chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE/PQC identified; Caller reports AE related to administration of expired PROQUAD; Excursion occurred 11/17/2020; This spontaneous report was received from a office manager concerning to a 3-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 17-NOV-2020, a dose of the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number reported as T016991 and expiration date as 11-NOV-2021) had a temperature excursion.  On 22-DEC-2020 (discrepant information as onset date was also reported as ''29-DEC-2020''), the patient was vaccinated with an expired (discrepant information as the vaccination date was on 22-DEC-2020 and the vaccine expiration date would be on 11-NOV-2021) and improperly stored dose of the mentioned vaccine at a dose of 0.5 milliliter (ml) for prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported.  This is one of several reports received from the same reporter.
Breakthrough case admission after 2 vaccines Pfizer 3/4/21 Lot# EN6206;  Pfizer 3/25/21 Lot# En6206
CLIENT CAME IN AND SAID SHE NEEDED AN MMR VACCINE.  I ASKED HER IF SHE HAD INSURANCE, AND SHE SAID THAT SHE DID NOT. STATED THAT SHE NEEDED THE VACCINE FOR HER JOB.  I ASKED HER IF SHE HAD EVER GOTTEN A VACCINE FROM THE HEALTH DEPARTMENT OR IN STATE. SHE STATED SHE HAD NOT.  I GAVE HER THE PAPERWORK TO FILL OUT AND WE GAVE HER THE VACCINE.  WHEN I PUT HER NAME INTO SYSTEM HER NAME CAME UP IN SYSTEM.  SHE HAD ALREADY GOTTEN AN MMR VACCINE ON NOVEMBER 13, 2023 AT OUR OTHER OFFICE.  I EXPLAINED TO THE LADY THAT SHE WAS SUPPOSED TO WAIT A MONTH BEFORE HAVING ANOTHER AND THAT SHE HAD NOT BEEN TRUTHFUL WITH ME.  SHE SAID SHE NEEDED THE SECOND VACCINE TO GO TO WORK IN ANOTHER STATE THAT WHY SHE DID THAT.  I CALLED MY SUPERVISOR AND SHE STATED THAT SHE HAD TOLD PATIENT THAT SHE HAD TO WAIT A MONTH BEFORE GETTING ANOTHER VACCINE.  I EXPLAINED TO PATIENT THAT HER VACCINE WOULD BE INVALID AND THAT THE COMPANY SHE IS GOING TO WORK FOR MAY NOT ACCEPT IT.  SHE SAID THEY TOLD HER SHE HAD TO GET THE SECOND ONE NOW.
Urticaria noted from face to lower extremities, to include trunk. Erythema with confluent paplable erythema, areas of central clearing, marked itching. Spares scalp, palms, and soles. All other areas of extremities and trunk are affected with no areas larger than a silver dollar unaffected. In general, he is in discomfort, crying, itching, and states that it itches and hurts. No respiratory distress. No involvement of oral mucosa. Given STAT injection of Benadryl 20mg and observed for one hour. Dismissed to home with oral Benadryl to be given every 6 hours for the next 48 hours then as needed.
hives; rash on breast/rash on inside of both arms and spreading/rash on neck/rash on face; redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), RASH (rash on breast/rash on inside of both arms and spreading/rash on neck/rash on face), ERYTHEMA (redness) and PRURITUS (itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for an unknown indication.     Concurrent medical conditions included Diabetes, Latex allergy and Drug allergy (statin and Vicodin drugs).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (redness) and PRURITUS (itching). On 10-Mar-2021, the patient experienced URTICARIA (hives) and RASH (rash on breast/rash on inside of both arms and spreading/rash on neck/rash on face). At the time of the report, URTICARIA (hives), RASH (rash on breast/rash on inside of both arms and spreading/rash on neck/rash on face), ERYTHEMA (redness) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
skin rash;face rash & swollen;lt arm swollen, shoulder to elbow (inj arm) & rash & h/a;
I had my 2nd vaccine over two-weeks ago. I have had significant malaise and deep muscle aches with weakness since then. I also have issues with no appetite, and getting nausea with eating more than a little bit. I have been minimizing my symptoms to my family and have not told extended family/friends because they would use it as an excuse to not be vaccinated. When should I be concerned about my symptoms?
