chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone HD was administered to a 64 years old female/no AE; Fluzone HD was administered to a 64 years old female/no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a Other Health Care Professional.  This case is linked to case 2019SA274329 (same reporter).  This case involves a 64 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy at the time of vaccination.   On 30-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number UJ268AAA via Intramuscular route in left deltoid.  It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age) and overdose(overdose). The vaccine was administered by a Physician or a Healthcare professional (not confirmed).  It was unknown whether adverse event was noted or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
same thing happens to me; Initial information was received on 15-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.   This case involves a patient (age and gender unspecified) who was sickness (Illness), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient was sickness (Illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Urticaria this AM with a 15 second seizure.  No fever.  All symptoms resolved without treatment except for the itchy urticarial rash.
At time of shot, burning in arm as serum was being injected, and extreme dizziness where I almost fell off the chair. Dizziness lasted for a few minutes which created nausea. Sat at site for approximately 25 minutes after shot. Left arm was sore between shoulder and elbow, which was to be expected. Later in the evening, experienced fatigue. When trying to go to bed around 11pm,  my left are was throbbing. I did take Tylenol at about 6pm. Throughout the AM hours, sever body aches started, extreme fatigue throughout the following day. Flu like symptoms continued the next day.  I had heard of these symptoms for the other shots but not for Johnson and Johnson. Hungry but too weak to actually cook.
Elevated fever, sz-2x; 103R dx OM point red rash ontorso started 8MAR91-hosp 8MAR91PM 11MAR91AM;
Patient came to ems table by staff complaining of chest pressure In the centre of her chest. No sob or other symptoms.  4 led ekg show nsr at 90 bpm. Rep 18 spo2 96% b/p157/60. Pt skin color was normal. . Pt sat down on tbe stretcher. After about 10 min pt states the pain has subsided.  Pt stats migh have been  indigestion.  Pt was advised to f/u with pcp.  Pt did not want to ge to er.
patient was looking to finish their vaccination schedule for Shingrix, having had received the vaccine approximately 4 years prior; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received approximately 4 years ago).   On an unknown date, the patient did not 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 Information: GSK receipt date: 30-DEC-2022 Reporters comment: The pharmacist reported that patient was looking to finish their vaccination schedule for Shingrix, having had received the vaccine approximately 4 years prior. No other information was provided, even after having been solicited.  Information about vaccine was unknown or vaccination site. The healthcare provider wished to not be contacted by the safety team but did wish to receive medical information. The reporter did not consent to follow up. Additional Supportive information: The patient received the vaccine 4 years ago and she did not receive the 2nd dose yet which led to incomplete course of vaccination.
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (expired vaccine used) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031B21A) for COVID-19 immunization. No medical history reported. On Sep 24, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 24, 2021, patient administered expired product (expired vaccine used). On Sep 24, 2021, administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient did not have any adverse event and did not require any medical attention.
Stiffness and pain in joints of bilateral wrists and hands beginning day after vaccination and continue currently
administered the first shot of Moderna Covid 19 Vaccine more than the recommended dose (1.65 ml) to a patient; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (administered the first shot of Moderna Covid 19 Vaccine more than the recommended dose (1.65 ml) to a patient) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1.65 ml. On 19-May-2021, the patient experienced ACCIDENTAL OVERDOSE (administered the first shot of Moderna Covid 19 Vaccine more than the recommended dose (1.65 ml) to a patient). On 19-May-2021, ACCIDENTAL OVERDOSE (administered the first shot of Moderna Covid 19 Vaccine more than the recommended dose (1.65 ml) to a patient) had resolved.        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.   Concomitant drug included unspecified  allergy medications.Treatment for the event was not reported. Reporter stated that patient was administered 1.65 mL of vaccine that was 4 (2+2) doses on alternative arms.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Added first dose start date,medical history and concomitant medication.
The parents of this patient related that the patient had a 3 day history of fever, fussiness, local red, warm, tenderness, and high pitched crying. Question shuddering behavior vs seizure-like activity.
I received the shot at approximately 5:00 pm on June 15th. When I woke up at 7:00 am the next day, June 16th, my arm was incredibly stiff and sore to the touch at the injection site. No noticeable abrasions, lesions, marks, etc. though. My body ached just like when flu symptoms are present. I have a slight elevated fever of 100 degrees, a headache, slight dizziness, some brain fog, and chills.
5 hours after receiving the flu shot, pt had diffuse redness of face and swelling of face. mother treated patient with a cool compress and redness improved by the next day. did not seek medical care at the time.
2 min after vaccine, felt dizzy, nausea.  some vertigo when turn your head. no respiratory symptoms, chest pain.  felt heart racing.  we gave her apple juice and had BP that was 142/96  HR 64-70  Sat on RA was 98%.  Felt a little better after juice, and felt like could stand and then was able to turn head without vertigo.  Then went to car, drank fluids, ate something, and sat in car for 30 min.   Then felt no vertigo and safe to drive.  That night had very bad headache, lasted about 24 hours.  Dizziness lasted for 36 hours.   HA was for 24 hours.
