chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual cramps; Blood pressure high; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Menstrual cramps) and HYPERTENSION (Blood pressure high) in a 46-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ELAGOLIX SODIUM, ESTRADIOL, NORETHISTERONE ACETATE (ORIAHNN) for Uterine fibroids.    Concurrent medical conditions included Uterine fibroids.   On 01-May-2022, the patient started ELAGOLIX SODIUM, ESTRADIOL, NORETHISTERONE ACETATE (ORIAHNN) (Oral) Unknown. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In May 2022, the patient experienced DYSMENORRHOEA (Menstrual cramps) and HYPERTENSION (Blood pressure high). At the time of the report, DYSMENORRHOEA (Menstrual cramps) and HYPERTENSION (Blood pressure high) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  In 01-May-2022, the patient began ORIAHNN, upon taking medication, she stopped experiencing menstrual spotting. She continued to experienced menstrual cramps. She concurrently had high blood pressure, since receiving COVID immunization and was currently on high blood pressure medication (unspecified). She did not give consent to be contacted.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Primary reporter contact for lot number information was unsuccessful.  The reporter's causality for the event of dysmenorrhea was a reasonable possibility and the reporter's causality for the event of hypertension was no reasonable possibility with ORIAHNN (ELAGOLIX).  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.
I received my first dose of the Moderna Covid vaccine on 1/11/2021. On the morning of 1/20/2021 (9 days post vaccine), I noticed a rash just below the injection site. Initially it was very hot and red.The appearance has changed almost daily. Each day it was larger and then became itchy. It now has a distinct border with more central clearing.
Suspected vaccination failure; I had the shot and have the Shingles; This case was reported by a consumer via interactive digital media (facebook)and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had Shingles. The reporter reported its hates to bust bubble. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary vaccination schedule for shingles, and laboratory test confirmation and time to onset for shingles were unknown at the time of reporting.
pruritis, welts Narrative: Pt received COVID vaccine in left deltoid on Saturday and woke up with itchy, burning rash on right inner forearm with two welts. Rash/welts dissipated by afternoon/evening.
Received the first dose on 12/16/2020, I tested positive for COVID on 12/28/2020.  I received my second dose on 1/7/2020, I was still having COVID symptoms. Symptoms worsened after the second dose. My heart rate has been out of control. I have been on steroids daily, because I was so short of breath.  I have not been at work since being diagnosed with COVID.  I went ahead and got the second dose, because my job told me that I had to get the second dose.  I still have fatigue,  elevated heart rate, blood pressure is till elevated. I have been started on blood pressure medication.  I have also been diagnosed with severe sleep apnea.  I had a sleep study performed. I am on  two new inhalers. One is a steroid inhaler for lungs and one is a rescue inhaler for when I am short of breath. It has not pleasant. Headaches are horrible and daily.  I went to ER, because headache was so severe. No medication I take for headaches work.  I have not been able to work since I was diagnosed with COVID.
Patient called to report that she did not have a period in September after receiving her first COVID vaccination in August. She started her period in late October but it is much lighter than normal. Concerned that they could be related.
I experienced an extreme headache that would not respond to 800mg of Advil nor 10mg of vicodin (that I had been prescribed for dental surgery on Thursday, March 18, 2021) that began at around 4:00am on Wednesday, March 24. The headache intensified through the day and by midnight on Thursday, March 25, I was incapacitated from the headache. I took the 10mg of vicodin at midnight on Thursday, March 25 and it did nothing for me. I was also suffered from a fever of 101.3 (taken orally and digitally), chills throughout my body and aches throughout my body, nausea and dizziness. I slept/rested/drank water and other fluids and ate two small meals with protein on Thursday, March 25. I stayed in bed all day. It is on Friday, March 26 at 10:18pm and I still have a headache (although it is not as bad as it was on Thursday, March 25). I still have body aches and I feel dizzy and nauseated. It almost feels similar to suffering from withdrawal from a depression drug if you miss a day.
