chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abnormal mentrual cycles I have been taking oral birth control pills since February 2017 to treat heavy periods and premenstrual dysphoric disorder. About 1 year afterward, I stopped bleeding during periods. I had not had a bleeding period beyond occasional minimal spotting until I received my vaccine on 9/21/2022. On 9/22/2022, I began 6 days of bleeding with typical PMS sypmtoms (cramps, back pain, nausea, mood swings). On 10/3/2022, I began another 6 days of bleeding with the same PMS symptoms. On 11/2/2022, I began another several days of bleeding, today is the 6th day and I continue to experience bleeding. Gastrointestinal symptoms I have lived with Irritable Bowel Syndrome and Gastritis for the past 9 years. I follow the Low FODMAP diet as my main form of symptom management. For the past 5 years, I have experienced intestinal spasms approx 2-3 times per year as a result of eating something that irritates my gut. Since receiving my Moderna Bivalent dose on 9/21/2022, I have experienced two unusually severe instances of intestinal spasms. This included diarrhea, racing heart and sweating, impending sense of doom, loss of consciousness as result of intense pain, intestinal pain. For both instances I had to miss days of work. This is an alarming frequency. Both instances occured after eating what I would previously have considered "safe foods" - Greek Yogurt and Brie cheese, respectively. I suspect that because there is a hormonal impact on the gut that influences severity of IBS symptoms, the vaccine may have elevated my sensitivity to certain foods. This symptom in particular is extremely disruptive to my regular life. I'm currently recovering from the second intestinal spasm and have been unable to eat solid foods for 24 hours without intense pain.
Nodule on both forearm; swelling along veins and they became painful; swelling along veins and they became painful; 2 superficial venous thromboses, one in my arm and another in my leg; 2 superficial venous thromboses, one in my arm and another in my leg; Deep vein thrombosis leg; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 25Jan2021 (Lot Number: EL3247), as single dose, for COVID-19 immunisation. Patient was vaccinated in the hospital. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not have COVID-19 prior to vaccination. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL0142) on 04Jan2021 at 11:30 AM in left arm and experienced nodule on extremity and vaccination site nodule. The patient experienced deep vein thrombosis leg (medically significant, life threatening) in 2021 with outcome of not recovered, nodule on both forearm (life threatening) on 25Jan2021 with outcome of not recovered, swelling along veins and they became painful (life threatening) in 2021 with outcome of not recovered, swelling along veins and they became painful (life threatening) in 2021 with outcome of not recovered, 2 superficial venous thromboses, one in arm and another in leg (life threatening) in 2021 with outcome of not recovered. It was reported that within hours from second dose the nodules reappeared. At this time, patient was told to take Allegra and did so for 4 weeks. A month later, patient began to see some swelling along his veins and they became painful. This developed into a DVT, deep venous thrombosis, in leg and 2 superficial venous thromboses, one in arm and another in leg. all the events required physician office visit. None of the events occurred at vaccination site, but physician believed they were triggered by receiving the vaccine. Treatment of Eliquis was initiated the day before report. Patient was not tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
I did not have an adverse reaction to the vaccine but I tested positive for Covid 19 on 01/31/2022. I did a Covid 19 home test plus a test at work that confirmed I was positive on 01/31/2022. I found out I was pregnant on 01/31/2022 too. At the end of February I had an ultra sound done and found that I had miscarried. On March 24, we found out we where pregnant. Three weeks ago, May 17, I had an ultrasound and found out we miscarried. I had to have an emergency DNC.  Please note we have five children.
received the shot on 2/12/2021 felt ok 2/13/2021 until noon on 2/14/2021 then had a fever achy  headache these symptoms lasted until 2/15/2021 until about 6 pm.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-APR-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was treated by a physician. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Arm hot, red, Swollen, tender to the touch, Swollen left breast.
Received Flu vaccine 1130AM 9/27/11 and 8 to 9 hours later temp to 104, vomiting and ? febrile seizure, seen in ER & sent home. No residual symptoms.
