chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose in 18th Dec 2018, did not get the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 18th December 2018 from batch number TP5E5, expiry date 15th November 2020).   On an unknown date, the patient did not receive 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: 16-JUN-2022  Reporter's comment: The patient did not get the 2nd dose. The vaccine administration facility was the same as primary reporter for the 1st dose. The reporter consented 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.
Symptoms started about 24 hours after vaccine and lasted only one day. Excruciating Leg pain, headache, fever, nausea, chills, fatigue, pain down arm and  where shot was given. I had covid in late December and these were also some but not all of the same symptoms.
The patient had administered Fluzone High Dose Quadrivalent has an egg allergy with no ae; Initial information received on 26-Oct-2021 regarding an unsolicited valid  non-serious case received from a pharmacist and non health care professional via number: 00829213..  This case involves an unknown age and unknown gender patient who was administered  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (contraindicated product administered).  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had Food allergy, Swelling lips and Tingling lips (ongoing status was reported as: yes).   On an unknown date, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  It was case of an actual medication error due to contraindicated product administered (latency: same day).  At the time of reporting, 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 the Directive 2001/83/EC and Module VI. 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.
Fungus toe left big after hematoma under nail was cleaned the first podiatrist failed to send lab specimen and second podiatrist submitted 06/27/2022 after 1st podiatrist unable to write accurate record. 1. Podiatrist consulted June 2021.  Sept 13, 2000 accident hematomas under both large toe nail was cleaned the nails not growing correctly changed in nail composition lifted off the skin under toe nails.  NO biopsy on the nails were removed both left & right big toes.  With a prescription written told right & left big toes had developed fungus June 2021 with incorrect medical record no biopsy thus changed doctor June 2022 with biopsy performed 6/27/2022 left big toe fungus prescription of Clotrimazole Topical solution still using June 2021 to June 2, 2023. NOT resolved. Never had any skin foot changes until April 2021 multiple medical problems. Submitted grievance first physician failed to file VAERS or biopsy & wrong diagnosis NEVER BIOPSY that the second performed  ALL records on electronic records wrong. NOT resolved. Large toe nail on right and left have not grown back to normal.  Twice a day require prescription to place on the toe.  With NO ability to bend as damaged nerve.
he developed as horrendous rash to the point that he is not able to sleep; he developed as horrendous rash to the point that he is not able to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 03May2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), INSOMNIA (non-serious) all with onset May2021, outcome "not recovered" and all described as "he developed as horrendous rash to the point that he is not able to sleep".  Additional information: Caller said he got his only shot of Pfizer covid vaccine on 03May2021, then 3 days after he developed as horrendous rash to the point that he is not able to sleep. Caller said he has seen a lot of dermatologists and neurologists and none were able to help him with his problem. Caller said he is going to another doctor, an allergist, this afternoon; he wanted to know if a condition like him has been reported with Pfizer and recommendation to treat the said adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
a 65 years old male inadvertently received Fluzone quadrivalent instead of Fluzone high-dose quadrivalent with no adverse event; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old male patient who received a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe (Lot number- UJ491AA, expiration date- 30-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination on 05-Oct-2020 instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.   It was a case of an actual medication error due to wrong vaccine administered (latency same day).  Adverse event symptoms: None 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.
Tdap given Rt arm - 6-12-12. 6-12-12 arm started burning and itching - pt got very sleepy and dizzy. Arm now has red swollen, area at injection site.
Possible febrile abscess-red, tender, swollen (small apple) at injection site, improved with symptoms therapy. Afebrile. Resolved over 5 days, now small nodule (01/06/05).
Patient given 3 cc of PNEUMOVAX IM.   Follow-up information received - (2) Chronic swelling on scar tissue of back - ruptured and drained pus. Started on CIPRO oral 500 mg tab BID X 6 weeks.
The afternoon of the day after I received the second dose of Shingrix I developed severe Tinnitus (ringing in the ears) so loud it made it impossible to sleep that night. On day3 the nurse practitioner prescribed anti-viral medicine - Valcyclovir - to be take 3 X  daily and about halfway through the next day the symptoms started to subside but they are still not gone.
Lymph nodes swollen. Stomach irritation and ulcerative colitis acted up within one month of last dosage. Continue pain under the arm.
The pt experienced a rash on the face, trunk and extremities starting the next morning. Benadryl recommended.
administered YF-Vax reflected IM administration instead of the labelled SQ route,with no reported adverse event; Initial information was received on 11-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 31 years old male patient who was administered vaccine yellow fever vaccine -us [YF-VAX] reflected IM (Intramuscular) administration instead of the labelled SQ (subcutaneous) route, with no reported adverse event while receiving   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jan-2022, the patient received a d suspect yellow fever vaccine -us at the dose of 0.5 ml total via intramuscular route (batch number: UJ371AB; expiry date: 21-Jul-2022) in unknown administration site for Immunization.  On 19-Jan-2022, the patient was administered yf-vax reflected IM administration instead of the labelled SQ route, with no reported adverse event (incorrect route of product administration) (latency: same day). Further reported that the nurse caller asked the patient if he had a card from the vaccination. The patient was not given a care from that other facility and nurse caller told him  that she could update the card she would create with the YF-Vax that he received elsewhere, but she needed him  to obtain all the information about the YF-Vax from  the other facility. Patient returned to the nurse caller on 11-Feb-2022 with the information. The documentation from the facility who administered YF-Vax reflected IM administration instead of the labelled SQ route. The nurse called the outside facility and was told by facility personnel that the notation of "IM" was only a documentation error and that the patient actually received the dose of YF-Vax as a SQ injection. The nurse asked the patient his impressions of the dose. To him it seemed the same as all the other IM vaccines he had received. The nurse has no way to know for sure whether YF-Vax was given to the patient by IM or SQ route. The nurse did not have any records of additional vaccines given on the same day as the YF-Vax. Also, the nurse administered other travel vaccines, but not on the same date as YF-Vax.   Action taken: not applicable.  Outcome: 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.
