chrisvoncsefalvay/vaers-outcomes huggingface dataset:
encephalitis; has stopped walking; diarrhea; getting sick/He is not doing well; This is a spontaneous report from a Pfizer Sponsored program. A non-contactable consumer reported for her brother that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EE8492), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Her brother was hospitalized after the COVID vaccine and has stopped walking. He was not doing well. He also had diarrhea. Her brother did get the vaccine and now he has encephalitis. He was in the hospital but he is out now. He got the vaccine and then started getting sick. And he is not the only one. She could send in evidence of all of this. The consumer was on the Internet and (social media name) reading about the COVID Vaccine. She has complaints about it not being FDA approved, and not being approved to prevent COVID-19. She just saw in another location that 30 people in a nursing home died. 30 people have died in nursing homes. There are 32 side effects and she has all 32 of them. She wanted to speak with the scientists or manufacturers of the COVID vaccine. Someone in development. She is really concerned about the vaccine. It has many side effects. It is not FDA approved. It is also not approved to prevent COVID-19. Even if you get the vaccine you could still get COVID. It is not studied long term. Even doctors have said that. There have been many deaths. You don't know what will come of it. She does not know why Pfizer does not pull this back. She has seen videos that have been taken down because Pfizer does not want people to see the real news. They need to show these on the real news. Consumer clarified that she did not have any side effects. She did not take the vaccine. She does not take any vaccines. People need to learn about their nutrition. They need to tell people to take Zinc, Vitamin C, stop eating animal products and meat. She is vegan and she has never gotten sick. No flu or anything. Meat lowers your immune system. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nosebleed after receiving Flumist intranasally. Patient received Flumist, then other vaccines by injection.  As other vaccines were being given, nosebleed began.
pt recv vax 16JAN96;pt's LMP 7DEC95 & 14FEB96 ultrasound was performed & confirmed that a fetus was 9wks gestation;MAR96 @ 12wks gestation the pregnancy was electively terminated;
On Tuesday September 13th, the client came into the facility and requested a bivalent covid Moderna booster during the vaccine clinic from 10 am to 2 pm. The client was given the monovalent Moderna booster in error.  Correct route and dosage used.  Incorrect medication. The client was informed of the mistake. They reported no side effects or issues. Staff members scheduled a date for the client to get the correct booster two months past the vaccination date on November 15th, 2022 as per CDC guidance.
sporadic muscle nerve pain in my left arm and left leg for a few days following the injection; sporadic muscle nerve pain in my left arm and left leg for a few days following the injection; headaches; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1284), via intramuscular in arm left on 08Jan2021 at 08:00 AM (at the age of 46-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included known allergies: walnuts. The patient's concomitant medications within 2 weeks of vaccination included ibuprofen (ADVIL), taken for toothache and amoxicillin, taken for toothache. It was reported that, the patient was not pregnant at time of vaccination. 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, has the patient been tested for COVID-19 was reported as no. On an unspecified date in 2021, after the 1st dose, the patient had sporadic muscle nerve pain in her left arm and left leg for a few days following the injection. Stated that, the patient also experienced headaches during that time. The reporter considered the events as non-serious. Treatment was not received for the events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Approx 15 hrs p/vax pt had screaming cry which lasted 3-4 hrs; Pt was seen in ER;
took home test and tested positive; took home test and tested positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 08Jun2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "took home test and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (08Jun2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Attended graduation over the weekend, returned home, was not feeling well, took home test and tested positive. Lethargic and cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Pt had very mild right sided facial swelling (submandibular) about 1 hour after receiving the influenza vaccine from another healthcare facility
second dose not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the 1 dose of Shingrix and second dose was not administered till the time of reporting, which led to incomplete course of vaccination. The reporter did not had more information regarding the situation as the patient contact them by phone to ask for recommendation. The reporter consented to follow up.
sense of smell and taste were impacted.; sense of smell and taste were impacted.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 15:30 (Lot number: FF2587) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELURYNG. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 07Mar2021, when the patient was 34 years old, for COVID-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9267, Location of injection: Arm Left), administration date: 14Feb2021, when the patient was 34 years old, for COVID-19 Immunisation. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 16Nov2021, outcome "recovered" and all described as "sense of smell and taste were impacted.". The event "sense of smell and taste were impacted." and "sense of smell and taste were impacted." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder, parosmia.  Additional Information: My sense of smell and taste were impacted. For example, sense of smell became heightened in some cases, muted in others, and distorted. My own scent (at least to myself) became oniony for several days after the vaccine - and I developed a metallic and off putting taste when eating things I'd usually enjoy like ice cream. One week after the fact I can eat from the same carton of ice cream and it tastes fine again. No covid prior vaccination. Tested covid post vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.   Follow-up attempts are completed. No further information is expected.
