chrisvoncsefalvay/vaers-outcomes huggingface dataset:
migraine; patient received postponed Dupixent dose after the INFLUENZA VACCINE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00545146) and transmitted to Sanofi on 01-Apr-2021.  This case involves a 36-years-old female patient who experienced migraine, while she received vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) 300 mg QOW route an unknown (with an unknown batch number) for atopic dermatitis.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious migraine (unknown latency) following the administration of INFLUENZA VACCINE and intake of DUPILUMAB.  This is also medication error case due to patient postponed her Dupixent dose and after the INFLUENZA VACCINE (intentional dose omission) (latency: same day).  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for migraine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
patient received two doses of the FLUZONE HIGH DOSE QUADRIVALENT, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00895738) and transmitted to Sanofi on 13-Dec-2021.  This case involves a 75-year-old female patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on 19-Oct-2021 (route, administration site, batch number and expiry date not reported) and again received a 0.7 mL (once) dose of the same vaccine (lot UJ733AB, expiry date 30-Jun-2022) via intramuscular route in the left deltoid on 13-Dec-2021 for prophylactic vaccination (extra dose administered).  Medical history, past medical treatment, past vaccination and family history were not provided.  No other vaccines was reported.  It was a case of actual medication error due to extra dose administered (latency was on same day with last dose).  It was reported "Medical Assistant is calling to report that a patient received two doses of the FLUZONE HIGH DOSE QUADRIVALENT. The first dose was given on 19Oct2021 and the second dose was given today. Caller is wanting to know what to do."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pregnant patient received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use and Nicotine dependence. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Sep-2020 and the estimated date of delivery was 01-Jul-2021. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 04-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2020, Pregnancy test: Positive. In 2021, Ultrasound scan: normal.         The patient took one year to get pregnant. Treatment information was not provided.
7 days after first vaccine I started feeling like I pulled a muscle in my right bicep (shot was in right arm) I waited a few days and the pain got worse and spread to my forearm. It was extremely painful and swollen. I could not straighten my arm. Where the pain was in my forearm red blotchiness appeared and got bigger over a day. I did have an endoscopy the day before and had and IV in for a short time.   I don't want this to be disregarded be both Birth control and having an IV can contribute to blood clots, I think it needs to be warned before getting the vaccine that those things can increase the risk of blood clots. So just avoid IVs around the time of the vaccine and maybe pause Birth Control.
This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 13:00 as dose 1, single (Lot number: Unknown), in right arm and on 27Oct2021 at 13:00 as dose 2, single (Lot number: Unknown) at the age of 65 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Depression" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes/ Paxlovid for COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient received Paxlovid as COVID-19 treatment from 29Jul2022 to 03Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient received the first dose of GARDASIL 2 years ago (in approximately August 2011) (dose, route and lot# unknown). The patient came into the office on the date of report (14-AUG-2013) to receive the second dose of GARDASIL (Lot#, dose and route unspecified). No adverse effect reported. Additional information has been requested.
Urticaria and rash x 6+ weeks.  Treated with Hydroxyzine, Pepcid,  and Triamcinolone cream.
Patient called today 09/29/17 at about 3pm reporting that her arm was red, swollen and hot and it was very sore to move. Since she got both shots in the same arm i wasnt able to identify which shot was causing these symptoms. I told her to watch it and asked if she had checked her temp. She has not but says the arm feels hot. I told her that if it gets worse definitely call the dr or go to someone who can evaluate this for her. I called her back just now to get more info to fill this out and she said it was feeling better but still very sore. Thank you. I told her keep a close eye on it and I would call her sunday and check on her as thats the next day I work at this store.
Headache hours after getting the shot that has been constant for 3 weeks and no medicine is helping. Dizziness and shakiness after getting the shot that hasn't gone away. High blood pressure after getting the shot.
peripheral neuropathy characterized weakness in calves & thighs w/sharp pain;some pain in arms 2-3wks p/initial sxs devel SOB;tx out patient basis w/naprosyn for pain;p/2 months still has some weakness but is better;leg pain & paresthesia 07/11/2000 14:20 Pt had originally reported "peripheral neuropathy" in 1995- no follow up was done. He has reported conditions to manufacturer also. Now diagnosed with Guillian Barre and is permanently disabled, muscle weakness, pain in extremities and is currently Tx with physical therapy. He is on workman's comp. Consent form sent for medical records.
Patient received less than the recommended dose; A spontaneous report, was received from a nurse, a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not reported. Concomitant medications were not reported.  On an unknown date in Jan 2021, one day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.  The nurse stated that they administered a vaccine and the patient received less than the recommended dose on an unknown date in Jan 2021. The nurse doesn't have any further information regarding the patient at this moment.   Treatment is not applicable  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event is not applicable; Reporter's Comments: This report refers to a case of vaccine underdose for mRNA-1273, unknown lot number  with no associated AEs.  Causality for this medication error is not applicable.
Lasted 12 to 13 days. Symptoms on "Emergency Dept." paper, dated 12 Sept. 2018.
