chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was given Menactra vaccine instead of the Meningococcal B, No AE; Initial information received on 15-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA129645 (same reporter).  This case involves a 21 year old male patient who was vaccinated with a 0.5ml third dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6576AA and expiry date: 15-Nov-2020) via intramuscular route in the left deltoid on 15-May-2020 instead of the vaccines MENINGOCOCCAL VACCINE B (lot number and expiry date not reported) for prophylactic vaccination.   The patient's past vaccination(s) included MENACTRA two doses.  The patient's medical history, concomitant medication, medical treatment(s) and family history were not provided.   It was a actual medication error due to wrong vaccine administered.   At the time of report adverse event was not reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Myalgias starting within 1 hour after vaccination, worsened throughout day that radiated to ipsilateral trapezius and rhomboid areas.  Starting around 16 hours after vaccination, severe subjective fevers and chills with severe headache that worsened with lying down. The headache was the most concerning symptom with tinnitus when laying flat in supine. It awoke me from sleep and prevented me from laying flat so I had to sleep upright on the couch. I took tylenol 500mg around 0200 and was able to sleep for a few hours. By 24 hours post vaccine, the headache and fevers/chills significantly improved so I could attend work the next day.
feeling of dizziness and becoming lightheaded at times; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 28Dec2020 06:00 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient had been having a constant feeling of dizziness and becoming lightheaded at times, it varied in severity but it was constant on 31Dec2020 08:00 with outcome of not recovered. Patient didn't receive treatment for events. The adverse events result in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered non-serious.
Hives around the jaw and back; This is a spontaneous report from a Pfizer sponsored program . A contactable female consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 23Apr2021 at a single dose for COVID-19 immunization. Medical history included allergies to medication. The patient's concomitant medications were not reported.  The patient experienced hives around the jaw and back on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approx 3 days after receiving the 1st dosage, experienced severe tingling in torso area. On the 4th day, a small rash, very sensitive appeared, by the 6th day rash continued to get worse and extremely painful. Went to see PCP Dr, diagnosed with Shingles.  Too concidential that this virus shows up 4 days after receving the Covid 19 shot. There has to be some relationship.
This case was reported by a physician and described the occurrence of dizziness in a 21-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous vaccination included ENGERIX B (GlaxoSmithKline; unknown given in May 2011). On 23 June 2011 the subject received 2nd dose of ENGERIX B (details unknown). On 24 June 2011, 1 day after vaccination with ENGERIX B, the subject experienced dizziness, nausea, vomiting, fever, diarrhea, chills and eyes burning. On 25 June 2011, the events were resolved without treatment. The physician considered the events were possibly related to vaccination with ENGERIX B.
This spontaneous report was received from a Certified Medical Assistant, referring to an 18 year old patient of unknown gender. Patient's pertinent medical history and concurrent conditions were not reported. The reporter stated that on 01-MAR-2013, the patient was vaccinated with the first dose of a GARDASIL (strength, dose, route, lot # and expiration date were not reported), and on 01-MAY-2015, received the second dose of the GARDASIL. The reporter stated that the third dose was not administered yet. No concomitant therapies were reported. No adverse effects were reported. No product quality complaints were reported. Additional information is not expected because the reporter did not allow to be contacted.
Approximately 15 minutes after vaccination, began to experience. Tingling sensation in bottom of both of my feet. 10 hours later, sensation has grown more intense. Sharp pains in tips of my big toes. Additionally, I am now also feeling numbness and tingling  in my calves. No treatment yet, watching-and-waiting while keeping doctor?s office apprised. Plan is to go to ER if muscle weakness or any loss of motor control occurs.
REDDENED RAISED AREA NOTED ON L ARM THE SIZE OF A SILVER DOLLAR. PCM MADE AWARE AND ASSESSED AREA. PLAN OF CARE DISCUSSED WITH MOTHER OF PATIENT. MOTHER OF PATIENT IS TO CONTINUE WITH COOL COMPRESSES AND GIVE PATIENT MOTRIN FOR PAIN OR DISCOMFORT INSTRUCTIONS GIVEN PER PROVIDER.