Pneumovax 23 was vaccinted on 16-JAN-2017 and Prevnar 13 was vaccinted on 07-NOV-2016; This spontaneous report has been received from a physician assistant (PA), via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2102USA006404), concerning a 65-year-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 07-NOV-2016, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), and on 16-JAN-2017 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (both: dose, route, lot# and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).   This is one of two cases regarding the same patient.; Sender's Comments:  US-009507513-2102USA006404:
first dose 2020 and second on 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7F94C, expiry date 11th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th September 2020).   On 29th May 2021, the patient received the 2nd dose of Shingrix. On 29th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: Pharmacist reported that, a patient received the 2nd dose of Shingrix later than recommended schedule which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
On 5-26-11 pt developed rash, received MMR on 5-17-11.
Patient called and reported that he has been having chest pain since about 4 hrs. after his flu shot on Wednesday. He called us on Friday's afternoon and was told to go to the doctor for treatment of chest pain.
Received MMR rt arm on 1/30/03. Noted red, warm, swelling rt arm on 1/31/03. No fever. Subsiding spontaneously. Currently minimal erythema, no tenderness, warmth or induration around injection site.
Information has been received from a registered nurse concerning a 78 year old female who was vaccinated with a first dose of pneumococcal vaccine 23 poyvalent (lot # 643504/0735M). Subsequently, the patient found that her injected arm was painful with no redness. The patient was treated with ibuprofen and ice application. As of 10/29/02, the nurse reported that the patient was feeling better. The patient sought unspecified medical attention. A product quality complaint was not involved. The nurse also provided information regarding other patients' experiences following vaccination with a dose of pneumococcal vaccine 23 polyvalent. Additional information has been requested.
15-30 after dose felt SOB, nauseous, dizzy, disoriented and felt like she may pass out. No wheezing, no swelling of tongue or lips. Later developed pain, redness and swelling at injection site. Seen in ED possible allergic reaction and possible cellulitis. Started on antibiotics and ibuprofen.
Headache, Myalgia & Arthralgia Narrative:  dose 1-day 1-3 sore at inj site dose 2-day 1-3- bruising/soreness at inj site; day 1-3- fatigue; joint/ muscle ache/ ha  Other Relevant History:
Patient received vaccinations TDaP and MCV4 in right deltoid on 4/11/17. That night noticed it was swollen, red and warm to touch. Pt. took TYLENOL on 4/12/17 and 4/13/17. Came to PCP to report reaction on 4/13/17. Tx: cool compress, ibuprofen and clindamycin.
Had 2 shots of Shingrix, however because of Covid they were 2 years apart; This non-serious case was reported by a consumer and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago prior to the receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: Had 2 shots of Shingrix, however because of Covid they were 2 years apart).  The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2023 The patient reported that he or she received two doses of Shingrix vaccine but due to Covid they were two years apart. The patient wanted to know if he or she need to receive the third dose and if he or she covered.
arm hurts more than with previous doses.; injection is red and there is a blister above where the bandaid was; injection is red and there is a blister above where the bandaid was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 at 16:00 as dose 3 (booster), single (Lot number: FL8095) at the age of 11 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FK5618, Route of Administration: Intramuscular), administration date: 07Dec2021, for COVID-19 immunization, reaction(s): "arm hurts"; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Route of Administration: Intramuscular), administration date: 05Nov2021, for COVID-19 immunization, reaction(s): "arm hurts". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26May2022, outcome "unknown", described as "arm hurts more than with previous doses."; INJECTION SITE ERYTHEMA (non-serious), VACCINATION SITE VESICLES (non-serious) all with onset 26May2022, outcome "unknown" and all described as "injection is red and there is a blister above where the bandaid was". Therapeutic measures were not taken as a result of vaccination site pain, injection site erythema, vaccination site vesicles.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not allergic to latex. Patient had no known allergies. Patient was not diagnosed with COVID-19 Prior to vaccination. The patient not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to a 2 year old patient. On 15-APR-2003 the patient was vaccinated with M-M-R II (dose 1, route, dosage and lot number unknown). On 25-APR-2003 the patient was vaccinated with VARIVAX (merck) (dose 1, route, dosage and lot number unknown). The nurse reported the two vaccines were placed too close together. No adverse effects were reported. On 08-FEB-2005, the patient received the second dose of M-M-R II (dose 2, route, dosage and lot number unknown). This is one of two reports on the same reporter link (1312USA007099). Additional information has been requested.
pt recv vax 7MAY97 & 19MAY97 pt exp soreness @ the inj site & redness the size of an orange @ inj site;
Patient scheduled early for his HPV 2nd dose. No adverse effects just administered early and will need to be repeated. I reviewed the next minimum date he can received the vaccine 9/27/2021 and gave him a print out of the forecast with minimum dates.
