chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Today, I am in day 10 after injection and I have gradually developed high rate of heart beat; Today, I am in day 10 after injection and I have gradually developed anxiety; Today, I am in day 10 after injection and I have gradually developed depression; Today, I am in day 10 after injection and I have gradually developed lack of good sleep (insomnia); I do have still general pain in my entire body; I do have still fatigue while have no energy; I do have still lack of motivation; After injection of the first dose on March 31, I felt weak; After injection of the first dose onMarch 31, I felt fatigue; After injection of the first dose on March 31, I felt weak and fatigue with some pain on injection site that I thought is normal; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 31Mar2021 at 09:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Mar2021, after the first dose of vaccination patient felt weak and fatigue with some pain on injection site that I thought was normal. On 09Apr2021 after 09 days of injection patient have gradually developed high rate of heart beat, anxiety, depression and lack of good sleep (insomnia), patient have still general pain in my entire body, fatigue while have no energy and lack of motivation. No therapeutic measures were taken as a result of reported events. The 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 patient felt weak and fatigue with some pain on injection site that I thought was normal, patient have gradually developed high rate of heart beat, anxiety, depression and lack of good sleep (insomnia), patient have still general pain in my entire body, fatigue while have no energy and lack of motivation was not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt experienced swelling/redness in a 4inx4in area around injection site. She was seen by Dr and prescribed cedphalexin 500 qidx7days. Sypmtoms resolved 2-3 days later. She is much better 10/9/17.
This is a spontaneous report from a contactable consumer reported via a Pfizer employee. A 16 years old male patient received TRUMENBA on 17May2017, at single dose, in left deltoid, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rash around injection on 17May2017. The reporter's sister sent him a picture and based on that, the rash was in a big oval and it was about 6 inches long and 4 inches wide. The event had not yet resolved at the time of report. The rash was getting worse and the patient was going to the doctor. No follow-up attempts possible. No further information expected.
brain- from tremors, brain fog and unexplained lesions; autoimmune disease; neuropathy; insomnia; neurological issues.; brain- from tremors, brain fog and unexplained lesions; brain- from tremors, brain fog and unexplained lesions; This is a spontaneous report received from contactable reporter(s) (Physician).  A 33-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ENCEPHALOPATHY (medically significant), TREMOR (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "brain- from tremors, brain fog and unexplained lesions"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy"; INSOMNIA (non-serious), outcome "unknown"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "neurological issues.".  Clinical course: Reporter also reported that patient states, today marks 8 months and three days post dose of Pfizer vaccine. The nightmare that she would have never imagined would happen just basically trying to do the right thing. She had been to multiple doctors and ER visits with no help or knowledge on what to do with this. she is now suffering from an autoimmune disease, neuropathy, insomnia, and neurological issues. So many other side effects mostly dealing with the brain- from tremors, brain fog and unexplained lesions. Patient is a 33-year-old mom of 2 special needs children who solely depend on her. This experience has been debilitating and ongoing which has caused her to almost lost her job and accumulating so many medical bills and not receiving any assistance from government or health system. People our losing their lives due to these vaccines. Some of them are losing everything we have worked so hard for because these injuries are debilitating.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported . No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Vaccination site pain, injection is consistent with the product safety profile
Headache within 24 hours.  In one month after second dose, new onset of hemicrania continua.
Felt chills, muscle and joint aches all over my body in the morning around 10 am and took ibuprofen, pain and chills went away, then again I felt same around 3 pm, again took ibuprofen and felt better.
Several hours after injection his R thigh and knee began to swell. He reported pain in the area. The pain and swelling worsened throughout the night and he was unable to walk on the leg the following day. He was seen in our office in follow-up the next day and diagnosed with limb swelling secondary to vaccine and instructed to provide supportive care. Due to worsening swelling he was seen in an ER later that night and diagnosed with cellulitis and prescribed KEFLEX of which he only had 1 dose. He was seen in our office again (by myself) on 7/11 (2 days after injection) and noted to have swelling of entire R leg however no erythema or warmth was noted in the leg or around the injection site. His reaction was again determined to be unilateral limb swelling secondary to vaccine.