Rash on left arm with moderate swelling at injection site, BENADRYL relieved symptoms within 2 days.
Case number PHEH2013US024965, is an initial spontaneous report received from a physician on 25 Nov 2013 with follow-up received on 07 Jan 2014. This report refers to an 81-year-old polymedicated female patient. Her medical history included hypertension, hypercholesterolemia, gastrooesophageal reflux disease, seasonal allergic rhinitis, diabetes mellitus type 2, arthritis, dementia due to traumatic brain injury, thyroid nodule, chin laceration, dizziness, impacted cerumen of both ears, pre-ulcerative corn or callous, orthostasis, neurological deficit present, glaucoma and elevated liver enzymes. She was hospitalized in 2010 due to intracranial hemorrhage and recurrent fall. She was vaccinated with FLUVIRIN (batch number: 1309801, expiry date: May 2014) inadvertently one dose from opened and unopened MDVs that were stored below the recommended mentioned temperature, at dose of 0.5 ml intramuscularly into left arm on 20 Nov 2013. The reporter stated that, the vaccine was not frozen upon administration and was unsure if the vaccine had frozen during the temperature excursion. It was reported that, FLUVIRIN was opened and unopened MDVs reached 32 Fahrenheit (F) for 6 hours on 14 Nov 2013 and 16 Nov 2013. On 17 Nov 2013, it reached for 31 F for 6 hours. No more information was available. Follow-up received from physician on 07 Jan 2014: Updated patient demographics, medical history, concomitant medications and site of vaccine administration.
Severe headache, malaise, and neck stiffness starting about 1 day after vaccine and lasting 3 days.  Symptomatic treatment with ibuprofen OTC.
slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; joint pain in elbows; extreme chills; migraine was at a level of intractable pain; maybe a low grade fever of 99F; This is a spontaneous report from a contactable other hcp (Anesthesiology, patient).  A 49-years-old male patient received second dose of bnt162b2  (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 07Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Medical history included migraines headaches. This was migraine plus; extreme pain which he took  migraine pain medicine.  The patient's concomitant medications were not reported. The patient previous received 1st dose of  bnt162b2.The other HCP reported: On Thursday 07Jan2021, he received the 2nd shot at 8:30am, then about 3-4pm he had symptoms of slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts.  Throughout the evening into the next day, he suffered chills that went away, joint pain in elbows; headache pain, which he had to do migraine medicine again. Saturday morning he felt better, he don't have a headache, but for a good 36 hours, migraine was at a level of intractable pain since Jan2021. He never had a fever, well maybe a low grade fever of 99F in Jan2021.  The even outcome of chills  was recovered Jan2021, headache was recvoered on 09Jan2021; outcome of other events were unknown.  Information on the lot/batch number has been requested.
Fever pt was acting crazy, crying spells pushing chairs over for no reason; nothing serious but don't know what affect it might have later so felt should be reported; pt recvd 2 DTP's in same day
Vaccine was expired on 22-Sep-2021 and patient administered on 08-Apr-2022; Patient received the Moderna vaccine beyond the 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was expired on 22-Sep-2021 and patient administered on 08-Apr-2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 22-Sep-2021 and patient administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was expired on 22-Sep-2021 and patient administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   This case contains information on 18th of 45 adult patients as described by the reporter.  No concomitant medication was reported.    It was reported that patient took vaccine on 08Apr2022, after the date reported as 22Sep2021. The expiration date reported as 22 Sep 2021.  All 45 patients were adults, who received the Moderna vaccine beyond the 30 days use by date and no additional information provided. Doses stored in standard freezer for the lot 031B21A with 2 degrees F high and minus 1 degrees F low on 31Mar2021 was reported.   No treatment medication was reported.
received only adjuvant portion; received only adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number D4PA4, expiry date 10th February 2023) for prophylaxis.   On 18th November 2021, the patient received Shingrix. On 18th November 2021, 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 details were reported as follows: The registered nurse reported that a patient received only adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not specify if it was 1st dose or 2nd dose of Shingrix. The reporter consented to follow up.
accidentally administered 1mL instead of the standard 0.5mL; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) was given twice the amount of the vaccine.    The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 09 Feb 2021, the patient received accidentally administered 1mL instead of the standard 0.5mL dose to a patient. The pharmacist was not in the office and did not have access to the Patient Information or Medical Information. Pharmacist is inquiring about the most common side effects reported with the Moderna COVID19 Vaccine. Pharmacist would like to receive information via email.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided  The event gave twice the amount of the vaccine was considered resolved on 09 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered, and overdose for mRNA-1273 with no associated AEs.
