chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Late second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (on December 2022 received 1st dose.).   On 31-MAY-2023, the patient received the 2nd dose of Twinrix. On 31-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose.). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 31-MAY-2023 A pharmacist reported about a patient who received the first dose of Twinrix in December 2022.  On 31 May 2023 the patient got the second dose.  The reporter wanted to know the minimum interval between the second and third dose in this situation.  The reporter did not provide patient information nor vaccine information. The reporter consented to follow up. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule.
losing their hair/lost hair; This spontaneous report from two contactable consumers reporting same event under the same suspect product for 7 patients. This is one of 7 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as singe dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Reporter stated seven patients off the top of head that were losing their hair since they had the vaccine, also reported these seven patients were having hair changing or falling out right after Pfizer vaccination, 7 patient who have lost hair. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.  Follow-up attempts completed. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101529886 same drug/event, different patient;US-PFIZER INC-202101530873 same drug/event, different patient;US-PFIZER INC-202101530874 same drug/event, different patient;US-PFIZER INC-202101530876 same drug/event, different patient;US-PFIZER INC-202101530872 same drug/event, different patient;US-PFIZER INC-202101530875 same drug/event, different patient
No issues reported until today (10/2/18) patient reported having shingles. Got case of shingles on right side of body from stomach area up to under breast area---first showed up on Sun 9/30--went to doctor's today and they confirmed it and also did bloodwork---gave rx for VALTREX and sample of LYRICA and was told to stay home from work (at school until next week).
No adverse events occurred to knowledge of pharmacy staff. This is being reported because Janssen vaccine was given as a "booster" to the patient after receiving Pfizer vaccine previously.
Patient said he felt dizzy OX 899 P89 called 911 for an ambulance.
Returned to clinic 9/7/2017 at 1000 am reporting fever, nausea emesis X3, back, head and neck pain a 10/10. Patient and spouse reported visual hallucinations starting at 1200 am on 9/7. Vital signs 100/60, 101.8, 111, 16 O2 sat 99%. Patient visually shaking, but responding appropriately. Ondansetron 4mg/2cc given IM at 10:29 a.m., Acetominphen 650 mg given p.o. at 1107 a.m.  Discharged to home at 1200 with instructions to take acetominphen or ibuprofen for fever, body aches. Patient noted rash to chest at 9pm on 9/7/2017, 9/8/2017 1100 Spoke with patient. She reports a little nausea, but able to eat. Also light headed. Diaphoretic, but fever free upon awakening this a.m.
Chills, fever, muscle aches, headache, soreness in arm where shot was administered. Neuropathy in pinkie and ring finger of arm where shot was administered. Bruising at injection site. All except headache and neuropathy resolved within 24 hours of onset.
Presented to hospital with a history of 3 days fever. Developed a red rash which started on face and spread within 5-6 weeks to all the body.
Patient received her second vaccine ( Covid-Pfizer)  the 5 minutes later, she  started feeling her tongue and lips swell and started coughing. 911 was called and Epinephrine was administered, 3 - 4 minutes later she started breathing better and EMS showed up.
12 year old had been given the vaccine Daptacel when it should have Adacel/No AE; 12 year old had been given the vaccine Daptacel when it should have Adacel/No AE; Initial information was received on 03-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 12 year old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Wrong product administered and Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included a dose of MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  On 03-Jun-2020, the patient received a 0.5 mL dose of (frequency: once) suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5643CA, expiry date- 17-Jul-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  Medical assistance stated a 12 year old had been given the vaccine Daptacel when it should have been Adacel. MA wants to know is there a different amount of Pertussis amount compared to Adacel to Daptacel.  At the time of report, no adverse event was reported.  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 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.
On 9/1/22- had hives 9 hours post Covid shot. Follow up on 9/6/22- hives persist, cleared with antihistamine, but come back in AM when meds wear off.
Client stated, after administered Hep A vaccine, client felt dizzy for almost half of the day and a week later after taking 2 capsule of the oral typhoid, client reports hives and itching.
