chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US004272 is an initial spontaneous report received from a consumer on 27 FEB 2014. This report refers to a 16-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on an undetermined date in DEC 2013, two weeks before Christmas. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 27 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
an extra dose of FLUBLOK was inadvertently given to a patient with no adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non health care professional via Media Information (under reference 00838813).  This case involves a 59 years old female patient who received an extra dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 26-Oct-2021, the patient received dose of the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot 2FAA2132 and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid and On 02-Nov-2021, she received dose of same vaccine (lot 2FAA2118 and expiration date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (same day latency).  It was reported "He wanted to know if there are any symptoms or special circumstances that the patient should be aware of with an extra dose of Flublok."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
MMRV given to patient when she is 14 years old. Cut off age for MMRV is 12 years old.
felt a bit of nausea; clammie, and shivers.; shivers.; felt feverish, but mytemp. Was 97.7; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, 4 days after receiving Shingrix, the patient experienced nausea, clamminess, shivers and fever. On an unknown date, the outcome of the nausea, clamminess, shivers and fever were unknown.   It was unknown if the reporter considered the nausea, clamminess, shivers and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient received Shingrix vaccine and felt a bit of nausea, clammy, and shivers.  The patient felt feverish, but temperature was 97.7. The reporter asked was this consistent to the side effects.
Resident received expired Modern vaccine, expired on 10/13/2021. No ASE noted.
After properly placing needle in pt left deltoid, syringe separated from hub of needle. No vaccine was administered from that dose. Needle removed from pt arm, incident explained in detail to patient. New syringe obtained and vaccine given to patient. Pt observed for 15 minutes post injection, no adverse events to patient
DIZZINESS; This spontaneous report received from a patient concerned  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.
I received the RVS shot on Sept. 13, and my arm was sore for 4 days.  Late Sept  16 at night, I woke up from sleeping on that side (left side where I received the shot) and moved it.  I immediately felt pain that was more painful than I'd ever felt before at the top of my  my left shoulder down to the injection site..  It made me cry--and I don't do that.  I immediately took 2 Advil tablets, and within a few minutes I fell asleep.  When I woke up at 7:30 a.m., the severe pain was gone, and now it only hurts a little when I move it in one direction.
Woke up with extreme dizzyness, nausea and cold/numb hands. After consulting with a doctor over the phone, was advised to go to the ER to check vitals and be examined. Blood pressure dropped when I stood up, after being screened for heart and stroke (negative), blood tests for anemia and electrolytes (negative), was given IV fluids. Determined that I had "vascular depletion" / dehydration (likely from antibody reaction / drawing on vascular system).  Additional symptoms included fatigue and sore arm).
Patient was given the vaccine, stated she feels like she was going to faint. Patient was given water & benadryl. Onsite EMS was called vitals Hr 84 BP 101/66. 4:42 she felt better and went home.
Patient received FLUZONE QUADRIVALENT 2017-2018 in the left deltoid, and then received PROLIA subcutaneously in the right upper arm. Within 60 seconds, the patient complained of lightheadedness. I instructed her to stay in her seat and to let me know if it got worse of she thought she was going to pass out. The patient promptly passed out and started to fall forward out of her chair. I was able to catch the patient and return her to a sitting position and called for assistance to lay her on the floor, and elevated her feet. A nurse from the walk in clinic next door came over to assist, and I had a technician call 911. While waiting for EMS to arrive, we talked to the patient who was alert to person and place, but was having difficulty breathing and her skin was pale. I took her blood pressure as 78/45 with a pulse of 77. Five minutes later it was taken again at 68/48 and pulse was 88. At that time she started shaking her hands and we asked her what was wrong and she stated that she was experiencing numbness/tingling in her extremities. EMS arrived shortly thereafter and they took her blood pressure again and it was 65/44 with a pulse of 88. She was then taken to Emergency Department. Patient reports no adverse events to any vaccines or to PROLIA previously.
