chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Registered Nurse called to report a PQC for GARDASIL 9. HCP reports that a Medical Assistant, who is a repeat device user was given a patient a GARDASIL 9 injection and was pushing the last bit of the dose into the patient when the barrel of the syri; RN reports that the MA was injured and received a cut from one of the shattered pieces of glass on her right middle; This spontaneous report was received from Other Health Professional and refers to a female of unknown age (medical assistant).  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-AUG-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/once, lot #W026151, expiration date: 20-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 16-AUG-2023, Registered Nurse called to report a PQC for GARDASIL 9. HCP reports that a Medical Assistant, who is a repeat device user was given a patient a GARDASIL 9 injection and was pushing the last bit of the dose into the patient when the barrel of the syringe shattered into multiple pieces. RN reports that the MA was injured and received a cut from one of the shattered pieces of glass on her right middle finger. RN reports that the MA was able to be treated with topical antibiotics and a band aide and did not require stitches. RN reports that the patient receiving the injection was not injured, and the full dose was given. PQC filed: 02453005. No further AE details. At the time of reporting, the outcome of the event laceration of finger was not known. The action taken with GARDASIL 9 regarding laceration of finger was reported as Not Applicable.  The causal relationship between laceration of finger and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
44 days has passed from dose 1; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (44 days has passed from dose 1) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (44 days has passed from dose 1). At the time of the report, PRODUCT DOSE OMISSION ISSUE (44 days has passed from dose 1) outcome was unknown. Not Provided      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.   This case was linked to MOD-2021-133228 (Patient Link).
Same evening post vax, the pt developed a temperature of 105.8 rectally. Also, he was fussy and listless.
Given Vx exposed for 1 week at 78°F; This non-serious case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Given Vx exposed for 1 week at 78°F). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 30-Mar-2023 The patient's daughter reported that the patient was given the Shingrix vaccination after the medication set out on a countertop for 1 week in a house that was 78 degree fahrenheit.   The reporter stated that the patient lives in an independent care setting with nursing services provided once weekly.   The reporter stated that the Shingrix was delivered to the home in a cold pack.   The patient removed the medication from the cold pack and set it on the countertop.   A nurse practitioner came to the home one week later and administered the vaccine (product storage error).   No further information was available. The phone number belongs to the reporter, as she did not want to give her phone number out of fear that GlaxoSmithKline may try to call the patient, report was made, was not on the call at the time.  The reporter did not want to give her address. The reporter consented to follow-up. The consent was asked but the reporter did not have the information for the physician. The patient received a dose of Shingrix after temperature exposure, which led to incorrect storage of drug.
seizure; Initial information received on 17-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a patient who experienced (seizure), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number, expiry date, route and site of administration were not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  On an unknown date, the patient had seizure (seizure) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  This event was assessed as medically significant as per IME list.  Lab data was not reported.  Final diagnosis was seizure.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for seizure.  Batch number requested.; Sender's Comments: This case concerns patient who had seizure following the vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. The patient's past medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Pain, swelling, redness around half of arm. Stomach cramps, vomiting, fever, shivering, headache.
Patient is now deceased (1.4.22); Hospitalized (1.3.22);  COVID positive (11.21.21 AND 1.3.22); fully vaccinated (prior hospitalizations - see section one for recent history / illness) Admission Date: 1/3/2022 Deceased:  1/4/2022 Discharge Disposition: Deceased   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Shock Septic shock    HOSPITAL COURSE: Patient s our 80 y.o. female who resides at assisted living facility with pmhx of insulin-dependent diabetes (presumed type 1), history of DKA, Parkinson's disease and dementia, CKD 3a, hx of DVT and PE on eliquis who presented to the ED via EMS after she was found to be confused this morning and hypotensive. She had mild AKI, leukocytosis, and bicarb of 6 with pH of 7.4.    Upon our evaluation, patient was requiring vasopressor support with norepinephrine. She was tachypneic into the 40s. HR continued to increase, patient in afib with RVR rates in the 200s. We attempted DCCV 1 time without success. She was given fentanyl of 50mcg and 2mg of versed for this. She did not tolerate this well. pH returned down to 7.16. Pressor requirements escalated and goals of care discussion had with DPOA (son) and daughter. Eventually it was decided for code status to change to comfort care. The patient had blood pressure MAPs in the 40s-50s overnight. Patient passed at 12:04 on 1/4/2022.
Expired dose used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose used) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021 at 11:37 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The Moderna vial (10 dose, 0.5ml) was removed from the freezer to the refrigerator on 10-11-2021 without any temperature variations in the transfer from the freezer.  No treatment was reported.