IT BURNED LAST EVENING AFTER SHE GOT THE SHOT, WHEN SHE TOOK OFF THE BANDAID IT WAS RED. TODAY THERE IS A RED SPOT WITH MINOR BRUISING.
Initial report received from a health care professional on 19 October 2010.  A 27-year-old female patient, with a history of allergies (not specified), received on 14 October 2010 a left deltoid intramuscular injection of ADACEL, sanofi pasteur Inc. lot number U3082AA and sanofi pasteur Ltd. lot number C3314.  She had no illness at the time of vaccination, had no adverse event following prior vaccinations and had no other vaccinations within 4 weeks prior to the ADACEL.  The patient's concomitant medications included SINGULAR, ALLEGRA, AVIANE and vitamin C.  On 15 October 2010 the patient developed a large local reaction at the left deltoid which included redness, pain, and swelling comparable to the size of a tennis ball.  She also complained of joint pain and swelling as well as generalized body aches and pains.  The patient was seen in the doctor's office and reported some improvement.  The outcome was reported as not recovered.  Follow-up information was received from the health care professional on 06 December 2010.  Based on this new information, it was determined that the event met seriousness criteria.  The patient had no known drug allergies, and no relevant medical history other than seasonal allergies.  Treatment included KENALOG 40mg intramuscularly, prednisone taper 10mg ("4, 3, 2, 1 x 2 days"), and KEFLEX 500 mg QID x 7 days.  The patient had not returned to the office, and the reporter was unable to provide an updated outcome.  No additional information was available at this time.  Documents held by sender: None.
I had a consistent migraine for 14 days following the second dose. Which I could not break with medication. It broke for one night after the 14 days and then it came back the  very next day and lasted about three days  (it broke each of those three nights of these days but then would come back again in the morning)- even with medication. And then finally after about three doctor appts ( neurologist ) and a cocktail of meds it went away. I also had really bad fatigue that lasted for months. I had some extra first vaccine but it was mild and this fatigue after the second vaccine hit me like a freight train.  Auto Injector once a month: Engility - Added  After the shot after the 14 day migraine. Changed from Rizatriptan to Sumatriptan. They also gave me a bunch of different kinds of cocktails to abort the migraine - Butaloprol (?) (Acetaminophen Caffeine cocktail to take once during the migraine and it didn't knock it out. Tried ibuprofen with one of the Triptans and that didn't work.  Other cocktail: Triptan; Ibuprofen; Prochlorperazine and a Benadryl, too, and that is what finally got rid of the migraine. I also had problems with breathing - was worse -  and I started coughing up phlegm really badly. The fatigue has slowly been getting better. That is still getting worked on - I did have some pre-existing fatigue beforehand and it's not quite back to that. I would say that I am about at 7 of trying to get back to my normal "10" if "10" was where I was before. It had gone down to a 4 or 5 before.  The phlegm issue comes and goes and with that the breathing is affected. I have sinus issues that have gotten worse - they started getting worse within the first week after the vaccine and got their worse about 2 weeks after.
Red, itchy, raised skin at injection site. Began 7 days after 1st dose, still itchy (not worse) 9 days later.
This case was reported by a nurse via call center representative and described the occurrence of intussusception in a 1-year-old male patient who received ROTARIX (batch number A41CB516A, expiry date 4th February 2017). Concomitant products included ENGERIX B pediatrics, PENTACEL and PREVNAR 13. On 6th January 2016, the patient received the 1st dose of ROTARIX (oral) 1 ml. On 22nd January 2016, 16 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization, GSK medically significant, life threatening and other: as per reporter) and vomiting projectile (serious criteria hospitalization, life threatening and other: As per reporter). On an unknown date, the outcome of the intussusception and vomiting projectile were recovered/resolved. The reporter considered the intussusception and vomiting projectile to be almost certainly related to ROTARIX. Additional details were received as follows: This case was not previously reported to anyone. The patient's birth weight was 8.75 (units unknown). The patient experienced projectile vomiting and was diagnosed with intussusception. On 23rd January 2016, the patient had surgery for intussusception and was hospitalized for 3 days. The batch number reported for ENGERIX B (LL434) did not exist and was updated to LL43A as per sales database.
fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated she had 2 doses of the Pfizer COVID vaccine in Mar, 21 days apart. She is close to her 6 months time from the 2 dose. About 3 and a half weeks ago she had fever related to bleach water cleaner she used to clean her drinking water. She said she switched to bottle water and it went away. She thinks its tied to her bad water use. She has several negative COVID tests and she has been monitoring herself, she isolated herself as well. Caller wanted to know if she can take the booster dose or should she wait to get it due to her fever 3.5 weeks ago.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
pt in Rehabilitation Center; tested positive for COVID on 1/24/22; per death certificate, pt passed away on 1/25/22 in the nursing home with the causes of death being Respiratory Failure, Pneumonia, COVID 19
Narrative:  03/11/2021 - Patient tested positive for COVID 06/07/2021 - Patient received Johnson & Johnson's Janssen COVID vaccine. 06/09/2021 - Patient reported to ED for cc swelling in left axilla. 06/28/2021 - Patient tested negative for COVID 07/28/2021 - Patient presented to ED with cc of left shoulder pain and chest pain. 07/31/2021 - Patient presented to ED with cc of left sided mid back pain and found to have multiple pulmonary emboli. Treated with enoxaparin and apixaban. Total of 3 day hospitalization.
