vaccine, flare/ couple small psoriasis spots on skin and lingering cold with HUMIRA(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
In 1988, post vax, the pt experienced sickness. The pt felt that sickness was related to Hep-B vaccine. Her physicians told her the sickness was not related to Hep-B vaccine. No further information is available.
Typical stuff, headache, muscle ache, the worse was the chills, I could not seem to get warm. It started with chills so bad that my teeth were chattering and I was shivering enough to wake the wife up.
Onset w/in 24 hours local redness that resolved by time of office visit.  Mild pain.
Slightly red area (3-4 inches diameter) around vaccination spot.  Spot is much more pronounced after showering.  Somewhat itchy.
3 hours after vaccine administered patient experienced sharp chest pain went to ER, had fever of 100.2 and shakes. ER did EKG, everything was okay with heart. About 2 hours later patient was back to normal and discharged.
Patient was vaccinated with this vaccine after the excursion; No adverse event; Patient was vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Hypertension, Depression, Anxiety, Cholesterol high and Gout.    On 04-Oct-2022 at 9:40 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Oct-2022 at 9:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion).    Concomitant products were not reported.  It was unknown whether patient even been diagnosed or tested positive for COVID-19. It was reported that moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events.   Treatment medications were not reported.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (route, dosage and dose number unknown; lot # K005083 exp 04-NOV-2014). On 13-OCT-2014 the patient received a dose of GARDASIL that was exposed to temperatures outside the proper storage range. No adverse effect was reported. This is one of two reports from the same reporter (1411USA006739). Additional information is not expected since there is no permission to contact physician.
A couple of hours after vaccination the patient removed her non-latex Coverlet bandage and directly underneath her arm was quite red and irritated. The swelling continued in her arm and around bedtime that evening she had chills and uncontrolled shivering but no fever. The next morning ( 9/25/18 ) she states she was itchy all over and throughout the day the itching and swollen red arm worsened. When she woke up on 9/26/2018 she had a severe rash all over her body and the area under both her eyes was swollen and painful to the touch. She saw her PA and PMD later that morning and they told her they believed she had cellulitis in the arm and an allergic reaction to the vaccine. They referred her to the advice of her allergist as to whether or not she should have the booster dose of SHINGRIX, and prescribed her Prednisone 20 mg, 2 tablets once daily for 5 days, but did not prescribe an anti-biotic. They did mark the area on her arm where the reaction was occurring and told the patient to call if the swelling went outside the area. When spoken to today ( 9/27/2018 ) patient stated that she is feeling better and that the swelling on her arm, and the rash, do appear to be diminishing. The area directly under where the bandage was, is still is the most irritated.
daily chronic headaches; Experienced approximately 15 migraine headaches over the course of 4 weeks; vision issues; sensitivity to light and sound; sensitivity to light and sound; extreme brain fog; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 (Lot number: EN5318) at the age of 43 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "daily chronic headaches"; MIGRAINE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Experienced approximately 15 migraine headaches over the course of 4 weeks"; VISUAL IMPAIRMENT (non-serious) with onset 06Mar2021, outcome "not recovered", described as "vision issues"; PHOTOPHOBIA (non-serious), HYPERACUSIS (non-serious) all with onset 06Mar2021, outcome "not recovered" and all described as "sensitivity to light and sound"; FEELING ABNORMAL (non-serious) with onset 06Mar2021, outcome "not recovered", described as "extreme brain fog". The events "daily chronic headaches", "experienced approximately 15 migraine headaches over the course of 4 weeks", "vision issues", "sensitivity to light and sound", "sensitivity to light and sound" and "extreme brain fog" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of headache, migraine, feeling abnormal.  Additional information: It was also reported that patient received other Pfizer vaccine same day 29Jan2021 administered in left arm as dose 2 with lot number EN6201 (as reported). The patient did not receive any other vaccine within four weeks. The patient had no known allergies. The patient had not COVID priori vaccination. Onset of daily chronic headaches started 06Mar2021. Experienced approximately 15 migraine headaches over the course of 4 weeks and then daily headaches with vision issues, sensitivity to light and sound and extreme brain fog. He had not been able to work or drive for 6 weeks at the time of this report. The patient was not tested for COVID post vaccination.    No follow-up attempts are possible. No further information is expected.
Pt experienced acute decompensation with increasing SOB, called EMS was hypoxic on presentation to ED with flash pulmonary edema, ECHO with severely reduced EF (10%). Required intubation, ICU admission and diuresis. Unlikely secondary to moderna booster given severe HFrEF however has not had frequent HF exacerbations and booster was only change per family.
Pt having chest pains with associated SOB and cough, sore throat, body aches, fever and chills. Diminished breath sounds bilaterally. No consolidation noted on chest xray. Pt admitted for further cardiac monitoring and work up.
Right arm with redness, swelling and hard to touch. Area measuring from shoulder to 2" above elbow. Put on Clindamycin and Augmentin.
Very sore arm several hours after the injection.  Next day had a terrible headache, general achiness, nausea, brain fog, and chills.  Did not feel better until the following day 11/7/2019.
arm was sore; arm was sore, muscular; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, COVAX US Support. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose (lot number: EH9899) via an unspecified route of administration (left arm, also reported as "in left shoulder") on 29Dec2020 around 09:30am at single dose; and the second dose (lot number: EL1283) intramuscular (left arm, also reported as "in left shoulder") on 19Jan2021 around 10:30 at single dose for Covid-19 immunization (also reported as "prevent Covid"). There were no medical history and concomitant medications. The patient confirmed that she received first dose on 29Dec2020, and she received the second dose on 19Jan2021. There were no additional vaccines administered on same date of the Pfizer vaccine. The patient reported that she took the second dose of the Covid vaccine on 19Jan2021 and stated that her husband was diagnosed being positive for Covid. The patient asked if she was exposed to Covid if she will still be asymptomatic. The patient further stated that she feels great and has no side effects from the vaccine. She later clarified that her arm was sore on an unspecified date, and it occurred with both doses. She added that it was just muscular and starting to get better. The patient further reported that yesterday her husband was diagnosed with a positive test for Covid. She added that she works with Hospice patients. She confirmed that she is not a hcp. She just needs to know if it is safe for her to start seeing patients if she has zero symptoms, and if she needs a negative Covid test. There was no treatment received for the adverse event. The outcome of events was recovering.
Swelling and redness at injection site also blotchy red spot, face, arm around injection site - injection site - left leg.
pt recv vax & devel nausea 1-3 days later; nausea would recur every evening & @ time of the report was increasing in frequency; No further details were provided;
Sharp pain in heart/chest in the middle of the night, around 0100 hours.  Could not move.  Paralysis feeling in chest.  Lasted 30-45 min.  Three to four weeks later, same thing but at 0500 hours.  Lasted one hour this time.  Reported to doctor to get EKG.  Not a heart attack.  Referred to cardiologist.
The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 23 September 2013. Three children of 10 years age and under than 10 had received FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
Pt developed a red ring around left arm at level of injection. It was swollen and "hard as can be" pt began taking diphenhydramine 25mg every 4 hours and iced the injection site. She came in at 1140am on 9/26 and I directed her to take at least one more dose of diphenhydramine. Her arm no longer had the red ring and felt slightly warm to the touch.