Systemic: Allergic: Swelling of Face/Eyes/Mouth/Tongue-Medium, Additional Details: Patient reported one side of face swollen and headache as well. She mentioned similar effects on 2nd dose (saw MD then) but wanted to get booster because of underlying conditions. Patient advised to monitor swelling and seek for medical attention if needed. Breathing normal (she reported).
Swelling L medial side with 4cm oval erythema patch, Neg warmth, neg puritis, neg discharge
Pt developed red rash and tenderness to injection site. Relieved by benadryl. Advised to call back with new/worsening symptoms.
super weak strange vibration running through my body a fight or flight syndrome causing me to shake extreme tiredness fevers that came and left through out the week chills mental fog sore arm all of  these symptoms lasted one week
Came to ER on 8/4/21 with complaint of frequent falls and urinary incontinence x 1 week. Complained of generalized weakness and balance problems and sore throat. Fever of 100.8. COVID19 test came back positive. Was admitted for observation. On room air at 95%. Placed on azithromycin and mucinex
No additional AE reported; Customer reported that a patient got an extra dose (4th dose) of GARDASIL 9. Patient received 1st dose of GARDASIL 9 on 8/10/2016, patient received the 2nd dose on 8/2/2021, 3rd dose on 8/3/2022 and an additional 4th dose on 11/21/2022. No additional; Patient received 1st dose of GARDASIL 9 on 8/10/2016, patient received the 2nd dose on 8/2/2021, 3rd dose on 8/3/2022 and an additional 4th dose on 11/21/2022.; This spontaneous report was received from a nurse (also reported as customer) and refers to a 20-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-AUG-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). The patient received the second dose on 02-AUG-2021 (Inappropriate schedule of vaccine administered) and the third dose on 03-AUG-2022. On 21-NOV-2022, the patient received an additional fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U031056, expiration date: 16-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Extra dose administered). No additional adverse event reported.
Within 12 hours of the fourth dose of Infanrix, the pt experienced swelling of the injection site from the hip to the knee, noted by his mother. The swelling was 2cm greater than the other thigh. There was warmth, erythema and tenderness at the injection site. The physician prescribed diphenhydramine (Benadryl), loratadine (Claritin), ibuprofen and cold compresses. The most recent information received on 4/18/00 reported the symptoms resolved within 48-72 hours.
I am in perimenopause and hadn?t had a period since January 2021. Within a couple of weeks of my first shot, I started my period which was medium flow and lasted 5 days.
Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Not feeling well). At the time of the report, VACCINATION COMPLICATION (Not feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitants was not reported. no known treatment reported.
Itching, swelling, redness, and injection site. Severe nerve pain shooting down all limbs, severe chills, fuzzy brain, all over joint pain, exhaustion
Sore throat and dizziness the first 2 days. Sore throat the second day. Currently have a fever of 99.8 and had a fever since 4/9/2021
nausea, light-headed, trembling. BP 117/72, HR 69, SpO2@98%, R 16
The first three days after the application I only presented with arm pain and a little pain in the lungs like pulsing not in a prolonged way. At eight days I started with flu symptoms the next day with fever and extreme body pain. Third day with cough, fouth day I lost my sense and smell and I took a Covid-19 test, it was positive. I treated myself and stared having fatigue, tiredness, pain muscular, and very sleepy. I was in quarantine treating myself for covid unil now I'm still in quarantine. The doubt exist if this is the result after appying the first dose. I consider myself a heathy person. I do not suffer from any disease, I have respected the protocol from the moment my country had the first case of Covid-19, I consider myself prudent in the use of a mask, gel, distancing, etc. and during those eight days interval betweek the  first dose August 13, 2021 to August 20, 2021 I had no contact with several people, I did not attend any massive events, I am an independent person an dI have my own office so I do not have co-workers nor do I live wit other people that week I was only form the office to my house. With the few people with whom I interact those days none were ill before or after being with me. Therefore, I have doubts that after being baccinated I will be one of the few cases that have a positive result for covid. I ask to please carify because I have doubts. Should I complete the sencond dose, or is it risky for me?
