chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered Fluzone High Dose 26Apr2019 that expired on 06Apr2019. No AE's were noted; Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old female patient who received a 0.5ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UI999AA, expiry date: 06-Apr-2019 via intramuscular route in the right arm on 26-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  Pharmacist states that he accidentally administered Fluzone High Dose on 26-Apr-2019 to a patient that expired on 6-Apr-2019.  No Adverse event.  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 and Module VI of the 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.  List of documents held by sender: none.
This is a spontaneous report from a contactable consumer or other non hcp. A first dose of female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. she had the Pfizer vaccine and it has not quite been 21 days since that dose. She stated her next dose if scheduled at 19 days after the first dose. She stated she takes a blood thinner for a-fib and stated this was Amlodipine. She stated she did not have any symptoms after her first dose other than a sore arm, which lasted 5 to 6 days, which was longer than her daughter. The caller stated she heard the second dose is more.She stated she heard people were dying from the second dose. She heard that what they put in the second dose is bad, like stuff from babies and that the dose is more than the first and that they aren't telling people what they put in it but it is bad. She wanted to know if the second dose was worse and if people died from it. The patient experienced her next dose if scheduled at 19 days after the first dose and sore arm. The outcome of the events was unknown.   Information about batch/lot number has been requested  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
lightheaded/Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization; Bnt162b2 (Dose: 3 (Booster)), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "lightheaded/Dizziness".  Additional information: Patient received 4th COVID vaccine (all were Pfizer) and 10 days out, experiencing a great deal of lightheaded/ dizziness, that feel was related to the last vaccine. It started 3 or 4 days after the last jab. Patient was researching it online and saw was not alone here. Patient did not experience this symptom with the first 3 vaccines. It was not pleasant.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
chest tightness, mild chest pain at time (atypical), heart palpitation, body aches, and fever after the covid vaccine 5 days ago.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: patient felt lightheaded after shot. I gave him a water bottle that when he placed on the ground he started to fall over/ lose consiousness. 911 was called immediately.  I was able to catch patient and tried lowering him to the ground as he regained consiousness. cold water was also used to cool neck area. ems took patients bp and wrote up report but patient refused to go to ED. fiance was called to drive home/ to go eat after 30 mins to ensure patient was stable, hydrated.
right arm pain; it was like he had the flu; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm pain) and INFLUENZA LIKE ILLNESS (it was like he had the flu) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (right arm pain) and INFLUENZA LIKE ILLNESS (it was like he had the flu). At the time of the report, PAIN IN EXTREMITY (right arm pain) and INFLUENZA LIKE ILLNESS (it was like he had the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-304906 (Patient Link).
received a dose with just adjuvant; received a dose with just adjuvant; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: The reporter was purchasing officer for pharmacy which covers multiple long term care sites. He reported that a few days ago the patient at a facility received a dose of SHINGRIX with just the adjuvant (missing antigen). Patient initials not provided. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of SHINGRIX with just the adjuvant (missing antigen) which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This case has been linked with the case US2022094104 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094104:Same reporter
1-2 hr p/vax pt awoke w/persistent crying x 1hr, inconsolable;pt given DPH & cessation of crying;
Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: FATIGUE (non-serious), outcome "not recovered".  Additional information: Caller stated that he called about the Comirnaty 12 plus Covid 23-24 SDV. Is the Covid booster, a Pfizer product. Was wondering, his wife had Comirnaty 12 plus Covid 23-24 a week ago. His neighbors all had it. Has been two weeks and they still experience fatigue. Wanted to know is that normal. In casual conservation they talked to each other about it. Is curious as to whether it is normal to be tired after two weeks for him and probably a week for them. Wondering if other people were reporting fatigue after two weeks.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316106 same report/drug/events, different patient;
Patient presented to emergency department on 9/20/2021 with abdominal pain, nausea, and vomiting. He was admitted previously from 9/15/2021 to 9/18/2021 for diverticulitis. He was found to be COVID-19 positive during screening for admission to hospital. He remained asymptomatic for COVID-19 infection during admission. He was discharged home on 9/23/2021.