No known patient adverse reactions or side effects; 1 dose of GARDASIL 9 was administered on 7/26/2022 / Temperature excursion; This spontaneous report was received from an Office Manager/Vaccine Coordinator referring to a 12-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  The Office Manager/Vaccine Coordinator reported that there was a temperature excursion just discovered, it occurred between 11-JUL-2022 and 15-JUL-2022. Vaccines involved in the excursion were Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (Captured in MARRS case # 2208USA003006), and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The vaccine undergo a temperature excursion of above 47 degrees Fahrenheit (F) (55.2F) for a period of 5 hours, and above 47 degrees Fahrenheit (F) (53F) for a period of 30 minutes (Product storage error). The vaccine did not underwent a previous temperature excursion.  On 26-JUL-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml intramuscular (IM), administered as prophylaxis, lot number was verified to be U032636 with expiration date of 26-OCT-2023. There were no known patient adverse reactions or side effects (No adverse event).  An excursion on 26-JUL-2022 was already reported.  This was one of two cases from the same reporter. ; Sender's Comments:  US-009507513-2208USA003006:
Tinnitus developing around nine days after shot. Symptoms remained for a few days and then (mostly) subsided. This happened after the first Pfizer dose (as reported here) and also after the second Pfizer dose 3 weeks later.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Headache, Uncontrollable stomach cramping and diarrhea (on the 4th day) seeing dietician and physician for symptoms.
injection site pain; swelling; chills; This is a spontaneous report from a Sponsored Program . A contactable female consumer (patient) reported for herself. A 16-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 21Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the caller asked what side effects were experienced by vaccine participants 16 years of age and older and for how long. Caller advised they experienced injection site pain, swelling as well as chills after the first dose of vaccine. The clinical outcome of the event was unknown.    Information on the lot/batch number has been requested.
Eye piercing headaches for 2 days and night sweats for 2 days. Injection site sore for 4 days.
Significant increase in tremors, worsening of Parkinson?s symptoms. Loss of appetite.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. There was no pertinent medical history, current conditions reported. It was unknown the patient was vaccinated with VAQTA, (dose, frequency, lot#, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses of VAQTA were exposed to highest temperature of 53F for 21 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 1403USA012856, 1403USA012858, 1403USA012859, 1403USA005464 1403USA012860 (same reporter link). Additional information has been requested.
Red rash on inside of elbow that was itchy. Started about 8 days after injection. About 4 inches long and 2 inches wide. Was not debilitating and not on list of COVID reactions so just ignored and it got lighter in color. After second injection on February 10 the rash and redness came back about 6-7 days later. Itchy but not terrible. Skin still has a light pink color in the area.
Fever, sore throat, vomiting. Nausea, dizziness, blurred vision, headache. Chest pain, cough  Outpatient clinc and well as ER visit for treatment. Bloodwork, cheat xray, cat scan, strep test and covid swabbed
persistent diarrhea; difficulty ambulating; weakness; dry mouth; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (persistent diarrhea), GAIT DISTURBANCE (difficulty ambulating), ASTHENIA (weakness), DRY MOUTH (dry mouth) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Uterine cancer (C55 UTERINE CANCER). Concomitant products included LENVATINIB MESILATE (LENVIMA) from 13-Nov-2020 to an unknown date for Uterine cancer.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (persistent diarrhea), GAIT DISTURBANCE (difficulty ambulating), ASTHENIA (weakness), DRY MOUTH (dry mouth) and FATIGUE (fatigue). At the time of the report, DIARRHOEA (persistent diarrhea), GAIT DISTURBANCE (difficulty ambulating), ASTHENIA (weakness), DRY MOUTH (dry mouth) and FATIGUE (fatigue) outcome was unknown. Not Provided          On 05-Feb-2021, the patient underwent CT scan with contrast and results were not available. Other relevant history included keytruda infusions. Treatment information was not reported.   Reporter did not allow further contact
Trembling, loss of consciousness periodically, memory lapse, nervousness after 15 mins of the vaccine administration
-March 4, 2020 - Morning after vaccine - Ankles swollen. I never had swollen ankles in the past. Bumps under skin on right forearm - felt like sand pebbles under skin. That has continued and is present now also.  - March 6, 2020 - Breathing became tight - remained that way for a good two months. Shortness of breath - Month of March - Rash was breaking out on  lower right leg and lower back. itchiness ( But, I was unaware that it was Covid Vaccine related)  Gradually became larger rash on right shin area.  Right ankle and leg started to swell.  - Last week of March,  First Week of April - Right leg became more swollen and inflamed. Then became frighteningly swollen. Rash on arms increased.  April 15, 2021 - Dermatologist appointment - He told me that the protective barrier on my skin had broken down. Prescribed Steroid cream, and CereVe moisturing cream morning and night. Cetaphil Gentle Skin cleanser used very sparingly on only parts of body absolutely necessary to wash, but not on rash area. No hot showers ever again. He said he would not need an antihistamine. Refused to address swollen leg and ankle. ( Your site tells me it is closing, so I do not have time to continue.)
