chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child was traumatized; Patient has only received half a dose, 0.25 ml of the Flucelvax Quadrivalent vaccine; Pharmacist was not able to push the vaccine all the way down; This is a spontaneous case, reported by a pharmacist to Med Communications (reference number: SEQ20-00089) on 07-Jan-2020, concerning a 12-year-old male patient.   The patient's medical history was not provided.   The patient's concomitant medications were not provided.  On 06-Jan-2020, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261219, expiry date: 30-Jun-2020, dose: 0.25 ml, route of administration: intramuscular, anatomical location: leg muscle] for prevention of seasonal influenza. The patient received half a dose because the pharmacist had not been able to push the vaccine all the way down (explicitly coded as Product use issue' and  Incomplete dose administered').  On the same day, after vaccine administration, re-administration was tried, but the patient was traumatized and because of that he did not receive the second half of a full dose.  At the time of initial reporting the outcome of 'emotional distress' was not reported.  This case was assessed as non serious.  The reporter did not provide the causality assessment to Flucelvax Quadrivalent.  Company comment: The patient experienced emotional distress after incorrect dose administered and the suspect product Flucelvax Quadrivalent use issue. Chronology is plausible. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event emotional distress is assessed as related. Incorrect dose administered and product use issue were assessed as not related per company's conventions.; Sender's Comments: The patient experienced emotional distress after incorrect dose administered and the suspect product Flucelvax Quadrivalent use issue. Chronology is plausible. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event emotional distress is assessed as related. Incorrect dose administered and product use issue were assessed as not related per company's conventions.
Swelling under arm, pain and swelling in injection site, swollen lymph nodes, pain in right arm radiating upwards, severe pain and numbness in both legs from hips and ankles. Falling over from legs being weak. Tingling sensation in both legs.
Patient presented to the ED and was subsequently hospitalized for Atrial fibrillation with RVR, Acute on chronic diastolic CHF within 6 weeks of receiving covid vaccination.
After receiving my J&J COVID vaccine on 8/28/2021, I spontaneously began menstruating just 4 days later on 9/1/2021 for the first time since 2017 without pharmaceutical intervention. To be clear, I have not menstruated naturally since 2017 due to medical issues (I am not in menopause bc I do still generate a uterine lining). For the past 4+ years, I have had to use 10 days of progesterone each time I wish to shed my uterine lining (since 2017). The J&J COVID vaccine-induced menstruation lasted 3-4 days of full bleed, with several more days of light bleed for a total of 7 days start to finish. Same thing happened to my sister who also no longer menstruates on her own. And she's reported to me that she's heard of this happening to several of her friends as well, including the reverse issue -- which is they have stopped regularly menstruating when before the vaccine, their menstruation was on time each month.
extreme fatigue and muscle aches; sleeplessness; weak; lasted for 36+ hours; took Motrin and rested; after 48 hours and continued Motrin am 95% recovered
A non-serious spontaneous report of a child got H1N1 LAIV in the eye was received from a pharmacist concerning a seven-year-old female. The relevant medical history was not reported for this patient. On 11-Dec-2009, the patient received H1N1, Intranasal. The child moved her head during administration of H1N1 LAIV, causing portion of vaccine to be administered to her eye. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
PATIENT FAINTED ABOUT 2 MINUTES. PATIENT WAS PALE, SWEATING, NAUSEOUS, & DIZZY.  PATIENT'S BLOOD PRESSURE WAS TAKEN 2 MINUTES APART UNTIL EMT ARRIVED.  PATIENT WAS ASSESSED AND EVENTUALLY WAS ABLE TO LEAVE WITH PARENT.
Minor patient received Covid vaccine (Pfizer) and became very dizzy and felt warm while waiting 15 minutes post-vaccination.  Patient's mother escorted him to the immunization room, where we elevated the patient's feet and gave him an ice pack.  Patient remained in immunization room with his mother, pharmacist and technician for approximately 15 more minutes.  He began to feel better and was able to leave the store with his mother.  Let the family know this would be reported and sent to VAERS.  Also informed family it would be best for this patient to receive his second dose in a doctor's office setting.
a pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to a patient, with no AE; a 54 years old patient was accidentally administered Fluzone High Dose Quadrivalent, No AE; a 54 years old patient was accidentally administered Fluzone High Dose Quadrivalent, No AE; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from the other health care professional via Medical Information (Reference number- 00358460).  This case involves a 54 years old female patient who was supposed to give INFLUENZA VACCINE INACT SPLIT 3V [FLUARIX], but the pharmacist accidentally grabbed and administered a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Prefilled Syringe lot UJ567AB, expiry date: 30-JUN-2021 via intramuscular route in the left arm on 09-Nov-2020 for prophylactic vaccination (Wrong product administered, product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No other vaccines given.  This was a case of an actual medication error case due to the event wrong vaccine administered and inappropriate age at vaccine administration  (latency: same day).  It was also a case of overdose (latency: same day).  No adverse event were noted and no treatments were administered to the patient.  Product used: Used.  First time product used: Yes.  Still using product : No. 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The nurse reported, that they gave FLUMIST quadrivalent for a patient, then later it was found that she was pregnant. The outcome of the event of pregnancy is unknown. The estimated date of delivery is 16-May-2014. The report was considered to be non-serious by the reporter.
16DEC97 8PM hives on thighs-very tired;17DEC97 12MN to 5AM vomiting-abd cramps;no fever;18DEC97 5AM to 19DEC9 abd cramps & nausea;19DEC97 10:30 resolved & went to school
Gastrointestinal diverticular ulcer flare up  Stomach pain, acid build up, GERD, bloating  for 2 weeks Treatment included prescriptions for 3 different antibiotics and 2 acid reducers  Allergic to Polyethylene glycol
Evening of vaccine: great deal of pain near injection site. Following day: more pain starting at elbow and going up arm all the way into the chest, arm is warm to touch and very swollen, Tylenol not relieving pain.
12/28/2021: Event occurred after 2nd vaccine. 86-year-old female who comes emergency department today as a possible code stroke.  Patient is unable to provide any medical information or history.  EMS who brought him to the emergency department daughter states that up until this episode this morning the patient was completely fine and at baseline. CT perfusion showed a large left MCA stroke with a significant penumbra.  I spoke to the neuro interventionalists at hospital who stated that the clot was too large and she was not a neuro interventional candidate.  She tested positive for Covid during her work-up and will be admitted to pulmonology critical care.
Has had fever for 2 days, leg pain, headache, dizziness, tiredness.
Agitation, Headache, dose #2 day #1 abnml taste;day #1 3a: OOB BILAT low leg muscle pain behind thigh/calf (grtr thanDose#1,) lulling HA, back to bed, alarm off at 5:35a, worse pain BILAT, applied heating pad, feeling a little hyper, tried to relax, pain increased throughou  Narrative: dose #2: day#1 abnml taste;day #1 3a: OOB BILAT low leg muscle pain behind thigh/calf (grtr thanDose#1,) lulling HA, back to bed, alarm off at 5:35a, worse pain BILAT, applied heating pad, feeling a little hyper, tried to relax, pain increased throughout daytime day2, inject sit tender, aftnoon; side of back soreness, 5:30p worst pain, thought going ED, applied top ointmt,to bed; woke day 3 3am, pain decr, burn start BILAT; 5:30a side of back burning; time of report- 10:15a moderate pain/ burning BILAT; leg, decr freq of using stiars. employee feels severity, walking with caution at this time  Other Relevant History:
Information has been received from a registered nurse concerning an approximately 6 month old patient who on 17-JAN-2008 was vaccinated at the physician's office with the second dose of ROTATEQ 4 months after the first dose (at 2 months of age) to complete the series. No adverse experience was related to this event. There was no product quality complaint. No further information is available.
Twenty fours after the shot I had flu-like symptoms which lasted for twelve hours. Three weeks after the vaccine I started to have extreme symptoms of Tinnitus which is constant. It is much worse than what I have experienced before. My hearing is also affected in my left year. The hearing loss started before the Tinnitus. The Tinnitus has woken me up at night and it comes in waves in both ears. It has been four weeks and it has not improved. I have had Tinnitus in the past since a car accident and is is usually manageable. It happens more often and is more severe. I plan to see an ENT to consult on the issue.