Information has been received from a registered nurse concerning a 21 year old female with no past medical history and no drug allergies who on 08-NOV-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 653978/0955F) (0.5 ml), intramuscularly in the left deltoid. Concomitant therapy included minocycline HCl (MINOCIN). On 08-NOV-2006 the patient experienced skin discoloration around injection site.  The discoloration was slightly lighter than her skin color and was shaped like a "C" to the other side was 20 mm. The area was not raised or sore. She mentioned that she had some mild soreness at the injection site for one to two days after the vaccine was initially administered. The patient had no other symptoms.  There were no relevant diagnostic tests performed.  Unspecified medical attention was sought.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning a 21 year old female with acne and no drug allergies who on 08-NOV-2006 at 1:20 PM was vaccinated with a first dose of GARDASIL (lot # 653978/0955F) (0.5 ml), intramuscularly in the left deltoid. Concomitant therapy included MINOCIN. On 08-NOV-2006 the patient experienced skin discoloration around left deltoid (injection site). The discoloration was slightly lighter than her skin color and was shaped like a "C" to the other side was 20 mm. The area was not raised or sore. She mentioned that she had some mild soreness at the injection site for one to two days after the vaccine was initially administered. The patient had no other symptoms. The area was still noticed approximately 8 weeks after vaccination, and denied other adverse reactions. Subsequently on 26-JAN-2007, the area was inspected. C shape was now a complete circle with center the same color as surrounding skin. After close inspection, the area was the same size and shape by Band aide used to cover injection site with lightened area corresponding to the adhesive on the Band aide. The patient received a second dose of GARDASIL on 26-JAN-2007. There were no noticeable skin changes at the time of the report. There were no relevant diagnostic tests performed. it was reported to be unknown if the patient recovered. Additional information has been requested.
Painful red area on (L) arm. Told to watch for signs of infection (Temp, area warm to touch, swelling etc.) call if symptoms change or worsen.
Initial and follow-up information has been received through Pregnancy Registry for a 22 year old female consumer with 2 previous full term deliveries  who on 28-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (lot # 656050/0245U).  There was no concomitant medication.  On approximately 04-Sep-2007, the patient had a pregnancy test which was positive (LMP approximately 04-JUL-2007).  The patient reported having an ultrasound;  however, no additional information was provided.  The patient sought unspecified medical attention.  On 30-OCT-2007, the patient had a positive pregnancy test.   The estimated conception date is 27-JUL-2007.  The estimated  date of delivery is 09-APR-2008.  In further follow up, a nurse practitioner reported that the patient delivered a female baby on 23-MAY-2008.  The baby weighed 10 pounds 2 ounces, was 20 inches, and the APGAR score was unknown.  The infant was macrosomic and had no other abnormalities or complications.  During pregnancy, the patient experienced anemia (HgE 10.9).  The patient experienced failure to progress because of the large baby during the labor/delivery.  On 14-DEC-2007, the patient had an ultrasound which was within normal limits.  On an unspecified date, the patient had a positive alpha-fetoprotein test.  There were no infections or illnesses during pregnancy.  Follow-up information was received from a nursing supervisor who stated that the patient went to their offices on 11-JUN-2008 suffering post-partum depression and was referred to "psych".  Additional information has been requested.
Patient received COVID-19 vaccination on 1/14/2021. On 1/17/2021, patient was transferred to Hospital s/p multiple cardiac arrests. Patient was hyperkalemic and in acute renal failure at time of transfer. Hyperkalemia was treated, but the patient suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF of 40-45% and elevated troponins.  Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021. Ultimately we suspect that the patients condition was a direct result of his underlying disease states, but wanted to make sure reporting was made available.
On 08/09/2023. Patient was vaccinated by RN for Measles, Mumps, Rubella(MMR), Polio, and Varicella. RN completed pre-screening of contraindications/precautions related to vaccine administration and patient medical history. Patient's Mother no history of adverse reactions with vaccines . No allergies or history of immune system problems/previous health conditions. Patient was vaccinated for varicella vaccine administered in Left arm subcutaneously and 2 minutes post-vaccine reported of numbness of ears, dizziness, and seeing of visual spots. Vaccine administered on both arms subcutaneously varicella on left arm measles mumps and rubella and polio on right arm. Patient was assisted to floor with yoga mat, patient is given juice and energy bar, and no further symptoms reported. Continued to monitor client while on yoga mat with legs elevated. Patient instructed to move legs and feet for blood circulation. Patient's vitals assessed at 1140 respirations: 16/min Blood pressure: 96/61 mmHg. Oxygen: 98% heart rate: 49 bpm. 1145 patient denies throat discomfort, or headache. Respirations: 18 Heart rate is 50 bpm Oxygen: 97% blood pressure: 91/63 mmHg. 1150 patient denies headache, no visual impairment, patient denies dizziness. Does not feel throat discomfort Respirations: 18 Heart rate: 53 Oxygen: 97% Blood pressure: 96/59mmHg. 1155 patient denies headache, dizziness, throat discomfort. Parents request and consent for remaining two vaccines, polio and MMR to be administered today. RN administered these two vaccines into client's right arm subcutaneously. Client did not have any further syncope symptoms. Client was observed for an additional 10 minutes post vaccination. Parents were educated on th signs and symptoms to watch for over the next few hours. Final set of Vitals taken standing: Respirations: 18 Heart rate: 68 bpm oxygen: 100% blood pressure: 102/66 mmHg. RN recommended following up  with a primary health care provider and seeking urgent or emergency services if needed as well as importance of providing hydration and nutrition prior to vaccine and maintaining a seated position post-vaccination. Patient left in care of mother, able to ambulate with an even/steady gait.