chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administering an expired dose of ADACEL with no reported adverse event.; Initial information received  on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 51 years old female patient who had administering an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for Immunisation.  On an unknown date, the patient received 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation was unknown, lot C5770AA and expiry date: 11-Sep-2022) via intramuscular route in unknown administration site for Immunization.  On 23-Sep-2022 the patient developed a non-serious event of administering an expired dose of adacel with no reported adverse event. (expired product administered) (latency: unknown) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  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.
On 9/10/00, the pt experienced a mild type seizure with stiffness and staring. It lasted 30-60 seconds.
received first dose of Shingrix vaccine 05Jun2018 / has not yet 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 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 5th June 2018).   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 case details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.   The reporter was not able to provide lot number or expiration date of 1st Shingrix dose. VAERS details were reported for the 1st dose of Shingrix. The reporter consented to follow up.
Tasted it; Headaches/ Headaches were so bad they brought tears to her eyes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Oct-2021 and was forwarded to Moderna on 06-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Tasted it) and HEADACHE (Headaches/ Headaches were so bad they brought tears to her eyes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 079C21A and 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, 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 DYSGEUSIA (Tasted it) and HEADACHE (Headaches/ Headaches were so bad they brought tears to her eyes). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Tasted it) and HEADACHE (Headaches/ Headaches were so bad they brought tears to her eyes) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-343847 (Patient Link).
DISCITIS; BLOOD CLOT IN FEMORAL ARTERY; BAD SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number were not reported and expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced bad side effect. On an unspecified date, blood clot in femoral artery, and discitis (dose number in series 1). The patient clarified that discitis was infections of discs in their back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in femoral artery, discitis and bad side effect was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211233462 (booster case with both dose numbers in series information).; Sender's Comments: -20211235699-covid-19 vaccine ad26.cov2.s-Discitis, Blood clot in femoral artery. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
MODERNA COVID VACCINE #3 GIVEN 8/15/21, LOT #017E21A; 1/27/22 pt was recently treated for COVID infection; 2/8/21 pt to hosp via EMS for worsening productive cough, hypoxia, pleuritic chest pain, generalized weakness; AKI; hypokalemia; community-acquired pneumonia given IV ABX; acute MI; refused cardiac catherization; made comfort care; pt passed away in the hospital
DEC2021 (SINCE LAST WEEK) Pt Had Covid vaccine and went to hospital with tightening in chest. Pt also missed 1 dose due to pharmacy delay.
Mom reports pt was lethargic, drowsy, p/DTP; pt cried when touched & the cry was not pts unual sounding cry; Fever did not go over 102; no local rxn noted; mom notified MD who instructed mom to observe & call again if no improvement in 2 hr
A nurse reported a 6 month old pt (gender not specified) received a 3rd injection of Prevnar, and Tripedia on 5/15/01. Within 12 hours, the child developed a fever of 102F-103F, fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is one of 3 identifiable pts from this reporter who experienced events following receipt of Prevnar (lot 474724). For information on the other 2 pts, see HQ1206422MAY2001 and HQ1206522MAY2001. The reporter was unable to specify additional pts involved. Additional reports will be generated when identifying information is provided.
Information has been received from a licensed practical nurse concerning a 13-year-old female who on 17-AUG-2007 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657941/0851U). There was no concomitant medication. On 21-AUG-2007, the patient experienced a red, itchy rash at the injection site four days after vaccination. It was reported one chickenpox lesion was located directly over the injection site. The patient sought unspecified medical attention. No diagnostic labs were performed. No more lesions developed and at an unknown date the patient recovered from all adverse events. A product quality complaint was not involved. Additional information has been requested.
Paralyzing weakness in bed; Headache; Chills, fever, and extreme sweating over a period of approximately 4 hours in total. Alone so could not leave bed safely to get to thermometer to take temperature. After around the 5th hour and after the sweating had subsided the temperature came in at 99.5 degrees. Sleep resumed and weakness continued until around 5:00 PM on the 29th. Slept well that night and felt stronger as of mid-morning on the 30th. Quite relieved because it was a scary experience. I feel it was the RSV because I have had Flu shots repeatedly over many years with no adverse events.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
swelling & redness of arm on 25APR97 according to mom;redness & swelling on arm upper part on touch, pain;
Patient requested booster dose of moderna shot (0.25 ml) and was given a dose of 0.5 ml.