Chills; headache; fever; tiredness; runny nose; 5th dose; 5th dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 14:00 as dose 5 (booster), single (Lot number: 59267-0304-02) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (3rd dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (4th dose, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "5th dose"; CHILLS (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering"; PYREXIA (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering"; RHINORRHOEA (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering", described as "runny nose"; FATIGUE (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, headache, pyrexia, fatigue, rhinorrhoea. No follow-up attempts are possible. No further information is expected.
About 3.5 hrs after my 1st shot I had a sudden onset of nausea for about 5 minutes (no throwing up) followed by abdominal pain for about 20 minutes.  After these, I had an episode of very loose stool and some mild diarrhea but only once.   For the remainder of the day my abdominal area was sore if I pushed slightly on the area.  Arm soreness the day of the shot was mild.  On the day after the shot almost no arm soreness except when I put pressure on the arm.  Noticed some intestinal gurgling after I got up in the morning (6:15am) for about 1 hour.   After being up for about 1.5hrs I began to feel very, very tired (around 8:15am).  This tiredness would come and go in waves.  Also during this time I would random short lived shooting pains (in lower left arm and also left intestine area). Also on the 2nd day around 10am by entire rib cage was tender to the touch or when reaching up.  I am still experiencing this tenderness which definitely hurts if I cough.  Moving around verses just sitting has helped to lessen the tiredness.  Also eating seems to lessen it as well.   This is everything I have had up until 26 hours after the 1st shot.
Moderna vaccine administered to patients post temperature excursion; Poor quality vaccine administered; 1st dose administered on 05-Nov-2021 and 2nd dose administered on 10-may-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-Nov-2021 and 2nd dose administered on 10-may-2022) in a 77-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if the patient has ever been diagnosed or tested positive for COVID-19. It was reported Acute illness at the time of vaccination and up to one month before and Chronic or long-standing health conditions were unknown.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-Nov-2021 and 2nd dose administered on 10-may-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-Nov-2021 and 2nd dose administered on 10-may-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The temperature excursion occurred at the facility on 09-May-2022. Reporter stated that it was a refrigerator excursion where the lowest temperature reached 26 degree Fahrenheit for about 15 minutes and the average temperature was 28 degree Fahrenheit. The entire excursion duration was about 5 hours. Reporter stated that the Moderna vaccine was used post excursion and administered to patients. No vaccine state changes were noticed. Patient did not report any adverse events.  No treatment medication was reported.   This case was linked to MOD-2022-592938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2022: Follow-up received contains significant information, included patient information, dose details, additional event and case narrative was updated.
Viral enanthem See attached office notes.  Follow up information received March 30, 2007 - Date of vaccination 01/05/2007 at 16:21 - Adverse event onset 01/07/2007 at 09:00.
Started feeling heart race, tried to calm self down, started feeling chest tightness on right upper side notified staff of incident.  Started within 15 minutes of receiving covid #1 dose,  vitals 127/70 93 100% on ra paramedics called consulted with ER takend to hospital for observation.  DC without medication to home. to follow up with allergist.  Denied trouble breathing.
Right  upper arm/ shoulder joint pain, numbness extending  7+ days, requiring naprosyn. Interrupting sleep and affecting work ability
APPROXIMATELY 10 MINUTES AFTER RECEIVING THE SHOT THE PATIENT BEGAN TO FEEL FAINT.  SHE QUICKLY PROGRESSED TO BECOME DISPONDENT, COLD TO THE TOUCH, WEAK, SWEATING PROFUSELY, AND FACE WAS PALE WITH BLUE LIPS.  AFTER LYING DOWN SHE BEGAN TO REGAIN HER COLOR AND BECAME MORE COHERENT.  PARAMEDICS ARRIVED AND CHECKED HER AND ALL VITALS WERE OK AT THAT POINT.