patient received yearly flu vaccine on 10/6/22.  patient called pharmacy on 10/8/22 and informed me (pharmacist) that she had throbbing, itching, bruising and a knot at the injection site; i confirmed not redness/heat.  after discussing with the patient, she stated that all of the these symptoms usually occur after any vaccine but were not present for this length of time and the know was larger than usual.  patient did indicate that the symptoms were getting better versus getting worse.  i told her that while these symptoms were not a "typical" response, they were not extremely rare.  i advised her to continue ibuprofen and ice and i would contact her the next day.  if symptoms worsened, go to er/urgent care.  i contacted patient on 10/9/22 and patient stated that symptoms were getting better but the knot was still present.  she stated that the itching continued and that when she scratched the area, it would swell.  she has no allergies to speak of (just sensitive skin) and tramadol causes itching.  i suspect a possible allergy to an inactive ingredient in the vaccine but unsure.  informed pt the if the know was still present on 10/10/22 to contact her primary care prescriber which was not indicated on the patient record and let him/her assess patient.  also recommended potential allergy testing.  i contacted patient on 10/10/22 and the patient stated that she was much better and any problems had resolved.  i am only reporting this because of the severity of the reaction that the patient reported.
PT RECEIVED 2ND DOSE OF ANTHRAX VACCINE AT 09:53 ON 17 OCT 07.  PT WAS ON AUTHORIZED PASS TO HOME OF RECORD WHEN THE ADVERSE EVENT BEGAN. AT 15:00 THE SAME DAY STATES HIS THROAT BECAME ITCHY, LIKE SOMETHING WAS STUCK IN HIS THROAT. LOOKED IN MIRROW AND SAW A SWOLLEN UVULA. HE WENT TO LOCAL ER, CHECKED IN, DRS GAVE HIM SOLUMEDROL INJECTION, 125mg IM. THE SWELLING DECREASED, MONITORED AND RELEASED HIM TO FOLLOW-UP. DENIES OTHER SEVERE LIFE THREATENING EVENTS. PT WAS SEEN TODAY FOR FOLLOW-UP.
2 days p/vax pt awoke w/muscle ache & spasm 5.5 x 4.5 cm induration w/edema erythema upper arm, RUQ abd pain;tx Relaple refused other NSAIDS, valium;
This spontaneous report as received from a 41 year old registered pharmacist reporting on herself, who on 29-JUN-2012 was vaccinated with two pediatric doses of RECOMBIVAX HB to equal one adult dose. No other co-suspects were reported. No concomitant medications were reported. The registered pharmacist stated that two hours after RECOMBIVAX HB was given on 29-JUN-2012, she began feeling extremely tired. She stated that she was so tired that she began to fall asleep driving as her eyes just kept closing. She also stated that she had a mild fever and vomited yesterday on 02-JUL-2012. Today, on 03-JUL-2012, she reported feeling light headed but had not vomiting and was not as tired as she had been. No treatment was given for the experience. At the time of the report, the registered pharmacist was recovering. The relatedness for began feeling extremely tired, feeling light headed, she had vomited and mild fever was unknown for RECOMBIVAX HB. Additional information has been requested.
A report has been received from a Health Professional concerning a patient born on 09-Oct-2008, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced administration of FLUMIST to patient with asthma. The outcome of the event of administration of FLUMIST to patient with asthma is unknown. The report was considered to be non-serious.