The Pfizer Covid vaccine I took several days ago has given me cramps, diarrhea, chills and some fever
swelling at injection site; woke up in cold/hot sweat and felt like a hurricane was going in my chest felt Feverish but had no fever felt achy; felt achy; I felt weak and drained the rest of the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11May2021 10:00 (Lot number: EW0141) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ulcerative colitis", start date: 2005 (ongoing), notes: Blood infusion 4 pints; "Osteoporosis", start date: 2019 (ongoing); "Colonoscopy" (unspecified if ongoing). Concomitant medication(s) included: MERCAPTOPURINE taken for colitis ulcerative, start date: Nov2005 (ongoing); ALENDRONATE taken for osteoporosis, start date: Dec2009 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Time: 11 AM, Anatomical site of injection: Right arm, Batch/Lot number: ER8732), administration date: 20Apr2021, for Covid-19 Immunization, reaction(s): "vertigo", "ILLNESS", "PAIN IN EXTREMITY", "VACCINATION SITE SWELLING". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swelling at injection site"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "woke up in cold/hot sweat and felt like a hurricane was going in my chest felt Feverish but had no fever felt achy"; PAIN (non-serious) with onset 2021, outcome "recovered", described as "felt achy"; ASTHENIA (non-serious) with onset 2021, outcome "recovered", described as "I felt weak and drained the rest of the day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site swelling, feeling abnormal, pain, asthenia.  Additional information: Prior vaccinations were reported as none. It was reported that, the patient had no reaction of significance to his first shot. Stated that, he took the second shot around 10 AM on 11May2021. At first, the patient had no reaction other than the slight swelling at injection site and went to bed at 1 AM. Stated that, he woke up in cold/hot sweat and felt like a hurricane was going in his chest felt feverish but had no fever, felt achy H continues for 3 hours then suddenly stopped. Stated that, he felt weak and drained the rest of the day but by the next day, he was fine. The question was will the booster elicit this same reaction or not. The reporter seriousness of the events was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
A nurse reported that a 9 month old female received an injection of Prevnar on 3/29/00. On 3/30/00, she developed a fever and a "quarter-sized" welt at the injection site. The infant recovered.
Narrative: 65M reports increasing BLE swelling s/p 2nd dose COVID vaccination. Patient reports worsening swelling with associated pressure to his fingers, hands and chest wall. Intermittent SOB. Denies chest pain, BL LE edema. No treatment in ED. Furosemide at discharge.
NO ADVERSE REACTION TO THE VACCINES.  Vaccine error: System said to give Pneumo-Poly: PPSV23/ PCV. His last pneumo dose was PPSV23 on 7/7/2020. I ensured he was over 1 year from last dose. I administered Pneumo-Poly PPSV23/PCV.   I collaborated with immunization program.  The second dose of PPSV23 is not valid because this person should have received PCV as their second pneumo vaccine. The website, which is linked CDC gives more specifics.  It is confusing, but, in short, when a person has 1 dose of PPSV23 first: For guidance for patients who have already received a previous dose of PCV13 and/or PPSV23, Adults with previous PPSV23 only. Adults who have only received PPSV23 may receive a PCV (either PCV20 or PCV15) ?1 year after their last PPSV23 dose. When PCV15 is used in those with history of PPSV23 receipt, it need not be followed by another dose of PPSV23. I will call patient and explain. Per the immunization program 1 year from this dose, he can receive a PCV15 or PCV20. There should be no side effects that go along.
Patient returned to clinic ~15 min after vaccine with complaints of swollen lips.  Patient screaming and upset.  Then rash developed about 30 minutes after vaccines.  Red spots all over hands and feet bright red and hot.  Benadryl and all disappeared in 30 minutes.
Rash within 12 hours of administration.  Fever.  Loss of appetite.  Somnolence.  Took twice to physician asking what was wrong- physician said "viral illness".  Last medical document indicates treatment was "reassurance".  My son did not speak again for 2.5 years.  He stopped eating all but 3 foods.  He started fixating on lights, fans, motorized objects.  Sounds began to hurt him.  All after the vaccine.  He left us and never came fully back.  He has negative tested for fragile X and mitochondrial disease.
Injection site is red; injection site itching; Headache; sore left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore left arm), VACCINATION SITE PRURITUS (injection site itching), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm) and HEADACHE (Headache). On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itching). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is red). On 19-Jan-2021, HEADACHE (Headache) had resolved. On 20-Jan-2021, PAIN IN EXTREMITY (sore left arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (injection site itching) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.        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.   .
Vaccine fridge temperature excursion on 11/12, dose considered invalid by  DPH
9 hours later it woke you up with joint pain and body aches.   Did not take any medicine.  At 7am, took some  ibuprofen. Felt sleep again and woke up with slight fever 99.4.  Took Motrin to reduce fever. Patient has not called doctor yet since it is similar to adverse events after 1st dose which took a couple of days to resolve.  Currently has pain at injection site.