This spontaneous report was received from a 65 year old female patient, reporting on herself via Pfizer on 14-APR-2016. It was reported that the patient had no pertinent medical history. On an unspecified date in 2012, the patient was vaccinated with a dose of Zoster vaccine live (manufacturer unknown) (dose, route and lot # not provided). Concomitant therapies were not provided. On 23-MAR-2016, the patient received a dose of PREVNAR13 and just hours after the shot the patient's arm started to hurt (also reported as "she got the pain in her arm from the time she got the shot") and on 25-MAR-2016 she started to get a rash. Then the rash got worse and her arm hurts (also reported as "pain got so bad") that she had to go to the emergency room on 02-APR-2016 where she was diagnosed with shingles. The patient mentioned that she was given the antiviral drug and pain medication for shingles. She provided the name as famciclovir 500 mg tablet, three times a day and gabapentin 100 mg capsule, 1 to 4 capsules every 6 hours for shingles pain. She also was given hydrocodone/acetaminophen. There were no laboratory tests performed. At the time of reporting, the patient had not recovered from shingles. Additional information has been requested.
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a Pharmacy intern. This case involves a 77-years old female patient who received vaccine FLUZONE HIGH DOSE lot UJ051AB, expiry date: 05-Jun-2019 via intramuscular route in the left arm on 16-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HAVRIX for Immunisation. It was actual medication error due to exposure via skin contact and vaccine underdose. It was reported that administered the FLUZONE HIGH DOSE vaccine, however some of the vaccine ran down her arm. It was reported that No A/E. 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 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. List of documents held by sender: none.
Inconvenience that occurs at bedtime; Red patches on skin/moving from one part of my body to another/armpit to chest/Not hives, looks like red patches of blood/ underneath my groin; This spontaneous case was reported by a pharmacist and describes the occurrence of DISCOMFORT (Inconvenience that occurs at bedtime) and ERYTHEMA (Red patches on skin/moving from one part of my body to another/armpit to chest/Not hives, looks like red patches of blood/ underneath my groin) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 018B21A and 018B21A) for COVID-19 prophylaxis.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE] (6 months prior to booster) in June 2021. Past adverse reactions to the above products included No adverse event with PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE]. Concurrent medical conditions included Seasonal rhinitis, Arthritis and Liver disorder (Elevated SGPT). Concomitant products included MILK THISTLE [SILYBUM MARIANUM] for Liver disorder, ASCORBIC ACID (VIT C) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced DISCOMFORT (Inconvenience that occurs at bedtime) and ERYTHEMA (Red patches on skin/moving from one part of my body to another/armpit to chest/Not hives, looks like red patches of blood/ underneath my groin). At the time of the report, DISCOMFORT (Inconvenience that occurs at bedtime) and ERYTHEMA (Red patches on skin/moving from one part of my body to another/armpit to chest/Not hives, looks like red patches of blood/ underneath my groin) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not experienced a similar event in the past.  Other Concomitant medications also included Glucosamine Chondroitin for arthritis and Centrum, Omega, Tumeric for unknown indication.  Pharmacist(patient) reported that side effects experienced after 8 days following his 1st Moderna booster dose. Patient did not experience any reactions with primary Moderna doses. Patient inquired about possibility of taking the 2nd booster dose, because patient's symptoms lasted 5 months and resolved on it's own without any treatment.   Patient went on to state that perhaps as long as the vaccine lasted. During the call, the patient mentioned that his doctor advised him not to take the 2nd booster.  Adverse event caused patient to seek medical care from primary doctor.  The events were resolved on it's own without any treatment.
Flu like symptoms began 12 hours or so after injection: headache, lethargy, naseau, felt "unwell".  Symptoms continued for 3-4 days.  Noted that I previously had COVID infection in April  2020 for which I was hospitalized for a week on oxygen.
Information has been received from a consumer concerning her daughter with no drug reactions/allergies who "last year" in 2008 was vaccinated with GARDASIL. There was no concomitant medication. Since then the patient gained a lot of weight and really depressed about it. It was unknown if the patient had sought medical attention. At the time of report the patient's status was not recovered. Additional information has been requested.
he had some discomfort around the injection site.; he thinks it is he that is getting affected when he was providing his address because he had trouble remembering his address and Zip code; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset Jan2022, outcome "unknown", described as "he had some discomfort around the injection site."; MEMORY IMPAIRMENT (non-serious) with onset Jan2022, outcome "unknown", described as "he thinks it is he that is getting affected when he was providing his address because he had trouble remembering his address and Zip code".  The lot number for bnt162b2 was not provided and will be requested during follow up.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: ENH6203), in left arm and on 05Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Dec2014, stop date: 28Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. from 26Jul2022.taken Paxlovid with lot 2815223.  No follow-up attempts are needed. No further information is expected.
Patient's physician recommended the patient receive the pediatric vaccine although he turned 12 several days prior to the injection and qualified for the adult vaccine.  No adverse events occurred.  No treatment indicated.  Will follow CDC recommendations to administer dose 2 with the adult vaccine.  Parent and physician aware.
This spontaneous report was received from a registered nurse, concerning an unspecified number of patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified dates, the patients were vaccinated with improperly stored doses PROQUAD (dose, frequency and route were not reported) lot # M042499 with expiration date of 17-APR-2018. The temperature of the PROQUAD was between 6 °F and 14 °F for a time frame of 1 hour and 30 minutes; no previous temperature excursion was reported. No adverse effects were reported and no product quality complaint (PQC) was involved. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001755:
Seriousness Criteria: Other- Medically Significant (OMIC) From initial information received on 02/Dec/2004 from a HCP regarding an adverse event occurring, it was reported that a 41-year-old male pt received a YF-VAX vaccination, lot number UE181AA, administered subcutaneously in the upper right arm on 02/Dec/2004. At the time of vaccination the patient was also taking Tylenol or Advil. The pt had no illnesses at the time of vaccination, nor did he have any pre-existing physician diagnosed allergies, birth defects or medical conditions. His last Yellow Fever vaccination was eight years ago. Reportedly within 60 seconds of vaccination the pt became pale, cold, and clammy, his eyes rolled back and he became unresponsive with labored breathing and general body tremors which lasted approximately 45 seconds. Upon treatment at the hospital ER the pt was awake, alert and oriented. Reportedly the pt recovered from this experience.
This spontaneous report was received from a 64 year old female patient regarding herself. The patient's medical history included queasiness from some unspecified medications (manufacturer unspecified). On 04-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly. On 04-OCT-2013, the patient experienced arm pain and on the morning of 05-OCT-2013, she found that she "could not get out of bed" and felt like she "had been run over by a truck." She had had a fever from 05-OCT-2013 through the time of the call. She also had a persistent headache which "has subsided." She had also been experiencing chills, "severe sweats," loss of appetite, severe fatigue, diarrhea, and recurring periodic pain in the injection arm. To seek medical attention, she went to an unspecified ER, saw her primary physician twice, and saw an unspecified nurse practitioner. She declined to provide any physician information and declined to provide her demographic information because she wanted to be anonymous. The patient received first received an unspecified pneumococcal vaccine (manufacturer unspecified) "about 20 years ago" and experienced "a little bit of arm pain for a couple of days afterwards" (related MARRS # 1311USA006607). The patient stated that unspecified vaccines administered "intramuscularly hurt more and "may cause more issues" than unspecified vaccines administered subcutaneously. Lab diagnostics studies performed included Blood work and urine and fecal cultures (results not reported). The outcome of arm pain, diarrhea, severe fatigue, loss of appetite, severe sweats, chills, "could not get out of bed" and felt like she 'had been run over by a truck" and fever was unknown. The outcome of persistent headache was reported as recovered. The related ness of the events with PNEUMOVAX 23 was unknown. This is 1 of 3 reports from the same reporter/same patient. Additional information has been requested.
Patient states that about one week after his COVID vaccine, he started randomly having numbness/tingling in his left arm all the way to his hand. He did state that his shoulder was very sore for a few days following the vaccines, which is common. However, this feeling that his arm is "asleep" comes and goes randomly.