chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient also reporting cough, body aches, malaise, and diarrhea for ~4-5 days; unable to pin down date of onset. He reports loss of smell that he endorses as 2/2 congestion. Patient vaccinated for COVID with 2nd dose in March, but brother and father were not and are currently treated for it with his father still in the hospital. At OSH, COVID + flu PCR combination swab + for COVID. No oxygen requirement.
pregnant patient given Bexsero, Menveo, Havrix; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB35AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number AMVA638A, expiry date 30th November 2022) for prophylaxis.   On 9th March 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Havrix and Menveo. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Bexsero at an unknown time during the pregnancy. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Havrix and Menveo, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was medical assistant. The reporter reported that pregnant patient given Bexsero, Menveo, and Havrix ,which led to vaccine exposure during pregnancy. The reporter consented to follow up with health care professional.
Brain fog; Migraine; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 (Lot number: ER8732) as dose 1, single and administered in arm right, administration date 19Apr2021 (Lot number: EW0162) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FISH OIL. The following information was reported: Feeling abnormal(non-serious), outcome "not recovered", described as "Brain fog"; Migraine(non-serious), outcome "recovered", described as "Migraine"; Headache(non-serious), outcome "not recovered", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling abnormal, migraine, headache.   Additional Information:Consumer stated, "I'm just calling to report some side effect for about a month from the vaccine (Pfizer Covid vaccine) now. So, pretty much it has been pretty major brain fog as well as headache migraines. After the first shot, it lasted for about a week and then it went away and then after I got the second shot, I got very severe migraine for a week again and then it kind of subsided a little bit but now the issue brain fog and headache that are pretty constant and I never really had either of both before, but is a very spark difference." Probed for DOB, consumer stated,"I'm 24, I'll just keep it to that, (DOB year withheld) the year. I'm saying I'm 24, year is (DOB year withheld) , that's all the information I will share."Any medical conditions or concomitant medications: Consumer stated, "No, I just take fish oil, its not really a medication, I just take fish oil." (Further not clarified. Hence, not captured in tab).Treatment: consumer stated, "Yes I've been taking some acetaminophen, Tylenol."  No follow-up attempts are possible. No further information is expected.
12 hours later started continuous shaking in legs, had chills, and felt feverish.  Symptoms lasted another day.  Today still very spacy, feverish, and weak.  Has taken Tylenol for symptoms.
Itching occurred after injection. 8 days after injection itching rash occurred around the injection site extending approximately 2.5 inches  in all directions from the site of injection. The rash is raised and itchy. Note that after the injection I had pain at the site of injection for two days which was quite severe and the site was mildly itchy. This resolved after approximately 4 days then then on day 8 the rash developed.  It has been two days and has not subsided.
I had headache; I felt high blood pressure; and had difficulty breathing; This is a spontaneous report from a contactable consumer (patient).  A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 13:00 (Batch/Lot Number: ER8737), age at vaccination of 39-years-old, as single dose for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing (Corn and Lactose). Concomitant medications included zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; cholecalciferol (CHOLECALCIFEROL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, high blood pressure when lying down and had difficulty breathing, all 04Apr2021 20:00. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 15Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
COVID; COVID; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jun2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "History of pneumonia" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID". On an unspecified date in 2022, the patient had treatment with Paxlovid for COVID-19 treatment. The patient had rebound COVID after Paxlovid with positive COVID test a few days after finishing with return of symptoms on 11Oct2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Covid 19 Treatment; (unspecified date) Negative; (11Oct2022) Positive, notes: Rebound COVID. Therapeutic measures were taken as a result of drug ineffective, COVID-19 including PF-07321332/ritonavir (PAXLOVID) from 01Oct2022 to 06Oct2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
2 inch x 3 inch area warm to touch, erythema, no induration, Tx: Augmentin Es
Swelling at injection site, night sweats, itching at site.  Currently stiffness in joint, skin peeling on upper left arm, mostly resolved now.