Shot given on 5-20-09 Pt came back in on 5-22-09 Rt arm red and swollen within the area of the shot.  (foster child missed this dose)
she felt like she had been in a car accident. My entire body was sore; I was very hungry - ate three breakfasts and a big lunch and was still starving; I had a 101 temp; chills; extreme joint pain; muscle aches; dizziness; exhaustion; she felt off; unusual hair loss; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 17:15 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation, 40 years old at doctor's office/urgent care. Medical history included coeliac disease, sjogren's syndrome, hypersensitivity (known allergies), all from an unknown date, and Covid-19 from Nov2020 (First, I had a mild case of COVID in Nov2020 and recovered fully). No other vaccine in four weeks and not other medications in two weeks. Patient is not pregnant. The patient's concomitant medications were not reported. On 06Mar2021 09:00, the day after first vaccine, patient had a 101 temp, chills, extreme joint pain, muscle aches, dizziness, exhaustion. The following morning on 07Mar2021, she felt like she had been in a car accident. My entire body was sore, she was exhausted, and she was very hungry - ate three breakfasts and a big lunch and was still starving. The following week (Mar2021) she felt off and experienced some unusual hair loss. She does not feel comfortable taking the second shot. Patient was asking some guidance on whether to take the second shot. Treatment was not given for the events. Outcome of the events was recovering.
It wasn't like everywhere just one spot; it is only in middle of my torso; It's not like it's red or anything, it just itches; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 01Mar2021 (age at vaccination: 76 years), as a single dose for COVID-19 immunization. The patient's medical history included blood pressure measurement and slight depression. Concomitant medications included colecalciferol (VITAMIN D), lisinopril, pravastatin and chlorothiazide. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9264 and expiry date was not reported), via an unspecified route of administration, on 01Feb2021 (age at vaccination: 76 years), as a single dose for COVID-19 immunization. On an unspecified date in Mar2021, the patient had it wasn't like everywhere just one spot; it was only in middle of her torso; It's not like it's red or anything, it just itches. The patient reported that she really did not have right immediately follow but couple days ago she started itching and she did not know if it's from that or what, but it's been 15 days since she had the shot. But she did not know if, because she could not think of anything else different that she has done to make her body itchy. The patient stated that she did not know if it's from that, she just wondered of it that was one of the side effects. She thought it was one of the side effects, because she did not do anything different. So, she was just calling to ask if that was possible. She used some anti-itch creams that she had and it's for anything that itches. It helped because she could sleep last night but then she got to put some more on. She was going to call her doctor to find out what to do for it but then she figured out to call you guys first. The patient used anti-itch creams some a couple of days ago and then she used it last night. It's not like it's read or anything, it just itches. It's little bit red when she itch it. Outcome of the event was not recovered.  No follow-up attempts are possible; No further information is expected
NAUSEA; FATIGUE/ TIREDNESS; CHILLS; SWEATING; HEADACHE; FELT MISERABLE; FEVER; ACHING BONES; This spontaneous report received from a patient via a company representative concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 06-MAR-2021 09:30 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 06-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.6 F. On 06-MAR-2021, treatment medications included: paracetamol. On 06-MAR-2021 17:00, the subject experienced aching bones. On 06-MAR-2021 18:30, the subject experienced fever. On 06-MAR-2021 19:30, Laboratory data included: Body temperature (NR: not provided) 100.3 F. On 06-MAR-2021 22:00, the subject experienced headache. On 06-MAR-2021 22:00, the subject experienced felt miserable. On 06-MAR-2021 22:00, the subject experienced chills. On 06-MAR-2021 22:00, the subject experienced sweating. Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 07-MAR-2021 04:00, Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 07-MAR-2021 09:00, the subject experienced nausea. On 07-MAR-2021 09:00, the subject experienced fatigue/ tiredness. Laboratory data included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, aching bones, felt miserable, fever, nausea, and fatigue/ tiredness on 08-MAR-2021, and chills, and sweating. This report was non-serious.
Vaccine administered beyond use date after the thaw process; Vaccine number 2nd and dose volume 0.25; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   The patient age was reported as 18 years 11 months.  No concomitant medications were reported. Vaccine Ndc Code was reported as 80777-0273-99. The patient did not had any adverse reactions and no reports of any reactions after the administration of the vaccine. No treatment information was reported.