Patient reported that she had a red, itchy rash on her face and arms. She also reported mild tightness in her throat.
induction of underlying autoimmune disease lasting at least 3 weeks.    muscle and joint generalized aches that are specific for her sjogren flares
Severe headache, pains in jawbone & chest, trouble swallowing - passed out twice. Paramedics responded to 911 call. Eventually pains subsided.
A report was received from health care professional on 19 November 2003, concerning a 54 year old male vaccinee who experienced angioedema which was considered to be medically significant (OMIC) the day after inadvertently receiving Fluvirin intradermally on 14 November 2003. On 15 November 2003 the vaccinee experienced angioedema with generalized blotchy edema and pruritus after inadvertently receiving Fluvirin intradermally. The vaccinee was treated with cetirizine hydrochloride. At the time of the report the angioedema was improved but continuing. There was insufficient information to determine the reporter's causality assessment. Follow-up pending. See ref: PJP-2003-0115.
Right sided rib pain; Pain at the injection site; Warmth at the injection site; Feeling faint off and on.  Never fainted; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th May 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site warmth and felt faint. On 10th May 2022, the patient experienced rib pain. On an unknown date, the outcome of the injection site pain and injection site warmth were recovered/resolved and the outcome of the felt faint and rib pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, felt faint and rib pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The case was self reported by the patient. The patient received her dose of Shingrix vaccine and next day, she started feeling faint off and on. The patient never fainted. The patient also reported that the day after her Shingrix shot, she had pain and warmth at the injection site.  The injection site symptoms have resolved, but she was still having intermittent bouts of feeling faint. In addition, she stated that she started with right sided rib pain this morning on day of reporting. The patient did not have any further information about the vaccine or want to give any additional demographics. The reporter did not consent to follow up.
Pt reported feeling light headed and reports swelling of the tongue. Initial BP upon report of complaint is 156/74, repeated BP at 1024 and 134/91 with 97%sp02. Initial spo2 was 97%.  Patient received Benadryl 25mg and continued to be observed.  Patient was released to home after 30 additional minutes of observation with some symptom relief.
Patient treated with BENADRYL as needed and ice as needed. Left thigh with mild erythematous macular rash at sites of both PROQUAD and KINRIX injections.
arm started to get sore; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 12:00, at single dose, for covid-19 immunization, at the workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 17:00, the patient's arm started to get sore and continued to get more sore throughout the evening. It was much better when she woke up in the morning of 27Jan2021, and the pain was fully resolved by 17:00 on 27Jan2021. No treatment was given for the event. The patient recovered from the event on 27Jan2021 at 17:00.
No adverse event reported however dose given as 2nd booster was expired at time of administration.  Vial was pulled from the refrigerator on 8/9/22 10:47Am.  Dose given from that vial on 8/10/22 2:31pm.
Patient came back to the pharmacy almost a month after vaccination still complaining of soreness of the arm. No redness, no swelling, no bruising, no range of motion issue. Just tenderness.
Information has been received from a registered nurse concerning a 70 year old female with no medical history who on 08-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  There was no concomitant medication.  On 09-NOV-2007 the patient developed a headache and her eyes won't focus.  The patient also had red spots on her body which had gone away.  No treatment was recommended.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested. 02/12/2010 No further information is available.
Pfizer-BioNTech Covid-19 Vaccine EUA I felt fine the day of the injection at 2PM (3/24/21). I slept poorly and woke up feeling exhausted (3/25/21). Developed a fever of over 101 degrees Fahrenheit and was resting in bed.  At around 2:45PM I used an oximeter and noticed how my pulse was steadily increasing within a few minutes - from 80's to over 135 and then I fainted. I was in bed and didn't fall. After I came back after maybe 1/2 minute I was still dizzy but started feeling better shortly. As my husband happened to observe me passing out we went to the ER. At around  3:45PM my blood pressure, when checked in the ER, was 102 over 58 and my temperature had gone back down to 98.4 degrees. I started feeling better quickly after that. I was tested for a heart attack which was negative and released later that evening.
Shingles rash on his back; Shingles rash on his back; Pain; Itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HIGH DOSE) for prophylaxis.   Previously experienced adverse reactions included shingles (30 years ago).   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received FLUZONE HIGH DOSE (intramuscular). In September 2019, couple of days after receiving Shingrix, the patient experienced shingles, rash, pain and pruritus. On an unknown date, the outcome of the shingles, rash, pain and pruritus were unknown.   It was unknown if the reporter considered the shingles, rash, pain and pruritus to be related to Shingrix.  Additional information received were as follows: The caller was wife of the patient, and patient also came on the line to provide information for the report. A couple days after receiving Shingrix, the patient experienced shingles rash on his back with associated pain and itching. The reporter consented to follow up.
Outbreak of herpes simplex virus around the lips.  Still ongoing.  Treating with Abreva.  I haven't had an outbreak of herpes simplex virus in over 10 years.  I feel that this outbreak is directly related to receiving the COVID vaccine as I have a strong immune system, no sickness, and no excessive stress.  I am a very healthy adult.  Medical workup for wellness was conducted 9/9/21 and blood work showed that Vitamin D level  had dropped to 14.  I'm not sure if this is related to the vaccine, but thought it was worth mentioning since it happened after receiving the vaccine and it dropped to such a low level.  Doctor prescribed a high dose vitamin D supplement.   Calcium levels dropped below normal levels.  This was odd as well as calcium levels have always been in the normal range.  Doctor suggested taking an over the counter calcium supplement to get levels back to normal.  I thought it was worth mentioning since this occurred shortly after the vaccine as well.   I experienced no serious side effects.  The only other side effects were the described side affects of injection site pain, fatigue and muscle aches. I also had a headache that was reoccurring over a few days.
left distal femur replacement and radical resection of femur and femur hardware removal. Patient tested positive for COVID 19 but remained asymptomatic
Pt received DTAP on 4/25/11. On 4/26/11 developed rash like blisters around area. On 4/28/11 cellulitis the size of saucer, warm - no fever.
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 04-MAY-2015, the patient was vaccinated with one dose of PROQUAD (Merck) that had been improperly stored (subcutaneous, lot # K025760, expiry: 08-JUN-2016, dose not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. This was unreported at the time of the original error and was found with a data search on the vaccine system. Shortly after this error was made an ID/birth date validiation requirement was put into place.
Pt received multiple shots listed below and passed out when yellow fever administered. Pt tried to stand up and limply went to ground. Held as best I could and got pulse. called tech to get 911. He woke up and asked not to call. Gave OJ after he sat up. Pt left store about 40 minutes later refused to go with paramedics they took vitals.
heat turned up to maximum in his room and he still felt cold; felt incapacitated in bed whole day; in bed whole day; muscle aches that never seemed to go away/muscle pain; fever; bad chills; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING COLD (heat turned up to maximum in his room and he still felt cold), GAIT INABILITY (felt incapacitated in bed whole day), BEDRIDDEN (in bed whole day), MYALGIA (muscle aches that never seemed to go away/muscle pain) and PYREXIA (fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0131A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Mild) and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, AMLODIPINE for Hypertension.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced GAIT INABILITY (felt incapacitated in bed whole day), BEDRIDDEN (in bed whole day), MYALGIA (muscle aches that never seemed to go away/muscle pain), PYREXIA (fever) and CHILLS (bad chills). On an unknown date, the patient experienced FEELING COLD (heat turned up to maximum in his room and he still felt cold). On 11-Mar-2021, GAIT INABILITY (felt incapacitated in bed whole day), PYREXIA (fever) and CHILLS (bad chills) had resolved. On 12-Mar-2021, BEDRIDDEN (in bed whole day) had resolved. At the time of the report, FEELING COLD (heat turned up to maximum in his room and he still felt cold) outcome was unknown and MYALGIA (muscle aches that never seemed to go away/muscle pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  Patient had annoying muscle aches in the morning, which would dissipate throughout the day.   This case was linked to MOD-2021-405274 (Patient Link).
Patient presented to the dr's office on 8/29/23 with shortness of breath, fever, general fatigue and malaise and pain at injection site. She was given an albuterol nebulizer treatment on 8/29/23 at the office and then was prescribed an albuterol inhaler and tylenol for fever and pain. She was also instructed to get a pulse oximeter and take her oxygen levels, temperature and blood pressure and report to the office the next day. On 8/31/23 she was admitted to the hospital.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 14 year old female patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot # not reported) on 19-NOV-2012. No other co-suspects were reported. There were not concomitant medications. The physician reported that on 19-NOV-2012 the patient was administered her first dose of GARDASIL and a subsequent urine pregnancy test was positive on that date. The patients LMP (approximately in 2012) and EDD were unknown. Initial exposure to GARDASIL was at an unknown gestational period. The patient sought medical attention at the office3. No treatment was given and the patient was referred to an obstetrician for follow up care. Complete blood count and metabolic panel were also ordered on 19-NOV-2013 (results not provided). Follow up information was received which stated that EDD was approximately July 2013. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-OCT-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2011, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.