This spontaneous report as received from a healthcare worker (office manager) refers to a multiple unspecified patients of the unknown ages and genders who on an unknown dates were vaccinated with improperly stored PEDVAXHIB (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patents sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Within an hour of shot, fever, dizziness, nausea, hot flashes, sleeplessness, body pain, arm pain, headache, leg cramps, and feeling like it was the worst flu I've ever had (minus respiratory issues). On day 5, it started to lessen to general malaise and a slight headache.
Bell Palsy, left side of face severe paralysis. Treatment Prednisone 20MG Tablets (7 days) / follow up with primary care doctor.
pt recv vax 7OCT98 lt arm;called office 9OCT98 c/o rash & pain in lt arm to elbow;no warmth to touch;no swelling;rash spread to other arm;
0.3ml of UNDILUTED Pfizer Vaccine was administered to patient.   Patient was monitored for an hour with no adverse reactions noted.  Patient had no complaints.      Vital Signs stable.   Patient instructed and signed up for V-Safe.  Instructed to report symptoms to V-Safe and Provider if needed.
have diarrhea not as bad from my second shot of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (have diarrhea not as bad from my second shot of the vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (have diarrhea not as bad from my second shot of the vaccine). At the time of the report, DIARRHOEA (have diarrhea not as bad from my second shot of the vaccine) outcome was unknown.
Vial stored post puncture vial was stored under refrigerator; Moderna doses administered past 12 hour; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 22APR2022 dose were administered to patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior. The patient had reported any adverse reactions to the expired dose administered.  Dose administered more than 12/24 hours post puncture Number of doses/vials was 7 doses. On 31MAR2022, the vial was initially stored in the refrigerator.  No concomitant medications were reported. On 21APR2022 at 10:20 AM, the vial was first punctured and administration of vaccine on 22APR2022 at 9:30 AM, 1:15 PM, 23APR2022 at 9:50 AM, 4:05 PM The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. No treatment medications were reported.
Case received from a healthcare professional in the USA on 03/Nov/2005. It is worth nothing that 4 other patient experienced similar reactions however only one report was made. A 62 year old female patient with a medical history of drug and fruit allergy and increase, had received on 27/Oct/2005 an intramuscular dose of influenza vaccine, batch number U1906AA, in the deltoid, and immediately after, she developed swelling at injection site and ecchymosis at injection site. Moreover, she became diaphoresic, red in color with increased heart rate. No "epi" was ever given. Her condition was improved but bruising and swelling at injection site persisted. The patient was allergic to peaches, PABA, sulfonamide and thiazides. She also had a history of blood pressure increased. The patient did not present with any illness at time of vaccination. She had annually received a dose of influenza vaccine for 11 years. She had concomitant treatment: baby ASA (3Xweek), enalapril (Vasotec), indapamid (Lozol), metoprolol (Toprol) and nifedipin (Procardia). Patient outcome was not recovered. Further information was requested. Follow up information was received on 15/Mar/2006 from a healthcare professional. Per the reporter, no epinephrine was given for these events, no lab was collected and it was felt that the causality of the reaction was food allergies. At the time of this report, the patient had recovered approximately one week post-vaccination around 03/Nov/2006. No further information is expected.
Patient may have potentially received an expired dose of vaccine after the 6 hours after being reconstituted.