Prior to receiving the booster shot, she was menopause for 13 months, Since she has had her period each month and the past month the flow was heavier; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose:2, Caller received 2 doses of Moderna COVID vaccine as the primary series), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose:1, Caller received 2 doses of Moderna COVID vaccine as the primary series), for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Jan2022, outcome "not recovered", described as "Prior to receiving the booster shot, she was menopause for 13 months, Since Jan she has had her period each month and the past month the flow was heavier".  Additional information: Patient received 2 doses of Moderna COVID vaccine as the primary series and received her booster dose with Pfizer COVID vaccine on 12Jan2022. Prior to receiving the booster shot, she was menopause for 13 months, Since she has had her period each month and the past month the flow was heavier.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient noted large area of redness, erythema (measured at 8 cm x 11 cm on 5/19/14) and intense pruritus with hard knot at injection site. Using Acetaminophen intermittently for past several days.
Information has been received from a registered nurse concerning a 17 year old female with asthma and no known drug allergies/reactions who on an unspecified date was vaccinated with the first dose GARADSIL and on 14-AUG-2008 was vaccinated with the second dose of GARDASIL (Lot No. 659184/0843X).  Concomitant therapy included SEASONIQUE.  On 14-AUG-2008 the patient developed dizziness and nausea immediately after administration and throughout the evening.  Patient has not responded back to the office's attempt to follow-up.  Patient sought medical attention, at the office.  Additional information has been requested.
Information has been received from a Registered Nurse (R.N.) concerning a 17 year old female with a cardiac murmur who on 28-NOV-2006 was vaccinated IM with her first dose of HPV, lot #654540/0800F. On 29-FEB-06 the patient experienced minor soreness around the injection site. The patient did not return for her 2nd dose until 27-FEB-2007. The patient recovered. Additional information has been requested.
Injection site swelled and hurt for 3 days with fever. Then developed chest cough, epistaxis, and scratchy throat.
Dizzy; Headache; This is spontaneous report from contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: SA6780 (not clarified appropriately), Expiration date, NDC number, UPC number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizzy and headache. The patient wanted to know what to do with these side effects and wanted to talk to Pfizer Medical Information Department. The outcome of the events was unknown.  Follow-up attempts are needed. Information about lot/batch number has been requested.
Initial Fever 102-103 x30hours Continuing Fever 99.5 -100.6 for 4 additional days Severe sore throat with Blister on uvula- Diagnosed with uvulitis Headache for 5 days Extreme fatigue - sleeping 12-14 hours 3 nights After vaccine  Missed 3 schedule shifts - Medical provider insisted and wrote note out of work greater than one week
This case was reported by a physician via call center representative and described the occurrence of focal seizures in a 74-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced focal seizures (serious criteria GSK medically significant), encephalitis (serious criteria GSK medically significant), tremor limb, tingling and vasculitis. On an unknown date, the outcome of the focal seizures, encephalitis and vasculitis were unknown and the outcome of the tremor limb was recovered/resolved and the outcome of the tingling was not recovered/not resolved. It was unknown if the reporter considered the focal seizures, encephalitis, tremor limb, tingling and vasculitis to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's relative. The age at vaccination was not reported. It was believed that the SHINGRIX was given in mid December 2018, exact dates of vaccination was not provided. The patient experienced might be a focal partial seizure. The patient experienced right sided arm shaking and tingling on whole right side of body had not subsided. On an unknown date, the patient underwent Nuclear magnetic resonance imaging and the results revealed potential vasculitis or encephalitis. The patient did not experience numbness, weakness, pain or rash, loss of consciousness and event related to bowel or bladder. The lot number, exact date of vaccination was not available. No official diagnosis had been made till the reporting time. Emergency room visit required. The reporter did not consent to follow-up. Lab Comments: On an unknown date, the patient underwent Nuclear magnetic resonance imaging and the findings revealed potential vasculitis or encephalitis.
Patient stated she had allergic total body rash. First rx filled for this was 12/13, 2nd 12/18/19 and 3rd 12/21/2019 -
Medication error occurred. Patient received bivalent 5-11 years Pfizer vaccine as second dose to primary series. Patient was supposed to receive monovalent 5-11 years Pfizer as a second dose vaccine. No adverse reaction.
Pt was given Pfizer 0.3ml and should have had 0.2ml.  Covid vaccine provider line called and will give second dose as 0.2ml.
No additional AE reported; VAQTA was inadvertently administered on 13 APR202 l after a temperature excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided.  On 13-APR-2021, the patient was inadvertently vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # T033304, expiration date was reported as 23-JUN-2022 but upon internal validation process, it was established as 02-APR-2022 (dose and route of administration were not reported) (Incorrect product storage).  There was no additional adverse effect reported. Administered doses of vaccine was stored in temperature of 9 degrees Celsius for 10 hours and 56 minutes. Data logger was involved. There were no previous excursions reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA003768: US-009507513-2104USA003667 : US-009507513-2104USA003622 : US-009507513-2104USA003606 :
Multiple satellite lesions confined to dressing post SPV. >100 lesions.   Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
ACCORDING TO PATIENT STARTED WITH FEVER AFTER VACCINE THAT EVENING . THEN THE NEXT DAY SHE STARTED WITH SWELLING OF THE LIPS, TONGUE AND GUMS SO WENT TO ER WHERE SHE WAS GIVEN BENADRYL, TYLENOL AND STEROIDS
Patient presented to the emergency department with nausea vomiting and diarrhea, shivering, with back pain in with sensation that she cannot stay warm. Patient states the symptoms started 2 days ago with generalized malaise. Upon presentation to the ED patient's blood pressure was 154/80, pulse 141, P of 100.4 and 02 sat 96%. Within 2 hours patient's blood pressures documented 60/40 rate of 1 04 and respiratory rate of 30 with an 02 sat of 94%. The patient's lab work revealed the following abnormalities: mild hyponatremia and hypokalemia (133, 3.4) with hypomagnesemia of 1.3, AKI with BUN 36, creatinine 2.5, GFR 20, bicarb of 13, transaminitis with an AST of 256, and ALT of 417, total bili of 1.2, alk-phos 163 Lactic 9.9, UA with 25 leukocyte esterase, 6-10 wbc's, 2 + bacteria, troponin 136, CRP 28. 1, CBC: WBCs of 1.6, and COVID positive, INR 1.4, APTT 37.9, PT 14.6. Patient had a CT of the chest abdomen and pelvis without contrast which revealed: 5 x 6 mm stone in the proximal LEFT ureter just beyond the UPJ with hydronephrosis on the LEFT and asymmetric perinephric stranding. Diverticulosis with no evidence of diverticulitis . No evidence of significant cardiopulmonary abnormality. No significant alveolar opacity. Low lung volumes. Chest x-ray revealed:No evidence of acute cardiopulmonary abnormality. After the patient became hypotensive, after being given 2 L of normal saline, magnesium, Zosyn, and Levophed IV, and after the patient's mentation started to decrease, Dr.  was called for assistance soft placed a triple-lumen central venous catheter the patient's left femoral vein. Patient was then placed on vasopressin.  Urology was called and the patient was taken to surgery for cystoscopy and ureteroscopy and stent placement.  Urine was collected for culture and patient was given intraoperative gentamicin in the Foley was placed.  When she returned from the OR she appeared much more comfortable and stated that her abdominal pain had resolved. She remained however on high-dose pressers. Later in the night she developed a return of lower abdominal pain that radiated into her back. She got out of bed and was standing at the side of her bed stating that she was in pain and was not feeling well. She was returned to bed and her blood pressure abruptly dropped and she was found to be in PEA arrest. She was coded until daughter was reached over the phone and they instructed the team to stop CPR
Woke up at 3:00 am, 12 hours after receiving immunization with fever of approx 100, chills and body aches.  Symptoms persisted for approx. 15 -18 hours.  Low grade fever and bad body aches. Took Advil every 5-6 hours for symptoms.  Woke up the following day and felt better, back to normal.