A few minutes after receiving the vaccine, patient started feeling light headed and dizzy. Then patient stated that she was having trouble breathing. We called 911. During evaluation by EMS, patient seemed fine but said she still experienced trouble breathing. She as taken to the hospital for further evaluation.
She only had one as it gave her a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (She only had one as it gave her a rash) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Psoriasis (she had problems with her Psoriasis). Concomitant products included TOFACITINIB CITRATE (XELJANZ) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (She only had one as it gave her a rash). At the time of the report, RASH (She only had one as it gave her a rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It was reported patient asked if patient could try another vaccine other than the Moderna vaccine. patient doctor advised not to take anymore vaccines for Covid.  No treatment medications were reported.
Intense Vaginal dryness and severe itching- Dr. said it looked like a herpes outbreak.
Headache, Myalgia, Arthralgia & UrticariaPruritus Narrative:  sweating, chills, upper body aching, not able to  lift left arm above shoulder hight, neck stiffness,
Patient developed purple bruising  1 day after vaccination. 2 days after vaccination, the patient's arm turned completely black and patient scheduled appointment with doctor. The symptoms continued to worsen with bruising and patient experienced bone pain. The doctor suggested physical therapy. 1 year later, patient had no visible bruising, but says that bone pain occurs occasionally.
Presented to the ED with c/o multiple falls ongoing for few days, with most recent today. COVID-19+ but asymptomatic
Patient reported sensation of throat swelling and shortness of breath IM epi given per protocol and 10mg zyrtec 911 called and patient taken to ER
Severe joint pain for 36 hours, unable to walk far distances or tolerate being up >2 minutes. Unable to achieve comfortable position. Visibly swollen axillary lymph nodes on side of injection starting 48 hours after injection
Pt had a slight itch, pulled her sleeve and noticed there were blotches (rash). Rash continue to spread down to elbow each day, swelling, redness, itchiness, stinging, and hot to touch. Turned from blotches to swelling of whole area. By the 9th, redness continued up neck and cheek and put ice pack on it. By Sunday it was gone. Pt did put hydrocortisone cream
Bladder problem; Cystitis; He has been really sick for 3 months after the second dose; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 (Lot Number: ER8735) (at age of 48-year-old) as 2ND DOSE, SINGLE for covid-19 immunization. Patient took the first dose of vaccine on 15Mar2021 (Lot Number: EN6204) (at age of 48-year-old) for covid-19 immunization, no reactions until the second shot. The patient medical history was none. Family Medical History Relevant to AEs was also none. Concomitant medications were not reported. Prior Vaccinations (within 4 weeks), there was no other vaccinations. The patient experienced bladder problem (hospitalization) in Apr2021 with outcome of not recovered, cystitis (hospitalization) in Apr2021 with outcome of unknown, He has been really sick for 3 months after the second dose (hospitalization) in 2021 with outcome of unknown. The second shot was on 03Apr2021. Bladder problem was two weeks after. It was 3 months back from this date. It was ongoing, his quality of life was gone. It was persisting. He sought out treatment from anywhere and everywhere he could. He has a bladder problem and he has several problems he didn't have before. It created what they call cystitis he thinks its IC for men. Cystitis stated the same time. It has worsened. Treatment was reported as "Yes, no just leave it at that". He has been really sick for 3 months after the second dose. The adverse events resulted in Emergency Room Visit and Physician Office Visit.
