chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the pt requested polio vaccine but by mistake recieved HPV (Gardasil 9) , there was no advers reaction just pt was upset that got the wrong vaccine, pt got the Polio vaccine on the date that the error got discovered at the different pharamcy
Pulsating Cramps (never experienced anything like them) and Unexpected menstrual bleeding. This is my first time getting my period postpartum. I am breastfeeding but have not made any recent breastfeeding/solid transitions.
Patient experienced a high fever (>103 degrees) that evening and went to the ER. She reports that she was fine the next day.
Lips and tip of tongue swelled..nurse at vaccination clinic gave me 2 benadryl Blood clot in right leg calf 4 days after injection...possible second clot in right thigh 9 days after injection unless it was same clot
it caused an allergic reactions; This is a spontaneous report from a non-contactable consumer (patient reported for herself) from the Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took palbociclib in tablets and experienced allergic reactions (capsule did not cause reactions). On an unspecified date, the patient stated that it caused allergic reactions. Patient was inquiring why it causes different reactions. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of unusual hair loss one week following her first Moderna COVID-19 shot 1-28-2021. Following her second Moderna COVID shot 2-25-2021, she still continues to experience hair loss.
This spontaneous report as received from an unknown type reporter refers to a 5 month old patient of unknown gender. On 01-APR-2014 the patient was vaccinated with a dose of ROTATEQ (lot #/batch # J012525, expiry date 09-APR-2015) dose, frequency and indication unspecified. The reporter stated that ROTATEQ was involved in temp changed. At the time of report, the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 29OCT95 & 1NOV95 pt exp hives;pt had dermatographism;
Day 2 chest hurt to breathe in deeply gave Tylenol subsided 2 days later. Had UTI symptoms on day 3 gave cranberry juice also subsided 2 days later symptoms were frequent urination, pain and burning during and after, hurt when laying down. Never had any type of infection in urinary tract before. All symptoms were very treatable just didn't know he would experience these. All other symptoms he went through were expected. Fever never went above 101 and he had a temp and flu symptoms for 3 days with swelling under his arm
numbness of left side of face/scalp; hyperesthesia of left face/scalp/ear; left sided submandibular lymphadenopathy; This is a spontaneous report from a contactable physician. A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular on 08Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing.The patient had no known allergies. It was unknown if patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 for covid-19 immunization on 18Dec2020 (lot number unknown), via intramuscular route in the left arm. The vaccination was administered in the hospital. On 08Jan2021, the patient experienced numbness of left side of face/scalp, hyperesthesia of left face/scalp/ear, and left sided submandibular lymphadenopathy. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment as gabapentin for the reported events. The patient was not tested for covid post vaccination. The events numbness of left side of face/scalp, hyperesthesia of left face/scalp/ear, and left sided submandibular lymphadenopathy were not recovered.   Information on lot number/batch number was requested.
Pt reported left arm numbness & light-headedness.  AAOx3. EMTs arrived and offered a snack and a drink.  Released after brief monitoring.
pt recvd vax; ? hrs after vax mom states pt eyes were rolled back; quit breathing for a short time; arms & hands were shaking;
Patient was here for covid vaccine and inadvertently given IM injection in the arm instead of the thigh.  Parent notified and was not upset  and stated that the child had no adverse reaction to the vaccine.  Nurse Immunization Coordinator notified.
This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's current condition, historical condition, historical drug, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, unit, route not reported) (expiration date and lot number not specified) as prophylaxis. On an unknown date the patient was failed to seroconvert for 14 of the serotypes in the vaccine. No adverse effects or pneumococcal disease was reported in the patient. Pneumococcal titers was performed on an unknown date. The patient was not treated for the adverse event. The patient sought medical attention by seeing a nurse practitioner. There was no intervention to prevent serious criteria. The outcome of the event was unknown. The reporter did not assess the causality of the event with suspect therapy. Product quality complaint was not involved. No other information was available.
rash on both legs above the ankle and spreading upward; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 73-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 05Feb2021 at 14:00 (Batch/Lot Number: EL9261, Expiry date was not reported) as single dose covid-19 immunisation. Medical history included diabetes mellitus and adverse reaction to narcotic pain relievers. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number and Expiry date was not reported) as single dose covid-19 immunisation. The patient did not experience covid prior to vaccination and covid was not tested after vaccination. On 05Feb2021, at 12:00 AM, the patient experienced rash on both legs above the ankle and spreading upward. There was no treatment received for the reported event. Outcome of the event was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Eyes swelled, pt had difficulty breathing; pt was taken to ER aobut 2 hrs p/given inject & kept a total of 5 hrs;
Pt c/o of chest caving in. Pt also have difficulty breathing and chest tightness.