On the evening of Friday, April 16th, 2021, I experienced increased body temperature, chills, severe nausea. I completed COVID-19 testing on 4/17/21 (both rapid test and PCR test were negative). I continued to experience persistent elevated body temperature (although not true fever), periods of warmth, chills, recurrent headaches (frontal), exhaustion, burping, more pale looking, and periods of lightheadedness (when at work and home, regardless of what I was doing). I scheduled a 'sick' visit with my primary care physician, completing a telehealth visit (per my MD) on 4/27/21 due to the aforementioned symptoms. I received a blood pressure monitor free through my health insurance and began taking my blood pressure at the beginning of May. My blood pressure during the first two weeks of May was averaging 95/62 (with peak blood pressure reading of 107/65) with my blood pressure cuff identifying irregular heartbeats on 5/6/21, 5/11/21, 5/12/21.  Although some symptoms resolved, I continued to experience periods of lightheadedness, chest pain/pressure in the middle of my chest, and soft blood pressure readings.  I saw my rheumatologist on 5/12/21 (who also documented a low blood pressure reading in office and wrote an order for an ECHO). I completed a telehealth visit with my GI, who advised to continue use of pantoprazole and increased PRN use of sucralfate. I continued to experience increasingly more frequent instances of lightheadedness, increasing chest pain/pressure, and my blood pressure continued to decrease. I was 'strongly advised' by my primary care MD's office to seek cardiac workup at an Emergency Room on 5/18/21. I presented to the Emergency Department on 5/18/21 at approximately 1330 and was discharged from the ED at approximately 3:30am on 5/19. I was advised to complete my already scheduled ECHO (scheduled and completed on 5/25/21), to seek the care of a cardiologist, and follow-up with my primary care MD.  I saw a NP  who is part of my primary MD's office on 5/20/21. I saw cardiologist on 5/27/21, who advised me to hydrate with liberal use of salt (due to persistent low blood pressure readings, documented during my in-person office visit). I completed a stress test on 6/18/21.  Due to persistent low blood pressure, my cardiologist started me on midodrine 5mg tablets twice a day and ordered a Ziopatch cardiac monitor to be worn for 5 days. I was advised by my cardiologist to see an endocrinologist as he is unable to identify the cause of my low blood pressure.  At the time of writing, I continue to experience low blood pressure, periods of lightheadedness, occasional chest pain/pressure in center of chest, and periods of increased fatigue.
Narrative: Symptoms: & chills, headache, malaise, fever to 99.4 x 1 day Treatment:
As far as we know, patient has not experienced any adverse effects. Pt was administered vaccine that was out of date and was mistakenly left in the cooler.
Information has been received from a physician concerning a 64 year old female with allergies to sulfa, erythromycin, "Celebrex" and "Indocin" and a history of hypoparathyroidism, hypothyroidism and lumbar disc degeneration who on 12-FEB-2007 was vaccinated with a dose of Zostavax (lot# 656608/0032U). Concomitant therapy included levothyroxine Na (LEVOXYL) and acetaminophen/hydrocodone bitartrate (LORTAB). Subsequently, within a few weeks, the patient developed polymyalgia rheumatica within a few weeks after administration of the dose. The patient's polymyalgia rheumatica persisted. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
round itchy, somewhat red injection site; Swelling at the injection site; round itchy, somewhat red injection site; Sore arms; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arms), VACCINATION SITE PRURITUS (round itchy, somewhat red injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (round itchy, somewhat red injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arms). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (round itchy, somewhat red injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (round itchy, somewhat red injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 07-Jan-2021, PAIN IN EXTREMITY (Sore arms) had resolved. At the time of the report, VACCINATION SITE PRURITUS (round itchy, somewhat red injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (round itchy, somewhat red injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
recurrent shingles rashes after second dose; recurrent shingles rashes after second dose; second dose may have been given while shingles; shingles rashes; Itching; second dose may have been given while shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) (batch number 9EY93, expiry date 15th April 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2022, the patient received the 1st dose of Shingrix. In 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, shingles, rash, itching and drug use for unapproved indication. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, shingles, shingles and drug use for unapproved indication were unknown and the outcome of the rash was recovered/resolved and the outcome of the itching was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, rash and itching to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-AUG-2022.  Reporter's Comments: Pharmacy intern stated female patient received first dose of Shingrix series. The patient did receive the second dose, but it was given at a different location so reporter was unsure of the date received.  Pharmacy intern stated it was believed the second dose might have been given while the patient had a case of shingles, but the patient did not know she had shingles at the time.  The patient reported she started having recurrent shingles rashes 3 months after the second dose.  She currently (at the time of reporting) did not have a rash but did still have itching.  The consent to follow up was granted. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting. As patient received second dose while patient having shingles, which led to drug use for unapproved indication.
Left nasalis muscle twitching/spasming constantly during the first day after vaccines were administered (12/08/2021), continuing on and off ever since then. Twitches happen especially when I yawn or stretch. Magnesium and vitamin D supplements have no effect on it. Currently awaiting doctor visit for treatment.
Redness, itchiness and heat below injection site and delayed about 2 days after injection
Headache, Myalgia, Fever, Body aches, low grade fever 99.5, headache
Patient describes continuing pain in arm, from 10/20/17 to 11/5/17. She states she does have a decreased range of motion, and soreness in her arm where the injection was given. She states that depending on how she moves her arm, she sometimes feels a pinching type of pain. She had some initial bruising, which has all subsided, but she is concerned about the lingering pain.