He got his vaccine, he was fine.  Two days later his left eye started to get double vision, double imaging.  If he moved his head quickly and moved back to center it was double.  When he gets up in the morning it is really bad.  As the day goes on it improves some, but not perfect.  It feels like he has pressure in his eye and is watering.    He went to an eye doctor 4 days after the vaccine, and they informed him that he has heard of it before being an effect from the shot, but everything looked fine.  He does have an appointment for follow up in 2 weeks, and if he is still having the problem then he would address it further.  He offered to give him steroids but he declined due to his diabetes.    He did read about it and did see that other people did have the same issue, and that it took time, so he opted not to take the steroids.  He has to forcefully focus to get it to clear to see something, and he is not able to drive due to this issue he's having.
I received the ZOSTAVAX vaccine at pharmacy on Friday, December 21, 2012 in the back of my left upper arm. I now have a half-dollar size blister on the back of my left shoulder. I am also starting to have tingling itchiness around my left waist.
I got a rash on my abdomen, on the upper part on bra line to the abdomen. I emailed my doctor & told her about it, she said keep a eye out on it.
SWELLINGAT INJECTION SITE, ITCHY, REDNESS. ICE HYDROCORTISONE CREAM
slight headache; arm hurt off and on; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) and PAIN IN EXTREMITY (arm hurt off and on) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TYLENOL (Took Tylenol 500mg).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced HEADACHE (slight headache) and PAIN IN EXTREMITY (arm hurt off and on). At the time of the report, HEADACHE (slight headache) and PAIN IN EXTREMITY (arm hurt off and on) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
according to her mother, 30 minutes after administration of the vaccine, the patient had a "mini seizure" that lasted about a minute . Mom called the doctor's office and the doctor didn't think it was related to the vaccine but the mom wanted us to report it
administered an extra dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA104A, expiry date 30-NOV-2023) for prophylaxis.   Concomitant products included Men ACWY-CRM NVS (Menveo).   On 02-MAR-2023, the patient received the 2nd dose of Menveo. On 02-MAR-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: administered an extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date:10-Mar-2023. Licensed Practical nurse called to inquire what to look for and how to proceed. Patient was administered another Menveo dose inadvertently in error. Reporter stated that it was already reported by someone else but unsure.  LPN does not want to be mixed in with this incident because LPN was not the staff who administered the extra dose but agreed to being anonymous. The reporter did not consent to follow-up. Patient received Menveo inadvertently in error, which led to extra dose administered.
headache; Initial information received on 05-Dec-2021 regarding an unsolicited valid social media non-serious case received from a consumer.   This case involves an 80 years old male patient who experienced headache, after receiving INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in 2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2021, the patient experienced a non-serious headache (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I had flu shot past month and ended up with headache for 5 days. I am 80."  It is unknown if the patient experienced any additional symptoms/ events.   It is unknown if there were laboratory data/ results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There will be no information on the lot number for this case.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have antibodies after getting tested. Has leukaemia on an unspecified date. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: negative on an unspecified date.  The outcome of the event was unknown. The event was considered as serious (medically significant).  Information on the lot/batch number has been requested.
Fever, arm pain at sight, armpit swelling and pain in left arm, excessive fatigue, body chills and sweats
died of Covid; died of Covid; was found collapsed and blue in their house; was found collapsed and blue in their house; This is a spontaneous report received from a contactable reporter (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, hospitalization, medically significant), COVID-19 (death, hospitalization, medically significant), outcome "fatal" and all described as "died of Covid"; CYANOSIS (death, hospitalization), FALL (death, hospitalization), outcome "fatal" and all described as "was found collapsed and blue in their house". The patient was found collapsed and blue, and was taken to ICU, and then died, date of death was unknown around 25Nov2021. The reported cause of death was covid-19, cyanosis, fall. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information in the case the association between the fatal events of Drug Ineffective, COVID-19, Cyanosis and Fall and the suspect product of BNT162B2 cannot be completely ruled out. The case will be reassessed on receiving follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died of Covid; was found collapsed and blue in their house; was found collapsed and blue in their house