chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLUZONE HIGH-DOSE dose was administered from the frozen shipment no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00814956) and transmitted to Sanofi on 29-Sep-2021.  This case is linked to cases 2021SA344085, 2021SA344225, 2021SA344344, 2021SA344823, 2021SA345076, 2021SA345205, 2021SA345236, 2021SA345293, 2021SA345361, 2021SA345367, 2021SA345483 and 2021SA345780 (same reporter).  This case involves an 81-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from the frozen shipment (product storage error).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 21-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ716AA, expiry: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low (latency same day).  It was reported "Can you please contact this customer re the stability of Influenza vaccines. Customer received their Influenza vaccines and a portion of the doses were frozen. They have administered some of the doses that they claim were not frozen. To Whom it May Concern, I am requesting information on how to return the flu vaccines that we received this year. We have 9 boxes of high-dose flu vaccines and 4 boxes of regular flu vaccines. They came to our office frozen, and therefore are no longer viable. We need to return these vaccines and get a refund. An Office manager reporting that doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen. The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  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 by the regulatory authority. 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.
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age  received PREVNAR 13, via an unspecified route of administration on 04Jun2018 at around 03:30 PM at a single dose for immunization. Medical history included central regional pain syndrome which the patient got from a knee replacement on unspecified date and glaucoma. Concomitant medication included XALATAN for glaucoma, Aspirin, oxycodone at 5 mg four times a day and vitamins. In the evening of 04Jun2018 (around 10 o'clock ), the patient experienced red hives all over legs and arms. The patient had a blood test right before and reported that everything was fine. The patient applied hydrocodone cream in response to the event. The outcome of the event was not recovered. Information regarding batch number has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for the first and second time were 16, 29 and R; 212, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for the third time were 24, 49 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Skin rash with hives in various places on my body including feet, neck, tops of hands, back, chest and arms.  The rash is itchy and burns and feel warm to the touch.  If I scratch the itch, my skin reacts drastically with hives and inflammation.  Eventually if I don't touch that spot for a couple of hours, it will go away.  Urgent care prescribed oral steroids for the rash which helped but after the full course of steroids, the rash still comes and goes. I do have a history of eczema but this is not normal.
Patient called this morning to report waking in the middle of the night due to severe arm pain. When the patient checked the injection site she noted a ruptured blister under the bandage. She stated it was about the size of a quarter. She also noted that there was another blister developing right near the other one. She noted that her upper arm was very red . She was advised to contact her physician for further inspection.
Narrative:  At the time of the report, a 44yo male with PMH of Cervical Spinal Stenosis, Cervical Spondylosis, Cervical Disorder, Nummular Dermatitis and ED. On September 23,2021, his attending physician reported a historical ADR of influenza vaccine induced dizziness classified as moderate. The report did not include influenza vaccine information (which vaccine, Lot #, mfg, who administered the vaccine, when and where it was administered ). Unable to find influenza immunization record.
accentuation (swelling) of lesions of MPCM; facial swelling; flushing; This literature marketed report has been received from the authors of a published literature article and refers to an adolescent patient with indolent systemic mastocytosis.  On an unknown date, the patient was vaccinated with human papillomavirus vaccine (manufacturer unknown) (lot #, strength, dose, route and site of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, strength, dose, route and site of administration were not reported) for prophylaxis.  On an unknown date, the patient experienced facial swelling, flushing and accentuation (swelling) of lesions of maculopapular cutaneous mastocytosis (considered to be progression of indolent systemic mastocytosis). Tryptase level was 62.9 ng/mL.  The outcome of events was unknown. The authors considered facial swelling, flushing and accentuation (swelling) of lesions of maculopapular cutaneous mastocytosis to be related to human papillomavirus vaccine (manufacturer unknown), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).  The event of indolent systemic mastocytosis progression was considered to be medically significant.  This is one of 2 reports derived from the same literature article (cross referenced with MARRS# 2006USA004886).; Sender's Comments:  US-009507513-2006USA004886:
This is a spontaneous report from a non-contactable pharmacist via Pfizer sales representative.  A patient of unspecified age and gender receive PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced limitation of arm movement and soreness. Events were non serious with outcome unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Individual experience anaphylactic reaction within 30 minutes of administration.  Epi Pen self administered.  Per Medical Evaluator direction, individual transported via ambulance to hospital.
Systemic: Dizziness / Lightheadness-Severe, Additional Details: pt felt lightheaded 1 min after recieving the vaccination.  pt fell to the floor and was resposive.  I elevated his feet and checked his vitals and called EMS. Pt was resposive the whole time. EMS showed up within 7 minutes and evaluated him and pt was released and fine to go home.  His wife drove him ome.
Development of conjunctivitis in right eye with onset of symptoms beginning the evening of vaccine administration.  For awareness, also received a COVID-19 vaccine on 9 November 2023 without side effects.
tested positive for COVID-19; temperature of 99°F; slight cough; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PYREXIA (temperature of 99°F), COUGH (slight cough) and COVID-19 (tested positive for COVID-19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 04-Feb-2021, the patient experienced PYREXIA (temperature of 99°F) and COUGH (slight cough). On 06-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). On 05-Feb-2021, PYREXIA (temperature of 99°F) and COUGH (slight cough) had resolved. At the time of the report, PAIN IN EXTREMITY (very sore arm) and COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 99 (High) 99 degree F. On 06-Feb-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included medicine for her blood pressure and 2 antidepressants. Treatment medication was not used.
This spontaneous report has been received from a nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB injection, lot # M025192, expiration date 21-MAR-2019 (dose and route of administration were not reported). No adverse effects were reported. The vaccine experienced a temperature excursion of 33.60 Fahrenheit degrees (F) for 5 minutes. There was no previous temperature excursion. Digital data logger was not involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received on 27-JAN-2017: all telephone attempts to obtain follow up information had been unsuccessful. Additional information has been requested.; Sender's Comments: US-009507513-1702USA003518: US-009507513-1611USA001487:
Initially, there was left sided neck and shoulder pain and severe headache which resolved after a few days.  After approximately 1 week, a pinch was noted in cervical spine when turning head to the left. This quickly progressed to severe left sided muscle spasm in left neck and shoulder resulting in neck and shoulder pain and loss of range of motion in neck.  At the time of this report, symptoms remain ongoing.  Medications: Tylenol, Motrin, Aleve, Mobic, Toradol, Flexeril, Medrol. Muscle spasms are situation, pain has plateaued, range of motion slowly improving.
Top of upper arm swelled and in pain. Silver dollar sized bruise. Pt states prior nausea and light-headedness had elapsed Friday night. Reoccurred 12 hours, post vax. Pt claims same reaction to arm but no light-headedness with shot #3. Still occurring.
1 day after Td booster, large (6-7cm) local reaction, T 100-102 degrees, myalgias/arthralgia.
Significant amount of hair started falling out.  Diagnosed 10/10/2016 by a Dermatologist as Telogen Effluvium following trauma to my body approx. 2 1/2 to 3 months prior.  I have been totally healthy and have had no trauma incidents except the vaccination. I believe that the PREVNAR 13 shot triggered this reaction that continues as of 10/22/2016 and I am told will continue for at least 6 months with 50% hair loss at a minimum.
No adverse events were reported. The vaccine was administered to the patient who is 17 year old.
Patient felt as if she would pass out and as if she needed to have diarrhea; resolved with positioning, time and application of cool rag over 10 minutes without LOC.
exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal) in 2000 and Penicillin allergy.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Jun-2020 and the estimated date of delivery was 11-Mar-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 08-Jan-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood glucose: normal (normal) normal. On an unknown date, Ultrasound antenatal screen normal: normal (normal) normal.     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.   The patient stated that she was feeling well and that she did not experience any complications.  No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  The estimated date of conception was reported as Jun. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: follow-up received on 29-Jan-2021 included patient information, medical history, due date, and product lot number; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 40-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
nervousness, nerve twitching, right side facial numbness and tingling, tingling in hands, hands cold, bells palsy, "pins and needles" feeling all over
FLU; COLD; This spontaneous report received from a patient concerned a 3 decade old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Crohn's disease (Moderate to severe adult Crohn's disease). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose and start therapy date were not reported, administered 1 in total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 3 decade old. On an unspecified date, the patient experienced flu, and cold (Dose number in series 1). On an unspecified date, patient received non-company suspect vaccine included: tozinameran (Pfizer biotech covid-19 vaccine) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose and start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with tozinameran (Pfizer biotech covid-19 vaccine) (Dose number in series 2) On an unspecified date, the patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tozinameran, and adalimumab was not reported. The outcome of the flu and cold was not reported. This report was non-serious.
