chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pregnant with no reported adverse event; Adacel was administered which was expired on 21Nov2021 with no reported adverse event; Initial information received on 23-Dec-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 39 years old female patient who was pregnant and was administered Adacel which was expired on 21nov2021 with no reported adverse event and received treatment with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 22-Dec-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE suspension for injection 0.5 ml once, lot C5630AA, expiry date: 21-Nov-2021 (strength was unknown) via intramuscular route in the left deltoid as prophylactic vaccination.  On 22-DEC-2021 the patient developed a non-serious event "adacel was administered which was expired on 21Nov2021 with no reported adverse event" (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "pregnant with no reported adverse event "(exposure during pregnancy) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Relevant prenatal testing after exposure was not reported.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Adacel was administered which was expired on 21Nov2021 with no reported adverse event, pregnant with no reported adverse event).  At time of reporting, the outcome was Unknown for the event Adacel was administered which was expired on 21Nov2021 with no reported adverse event and was Unknown for the event pregnant with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.   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.
Acthib took 0.5 ml 1x for TB skin test ,with no reported adverse event; patient accidently received 2 doses of ACTHIB,with no reported adverse event; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old male patient who experienced patient accidently received 2 doses of HIB (PRP/T) vaccine [ACT-HIB] and took 0.5 ml 1x for tb skin test ,with no reported adverse event vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) vaccine at dose of Total 0.5 ml via intramuscular route in unknown administration site (strength, formulation, batch number, expiry date: Unknown) for Immunization (immunization) and TB skin test (Mycobacterium tuberculosis complex test) with no reported adverse event (product use in unapproved indication) (unknown latency)  On 03-Apr-2023 the patient developed a non-serious patient accidently received 2 doses of acthib with no reported adverse event (extra dose administered) (unknown latency) following the administration of HIB (PRP/T) vaccine.  No lab data reported.  Action taken: not applicable.  Outcome was Unknown for both the events.   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.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from an other health care professional and referred to a 2-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2022, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot # U031544 has been verified to be a valid lot number, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (dose, strength were not provided), and with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (dose, strength was not provided).   The administered doses of the vaccines experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175:
Pneumonia Chest Cong. Cough, SOB Resp. Distress.
Heart pain worse lying down and on exertion- stayed propped up; Can't think well; Brain fog; Chest pains and discomfort; Chest pains and discomfort/ felt like a elephant on chest; Reduced ability to ambulate due to chest pain; Tachycardia; Had fever (102 f); My arm was more swollen than the time before; The pain was more delayed than the time before/pain over hours spread across my upper back into my right arm and chest and back; Chest back pain worse with movement; Could not stand for two days due to pulse getting even higher standing.; Could not stand for two days due to pulse getting even higher standing.; Entire upper torso hurt.; Felt short of breath/ it hurt to breathe in; it hurt to breathe in; had to use urinals from bed because pulse; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Jun2021 15:30 (at age of 38 years old, Lot Number: EW0180) as a single dose for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lorazepam, diazepam, paroxetine, bisoprolol. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 20May2021 12:15 PM (at age of 38 years old, Lot Number: EW0167) as a single dose for covid-19 immunization. The patient experienced brain fog and chest pains and discomfort, reduced ability to ambulate due to chest pain, tachycardia, had fever (102 f). After receiving the vaccine on 10Jun2021 22:00, the patient arm was more swollen than the time before and the pain was more delayed than the time before. This time the injection pain over hours spread across my upper back into he right arm and chest and back. He had tachycardia and had to increased beta blocker (bisoprolol). Could not stand for two days due to pulse getting even higher standing. Temp of 102. Entire upper torso hurt. Heart pain worse lying down and on exertion-stayed propped up. Chest back pain worse with movement. Felt short of breath. Thought had caught COVID while getting vaccine tested three times, was negative each time. Chest pain and tachycardia slowly improving, but brain fog has been impossible. Can't think well. Having moment of clarity now which was why writing now. It hurt to breathe in, felt like elephant on chest, had to use urinals from bed because pulse. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received included Increased bisoprolol dosage for tachycardia. Since the vaccination, the patient had been tested for COVID-19. Nasal Swab, Pixel by  on 15Jun2021 was Negative. The outcome of the events " Chest pain and tachycardia" was recovering, for event " Can't think well, Brain fog" was not recovered. The outcome of other events was unknown.