Itchy hives began about 2 1/2 days after Janssen vaccination and continue to occur every day for more than 2 months at this point.  I also experienced severe chills the night of the injection.  I have only had hives one other time in my life and that happened 5 years ago in 2016, about 2 weeks after I started on insulin.  They lasted 3 days.  Sought treatment from a doctor and was referred to an Allergist.  Tried Benadryl and Benadryl cream, Pepcid Complete, Claritin and Xyrtec.  Currently treating with Allegra and Pepcid twice a day.   Hives start to break through about 11 hours after last dosage.
Patient states that shes noticed some numbness and less dexterity in 2 fingers on the arm that got the vaccine.
Localized swelling at injection site. 06/08/2012 @10:30am pt reports swelling and redness spreading down her arm.
Weak; Not eating as much as before; on-and-off sleepiness/Slept all day; "not feeling like herself"/Currently experiencing the symptoms and feeling worse.; Could not hold anything; Chills; Tired; Feeling nauseous; Vomiting; Feeling "under the weather"; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVITY TO WEATHER CHANGE (Feeling "under the weather"), ASTHENIA (Weak), DECREASED APPETITE (Not eating as much as before), SOMNOLENCE (on-and-off sleepiness/Slept all day) and FEELING ABNORMAL ("not feeling like herself"/Currently experiencing the symptoms and feeling worse.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced SENSITIVITY TO WEATHER CHANGE (Feeling "under the weather"). On 11-Jun-2021, the patient experienced ASTHENIA (Weak), DECREASED APPETITE (Not eating as much as before), SOMNOLENCE (on-and-off sleepiness/Slept all day), FEELING ABNORMAL ("not feeling like herself"/Currently experiencing the symptoms and feeling worse.), MOBILITY DECREASED (Could not hold anything), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Feeling nauseous) and VOMITING (Vomiting). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SENSITIVITY TO WEATHER CHANGE (Feeling "under the weather"), ASTHENIA (Weak), DECREASED APPETITE (Not eating as much as before), SOMNOLENCE (on-and-off sleepiness/Slept all day), FEELING ABNORMAL ("not feeling like herself"/Currently experiencing the symptoms and feeling worse.), MOBILITY DECREASED (Could not hold anything), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Feeling nauseous) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient just recently did the COVID test and still waiting for the result to come back.
39 y/o female c/o dizziness 15 mins after receiving the first dose of the vaccine. She noted that she had COVID-19 in Dec 2020, took OTC tx at home, other med hx is MVP. She was assessed and monitored by NP, EMT, and paramedic. BP  - 143/87, HR.
Patient received MMR, DPT and IPV at clinic on 2/2/00. Presented to ER on 2/3/00 with complaints of warm, swollen, painful left deltoid. Diagnosed as allergic reaction, probably to DaPT vaccine.
Dr notified by mother, I called mom "child was riding back home with dad when eye lids started swelling, then mouth, then ear lobes. Went to ER got Epipen shot and kept overnight for observation" - angioedema with vomiting treated with steroids and epinephrine.
I noticed hives on my torso at 4:00pm the following day.  They have gotten worse over the past week.; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/Lot Number: EN6203), via an unspecified route of administration on 01Mar2021 17:45 as SINGLE DOSE for covid-19 immunisation. Medical history reported as none. No Known allergies. Concomitant medication included ascorbic acid (VIT C). The patient noticed hives on her torso at 4:00 pm the following day on 02Mar2021. They have gotten worse over the past week. The patient received prescription cream, OTC allergy medicine for the event as a treatment for the event.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot # and expiration date were not provided). The vaccines were exposed to 0.4 degrees C during 518 hours. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
about 5min p/vax pt had bad h/a, lightheaded, 935AM threw up x 2 large amounts, very pale;put head between legs;h/a went away;940AM BP 108/74, P64, no SOB;
swelling on the arm of the vaccination; redness on the arm of the vaccination; loss of appetite; being very cold; soreness in the vaccination arm; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 20-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (being very cold), DECREASED APPETITE (loss of appetite), PERIPHERAL SWELLING (swelling on the arm of the vaccination), ERYTHEMA (redness on the arm of the vaccination) and PAIN IN EXTREMITY (soreness in the vaccination arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 043B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced FEELING COLD (being very cold), PAIN IN EXTREMITY (soreness in the vaccination arm) and CHILLS (chills). On 19-May-2021, the patient experienced DECREASED APPETITE (loss of appetite). On 20-May-2021, the patient experienced PERIPHERAL SWELLING (swelling on the arm of the vaccination) and ERYTHEMA (redness on the arm of the vaccination). At the time of the report, FEELING COLD (being very cold), DECREASED APPETITE (loss of appetite), PERIPHERAL SWELLING (swelling on the arm of the vaccination), ERYTHEMA (redness on the arm of the vaccination), PAIN IN EXTREMITY (soreness in the vaccination arm) and CHILLS (chills) had not resolved.            No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.