1st vaccine injection on 5/18/2021 was what I believe to be pretty usual to what I've experienced from others.  2nd Vaccine on 7/13/2021 was ok with just sore arm at first, but I realized by the 2nd or 3rd day that my arm, shoulder and hand were really sore. I had recently been on 1 week of Prednisone and then an Ultrasound guided injection for my right shoulder that has been really needing total replacement for about 2 years. Now this sudden Left shoulder pain is pretty scary to me as I did not 'do' anything to promote the pain (other than the vaccine). I know the pain Too well of my Rt shoulder to know that something was very wrong in my left. I called Dr. who told me that she definitely thought that it was related to the shot and that if it continued she would order an mri. Within 2 days, I recontacted her office about the overall pain exceeding my usual limits. She ordered the mri which was done on 7/30/2021. The results were not only surprising to me but really sent me into panic as well. The report said of a full thickness tear and things about the infraspinatus tendon and something about Bone Marrow. I do not fully understand the report and the only response that I have received from the Dr is that she is inquiring with another Dr, whom I am also a patient (for the Rt Shoulder). I have not heard anything this week yet as to any further testing, or what can be done to improve what is happening. This has put me to being Very Limited as I have depended upon my Left arm/shoulder to accommodate when my Rt cannot. I had previously had NO Pain at all in this arm so the report to me is mind blowing..and quite painful.
Dizziness, Vasovagal episode almost 2 hours post vaccine. Heart palpitations followed by high blood pressure.  Treated with IM dexamethasone 8mg & Verapamil 40mg.
Increase in stereotypics @ this time after H1N1 injection also tapering off risperdal probable cause of increase stereotypics. Unable to get vaccine information given by the health department.  We did not administer the vaccine.
4 days of screaming 1/2 hrs - 1 hrs @ a time;
Mother called to 1/7/04 to notify of brother's rash (triplets) note fine macular papular areas B thighs only at this time. No pruritis no vesicles noted. Advised mother to observe and treat prn for fever and pruritis and consider MD appt. No ASA. 1/9/04 was seen by MD
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA262407 from same reporter. This case involves an unknown age male patient who experienced pain, shivering and fever, while he received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious pain with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious shivering with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious fever with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not provided. Final diagnosis was fever, shivering and pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for fever, as Unknown for shivering and as Unknown for pain. List of documents held by sender - none.
Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 81 and brought to the Hospital ER on 3/4/21 w/ a STEMI. He did not recover and later passed away there on 3/10/21. Comorbidities include diabetes, HLD, HTN, cardiac murmur.
about to get a migraine; stuffy nose; runny eyes; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (about to get a migraine), NASAL CONGESTION (stuffy nose) and LACRIMATION INCREASED (runny eyes) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced MIGRAINE (about to get a migraine), NASAL CONGESTION (stuffy nose) and LACRIMATION INCREASED (runny eyes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MIGRAINE (about to get a migraine), NASAL CONGESTION (stuffy nose) and LACRIMATION INCREASED (runny eyes) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications reported.  Reporter did not allow further contact
A report has been received from a registered nurse via sales representative concerning a patient of unknown gender and ethnicity. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date the patient received FLUMIST, 0.2 millilitres. Representative stated that she was told by a nurse in a doctor's office that one of the doctors patients experienced a wheezing attack a couple of weeks after received the FLUMIST vaccine. Action taken with FLUMIST was unknown. The outcome of the event of wheezing attack was unknown. The report was considered to be non-serious by the company physician.
-10 mins after vaccine patient had vasovagal syncope passed out for 10-15 seconds w/o memory of incident -Friday - 6/21 - AM - patient had 2 dots on L deltoid (injection site) that were very itchy.  -6/21 evening patient arm red & inflamed at injection site 10cm x 7.5cm in diameter  -6/21 evening patient given single dose of Children's benadryl 200mg ibuprofen, and ice pack.  -6/22 - around noon patient started to develop white ring around injection site surrounded by larger red ring total diameter about 10.5cm x 10 cm. Patient states that rash is no longer itchy at this time. Given PO Bendadryl one Children's tablet and 200mg ibuprofen. -6/22 - at 3:45pm patient came into urgent care  Patient Rx'd prednisone 20mg oral tablet - 1 tab PO BID x 3 days  Heat & ice packs for 20mins with 1 hour breaks PRN alternating.  1% hydrocortisone cream, twice daily PRN  -Patient following up with Pediatrics on Monday June 24, 2019
The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022; No Adverse event; Received expired  2nd dose after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022).    No concomitant medication information was provided. The patient received 2nd dose (6-11 year) beyond 30 days in the refrigerator. It was reported that the vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day. Number of doses/vials were 3 doses/1 vial (6Y-11Y vial). The vial did not undergo any temperature excursion. No treatment medication was provided. This case is created for pediatric patient 3.   This case was linked to US-MODERNATX, INC.-MOD-2022-636320, US-MODERNATX, INC.-MOD-2022-636327 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-636320:Paediatric patient -1 US-MODERNATX, INC.-MOD-2022-636327:Paediatric patient -2
Shot taken with no issues at 9:54am, April 4, 2021. At 5:30pm, same day, became immediate flush, dizzy, barely made it to bathroom, violently vomiting all that was in my stomach.  This was followed by severe chills, the shakes and a mild headache.  Took (2) Tylenol at the time of the shot, drank many ounces of water all day but still had this issue. Took another (2) Tylenol after vomiting and more water. Went to bed at 8pm.  Woke at midnight, 4/5/21, severe headache, now took (2) Advil and slept better until Mon. Morning, 4/5/2021.  Experienced two sluggish, low energy days and still have no appetite. What the heck????