A report was received from a health professional on 10/21/02, concerning a female vaccinee in her early 30's who experienced finger tingling after receiving Fluvirin vaccine on approximately 10/15/02. On approximately 10/15/02, on the evening of the same day that she received her Fluvirin vaccination the vaccinee experienced finger tingling in her ring and little fingers. The finger tingling had not resolved at the time of this report. The reporter has assess the relationship of the vaccine to the event as unclassifiable. Update (1) 01/02/03: The 22 year old vaccinee experienced Raynaud's disease a few hours after receiving the Fluvirin vaccine in the left deltoid muscle. The vaccinee experienced tingling in the left ring and pinky finger on 10/15/02, which lasted for several days. The attending nurse recommended ibuprofen. The vaccinee has recovered.
fever of 99.8 at 6 am the morning after the 2nd dose, subsided on it's own the same day, general fatigue for about 16 hours
Case number PHEH2013US025958 is an initial spontaneous report received from a nurse on 16 DEC 2013 with a follow up information received from the physician on 13 JAN 2014. This report refers to a 20-years-old female patient. Her medical history was reported. Her vaccination history included administration of diptheria, tetanus, acellular pertussis (other manufacturer, batch number, not reported). hepatitis A (other manufacturer, batch number: not reported)., hepatitis B (other manufacturer, batch number: not reported), hemophilus influenza type B vaccine (other manufacturer, batch number: not reported; inactivated polio virus vaccine (other manufacturer, batch number: not reported), mumps, measles, rubella vaccine (other manufacturer, batch number: not reported), and varicella virus vaccine (other manufacturer, batch number: not reported. She also received a dose of MENVEO (batch number: not reported) on 26 AUG 2008 which was well tolerated. Her concomitant vaccinations included administration of HAVRIX (other manufacturer, batch number: 5B23A720EL) and GARDASIL (other manufacturer, batch number: J011272); both vaccines administered at a dose  0.5 ml intramuscularly on 16 DEC 2013. It was reported that she was vaccinated intramuscularly with MENA lyophilized powder of MENVEO (batch number: M13050, expiry date 31 MAY 2015) reconstituted with sterile water instead of MenCYW-135 liquid component on 16 DEC 2013 as booster dose. No adverse events were reported following the maladministration.    Follow up information received from the physician on 13 JAN 2014. Patient demographics (weight and height), vaccination history, concomitant vaccinations, vaccination date and expiry date of suspect vaccine updated.
A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning an 44-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 13-Feb-2012. The patient inadvertently received expired product on 16-Feb-2012. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 26-Mar-2012: The reporter stated that the patient did not experience any adverse events and the patient received FLUMIST very soon after it expired.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), LIP SWELLING (Lip swelling), SWELLING (Swelling around eyes) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced LIP SWELLING (Lip swelling). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), SWELLING (Swelling around eyes) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), SWELLING (Swelling around eyes) and HEADACHE (Headache) outcome was unknown and LIP SWELLING (Lip swelling) had resolved. No concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-29218.
Information has been received from a nurse concerning a 23 year old female patient who in April 2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot # not provided) and on 17-Jun-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot # not provided). After the second dose the patient developed left arm weakness, pain at the back of the shoulder, swollen glands and a lump on the neck. At the time of reporting, the patient sought medical attention at the office on 07-Jul-2008 for these symptoms. The patient had not recovered. Additional information has been requested.
A 7-year-old patient received FLUBLOK QIV vaccine with no AE; The nurse advised that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent no AE; Flublok are similar to the colors used for Fluzone Quadrivalent no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via consumer/non-health care professional via agency (Reference number- 00805127) and transmitted to Sanofi on 08-Oct-2021.  This case is linked to case 2021SA339055 (same reporter).  This case involves a 7-year-old female patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age), instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered) as FLUBLOK QIV and FLUZONE QUADRIVALENT are similar to the colors (Product appearance confusion).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2128, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  It was case of actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered and product appearance confusion (latency same day).  It was reported "Two children under the age of 18 years old were administer with Flublok. The nurse (reporter) advised the Sanofi Representative that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent. It was reported that the children's parents have been notified. Both children were administered a dose from the same lot number."  No other 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 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.