Chest pains, low blood pressure,  increased heartrate, fatigue,  headache, bruising,  fever, redness around injection site
This case was reported by a healthcare professional and described the occurrence of lightheadedness in a female subject aged between 20 and 29 years old who was vaccinated with ENGERIX B (GlaxoSmithKline). On the morning of 20 October 2010 the subject received unspecified dose of ENGERIX B (20 mcg, unknown route, unknown arm). On the morning of 20 October 2010, less than one day after vaccination with ENGERIX B, the subject experienced lightheadedness. The subject attended the Emergency Room, but was not hospitalized. On 20 October 2010, the event was resolved. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. The healthcare professional reported that 3 subjects had experienced lightheadedness after vaccination with ENGERIX B. This is case 3 of 3 (see case IDs A0888918A and A0888943A for the other reports). Follow-up information was received on 10 November 2010 via physician who reported the 19-year-old subject's immunization series with ENGERIX B was discontinued. At the time of the report no other information was provided. The lot number was reported as AHBV855AA from the reporter; however, based on a safety lot number review, the lot number was updated to AHBVB855AA.
Nausea, fatigue, shortness of breath, shaking feeling in the body, headache all within the same week of the shot which was 4/5/2021. Shaking feeling still on going as of 4/13/2021
On 6/30/01, pt felt light-headed, dizziness and fatigue but was able to work. The next day, 7/1/01, the pt felt light-headed, general malaise and tightening throat but had no SOB. She reported to ER. During walk to the hospital, pt had to stop twice to "rest and regain momentum" secondary to fatigue. Vital signs were stable but the pt was put on oxygen and IV was started and she was given something for dizziness. The dizziness resolved and has not returned. Pt was discharged with acetaminophen and bed rest prescribed, to return to clinic in 2 days. On 7/3/01, the pt had worsened muscle pain and spasms in arms, spine, back and shoulders, worse on the left side. Also had mid-sternum pain sensation to pressure. Methocarbamol was prescribed, 500mg tablets, 2 taken 4 X a day. Pt returned to clinic on 7/9/01 for appt. She reports she is doing better but still with fatigue and dull muscle ache. She had been using her back brace and taking Methocarbamol as needed. She is to return to work 7/10/01.
Pt recvd 3 doses of Engerix-B on 8NOV90; 14DEC90 & 2MAY91; JUN91 Hep B surface antibody was neg; pt began another series, recvd booster dose of Recombivax on 27JUN91 & 23AUG91;
pt vax hepta B.  pt ex shortness of breath, chills, fever, disorientation, and weakness.  Pt seen in er.
Pt reports to have developed muscle aches 5 days after 2nd dose which lasted a month. She says she had a fall as a result of these muscle aches. After 1 month, she developed skin blisters on her hands that lasted 2-3 weeks. At time of reporting to me (7/11/21), she said the skin on her fingertips still "felt thickened". She also developed a rash on her neck and flaking, psoriasis like plaques on her ear lobes, the latter of which present at time of reporting to me. The rash had mostly healed at time of reporting. Pt reports that she went to her PCP and they ran tests but couldn't find any underlying issue. Her PCP thought that the immune reaction to the vaccine may have caused an underlying autoimmune condition to flare. The pt said she has never had any autoimmune issues before, but they did run in her family.
Diagnosed with Rheumatoid Arthritis April 15, 2022. Chronic pain in all joints, Visual changes, Fatigue, Headaches Probable diagnoses of Rheumatoid Arthritis by GP March 10, 2022 Rheumatoid Arthritis diagnosed by GP, prescribed Hydroxychloroquine
Came into office 1-25-06 complaining of leg pain.  Examined by Dr; found to have severe quadricep muscle spasm, fever and swelling to the site of vaccine.
Information has been received from a pharmacy purchaser concerning a senior citizen patient (age and gender not specified) who on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650452/0753P) in a senior center during an immunization clinic.  On an unspecified date. "recently", the patient developed "severe pain at the injection site", so much so the patient "could not sleep at night".  It was also reported that the patient had "swelling present".  The patient went to the emergency room for unspecified treatment.  At the time of the report, the outcome of the events were unknown.  Additional information is not expected.
Pain (severe) at injection site; saw PCP. Pt was referred to orthopedist. Pain and numbness in (L) fingers continued. Pt saw orthopedist specialist in shoulders who diagnosed adhesive capsulitis. Dr said mist likely secondary to flu vaccine (saw this dr 1/24/14).