I had flu like symptoms; This case was reported by a consumer via interactive and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the1st of 2 shots on the arm and experienced flu like symptoms. The patient added that, the place where they administered the shot to the patient was awful.
Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Date: 22Dec2020, NDC number, lot number, expiration date: Just has lot number, EJ1685.), administration date: 22Dec2020, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses."; BNT162b2 (DOSE 2, SINGLE, Date: 12Jan2021, NDC number, lot number, expiration date: EK4176), administration date: 12Jan2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses.". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses.  Additional information: Reporter repotred that she tested positive for Covid for the first time on 24Dec2022 and was still positive on 26Dec2022. Caller's last vaccine was on 12Nov2022, she did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses. Just got the sore arm with the 5th dose. There is a product complaint to report; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201401445 similar report from same reporter;
The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022; No adverse event; dose administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022).    No concomitant medications were provided. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursion. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-668207, US-MODERNATX, INC.-MOD-2022-668172, US-MODERNATX, INC.-MOD-2022-668074, US-MODERNATX, INC.-MOD-2022-668208, US-MODERNATX, INC.-MOD-2022-668215 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668207:Same reporter US-MODERNATX, INC.-MOD-2022-668074:Same reporter US-MODERNATX, INC.-MOD-2022-668172:Same reporter US-MODERNATX, INC.-MOD-2022-668208:Same reporter US-MODERNATX, INC.-MOD-2022-668215:Same reporter
This spontaneous report as received from a registered nurse refers to a 1 month old patient of an unknown gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 31-MAY-2016, the patient was vaccinated with VAQTA (the dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). No concomitant medications were reported. Despite being vaccinated at the reported age, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
no additional AE; received on 3/21/2023; received on 3/15/2022; This spontaneous report was received from a registered nurse referring to an 84-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 21-MAR-2023, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 mL, administered for prophylaxis (lot# W019639, expiration date 06-MAY-2024; strength and route were not reported) (extra dose administered), but she had already received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on 15-MAR-2022 (inappropriate schedule of product administration) and 09-MAR-2021 (strength, dose, route, lot #, expiry date, and route of administration were not provided). No additional information was provided. No additional adverse event was reported.
covid vaccine given at 1030am 12/28/20 bed ridden from pain, dizziness, nausea, and lightheadedness from 2pm 12/28/20 to 4pm 12/29/20. severe muscle pain in L upper pain which peaked around 1230am generalized muscle aches dehydration even though constant fluid drinking nausea, lightheadedness, dizziness if speaking more than one sentence at a time, shortness of breath  vitals (taken 5pm 12/29/20) BP 131/87 (normal is usually 116/56) HR 95-105 (normal resting is around 70s-80s)
KINRIX and MMRV given 11/3/17, noticed red area swelling (R) thigh 11/4/17 increased 11/5/17 seen in ECC large erythema and discoloration Dx with cellulitis, gave Septra single dose, BACTRIM and Mupirocin ordered. Seen by PCP 11/6/17 almost completely resolved.
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A, 030L20A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines).    Concomitant Medication use information was not provided by reporter.  A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines.   It was unknown that the patient ever been diagnosed with/tested positive for COVID-19  It was unknown that the patient had acute illness at the time of vaccination and up to one month before.  It was unknown that the patient had any chronic or long-standing health conditions.  It was unknown that the patient was prescribed OTC medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event.  Treatment Medication use information was not provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow up received that contains significant information includes added reporter details, updated age of patient, added suspect product of the 4th dose route of administration and location of vaccination, added event start date and updated I narrative information.; Sender's Comments:  MODERNATX, INC.-MOD-2023-704260:Master Case
spreading of soreness; itching; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced pain and pruritus. On an unknown date, the outcome of the pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. Almost 2 weeks after receiving Shingrix, the patient had a spreading of soreness and itching.
body temp 84.7, sweating, light headed and dizzy. Daughter had normal temp using same thermometer.
Headache for both vaccines, some pain in arm for both vaccines. Day 4 after the second vaccine, I started to experience pain in my mid-side/back when I woke up, around 0600. It has now been 2 weeks since this vaccine, and I am still feeling this pain, but only with pressure. If I stretch, I feel discomfort. The area it hurts is not a very large spot. I cannot feel if it is a lump or has taken a shape, where it is located on my back/side, so I cannot tell if this is just my skin or something underneath. I looked in a mirror and it does not appear to have any physical appearance, but it hurts with light pressure.