Pneumo 23 given and should of been Prevnar 13.  No adverse reaction.  Per Pharmacist no harm to patient
My son began experiencing severe headaches and body aches approx. 5 hrs after the meningitis vaccine was administered in his right arm. The next day he stayed home because he was having terrible headaches, body aches and the affected arm was very inflamed, swollen (the size of a grapefruit) red and hot to the touch. There was no fever but we wouldn't know because we were giving him Advil to help with the aches and pains. 24 hours after the administration of the vaccine we had to take him to the ER because he was complaining of dizziness and experiencing lethargy. At the hospital they ran blood tests which came back negative and gave him an IV bag of saline and pain meds were administered intravenously. By midnight he was feeling much better so he was sent home. Friday he stayed home from school as well. He was feeling better but was still having some headaches and was a bit sore and his arm was still swollen but 50% smaller than the day before. By Saturday, (72 hrs after he got the vaccine) he was back to normal.
This vaccine was not properly diluted with 1.3 milliliters of 0.9% sodium chloride prior to administration.
Rash; Injection site itching; Injection site redness; Injection site little puffy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site little puffy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 0481321A) for COVID-19 vaccination.     The patient's past medical history included Hives (when very young).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, 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 RASH (Rash), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site little puffy). At the time of the report, RASH (Rash), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site little puffy) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up was received Patients demographics was updated On 11-Aug-2021: Follow-up received on 11-AUG-2021,contains significant information with updation of weight, Race batch no ,Dose 2 addition
I received my sixth dose and later that day, I went to visit a friend at a nursing home and they took my temp and it was 90.2. They checked it twice and it was still 90.2 The next day, I started to break out in a rash and my entire body was light red. The rash didn't itch though.
Swelling hands, Pt is diabetic - BS was elevated needing to increase basal rate on insulin pump. Next day - swelling hands, hives to chest, feeling of anxiety, BS continued to be elevated.
Headache, Myalgia, Arthralgia, Fever, flu like symptoms, chills Narrative:  Approximately 4 hours after vaccine administration, began to have headaches. Then progressed to fever, body aches, chills. She missed one day of work due to symptoms
Tired night vaccine was given, left arm very sore. Arm turned red. High Temp 102 degrees F itchy, welts on thighs.
March 17, date of 2nd shot, a very minor sore arm for 3 days.  Then I was  fine.   April 1 starting a little off, and woke up on April 2 dizzy when moving my head.  April 3, I was worse and when I arrived to the kitchen, I spun out so dizzy, hit the floor.  Hurt my hip, hands and knees, plus had a hard time getting up.  Felt sea  sick combined with Vertigo.  I have been been dizzy ever since, when I get up to walk, or bend, or turn my head.  This morning (April 7)  when raising up off my pillow, I uncontrolledly, body slammed back onto the bed... typing this I am light headed.
Patient had "abnormal movements" prior to vaccines.  On day of vaccines, patient developed inconsolable crying, myoclonic jerks, eventually with eye and head deviation.  On the subsequent day, he had a single 10 minute generalized tonic-clonic seizure. Discharge Summary received on 2/02/2005 states pt experienced diarrhea.  Patient already had developmental delay prior to vaccination.
lost vision; migraine; unable to lift head; chest pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, administered at the right arm on 07Apr2021 10:45 (age at vaccination was 26 years) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient experienced lost vision on 07Apr2021 with outcome of recovered on an unspecified date, migraine on 07Apr2021 with outcome of recovered on an unspecified date, was unable to lift head on 07Apr2021 with outcome of recovered on an unspecified date, chest pain on 07Apr2021 with outcome of recovered on an unspecified date, and nausea on 07Apr2021 with outcome of recovered on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of lost vision, migraine, unable to lift head, chest pain, nausea that included migraine medication, ibuprofen, and nausea medication.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
slight fever, coughing, sore throat, soreness/body aches (went to see doctor to get medicine)