Received her first covid-19 vaccine on 12/29/20. Her first dose was Pfizer Lot Ek5730. She was supposed to receive her second dose of Pfizer and was accidently injected with Moderna COVID-19 vaccine instead.
patient was given flublok to14 years old with no reported adverse event; Initial information was received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 14 years old female patient to whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] was given with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ893AA expiry-09-Jun-23) (dose, formulation and strength: unknown) intramuscular route in the left arm for immunization.  On 15-OCT-2022, patient was given flublok to14 years old with no reported adverse event (off label use) (latency same day).    Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  At time of reporting, the outcome was Unknown for the event patient was given flublok to14 years old with no reported adverse event.
Fever 8:30 PM with chill on 12/11/07, took 3 Advil, 2 PM 12/12/07 broke with sweating, no fever on 12/12/07 at 9.30 AM,  but still warm, swelling, erythema at site of injection.
Flared up peripheral neuropathy symptoms within 30 minutes including numbness tingling in toes, hands, feet, legs, face/head, and back. Included muscle pains and spasms and ear pain. Pain from pressure on almost any part of body.  Worst the first week but symptoms have continued 3 weeks afterwards.  Still muscle pains, numbness and tingling:
2-3 days after receiving Hep B #2, patient began having tingling in left arm, from under arm area to little finger and to some extent on top of arm.  Has continued to have numbness/tingling occasionally since.  Per his MD and our medical director, patient will not received 3rd Hep B until specialist runs tests/makes diagnosis or condition improves.  Patient is not recovered at this time.
Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Rash - Near Injection Site; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE RASH (Rash - Near Injection Site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 01-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE RASH (Rash - Near Injection Site). On 21-Feb-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE RASH (Rash - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment "Ointment" - Self medicating to try to alleviate the symptoms. No concomitants provided
pt recvd vax;devel gen body hives;pt indicated that the hives may have been a rxn or allergy to thimesoral
chest pain, bursitis in the left arm, bad headaches, pain in the left side of  face, numbness, burning and tingling in the extremities
went below 32F, used after excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number ABXC08AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) and (batch number XM2N7, expiry date 1st April 2024) for prophylaxis, HBV (Engerix B) (batch number 5M93R, expiry date 5th April 2024) for prophylaxis, DTPa (Infanrix) (batch number LS444, expiry date 16th September 2023) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25th March 2024) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and Boostrix. On an unknown date, the patient received Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 27-JUL-2022 Reporter's Comments:  The practice coordinator reported that Bexsero, Boostrix, Engerix-B, Infanrix, Kinrix, and Pediarix vaccines went below 32 Fahrenheit on 3rd June 2022 and on 13th June 2022.  The lowest temperature was 31.8 Fahrenheit.  The practice Coordinator reported the vaccines were used after the excursions.  At the time of the call the reporter did not have information on the number of doses administered, any of the patient information, or dates of administration.  The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional supportive information: The patient received a dose of Bexsero, Boostrix, Engerix-B, Infanrix, Kinrix, and Pediarix which was went below 32 Fahrenheit and used after the excursions, which led to incorrect storage of vaccine.
Patients mother filled out form indicating patient was 12 when the child was 11 years old.  Doctors office was contacted to follow up with patient.  Spoke with mother on phone and mother stated child was fine.
This spontaneous report as received from a pharmacist refers to a currently 65 year old female patient. In August 2016 (reported as a year ago) the patient was vaccinated with ZOSTAVAX for immunisation. Other suspect therapies included sterile diluent. The patient developed Shingles within one year of the vaccination on an unspecified date. The outcome of Shingles was unknown. The causality assessment was not provided.