PATINET RECEIVED THE FIRST DOSE OF PRIMARY SERIES OF COVID 19 VACCINE (MODERNA). HOWEVER, AS SOON AS THE VACCINE WAS ADMINISTERED TO PATIENT, SHE EPXERINECED LIGHTHEADEDNESS, DIZZINESS AND NAUSEA. THE IMMUNIZER CALLED FOR HELP AND THE PHARMACIS WENT OUT TO IMMUNIZATION STATION WITH EPIPEN, BENADRYL, AND OTHER FIRST AID KITS. PATIENT WAS CONSCIOUS AND STABLE. SHE WAS COHERENT AND ANSWERED QUESTIONS. WE OFFERE TO CALL 911 HOWEVER PATIENT REFUSED. PATIENT STATED THAT SHE WAS SO EMBARRASED. PHARMACIST OBSERVED AND MONITORED THE PATIENT FOR 15 MINUTES. NO FURTHER MEDICAL HELP NEEDED.
On 21st -22nd morning started having severe vomiting x 8-10 episodes with nausea, chills, and headache. On Sunday 1/24/21-1/26 started with severe epigastric sharp upper abdominal pain, never had before. Was getting worse. Went to virtua ER on 1/26/21 evening, had ct scan with contrast showing fluid around galbladder and ultrasound showed wall thickening to 11mm, positive Murphy?s sign and fluid around galbladder. I was admitted overnight and surgeon had recommended removal due to ejection fraction of 12% from hida scan done on  1/27. Endoscopy was done also and was negative. Cholecysitis was the presumed diagnosis, with normal LFTS. I left and returned to ER where they did repeat ct scan showing distention , pain continued. Admitted for 1 night.  Pain was improving on Friday 1/29 , when I was discharged after repeated ultrasound showed resolved fluid. No history of any previous GI issues and no gallstones were noted on any imaging. I consume a healthy diet. Now having continued epigastric pain but improving.
Vial was initially stored in the refrigerator on 10 Jul 2023 , dose administered after 30-day Use By Date on 15 Aug 2023; No adverse event; Vaccine administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10 Jul 2023 , dose administered after 30-day Use By Date on 15 Aug 2023) and NO ADVERSE EVENT (No adverse event) in a 16-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10 Jul 2023 , dose administered after 30-day Use By Date on 15 Aug 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10 Jul 2023 , dose administered after 30-day Use By Date on 15 Aug 2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10 Jul 2023 , dose administered after 30-day Use By Date on 15 Aug 2023).    No concomitant medications were provided.  The vial did not undergo any temperature excursions.  Vial size was reported as 2.5 milliliter.  No treatment medication was provided.  This case was for patient 3 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-737984 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737984:Patient 1
Information has been received from a nurse practitioner concerning a 27 year old white female who in 1999 was vaccinated with hep b vaccine recombinant. Twenty four hours post vaccination she experienced a non-itchy rash. Subsequently, the nurse practitioner stated that she had not administered the "original dose" of the vaccination. When the pt received subsequent hep b vaccine recombinant vaccination upon being hired, the pt had no reaction while she was monitored. This series was started on 03/12/2001. The nurse practitioner believed that the pt was either mistaken about the rash or the rash was coincidental to the vaccination. No additional info is expected.
Mother noticed the swelling and redness of pt's R upper arm. Hot to touch. Our office gave patient BENADRYL per mother's request.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (about 15 years ago when she was forty). Previously administered products included Flu vaccine (for tolerance of 1st dose refer case US2019GSK037431). On 9th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th January 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain and muscle tightness. In January 2019, the patient experienced injection site rash, injection site blisters, injection site itching and injection site discoloration. The patient was treated with Alcohol. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, muscle tightness, injection site rash, injection site blisters and injection site itching were recovered/resolved and the outcome of the injection site discoloration was unknown. It was unknown if the reporter considered the injection site pain, muscle tightness, injection site rash, injection site blisters, injection site itching and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX late morning and by early evening she was experiencing pain, soreness and tight muscles around the injection site. About 1.5 to 2 weeks later, she broke out in a rash on her left arm around the injection site. The rash was itchy. The area was darker initially in color and slightly itched and then the rash presented itself. The patient applied alcohol to the area to dry it up and it was finally drying up. After applying alcohol, the area turned bright red but dried up. The reporter gave consent to follow up. This case has been linked with US2019GSK037431, reported for same patient.
Hospitalized for High Pulse and low blood pressure. 6 months of testing. Diagnosed 04/13/2015 with POTS.