pt recv vax 31OCT96 & has hx of severe allergies;1NOV96 pt devel hives;pt was seen for sx;pt has recovered;
Near syncopal episode, revived with smelling salt. Water and snacks offered. Patient has history of fainting with needles. After laying down for several minutes she was able to sit up to eat and drink. Patient able to walk out, father at her side for assistance.
expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA66AA, expiry date 31st October 2021) 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.   On 16th November 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 16th November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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 age at vaccination was unknown but it could be 16 or 17 years. The reporter stated that, an expired dose of bexsero was administered to the patient, which led to expired vaccine used. The reporter consented to follow up.
This spontaneous prospective pregnancy report has been received from a 28 year old female patient concerning herself. The patient's concurrent condition included polycystic ovary syndrome (PCOS). The patient had experienced full-body hives "within 24 hours" of taking penicillin (unspecified). She was also allergic to mold and pollen. On 03-APR-2015 the patient was prescribed (Oka/Merck) VARIVAX (strength: 1350 U, dose, lot # and route were not reported) for a pre-existing condition, polycystic ovary syndrome (PCOS). Concomitant therapies included metformin. The patient reported that she became pregnant after she received (Oka/Merck) VARIVAX. The last menstruation (LMP) was on 08-APR-2015. The date of contraception was estimated on 22-APR-2015. On 27-APR-2015, the patient experienced "a stomach flu". Her physician prescribed an unspecified medication to manage the symptoms of her stomach flu. The patient was fully recovered from the stomach flu on 02-MAY-2015. The patient received only one dose of (Oka/Merck) VARIVAX. The patient stated she took pregnancy test on 15-MAY-2015 and the test was positive. She emailed her physician the results to inform that she was pregnant. The estimated date of delivery was estimated on 13-JAN-2016. The fetal outcome was unknown. Additional information has been requested.
Patient received 2nd Pfizer on 02/16/2021. Patient developed symptoms related to COVID-19 on 09/07/2021. Patient received positive results on 09/13/2021.
FEVER, CHILLS, TIREDNESS, NAUESA, WENT AWAY, DIZZYNESS
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in November 2015, the patient was vaccinated with improperly stored doses of PROQUAD (Merck) (unknown strength and route) lot # L024122 and expiry date of 30-DEC-2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Red, swollen and inflamed around injection site. Patient is going to take Benadryl and apply topically also and monitor.
Headache, Fever, NauseaVomiting, backache, chills Narrative:
At first arm sore, then on 11/08/2010 began having pain, numbness, and weakness radiating down her lt arm into her fingers and up into her upper back and side of her neck. Tingling bilat feet. Lightheaded, nausea, vomiting, fatigue, feeling out of sorts, head feels pressure. Seen by physiatrist on 11/09/2010. Seen by another work comp MD on 11/11/10. Treated with skelaxin for h/a. Labs all normal. No dx of rabdo. Not Guillain-Barre, neurologically intact. may be "muscular response to even slight trauma and this will most likely self resolve. However, one is not unable to completely rule out brachial neuritis" given oral steroids one week. Light duty at work. Work comp claim denied. Last seen by WC Dr on 11/17/10. Seen by her private physician and returned to work w/o restiction 12/2/2010.
BAD REACTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request Batch number. No concomitant medications were reported. On an unspecified date, the subject experienced bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
No adverse effects; a male patient was administered two live vaccines less than 28 days apart; This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Pertinent medical history, drug reactions and allergies were not reported.  On 19-JUL-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot number: R030610, expiration date: 23-OCT-2020; dose and route of administration were not reported). On 13-AUG-2019, he was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number, expiration date, dose and route of administration were not reported). Therefore, the patient was administered two live vaccines less than 28 days apart (inappropriate schedule of vaccine administered). Sterile diluent (lot number: S005075, expiration date: 08-AUG-2021) was used as a concomitant medication. No adverse effects were reported.