chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N021723 with expiration date 10-AUG-2019 or lot number N024567 with expiration date 07-SEP-2019, the reporter was not sure which lot the patient received, (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion in the range between 15°F to 46°F with a time frame of 228 hours and between 47°F to 77°F with a time frame of 14 hours, as recorded by a data logger. The vaccine did not have any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is a non-valid case due to lack of patient identifiers. Upon receipt of follow-up information it was determined that the case is now valid because patient identifier was received. Follow up formation was received from the nurse practitioner on 12-MAR-2018. This report refers to a 5-year-old female patient. The patient concurrent condition included autism spectrum disorder, allergy to egg, peanuts and OMNICEF. The patient was previously vaccinated with one dose of VARIVAX and M-M-R II but any vaccine was administered within 4 prior weeks. The patient did not have any illness at time of vaccination. On 13-FEB-1018, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot # N021723, expiration date 10-AUG-2019), subcutaneously for prophylaxis. Concomitant therapies included M-M-R II subcutaneously and KINRIX. It was reported that there was no reaction from the vaccine and that the vaccine was exposed to excursion of temperature range prior to being administered. No prescription drug treatment was required.
Case number PHEH2016US030272, is an initial spontaneous report received from a pharmacist on 15 Nov 2016. This report refers to a 77-years-old female patient. Past medical history and concomitant medications were not reported. This patient was vaccinated with a single dose of FLUAD (batch number: 166003, expiry date: Apr 2017) intramuscularly, on 15 Nov 2016. On the same day after vaccination, vaccine leaked on patient and partial dose administered as some of vaccine trickled down her arm. No adverse event was reported following this administration error. The pharmacist assessed the case as non serious.
COVID-19 was mild and all in my nose and was like a sinus infection. And lasted about 6 days. I took Mucinex. I also got posin ivy the very next week after having COVID-19.
Patient experienced flu-like symptoms and rash on entire body for a little over a week after each shingrix shot
Daily dizziness; spinning head; nausea; This is a spontaneous report from a contactable healthcare professional. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982) via intramuscular route of administration in the right arm on 01Feb2021 at 17:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and elevated cholesterol. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ), rosuvastatin calcium (CRESTOR), fexofenadine hydrochloride (ALLEGRA) and Botulinum toxin type a (BOTOX) all on unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: EL3302) via an unspecified route of administration in the right arm on 11Jan2021 at 18:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. On 03Feb2021 at 12:00, the patient experienced daily dizziness, spinning head followed by nausea. The events had resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the adverse events. The clinical outcomes of the events daily dizziness, spinning head followed by nausea was not recovered.   No follow-up attempts are needed. No further information is expected.
has had ongoing liver and bile duct infections since March 2021.  She went to hospital ER on 7/16/2021 with a fever.  Her family members were sick with COVID-like symptoms the week before and she was exposed to them.  Thus the family requested that she be tested for COVID and was found to be (+).  Her MDs admitted and treated her for liver and bile infection issues primarily and oxygenation was fine and was on room air. She was not formerly hospitalized due to COVID but was put on COVID floor bc of positive test. ONce liver and bile infection issues were resolved, she was discharged home on 7/20/2021.
I get vertigo when laying down and rolling onto my side. I also get it when sitting up. Also when I raise my head to look up. In most instances it passes within 5-10 seconds. The same thing happened after my flu shot last year.
Swelling of lips, ears, hives on face.  Itching of throat.  Relieved by Benadryl, but recurrence daily x 3 days.
This spontaneous report was received from a medical assistant, referring to a 30 year old female patient. The patient did not have any historical drugs, medical history, concomitant therapies or concurrent conditions. On 31-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 lot# N025428, expiration date 19-JUN-2020 (also reported as "09-JUN-2020"), intramuscularly, for prophylaxis (strength, dose and frequency were not reported); 5 days early. On an unknown date in August 2018, the patient began to experience irregular vaginal bleeding (menstruation irregular). The patient sought medical attention with her physician and she did not receive any treatment; diagnostic laboratories were not performed. At the time of reporting, the outcome of menstruation irregular was unknown. Additionally, the causality assessment between menstruation irregular and GARDASIL 9 was not provided.