Large red welt at vaccination site with skin hot to the touch and pain.  Welt is the size of a half-day coin.
horrible pain; had the vaccine, have them again/suspected vaccination failure; had the vaccine, have them again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them 9 years ago for 6 weeks horrible pain) and pain (had horrible pain ).   On an unknown date, the patient received Shingles vaccine. In July 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: Reporter's comment: The case was received from the consumer via interactive digital media. The patient had them 9 years ago for 6 week and horrible pain.  The patient had the vaccine after that and had them again now going into his/her 3rd week. The patient also experienced horrible pain again. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Shortly after I left the center I started to feel a thickening of my tongue,  as well as a weird taste.  It lasted for several hours.  Upon advice of my doctors I did not receive the second injection.
considerable hearing loss in both ears; This case was reported by a consumer via interactive digital media and described the occurrence of hearing loss bilateral in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hearing loss bilateral (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss bilateral was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss bilateral to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient recently got Shingrix vaccine and had considerable hearing loss in both ears. The reported wanted to know if it was temporary. The follow up would not possible as no contact details were available.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 52-year-old male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020). Concomitant products included SHINGRIX and AMBIEN. On 20th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st May 2018, 1 days after receiving SHINGRIX, the patient experienced chills, joint pain, fatigue, fever and influenza-like symptoms. On an unknown date, the outcome of the chills, joint pain, fatigue, fever and influenza-like symptoms were not recovered/not resolved. The reporter considered the chills, joint pain, fatigue, fever and influenza-like symptoms to be possibly related to SHINGRIX. Additional details were provided as follows: The case was reported by the pharmacist. The pharmacist stated that the patient received 1st dose of SHINGRIX 2 months ago and did not have any issues with the 1st dose. The pharmacist stated that the patient received the SHINGRIX vaccine yesterday in unknown arm. The patient was experiencing flu-like symptoms that include chills, fatigue, fever, severe joint aches and joint pain.
Tested positive for covid, hospitalized to get antibody therapy; Tested positive for covid, hospitalized to get antibody therapy; This is a spontaneous report from a Pfizer-sponsored program,  received from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on 23Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received 23Feb2021 scheduled second shot the day after the present report (16Mar2021). Tested positive for COVID, hospitalized to get antibody therapy. He had question about getting second shot. The outcome of the events was unknown.  Information about lot/Batch number has been requested
Received second dose 8 months apart from 1st; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 months apart from 1st) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 months apart from 1st). On 29-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 months apart from 1st) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
PATIENT REPORT MUSCLE PAIN, DIARRHEA, SORE THROAT, EXTREME FATIGUE THE SECOND DAY IN THE MORNING
hives few days later; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives few days later) and VACCINATION SITE PAIN (vaccination site pain) 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 Hives (mild hives before her first vaccination). Concurrent medical conditions included Penicillin allergy (reaction to Pennycillin). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and HYDROXYZINE for an unknown indication.    On 10-Feb-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 URTICARIA (hives few days later) and VACCINATION SITE PAIN (vaccination site pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives few days later) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient took Benadryl before she got the second vaccine to keep the hives down.  Treatment information for the event sore arm was not provided by the reporter.   This case was linked to MOD-2021-337946 (Patient Link).   Reporter did not allow further contact
Six Month Old Received Heplisav-B; Initial Report Received on 18-Jul-2019  A vaccine manager reported that a six-month old female patient (race unknown) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Relevant medical history, concomitant medications, and allergies were reported as none.    On the morning of 18-Jul-2019, the patient was administered with a dose of HEPLISAV-B (lot # 933093, expiration date 11-Apr-2021, and NDC # unknown) from a pre-filled syringe. The vaccine was administered by a nurse at a clinic. The patient experienced no adverse events and was doing well. The patient was also administered Pentacel (diphtheria, tetanus, pertussis, polio, and haemophilus influenza type B vaccine), Prevnar 13 (pneumococcal vaccine), and Rotateq (rotavirus vaccine) on this date.   At the time of this report, no adverse events were reported.   The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B.; Sender's Comments: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B.
Patient presented to clinic today for 2nd dose of Moderna, reported to nurse that 3 weeks after vaccination, woke up that morning with tongue tingling, right side of mouth numb and drawing, unable to shut right eye. Reports he saw his provider and was diagnosed with Bell's Palsy.  Was given Prednisone 50mg PO QD, an anti-viral (patient did not know the name), and eye drops. Nurse contacted our medical director who recommended we hold on giving 2nd dose and have patient first discuss with primary MD.