chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 16-FEB-2018 and 05-SEP-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020; lot# N032956 and expiration date 13-JUL-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
PT BRIEFLY PASSED OUT BUT WOKE UP SHORTLY AFTER SLIGHTLY DAZED. PT WAS GIVEN WATER AND BENADRYL, SHE WAS ALERT AND ABLE TO GET UP AND SIT UNTIL EMS ARRIVED.
Pt recv vax on 8/26/97; on 8/27/98 pt exp vax site erythema, induration & pain (7x4 cm); tx=Benadryl & cold compresses.
01/14/2022 vaccination. 05/28/2022 I had a slight fever on the 28th. 05/29/2022 COVID-19 positive. 06/01/2022 Started on COVID-19 medication; benzonatate. I am still having residual affects but I am unsure. I just went to the doctor in July 2022 in regards to sore and itchy throat. Inflammation in throat and Dr. provided medication. Do not know if related to COVID-19.
Case number PHEH2014US025091, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 57-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Pain in shoulder areas, increased weakness, pale, dizzy on 8/1/01 on 8/2/01 early AM had respiratory difficulty, severe lightheadness, weakness, fainting. BP 190 over 100. Taken to ER for symptoms.
Ive been diagnosed with ADEM by findings from a MRI  inflammation of cervical spine and brain , symptoms began around a week after 2nd shot and got worse for about a month , pain in neck ,tingling though body , headaches, sunburn feeling in torso , fatigue , bilateral numbness in hands,  loss of bladder pressure,  erectile dysfunction
About two weeks after the shot I started noticing the following symptoms: Dizziness/lightheadedness, brain fog, loss of balance,  ears ringing, pressure behind the top  my nose,  neck pain/tightness running up to my head, nausea,
INJECTION SITE: swollen with "blister' within same day - scaly rash 1" from injection site started same day - still has rash at present (approx 2 weeks from injection date)
Information has been received from a pharmacist concerning a 73 year old female with penicillin allergy, sulfa allergy and allergy to tetanus toxoid who on 02-FEB-2010 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX (Merck) (lot# 663775/1789X; expiry on 11-JUN-2010). Concomitant therapy included levothyroxine Na, MOBIC, ADVAIR, simvastatin (MSD), TENORETIC, NORVASC and PREMARIN. On approximately 17-MAR-2011 ("about 10 days ago"), the patient developed zoster after administration of ZOSTAVAX (Merck), the zoster rash is located on the side of her forehead and down into her eye. VALTREX was prescribed on 17-MAR-2011, 1 gram three times a day for the treatment of the adverse event. There was no labdiagnostics studies performed. At the time of the report, the patient was recovering from her adverse event. Follow up information has been received from a physician reported that the patient with penicillin allergy, sulfa allergy and allergy to atenolol was vaccinated with a dose of ZOSTAVAX (Merck) which diluted with ZOSTAVAX (Merck) diluent (lot # 5013X). On 16-MAR-2011, the patient developed pain behind right eye radiating to forehead and scalp. On 16-MAR-2011 (also reported as about 17-MAR-2011), shingles broke out at right side face encompassing eye, ear, scalp. The patient experienced lens opacity to implant right eye, double vision, swelling and post neuralgic pain. The patient visited a doctor and was treated with VALTREX and HYRICA. The patient still had pain and swelling as of 13-APR-2011. At the time of the report, the patient had not recovered from her adverse events. Shingles broke out, lens opacity to implant right eye, double vision, swelling and post neuralgic pain were considered to be disabling and other important medical events by the reporter. Additional information has been requested.
I started getting itchy bumps in my body and scalp, I went to dermatologist she told me I have eczema. They are all over my body but scalp is really bad.
Swelling at site, so much pain it is difficult to sleep creating insomnia, fever of 99.3, nausea.
Pt experienced headache, redness and soreness at injection site, possible yeast infection (vaginal). Burning sensation on side of tongue, neck stiffness.
My menstrual cycle came early the day after my first shot and did the same thing after the second shot. The very next day. The first time it happened I thought I had counted my days wrong but after the second vaccine I knew it wasn?t due for another week. My period in March was a longer cycle and had no real flow just heavy spotting for more days.  It struck me so that I thought it should be reported.
2 hours after vaccination my eyeballs begun to hurt. Fever, chills. I went to eye clinic to get my eyes checked and was referred to go to an eye specialist. I was admitted upon arrival as, the doctor found out from an MRI and other test run that, my optic nerves were inflamed. I was admitted in the hospital for 5 days. The doctor then stated I am having symptoms of Multiple sclerosis.