I had my vaccine shot at 6:50 in the afternoon, went home, felt sore and pain in my right shoulder where I had the shot, sleep, took some advil pm so I can sleep, wake up today to get ready for work,(March 19), I  cant move my right hand especially when im trying to lift it, causing too much pain, texted and called my company that i cant come to work because moving my right hand causing too much pain, called my doctor also
Onset severe bilateral knee pain, spreading to proximal lower leg and distal anterior thighs. No benefit from TORADOL 30 mg IM. Excellent relief with oral Prednisone. Exam remarkable for mild effusion in knees bilaterally only
This spontaneous report refers to a patient of unknown age who is also a pharmacist. On an unknown date the patient was exposed to ZOSTAVAX vial 19400 PFU (dose, lot, expiry date unknown). In the past, the pharmacist had got some of the ZOSTAVAX solution on her skin while priming a needle prior to administration to a patient. The pharmacist had never experienced any adverse effect as a result of getting the ZOSTAVAX solution on her hands, and she has not notified her healthcare professional and did not seek medical attention. Recently, on an unknown date in approximately 2013, the pharmacist discovered that she was pregnant. Last menstrual period was approximately 2013, EDC, EDD could not be estimated. Additional information has been requested.
Pt recvd vax & was found to be a nonresponder p/the 3rd dose; additionally 24 hrs p/3rd dose exp nausea;
mom called & stated pt has fine rash under neck & on rt side of face, cheeks & corner of eyes & on upper chest above nipple line;not raised;denies pt crying or inc temp;no problems @ inj site;
we gave a Janssen Covid imz (1st dose) to the pt. Pharmacy Immunizing tech gave the IMZ.  After receiving the IMZ, the pt was seated in the pharmacy area waiting the 15 minutes as instructed.  Tech noticed the pt was on the floor and he went out to assist the pt. As tech was helping the pt I went to assist and asked the pt if he needed us to call an ambulance and he said no. We gave him some water and he said he felt like he had low blood sugar so we gave him some candy to eat. After eating the candy and drinking a couple glasses of water he said he felt like nauseated. I brought out a trash can to give to the pt and he threw up a little.  I did notice he had some sweat on his forehead and the pt was wearing a winter hat and a jacket so the fainting could have been because he was overheated or a combination of low blood sugar and being over heated.  Store management did come around and asked if teh pt needed an ambulance. The pt stayed in the pharmacy area for about 15 minutes and he regained composure. He had called someone to ask for a ride. I went out again to make sure he was allright and he said his ride was here to pick him up and he left.
A non-serious, spontaneous report of fever, headaches and threw up multiple times has been received from a consumer concerning a 40-month-old female, subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications were reported. The patient received H1N1, Intranasal on 02-Oct-2009 at 4:30 PM. On 03-Oct-2009 between eight and nine AM the patient experienced fever, headaches and threw up multiple times. The vomit was described as thick, yellow liquid. The patient did not require medical attention and on an unknown date the patient recovered from the symptoms of fever, headache and throwing up.
facial swelling; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration in left arm om 11Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included seasonal allergies and urinary incontinence from an unknown date and unknown if ongoing.  Concomitant medication included cetirizine, atenolol (NORTELOL) and oxybutynin. The patient was previously vaccinated with first dose of BNT162B2 (lot number: EH9899) via unspecified route in right arm ,on 22Dec2020 09:30 AM, for COVID-19 immunization. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced facial swelling on 11Jan2021 18:00 treated with diphenyhydramine (self administered). The outcome of the event was recovered on unspecified date.
Patient states she has never has heart problems before, she started having shortness of breath and sensation of heaviness on her chest and was hospitalized from 09/13-09/20/2021; now she has new onset and diagnosis of heart failure and atrial fibrillation, she wanted to report in VAERS in case it was related to the vaccine.
Pt recvd 3 doses of Engerix-B & was found to have a neg titer; pt recvd 4th dose of Engerix-B 2MAR92 & now has a pos titer result;
Soreness at injection site; Feeling tired; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 28Mar2021 12:15 (Lot number: ER8732) at the age of 57 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6206, Administration time: 12:15 PM, Route of administration: Intramuscular, Vaccine location: Left arm), administration date: 07Mar2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Mar2021 10:00, outcome "recovered" (2021), described as "Soreness at injection site"; FATIGUE (non-serious) with onset 29Mar2021 10:00, outcome "recovered" (2021), described as "Feeling tired". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: The patient had no known allergies to medications, foods, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
PATIENT SAID SHE DIDNT GET HER PERIOD AND ALSO AFTER THE SECOND DOSE SHE DIDN'T GET HER PRIOD
No adverse event; HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022/Maximum temperature reached: 46.5F; Excursion took place 15Dec2022 through 27Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022), POOR QUALITY PRODUCT ADMINISTERED (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022/Maximum temperature reached: 46.5F) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-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) 1 dosage form. On 15-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022). On 19-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022/Maximum temperature reached: 46.5F). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022), POOR QUALITY PRODUCT ADMINISTERED (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022/Maximum temperature reached: 46.5F) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022) and POOR QUALITY PRODUCT ADMINISTERED (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022/Maximum temperature reached: 46.5F).    No concomitant medication was reported.    It was reported that first time excursion started on 15-Dec-2022. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine and also no reports of side effects had been reported to them. All patients received vaccines at pharmacy. No treatment information was reported.