Patient came to me describing a red, itchy, rash across his right upper arm, upper chest and back, and along left upper arm. There were no hives/bumps. He said it felt and looked similar to a mild sunburn and was quite itchy. He said it didn't bother him but wanted to tell me about it. It resolved 4 days after shot and he did not take any medication to help it. He did comment that he is allergic to penicillin, and that he had many issues with allergies/hives as a child. He carried an epi-pen as a child as well.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Dizziness and SOB
COVID 19 (Drug ineffective); COVID 19; 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 female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 11:00 as dose 5 (booster), single (Lot number: 6J2524) at the age of 64 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 08Mar2021 at 15:30 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 at 14:00 as dose 2, single (Lot number: ER8733), in left arm, on 08Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 03May2022 at 11:30 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "MGUS" (unspecified if ongoing); "Coronary artery disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN, start date: 01Jun2017, stop date: 22Sep2023. The following information was reported: COVID-19 (medically significant) with onset Sep2023, outcome "recovering", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Sep2023, outcome "recovering", described as "COVID 19 (Drug ineffective)". Therapeutic measures were taken as a result of drug ineffective, covid-19.
This is a spontaneous report received from a contactable reporter(s) (Physician). A 76-year-old female patient (not pregnant) received BNT162B2, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "h/o cancer" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: rebound covid symptoms with new positive test 7 days after completing Paxlovid with cough, runny nose. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: COVID 19 Treatment (Paxlovid) was from 13Jun2022 to 18Jun2022. The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Started feeling tightness in chest and hard time getting a full breath. It gets worse in the evening and makes me panic because I feel that I can't breath.
(R) arm has mild swelling and redness to injection sites. However, moderate redness to BCG site (no shot in here).
Body aches, fatigue, low grade fever, swelling at injection site, soreness and warm to the touch.   Started the day after 2nd vaccine injection.
I am unsure of the exact time of onset. Husband received vaccine to prevent shingles, wife immediately thereafter developed shingles.
I hava an abnormally high blood sugar reading / my blood sugar went up; feeling a little blah; This case was reported by a consumer via call center representative and described the occurrence of blood sugar increased in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included steroid injections (abnormally high blood sugar reading with steroid injections).   On 14th May 2020, the patient received the 2nd dose of Shingrix. On 15th May 2020, 1 days after receiving Shingrix, the patient experienced blood sugar increased and feeling abnormal. On an unknown date, the outcome of the blood sugar increased and feeling abnormal were unknown.   It was unknown if the reporter considered the blood sugar increased and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and wondered if it contained steroids.  The patient had an abnormally high blood sugar reading this morning (on the day of reporting) and have had this occur with steroid injections. The patient felt abnormal and was curious to know if it contained steroid.
Muscle pain cervical spine area; Headache; Fatigue; Not feeling well; Loss of energy; Pain; swelling; redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 8th November 2021) for prophylaxis.   On 10th September 2019, the patient received Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, muscle pain, headache, fatigue, feeling unwell and loss of energy. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved and the outcome of the muscle pain, headache, fatigue, feeling unwell and loss of energy were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, muscle pain, headache, fatigue, feeling unwell and loss of energy to be related to Shingrix.  Additional information received were as follows: The patient developed redness, swelling, and pain at the injection site located in the left deltoid. The symptoms resolved after few days. The patient went on to complain of muscle pain in the head and neck area, no energy and fatigue lasting over several weeks after the vaccination. The patient went and had blood work performed to determine the origin of the symptoms but the reporter did not have the results to report. The reporter consented to follow up.