The patient received her vaccine and sat in the observation area for 15 minutes,  Once her 15 minutes was over,  she stood up and began to feel dizzy.  She went to the ground but did not injure herself.  She stated that she felt dizzy, saw black spots, felt cold, and was beginning to sweat.  We gave her water, tissues, and observed her until she felt better.  She stated that this normally happens to her with every vaccine, so she knew it would happen.  She stated she felt better around 1pm, declined medical treatment, and was able to leave with her family.
administrated / an expired dose of Menveo on April 30 2021 /expired on March 31 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 26-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA268A, expiry date 31st March 2021) for prophylaxis.   On 30th April 2021, the patient received Menveo. On 30th April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided follows:  The age at vaccination was not reported. On 30th April 2021, the  patient received Menveo which was expired on 31st March 2021, which led to expired vaccine used. No adverse events reported. The reporter consented to follow up.
muscle pain fever headache fatigue chills nausea all very bad, except for the nausea and headache
Information has been received from a physician concerning an over 65 year old female who in January 2007, received 0.65 ml dose of Zostavax (Oka/Merck). On 31-OCT-2007, she developed shingles. Unspecified medical treatment was sought. At the time of this report, it was reported that she has not recovered. A product quality complaint was not reported. Additional information was not available. Additional information has been requested.
Vaccine administered at outside facility. Pt. is a 16 yo male with no significant PMH admitted on 4/26 with myocarditis, elevated troponin, and abnormal EKG. Pt. states that he was feeling his usual self until the day that he received his 2nd dose of the COVID vaccine on 4/24. On 4/24, he started to have a headache and subjective fevers. On 4/26, he reports having substernal chest pain at rest, non-radiating, associated with shortness of breath. Patient took tylenol with minimal relief. Patient denies cough, congestion, abdominal pain, nausea, vomiting, diarrhea, rash. No sick contacts. Since admission, troponin has been rising (up to 16), BNP normal, CRP to 87, ESR normal, CBC and electrolytes unremarkable. Clinical course and findings consistent with myocarditis. ID consulted for infectious workup and management. In my prelim recs upon admission, I recommended a dose of IVIG and holding off on steroids and antibiotics.
Within the first 5 minutes after receiving first dose patient vomited. The patient reported moderate anxiety leading up to the appointment and after the dose was given. After vomiting she reported feeling much better.
No Adverse Event; patient has received moderna bivalent after Pfizer bivalent,; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has received moderna bivalent after Pfizer bivalent,) and NO ADVERSE EVENT (No Adverse Event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Primary dose 1) on 10-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Primary dose 2) on 31-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Booster) on 02-Oct-2021, PFIZER BIONTECH COVID-19 VACCINE (Bivalent booster) on 15-Sep-2022 and Influenza vaccine today. Past adverse reactions to the above products included No adverse event with Influenza vaccine today, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 23-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has received moderna bivalent after Pfizer bivalent,). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has received moderna bivalent after Pfizer bivalent,) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has received moderna bivalent after Pfizer bivalent,).    Concomitant products were not reported.  It was reported that patient received other vaccines in 4 weeks prior to COVID-19 vaccine. Patient came back 15 mins later receiving the Moderna bivalent.  Treatment medications were not reported.
Tender for 4-5 days after, Hives that then turned into hard spots, light bruising and raised, warm skin.
received COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had atonic reaction: involuntary muscle movements and lasted for 3 days,
Information has been received from a nurse concerning a 13 year old female with no reported medical history who on 15-MAY-2007 was vaccinated with her first dose of GARDASIL (lot number not given) intramuscularly and on 6-DEC-2007 was vaccinated with her second dose of GARDASIL. The nurse reported that on 15-MAY-2007 the patient developed a fever of 101 degrees Fahrenheit and also had a knot in her arm at the injection site after receiving the first and in December 2007 developed a fever of 101 degrees Fahrenheit and also had a knot in her arm at the injection site after receiving the second dose. The patient outcome was unknown at the time of reporting. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/14/2008.  Information has been received from a nurse concerning a 11 year old female student with no reported medical history who on 15-MAY-2007 was vaccinated with her first dose of GARDASIL (LOT#654369/0961F) intramuscularly to the right deltoid and on 6-DEC-2007 was vaccinated with her second dose of GARDASIL (LOT# 658556/1050U) intramuscularly to the left deltoid.  There were no illnesses reported at the time of vaccination.  The nurse reported that on 15-MAY-2007 and 06-DEC-2007, following vaccination with GARDASIL, the patient developed a fever of 101 degrees farenheit and also had a knot in her arm at the injection site.  The patients outcome was unknown at the time of reporting.  No product quality complaint was involved.  Additional information has been requested.
Episode of PAC's (which patient has prior history of). Patient reports they began day after vaccine (09/23/2015) and continued until 9/24 or 9/25. Patient left a message with my corporate voicemail and with her primary care doctor on 9/25, but did not seek any further treatment.
315PM devel hive @ inject site; hive 2 1/2 cm x 1 cm, BP 102/62, P92; c/o itching @ site of inject; DPH given;
ARM Injection site sore red  Muscle aches Joints sore  Fatigue  24 hours
I received this injection at 1830 on Oct. 24, 2009.  At approximately 06:34 PM, I could smell the medicene in my nose then could taste the medicene in my mouth.  Excessive salivation and coughing occurred.  Hoarsness and hives approximately 20 minutes later.  Hives/flushing/rash all over the body, including hair.  Took 25 mg. Benadryl po at 1930.  Took another 25 mg at 2000.  Rash and hoarseness continued approximately 36 hours.