Pregnant patient received the 1st dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) in a 44-year-old female patient (gravida 5, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Prior Use), Induced abortion (2 times in 2000 and in 2001) and Miscarriage (Spontaneous abortion) on 14-Oct-2011. Concurrent medical conditions included Hypothyroidism (since 2009). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and SERTRALINE for an unknown indication.    On 29-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 05-Dec-2020 and the estimated date of delivery was 18-Sep-2021. On 29-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  On 29-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported Induced abortion Nov2001 and Apr2000,also history of Spontaneous abortion on 14OCT2011 and had a full term child birth.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Internal review on 21-Jul-2021 resulted in updates to the pregnancy details
she felt chills, weakness, soreness in the arm, and lower back pain after the first dose; she felt chills, weakness, soreness in the arm, and lower back pain after the first dose; she felt chills, weakness, soreness in the arm, and lower back pain after the first dose; she felt chills, weakness, soreness in the arm, and lower back pain after the first dose; This is a spontaneous report received from a contactable consumer (reporting on herself) via Pfizer-sponsored program . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she felt chills, weakness, sore-ness in the arm, and lower back pain after the first dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Left thigh with 2-3cm x 1-2cm erythematous and slightly swollen - with some mild firmness and tender to touch
18SEP91 mom stated pt became very pale & lethargic; thought respirations shallow; poss low grade fever; 18SEP91 transient DTp rxn; ER visit-color-nl, resp-reg, HR-reg, fontanels-nl;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 25-SEP-2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
She began to have headaches, fever, and sore throat. They tested her for Strep, COVID-19, and Flu, but all were negative. She began to get worse. Later I took her temperature, and it was 104. She also started to breathe heavily, have a stuffy nose, and had an extreme nosebleed, and a lot of coughing. We then rushed her to the emergency room, and she tested positive for Strep. During this time, she broke out into hives as well. The hives started to go away, but her mouth became very drive and had bumps on her tongue and mouth. We went back to the HCF, and they told us she had Coxsackieviruses, which lead to hands, foot, and mouth.
Patient received Moderna COVID vaccine dose #1 on 4/30/21 at another facility. Patient came to our facility for dose #2 on 6/29/21, but inadvertently received Pfizer COVID vaccine (instead of Moderna). There's no adverse event to the patient, this is being reported as an administration error.
This spontaneous report was received from a other health professional (medical assistant) which refers to an unknown number of patients of unknown ages. On an unknown date the patients were vaccinated with GARDASIL, 1 DF. Other suspect therapies included PNEUMOVAX 23, PROQUAD (Merck) and VARIVAX (Merck). Route and indication were not provided. On an unknown date the patients experienced have been administered GARDASIL, PNEUMOVAX, PROQUAD, and VARIVAX that were improperly stored and no adverse effects. No concomitant medication were provided. The outcome of have been administered GARDASIL, PNEUMOVAX, PROQUAD, and VARIVAX that were improperly stored and no adverse effects is unknown. Action taken with the therapy drugs was not reported. No further information were provided.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6° Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA002453.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 4:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month. On 04-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened. The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.   This case was linked to MOD-2021-402935 (Patient Link).
vaccine diluent used was sterile water not 0.9% sodium chloride - vaccine error but no adverse event. Patient re-vaccinated.
Received BEXSERO to left deltoid, the next morning noted inability to move left shoulder. Mild pain over injection site. No H/O injury. Pt doing home physical therapy.
inconsolable >3hr w/in 8hr of vax;finally settled 10PM & slept thru noc;
On 1/20/21 I had the 1st Covid 19 vaccine in my left arm at 1:10pm and at exactly 9:00pm that evening I experienced a pain on my right side that went along the outside starting at the base of my little toe and continuing to the heel of my foot and from there going right on up the outside of my right leg to the base of my hip.  At  this point I laid down which made the pain a little better.  I tried rubbing the area  but that didn"t help much.   I did take one advil an hour before bedtime but the moderate pain stayed the same.  At midnight I went to bed and was able to sleep.  By morning I was fine.
mom reports sz on about 2JAN97 & high temp sz on 9JAN97;
BREAST CANCER; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021(date unspecified), the patient was diagnosed with breast cancer and had surgery for the breast cancer in SEP-2021 (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breast cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211017470-COVID-19 VACCINE AD26.COV2.S-Breast Cancer. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Starting about 5 days after the vaccination I began to become extremely exhausted upon little exertion. My appetite decreased significantly and I began losing about a pound a day.  I am having trouble sleeping even with sleeping medication.