10-1-07 - Pneumonia shot right arm. By PM 10-1-07 - upper arm hard, swollen, hot, painful itching. 10-2-07 called my doctor. Was put on medication advised to cell doctor- I notified pharmacy
No adverse event; Moderna bivalent booster today 12Jan2023, but she found out the patient already got the bivalent booster back in October.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Moderna bivalent booster today 12Jan2023, but she found out the patient already got the bivalent booster back in October.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: recombinant Shingrix received today 12Jan2023 on 12-Jan-2023. Past adverse reactions to the above products included No adverse event with recombinant Shingrix received today 12Jan2023.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Moderna bivalent booster today 12Jan2023, but she found out the patient already got the bivalent booster back in October.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Moderna bivalent booster today 12Jan2023, but she found out the patient already got the bivalent booster back in October.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Moderna bivalent booster today 12Jan2023, but she found out the patient already got the bivalent booster back in October.).    No relevant concomitant medications were reported. No treatment medication reported.
RESPIRATORY ISSUES; This solicited report received from a patient: Call Center concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient was treated with Simponi aria (golimumab) (solution for infusion, route of admin, and batch number were not reported) 50 mg, frequency, and therapy dates were not reported for rheumatoid arthritis. The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced respiratory issues, and was hospitalized (date unspecified). The patient had spent 8 days in the hospital and discharge date was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with golimumab was not reported. The outcome of respiratory issues was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and respiratory issues was not related; and between golimumab, and respiratory issues was not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20231078069-  covid-19 vaccine ad26.cov2.s-respiratory issues. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related. 20231078069-golimumab-respiratory issues. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related.
Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022; Received expired booster dose beyond MFG expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022 at 9:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator - 06APR2022 10:30AM The vial Didn't undergo any temperature excursions  No Concomitant Medications were provided by the Reporter No Treatment Medications were provided by the Reporter
Fever over 101.1, Vomiting's Diherrea, Extreme joint pain cannot walk for 2 weeks, Rash on inside of arms and legs still going on since 28 July 2021 thru current.
Starting 04/27/2022, I had stuffiness, a cough, fever and decided to do an at home rapid antigen test and it came back as positive. I reached out to my doctor and they prescribed me an antiviral medication. I have been taking that (3 days in) and I am feeling much better now. I have some fatigue and still have a slight cough but nothing to be concerned about.
The day following vaccination patient experienced nausea and a temperature over 101 degrees. Patient was standing over sink and says she fainted without any warning signs.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unspecified age and gender who on unknown dates received M-M-R II (doses, routes and lot numbers not reported) exposed to 11 C for 96 hours. No adverse effect reported. This is one of several reports received from the same source (related MARRS numbers 1212USA004999, 1212USA008807). Attempts are being made to distinguish individual patients mentioned in this report.
This case was reported by a pharmacist (subject) and described the occurrence of hepatitis b in an adult female subject who was vaccinated with TWINRIX (GlaxoSmithKline), Hepatitis a + b vaccine. Concurrent medical conditions included needle stick in 2012 (approximately 6 months ago). The pharmacist stated that "it was unknown if the source was positive for Hepatitis B Surgace Antigen." Historic vaccination included hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given on an unspecified date "20 years ago". On an unspecified date the subject received 1st dose of TWINRIX (unknown details), on an unspecified date the subject received 2nd dose of Hepatitis a + b vaccine (unknown details), and on 17 August 2012 the subject received 3rd dose of Hepatitis a + b vaccine (unknown details, left arm) and experienced extra dose administered. The subject received 4 doses of the hepatitis b antigen. In February 2013, at an unspecified time after vaccination with Hepatitis a + b vaccine (2nd dose) and TWINRIX (1st dose), 6 months after vaccination with Hepatitis a + b vaccine (3rd dose), the subject experienced hepatitis b and vaccination failure. The pharmacist stated that monthly blood work had been conducted since a needle stick approximately 6 months ago (approximately August 2012). The pharmacist has been "told that she was positive for Hep B antigen. She was "not sure if she has Hep B from the needle stick or if she has a positive result from the vaccine she completed in August." The pharmacist also stated that she was sure the first dose was TWINRIX but was unsure if the remaining doses were TWINRIX. Relevant test results included a positive result for Hepatitis b antigen in February 2013. GlaxoSmithKline considered this case serious. At the time of reporting the outcome of the events were unspecified.