Metallic taste in my mouth; Tired; Headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 04Mar2021 at 11:15 (at the age 59-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 25Mar2021 at 11:30 (at the age 59-year-old), each as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient previously received morphine (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergy. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced metallic taste in mouth, tired and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of metallic taste in mouth, tired and headache were not resolved.  No follow-up attempts are needed. No further information is expected.
Has never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 14th June 2021 from batch number 4Y2P4, expiry date 23rd January 2023).   On an unknown date, the patient did not 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 Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comments: The patient had never received second dose. The reporter did not give consent to follow-up. Additional supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
pt recv vax 9SEP97 & 1hr p/vax pt exp a bull's eye local rxn @ the site of inj as well as the hand;pt used an OTC steroid cream on the area;pt recovered by 11SEP97;
Diverticulitis - Sigmoid Colon  Treatment - Bed Rest Outcome - Recovered but have abdominal cramping for over a month since
No side effects reported; HCP calling to report GARDASIL 9 was inadvertently administered to a 4 month old patient. No side effects reported.; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of unknown gender. No medical history, concurrent conditions nor concomitant medications were reported.  On 28-AUG-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (0.5 mL, lot # W026977 has been verified to be a valid lot number for formulation pre-filled syringe, expiration date 04-JAN-2025) for prophylaxis (Inappropriate age at vaccine administration). No side effects reported. No additional adverse event (AE)/ product quality complaint (PQC) (No adverse event).
Early afternoon, had headache, tired, generally "blah" feeling. Mid-late afternoon, took aspirin but felt progressively worse. By evening/night, very sore on left side, painful to breathe or move (left side only). Early Saturday morning, had huge painful swelling to left axillary area that lasted 3 days.
Patient was administered a 3rd dose being a 0.5 mL Moderna dose on accident instead of the Pfizer booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient was administered a 3rd dose being a 0.5 mL Moderna dose on accident instead of the Pfizer booster) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient was administered a 3rd dose being a 0.5 mL Moderna dose on accident instead of the Pfizer booster). On 23-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient was administered a 3rd dose being a 0.5 mL Moderna dose on accident instead of the Pfizer booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received first two doses of Pfizer vaccine. No side effects reported by pharmacist. First Pfizer dose on 30-Mar-2021 and second dose on 20-Apr-2021.
Pt. reported having flu like symptoms and headache the following day after vaccine administration.  She had labs drawn on 04/02/21 that showed leukopenia and neutropenia. She reported flu like symptoms and headache lasted for 24 hours and has resolved
HIVES, weakness, numbness, tingling, swollen throat, abdominal cramping, sweating
Redness remained in the arm; hurting; tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness remained in the arm), PAIN (hurting) and FATIGUE (tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness remained in the arm), PAIN (hurting) and FATIGUE (tired). At the time of the report, ERYTHEMA (Redness remained in the arm), PAIN (hurting) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.  Concomitant drug details not provided.
The pt developed 5cm x 10cm area of redness and induration at vaccine site.