12/23  I woke up around 3am in the morning with a headache, body ache, fatigues, no fever or cough.  12/26 went to an Urgent Care for COVID-19 and got results 12/27 I  was positive for COVID. On 12/27 I lost my taste and smell and started experiencing SOB which lasted for the next couple days.
She read in the Fact sheet that this could be a severe allergic reaction; shivering; temp was up; pale; dizzy; elevated heart rate; weakness; muscle ache pains; Woke up in the middle of the night; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer (patient).  A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 08Jun2021 (at the age of 20-yearsr-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date on Jun2021, the patient experienced woke up in the middle of the night with shivering, temp was up, was pale, dizzy, elevated heart rate, weakness, muscle ache pains trying to calm down, but trying to get to relax from shaking/shivering. She read in the Fact sheet that this could be a sever allergic reaction and was wondering if she should received the second dose of the vaccine. As noted in the Fact Sheet for Recipients, should not get the Pfizer-BioNTech COVID-19 Vaccine if the patient had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the events were unknown.   Information regarding Lot/Batch number has been requested
This spontaneous report as received from a registered nurse refers to a identifiable adult patient.  The patient's medical history, concurrent condition and concomitant medications were not reported. On December 2017, the patient was vaccinated with pediatric doses of VAQTA lot # N017094 expiry date 26-MAY-2018 by intramuscular route for prophylaxis. No adverse effects reported. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1802USA012042: US-009507513-1802USA011849.
53 year female presented to vaccine clinic, scheduled for a Moderna booster. Reconciled past immunization records on system, pt had received 1st  dose (2/08/21) and 2nd dose (3/04/21) of Moderna and indicated to proceed with administration of 3rd dose. Pt received 0.5cc of Moderna on 10/25/21 @ 11:52, double the recommended volume of 0.25cc for booster. Pt did not have any allergic reaction or adverse event during 15 min monitoring period nor upon leaving.
night after injection I got rash and hives all over the body. Neck eyes, arms legs, thighs and butt, back, pretty much everywhere. I have taken Benadryl and it is not helping  a whole lot. Called the Dr but i have not heard back yet.
ITCHY RASH /BUMPS ALL OVER BODY LASTING AT LEAST 2-3 DAYS FINGERS AND HAND SWOLLEN BURNING SENSATION ON CHEST DECLINED ANY DETERGENT OR SOAP CHANGES OR ANY CONTACT WITH OUTSIDE ALLERGENS/IRRITANTS
11/12 - sudden onset severe abdominal pain and fever (no nausea) and vomiting x 11 hrs. 11/14 - sudden on set abdominal pain and vomiting x 8 hrs. 11/15, 11/17, 11/19, 11/20, 11/22, 11/23, 11/25, 11/26, 11/29, 11/30, 12/2, 12/3 - sudden onset abdominal pain x about 5 hrs each day with intermittent vomiting.
She felt strange so she sat down then fainted (her head fell to the side) then she turned blue. In a few seconds, she awoke then turned bright red. The redness lasted for seconds 911 was called who determined her reaction was no way related to the shot.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK9231), on 20Jan2021 as dose 2, single (Lot number: EL3246), on 14Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 20Apr2022 as dose 4 (booster), single (Lot number: Pk9894) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: lemongrass" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "overweight" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Gabapentin, reaction(s): "Known allergies: gabapentin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, latency 3 months 30 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received other medication in 2 weeks. The patient received antiviral treatment for Covid-19 from 09Aug2022 to 14Aug2022. Rebound Covid infection on 19Aug2022 with new symptoms started 5 days after completion of treatment.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information in the case the reported events Vaccination failure, Covid 19 are assessed as related to suspect drug .