We have been on vacation since, 5/21/22. On 5/31/22, we were staying at my inlaws, I had a runny nose and slight cough that I attributed to allergies or the sniffles after get wet and cold on 5/30/22. On 6/1/22, my nose was running again and I was tired, but we went golfing. On 6/2/22, I took a Home Covid Self Test, just to rule out Covid. It was positive. I made an appointment online at a nearby Clinic to get a Rapid Antigen Test. I was able to be tested that afternoon. Again, I tested positive. Because of my Type 2 Diabetes, the Nurse Practitioner said I was eligible for an antiviral medication. My symptoms are gone, as is the medication.
Soreness at the injection site post first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site post first dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site post first dose). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site post first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter   This case was linked to MOD-2021-030677.
expired vaccine was administered; This spontaneous report was received from a physician and refers to a patient of unknown age (reported as 26 (unit not provided)) and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 28-AUG-2020, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S021729, expiration date 20-AUG-2020 (strength, dose, site and route of administration were not provided) for prophylaxis (expired product administered). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021729; expirationdate: 20-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
He was lifting a box at home and had sudden onset of right sided weakness and right sided facial droop and slurred speech
Inflammation, pain, the area got purple/brown (similar to a bruise from a hit). Patient put ice on and then a water bubble sprout (it is understood that it was because of the ice). The patient sent to the ER on 10/11/2019 @ 11:30am where they administered silvadene and benadryl. The discharge instructions were to continue with silvadene.
Interchange of vaccine products; inappropriate schedule of vaccine administration; No adverse effects reported; This spontaneous report was received from the patient's mother and refers to a 18 year old male patient. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.     On an unknown date, when he was 16 years old, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis. Then, when he was 18 years old, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and another dose when he was 20 years old for prophylaxis (route of administration, lots numbers and expirations dates were not reported for both vaccines)( interchange of vaccine products and inappropriate schedule of product administration). However, no adverse effects were reported.
Patient just got vaccinated with 1st dose of Moderna one week ago.  developed fever and body ache 5-6 days later.
really sore injection arm; Initial information was received on 05-Dec-2022 regarding an unsolicited valid non-serious case received from a patient.  This case involves 64 years old female patient who had really sore injection arm after receiving vaccine influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 2021, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (frequency: total) (form, strength, dose, lot number, expiry date: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of really sore injection arm (pain in extremity) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Reportedly,  She says that she is due to take the FLUZONE HD QIV vaccine and wants to find out how bad the side effects are. She also stated that she had a really sore injection arm after receiving Flublock last year but she had reported it at that time.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (really sore injection arm).  At time of reporting, the outcome was Unknown for the event really sore injection arm.
Headache within 30 minutes of injection. Next 24 hours included headache, fever, chills, body aches, nausea, lightheadedness
Extreme head ache, chest pain, fever 101 F. Gave 1000 mg Tylenol, albuterol via nebulizer Q4hr. Died 3/20/2021 approx 11:00 am from Cardiac Arrest.
PT WAS GIVEN A 2ND DOSE OF MODERNA BI-VALENT BOOSTER.  NO ADVERSE REACTIONS NOTED.
throat infection; Upper Respiratory Tract Infection; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (patient) reported, A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, received the first dose of Covid-19 vaccine on 03Feb2021 and asked for the time of appointment for a second dose due on 25Feb2021. On an unspecified date, she mentioned that she had a throat infection last week, had Upper Respiratory Tract Infection. Outcome of the events was unknown.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient given second dose of Prevnar 13, after already receiving a dose on 1/31/2022.
Pt recvd Engerix-B exp sensory paresthesia (mouth, arm, leg) mostly on rt side, 3-4 days p/1st vax; pt has been seen by neurologist;