1st dose over two years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, over 2 years ago).   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 Information: Additional Information: GSK Receipt Date: 25-MAR-2022 Reporter's Comments:  The reporter asked should he/she still receive 2nd dose after close to 3 years, would it be effective.  The reporter failed to get the 2nd shot since. Additional Supportive Information: The case was reported via interactive digital media. Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Dizziness  116/68/60    o2-99%  Pateint refused to stay longer for observation, stated she is ok to leave.   #21 sent home
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. No Medical History information was reported.On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications reported by reporter. No treatment medications provided by the reporter.
mom states pt had a nightmare Saturday noc, & has slept only about 4 hrs a noc since the inject; can't relax enough to go to sleep;
On Wednesday April 14th I got my second vaccination shot. The following day I had a 103 F fever, body aches, chills, migraine, sore muscles, couldn't walk, excessive thirst. Those effects lasted all day and I felt better on Friday. Saturday night chest pain started along with sore arm getting worse. I took ibuprofen and melatonin to sleep. Woke up Sunday morning and pain came back and gradually got worse until I went into the ER around 9 am. They gave me Morphine to put the chest pain at bay. Then transferred me by ambulance to a different hospital with a cariology department. They treated me as if it was Myocarditis and also got an x-ray of my chest. The next morning I had an MRI and that is what confirmed it to be Myocarditis. I was then discharged with lots of medications to keep the inflammation down.
This is an instance of COVID-19 breakthrough disease after which death occurred.  The individual was vaccinated with the Moderna product on 02/02/2021, 03/03/2021, and 08/24/2021.   They became symptomatic for COVID-19 disease on 01/06/2022 and tested positive for COVID-19 on 01/10/2022 via antigen test.   They were hospitalized related to this illness and discharged. However, they died on 02/01/2022.
During 30 minute observation period patient began to have a rash across their chest consistent with hives and reported numbness and tingling of the R arm.  Denied any other symptoms including SOB.  Patient was taken to the ER for further observation where 50mg PO Benadryl was given.
Full disability; Got shingles from the vaccine/Ssupected vaccination failure; Shingles never went away; No immune system left; This serious case was reported by a consumer via interactive digital media and described the occurrence of disability in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced disability (Verbatim: Full disability) (serious criteria disability and GSK medically significant), vaccination failure (Verbatim: Got shingles from the vaccine/Ssupected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles never went away) and immune system disorder (Verbatim: No immune system left). The outcome of the disability, shingles and immune system disorder were not recovered/not resolved and the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the disability, vaccination failure, shingles and immune system disorder to be related to Shingles vaccine.     It was unknown if the company considered the disability, vaccination failure, shingles and immune system disorder to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient's daughter/son via interactive digital media. The patient got shingles from the vaccine and her shingles never went away.  The patient had been on full disability for 19 years.  The patient had no immune system left. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient reported swelling started in knuckles of both hands 2 days after receiving the vaccine, continued to worsen until date she received the second dose. Described as throbbing, feels like arthritis.
23 Weeks Pregnant and Currently Taking Hep Vaccine; Initial Report Received on 04-Jan-2022  A pregnancy patient (gestation period 23 weeks) reported that she (age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization   No medical history was reported.   No concomitant medications were reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, and injection site unknown).  No additional information was provided. Permission was not obtained for providing demographic information. There was no response to follow-up conducted by the registry and permission for Dynavax to follow-up with the HCP office was not obtained.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with ZOSTAVAX.  Subsequently the patient broke out in "shingles like pox" on her forehead and stomach post vaccination.  The reporter is not interested in VZV Analysis by PCR.  The patient's "symptoms" resolved.  At the time of reporting the patient was "okay".  No further information is available.
Severe muscle and joint pain lasting about 36 hours. 7-7-8/10 on pain scale.  Fever of 102.3 lasting for about 8-10 hours.  Fever broke early morning Saturday.  Sweats and severe chills that caused entire body to shake lasting about 6-8 hours Friday night.  No OTC meds helped. Tried Advil and Tylenol.  Stayed in bed and waited it out. Decided not to call doctor after reading info booklet on vax saying it was ?normal ? reaction to have pain, fever, sweats and chills.  All symptoms were subsided by Sunday evening.
Chills then a few hours later faster heart rate and feeling very hot. Due 6/17. No pregnancy complications.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The physician reported that he personally received a shot of SHINGRIX and it was very painful. The reporter did not provide any detail as it was short conversation. The reporter was not agreed to be contacted for follow up.