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 37-year-old female patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 25th July 2022, the patient received Havrix. On 25th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 25-Jul-2022 Reporter's Comments: The reporter was an agent from the service center.  The patient was administered Havrix vaccine on 25th July 2022 to a patient, then realized the dose was expired. Additional Supportive Information: The patient was administered with Havrix vaccine, which was already expired, which led to expired vaccine used.
23 hours after receiving dose, Hives developed and by Noon I was experiencing heavy chills. Began taking Benadryl 4x/day and HydroCortison 1/2% cream.  Stayed warm
Severe ongoing headache, fatigue, lightheadedness, tiredness since the day after the injection.
Patient is stating that she has been having arm/shoulder pain at the injection site and it is still persists.
Muscle aches to both arms approximately 2 hrs. after vaccines.  Tenderness started same day.  Wakes up 4-5 times a night due to pain in arms.  Pain in back of neck and across shoulders day after vaccines.  Saw PA at Clinic.  States told vaccines caused "blood vessels to swell".  Given Flexeril one three times a day.  Continues with pain in both arms today.  Has followup appt with private MD on Monday per patient.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # reported as M000995, expiration date reported as 06-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8.4 degrees Celsius for 14.5 hours. There was previous excursion of -8.5 degrees Celsius for 37 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
very high fever (mom did not have thermometer but states whole body very hot-lethargic & body shook;vomited wouldn't take APAP-later able to give APAP & fever went down
pt came in and asked for 2nd dose of shingrix today.  after recalling regular customer and looking at pt's file, pt completed series on 12.6.2018 and 3.27.2019 administered.  Extra dose administered on 1.9.2023
About 2 weeks after receiving vaccine, I had an outbreak of genital herpes.  I have not had an outbreak in many years.
This is a spontaneous report from a contactable physician via a company representative. A child patient of unspecified age and gender received PREVNAR 13, lot no and expiration date unknown, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The physician stated they have a child patient with low pneumo titers after 4 pcv13. Outcome of the event was unknown. Information on the batch number has been requested.
Woke up next day with sore/swollen area around injection site and eventually had a purple/redness color. There were no hives nor angioedema. Soreness, swelling, color slowly improving. She was seen in provider office on 10/25/2018 with continued symptoms but much better than 10/20/18. There are no signs of cellulitis. She has been icing area.
Adacel given in left deltoid then she had tingling down arm into fingers right away then over the next days start with spot like rash all over body.
Pt recvd 1 dose of Engerix-B & 2 hrs p/inject devel stiffness of the lt arm & erythema @ inject site; 4-6 hrs post inject tingling & numbness, also edema, soreness & pain; tinnitus;
Fever (100.8), headache, chills, delirium, body aches including chest pains.  From 8AM to 8PM on 11/11/2021 I could not get out of bed, fall asleep and was shivering uncontrollably.  My main concern was the feeling of pressure in my chest.  At 8PM my fever began lowering and I was able to fall asleep.  On 11/12/2021 I was examined at Hospital, byt Doctor who reported that the joints connecting my sternum were inflamed due to vaccine which created the feeling of discomfort.  I was starting to feel better by the end of the day.
This spontaneous report was received from a registered pharmacist and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medication were not provided. On 20-MAR-2017, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 intramuscularly, once, lot # L035686, which expired on 16-FEB-2017. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Headache,  nausea,  loss f energy, aches and pains in joints. Loss of appetite.  Rash and swelling in arm on day 4.
Developed hives within 2 hours of getting DTAP 4, given Benadryl every 6 hours, hives resolved after 2 days.
Increased temp, febrile seizure approx 5 mins, inpt? tj? temp 24-30 deg; Family history epilepsy in cousin *F/U report on 3/5/03: Elevated temp leading to seizure of about 5 mins.*
Noted to have symptoms of pericarditis with pleuritic chest pain and chest pain when lying flat occurring a couple days after administration of covid-19 vaccine. Cardiac MRI obtained on 10/15/21 showing circumferential late gadolinium enhancement of the pericardium consistent with active inflammation (pericarditis). Undergoing treatment for pericarditis.