Information has been received from a registered nurse concerning a 10 month old female patient with no pertinent medical history and no drug reactions or allergies who on 23-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot number 669829/0076AA, Expiry: 30-OCT-2012) 2ml oral. On 23-AUG-2011, the patient was vaccinated with the second dose of ROTATEQ (lot number 668818/1559Z was an invalid lot number for ROTATEQ, Expiry: 30-SEP-2012) 2ml oral. On 24-OCT-2011, the patient was vaccinated with the third dose of ROTATEQ (lot number not reported) 2ml oral. On 21-MAR-2012, the patient was seen in the doctor's office for an ear infection. She was treated with OMNICEF. On 22-MAR-2012 the patient experienced vomiting, diarrhea, dehydration with fever and stool positive for rotavirus. Subsequently, the patient recovered from vomiting and stool positive for rotavirus. On 22-MAR-2012, the patient was seen in the emergency room with vomiting, diarrhea, dehydration with fever. It was reported that OMNICEF was discontinued when vomiting started. The patient was treated with unnamed intravenous fluids and ZOFRAN. Stool was positive for rotavirus. She was released to her home. The patient returned to the emergency room on 23-MAR-2012. Hospital staff was unable to establish an intravenous line but repeated ZOFRAN. The vomiting stopped, not taking fluids but having diarrhea. The patient was sent home and was seen in the doctor's office on 25-MAR-2012 and on 26-MAR-2012 and doing better. It was reported that today, 27-MAR-2012, the patient had a normal stool. At the time of this report, the patient was recovering from ear infection, diarrhea and dehydration with fever. The events were considered to be an other important medical events by the reporter since they required intervention to prevent serious criteria. Additional information has been requested.
Headache, Myalgia, Arthralgia, Diarrhea, weakness,fatigue Narrative:
No adverse effects were noted; patient received a dose of PROQUAD and VARIVAX, but was scheduled to receive a dose of VARIVAX and MMR II.; patient received a dose of PROQUAD and VARIVAX, but was scheduled to receive a dose of VARIVAX and MMR II.; This spontaneous report was received from a nurse and refers to a 5-year-old female patient. The patient's pertinent medical history, other concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.   On 10-FEB-2023, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 milliliter (ml) once, lot #W010528, expiration date: 25-SEP-2023, and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml once, lot #W003818, expiration date: 02-FEB-2024; both vaccines administered subcutaneously for prophylaxis (strengths and anatomical sites injection were not provided), but was scheduled to receive a dose of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection. The patient had never received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) in the past. The patient did not receive the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), as the nurse inadvertently administered the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) instead (wrong product administered and accidental overdose). No adverse effects were noted (no adverse events).
Covid19 breakthrough.  1st vaccine received on 03/12/2021.  2nd vaccine-04/09/2021.  3rd vaccine 11/02/2021.  87 y/o with PMHx of HTN, Diabetes, HLD, CP, TIA, CABG presents to ED with increased confusion, slurred speech, increased weakness/inability to ambulate, fever, cough and mild congestion.  Room air sat 100%.  CXR with no acute findings.  TIA workup and per ID-no particular tx indicated for Covid19.
Several days after administration pt. developed fatigue, hair, vomiting, diarrhea, still going 2 wks after administration.
Her arm is very painful and swollen and very itchy; Her arm is very painful and swollen and very itchy; Her arm is very painful and swollen and very itchy; This is a spontaneous report from a contactable consumer (patient's daughter). A female patient (reporter's mother) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 20Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's arm was very painful and swollen and very itchy on Apr2021. The reporter was wondering if she should be concerned and the patient wants to know why she had these side effects. The reporter asked that how long her mother should wait after her second dose to get the full efficacy of the vaccine. The outcome of the events was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received Zostavax 7/31/06 developed rash along left T/O dermatome, entirely within 24 hours, seen 8/3/06 rash was starting to fade.
If a 12 year old was given the moderna vaccine by mistake can it cause them harm ?; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (If a 12 year old was given the moderna vaccine by mistake can it cause them harm ?) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (If a 12 year old was given the moderna vaccine by mistake can it cause them harm ?). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (If a 12 year old was given the moderna vaccine by mistake can it cause them harm ?) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter asked if a 12 year old was given the Moderna vaccine by mistake can it cause them harm.  No treatment information was provided.   Reporter did not allow further contact