Started with tight throat , then a red rash appeared on face . Had to start Zyrtec . Now have immense stomach pain  and back pain . Have taken several Covid tests at testing location  , all negative
Soreness Injection Site (A little sore); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness Injection Site (A little sore)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness Injection Site (A little sore)). On 06-Mar-2021, VACCINATION SITE PAIN (Soreness Injection Site (A little sore)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Patient felt light-headed, began sweating and trembling, and passed out. EMS provided water and continued to monitor patient.
Dull headache in back of head and back of neck rated 7/10. Bilateral swollen lymph nodes under arms. Swollen, soft, non tender
Pt developed high fever 105 degrees F at home-accord to parents at 3-4 hrs after vaccination.
This spontaneous report has been received from a licensed practical nurse referring to a 16 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Severe vomiting (10 times) began about 10 minutes after the shot was administered and the vomiting episodes went on for about 45 mins.  This was followed by extreme fatigue and lack of interest in eating.
As soon as HPV vaccine was given pt's body "jerked out of chair" & fell on floor on L side hitting L supraorbital area.  Hematoma 5cm.  Pt stated she felt dizzy & lost consciousness for a second or two.
Left arm pain for 1-2 days after both shots; headaches after 1st shot (3/5/2021), worsening of left jaw pain due to TMJ dysfunction after 2nd shot
high pitch crying for 3-4 days; t104 for same period of time cried as if in pain when picked up to be held; treated w/Rocephin ATB shot & pt Advil on 20FEB; CBC & blood CXS-WNL; f/u in 2 days w/improvement
(L) thigh where proquad was given, became red and itchy immediately after injection administered. (Redness approx. 2" in diameter) Pt was given oral Benadryl (12.5mg/5ml) 2.5ml, itching & most of redness resolved within 20 minutes of taking medication. No respiratory distress was reported
Client was vaccinated and went to the observation area, while there he complained of lightheadedness.  Client placed in wheelchair and taken to private area in reconstitution section where his vitals were taken.  While in chair he was offered a bottle of water and asked if he wanted to lay down; he did in supine position. Vitals repeated while he was lying down.  Client was asked if he had eaten and hydrated and he replied that he had not.  He was asked by EMS if he was feeling better and wanted to be taken to an ER.  Client stated he would stay here until he felt better and refused to be transported.  Client left the area at 12:30 walking on his own.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be 1) 19-NOV-2012 and 2) 14-AUG-2013. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016). The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 15 months old child patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Brief seizure, patient came to consciouness within 30 seconds and was coherent and denied ambulance or any further care . Sat in chair for 30 minutes and said he was fine and apologized for event as he said he had seizures before but did not volunteer the information before shot.
Localized upper arm/shoulder pain in the area of injection, and muscular and joint weakness of the upper arm for 5-7 days
Severe joint pain, numbness, tingling and twitching of extremities, fatigue, weight loss, tinnitus, tactile illusions, pain and sluggishness in right leg.
Pt. c/o dizziness 10 to 15 minutes after receiving the vaccine. Pt. stayed for longer observation then after 10 or 15 extra minutes said he was feeling better and requested to go to class. Approximately 10 minutes later I was called to the patient's class, found pt. sitting in the chair in the hall with his mother, teacher, and school NP. Pt. was diaphoretic but AAO, c/o pain in the middle of the chest not radiating anywhere. Pulse 65, respirations 20, b/p 170/116. The mother said, " he received his Abilify shot yesterday, and getting the covid shot today was too much medicine". Pt. started to have slight tremors with looking straight ahead for about 10 to 20 seconds then would stop x 3. Capillary blood glucose was obtained and was 93. EMS arrived and took over care.
Total body erythematous rash, sl raised; sl t00 R w/APAP on board; MD suspects rxn to DTP;
Dizziness, fast heart rate, increased blood pressure, tingling in mouth and throat, dryness in mouth, and feeling hot.