Varicella shot was injected in his thigh on 11/02/2017 and on 11/04/2017 he started running fevers, face swelling, dizziness, weakness, fatigue, loss of appetite, wouldn't drink fluids, red bumps appeared and started multiplying every day, itching, soreness, scabbing, throwing up, fevers every day, body covered in chicken pox.
dose involved in excursion administered to 2 year old; The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge  and administered on 15 Sep 22; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose involved in excursion administered to 2 year old), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge  and administered on 15 Sep 22) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose involved in excursion administered to 2 year old), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge  and administered on 15 Sep 22) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose involved in excursion administered to 2 year old), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge  and administered on 15 Sep 22) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (dose involved in excursion administered to 2 year old) and PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge  and administered on 15 Sep 22).    No concomitant medications was reported.  The nurse had a temperature excursion for 7 hours. They wanted to make sure that the vaccines were still viable. Nurse used the temperature excursion tool online, but was not sure if she done that right. One dose was administered on 15 Sep 2022. The product was monovalent with dose of 0.25 ml. at the time of temperature excursion the vial was stored in the fridge. Maximum or minimum temperatures reached, as applicable were min 33.2 F, max 35.9 F with excursion duration of 7 hours. The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge at the time of reporting. There was no change in the visual inspection and no any vaccine stage change noted. The number of vials or doses impacted were unknown with no previous excursions.  No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2022: Non significant follow up- reporter email address updated.
Itchy rash; Red liquid filled bumps all over both arms, legs and feet; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Jul2021 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced itchy rash and red liquid filled bumps all over both arms, legs and feet. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events itchy rash and red liquid filled bumps all over both arms, legs and feet was not resolved at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
administration of FLUBLOK instead of FLUZONE HIGH-DOSE QUADRIVALENT to a patient over 65 years of age with no reported AE; FLUBLOK accidentally given instead of FLUZONE HIGH-DOSE QUADRIVALENT to a patient over 65 years of age with no reported AE; Initial information on 07-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/Non-HCP.  This case involves a 66 years old female patient who was administered flublok instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae and flublok accidentally given instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae while receiving vaccine influenza quadrival a-b vaccine [fluzone qiv].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 31-Oct-2022, the patient received a dose of suspect influenza quadrival a-b vaccine (dose- o.5 ml daily (QD), lot UJ893AB via intramuscular route in the left deltoid and expiration date- 09-Jun-2023) (strength and formulation : not reported) as influenza.  On 31-OCT-2022 the patient was administered flublok instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae (wrong product administered) and flublok accidentally given instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae (accidental exposure to product) (latency- same day for both events) following the administration of influenza quadrival a-b vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (administration of FLUBLOK instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae, flublok accidentally given instead of FLUZONE HIGH-DOSE QUADRIVALENT to a patient over 65 years of age with no reported AE).  At time of reporting, the outcome was Unknown for the event administration of flublok instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae and was Unknown for the event flublok accidentally given instead of fluzone high-dose quadrivalent to a patient over 65 years of age with no reported ae.  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.
Severely swollen upper lip (estimate twice+ normal size due to swelling) which first started September 3 at 1 am.  Body aches, stomach aches, head ache, shivering  experienced September 2nd but had subsided by early morning Septermber 3rd.  Swollen lip still present as of the date and time of this filing.
Pruritis, hive like hyperemia at injection site. Treated with hydrocortisone cream and BENADRYL.
Pt. c/o shortness of breath with chest tightness 10 minutes after 1st COVID injection. Pt describes it as squeezing and a little bit of swelling in the bottom of her throat, reports symptoms are persisting. Pt. has a history of asthma and high blood pressure which she takes medication for. Vitals reviewed and BP higher than reported home readings, pt. reports taking home medication. Pt given Benadryl 50mg/mL IM to left gluteal. After Benadryl, pt. reports symptoms improved and BP also improved. Pt. prescribed EpiPen to go home with and instructed to bring it to 2nd vaccine appt.
Swollen red spots numbness pain down by breast on left side soreness on armpit on left side
Received the Moderna vaccine (1st dose) on 4/21/21 at the vaccine site -- suffered aches, flu-like symptoms, menstruation occurred 2 days earlier than usual/ much heavier flow starting on 4/23/21.  Following second dose, 5/19/21 at the same location -- suffered severe muscle aches, fever (approaching 100 degrees) and flu-like symptoms. Bedridden for a day.
Swelling at injection site. Three days after injection, severe itching that has not subsided to date.
Patient spoke with pharmacist about tingling in left hand and soreness in left arm after receiving flu shot. Patient was unsure if flu shot caused the symptoms and did not contact pharmacy for 2 weeks. Patient has stated symptoms have slowly subsided and she has continued normal activities.
When blowing nose it was bloody. No blood draining. Occurred at some point overnight until early/midmorning.  May or may not have been related to vaccine.