Approx. 8 hours, post vax, pt developed some raised, dusky, mottled, reddish cobblestone area 2.5cm distal to injection site forming 5cm X 8cm. Treated with corticoid ointment, topically with good results. Some redness then on 1/13/03.
24 hours after administration started having fever up to 101.5, chills, body aches, headache. Fever and chills lasted about 12 hours. Headache and body aches continue past 24 hours
This spontaneous report was received from a licensed visiting nurse, referring to seven unspecified patients of unknown ages and genders. There was no medical history and concurrent conditions reported for the patients. On 05-OCT-2015, the seven unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L010145, expiration date 24-MAR-2017 (dose, frequency and route were not reported). No concomitant medications and no adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Pt recvd 1st two doses of Hep B vax 26JUL90 & 26AUG90; On 27FEB91 pt recvd 3rd dose of vax & immediately had resp problems & was treated w/an unspecified antihistamine;
an expired, administered dose of ROTATEQ; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 22-OCT-2020, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (once, lot# S004397 and expiration date 19-OCT-2020; strength, dose, route of administration, were not reported) for prophylaxis (expired product administered). The product never underwent a temperature excursion, and the administration was supported via the post-expiry table.
Mother reported that three days after receiving Menactra, child complained of feeling lightheaded, dizzy and very tired.  Sibling received Menactra and Adacel, reported same symptoms with syncope.
Fever; muscular spasms; tiredness; headache; This is a spontaneous report received from a contactable consumer(patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FC3180 and expiry date not reported) via an unspecified route of administration, at the age of 35-year-old, on 27Aug2021 13:45, at the left arm, at dose 2, single for covid-19 immunisation in a Pharmacy/drug store. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number- FC3180 and expiry date was not reported) via unspecified route of administration, at the age of 35-year-old, on 06Aug2021, 12:00, at the left arm, at dose 1, single, for covid-19 immunisation. The patient is not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks. The patient did not have other medications in two weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 27Aug2021, 22:45, the patient experienced fever, muscular spasms, tiredness, headache after 9 hours from the second shot. The patient did not receive treatment in response to the events. The outcome of the event was recovering at the time of report.
Night of vaccination: Immediate intense pain at injection site - subsided slightly after movement 5:00PM - Chills, tiredness 8:00PM - Low grade fever 99.1 10:00PM - Fever 100.4, extra strength Tylenol taken 11:00PM - fever breaks, immense headache, elevated heart rate 12:00AM - headache begins to subside due to Tylenol, still elevated heartrate 12:30AM - falls asleep  Next day: 8:00AM - woke up with slight headache, no fever, slight nausea, arm pain subsided slightly 10:00AM - extra strength Tylenol re-administered 11:00AM - headache breaks for rest of day The rest of the day was waves of tiredness  The following day: Tiredness continues, arm pain begins to subside  Third day following vaccine: Felt more like myself, occasional sore arm which subsided after the week mark
pt recvd vax & had convulsion; 2 episodes vasal vagal syncope; light headed, cold & diaphoretic all over; no abn neuro signs or shock; VS nl
Case number PHEH2014US021910, is an initial spontaneous report from a pharmacist received on 30 Oct 2014. This report refers to a 70-year-old male patient. Medical history and concomitant medications were not reported. On 29 Oct 2014, the patient received intramuscular dose of MENVEO (batch number: X12098) that was expired on 30 Jul 2014. No adverse event was reported following this medication error (expired vaccine used).
This spontaneous report as received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
TOOK 2 DOSES OF CRUSHED VIVOTIF; A spontaneous case report was received from a pharmacist on 16-Jul-2019 for three consumers.  Based on the information obtained from a pharmacist, three individual case safety reports PVX201907-000597 (PVX2019-1841; first consumer), PVX201907-000598 (PVX2019-1842; second consumer), PVX201907-000605 (PVX2019-1864; third consumer) and were created and cross-linked in the database.  This case describes a female consumer who "took 2 doses of crushed Vivotif" (PT: Wrong technique in product usage process). The consumer was receiving oral Vivotif capsule (one dose every other day) for typhoid fever prophylaxis.  Case report: It was reported that the caregiver crushed first two capsules of Vivotif and gave it to the consumer. However, the consumer took the rest two doses normally.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000598: US-PaxVax Berna GmbH-PVX201907-000605: