chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 81 year old female consumer regarding herself with breast cancer in remission as reported ("I'm in remission, I think"), diabetes, neuropathy, high blood pressure, "Stenosis" and "a lot" of drug reactions or allergies. The patient's medical history included breast cancer. About five years ago, approximately in September 2008, the patient was vaccinated with ZOSTAVAX dose 1 injection, route reported as under the skin (concentration, lot, route and expiration date were not reported). Concomitant medication were unspecified by the reporter. On an unspecified date the patient underwent a partial mastectomy. On 18-AUG-2013 the patient woke up with pain in her breast where she had a partial mastectomy. The patient could not tell what the pain it was. She thought if that she was just having pain from having part of breast cut off. Soon after, the patient back started itching real bad and also was having muscle pain. She went to the doctor and had blisters all over the back. On 18-AUG-2013, the patient went to the doctor and dermatologist who diagnosed her with Shingles. At the time of the report patient stated "still have a some scabs". Lab diagnostic studies performed on an unspecified date included, computer axial Tomography (CTA) scan, magnetic resonance imaging (MRI), Positron emission tomography (PET), X Ray, blood work and "a lot of bladder work", unspecified lab test reported by the patient as "you name it I've had it", results were not provided. On unknown date the patient received treatment of cream and antiviral pill. At the time of the report the patient was recovering from shingles. Partial mastectomy and pain in my breast outcome was unknown. Upon internal review partial mastectomy was considered as an other important medical event. Additional information has been requested.
Initial information received on 09-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 days old female patient who received DAPTACEL instead of HEPATITIS B VACCINE. 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 DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. It was a case of actual medication error due to Wrong vaccine administered. Adverse event was unknown. 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.
Administered the Moderna COVID-19 vaccine to a 13 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered the Moderna COVID-19 vaccine to a 13 year old patient) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered the Moderna COVID-19 vaccine to a 13 year old patient). On 12-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered the Moderna COVID-19 vaccine to a 13 year old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
pt recvd vax & 8 days later exp memory loss, inability to concentrate, hot flashes, repetitive movements in rt arm & eye;was nonsensical & kept repeating phrases;pt seen in ER:no treatment given;event spontaneously resolved w/in 45min
Contracted Covid in between doses; had body aches, chills, swelling at injection site, febrile for two days after second dose
March 17th - The night of injection I felt like a small SUV ran over me. By late night it turned into a MAC truck. I had a massive headache, 101.6 fever, chills, and overall just feeling unwell. I felt "plugged in". I could taste metal taste. March 18th - I just felt flu-ish. March 19th - I started having right ear pain and all my lymph nodes felt heavy. Still tasted metal. March 22nd - I was up all night and mouth pain on both sides. I went to Urgent Care thinking I had an ear infection and/or sinus infection. My sinuses and ear were fine and they believe it was an adverse reaction to the vaccination. I received Prednisone, but that has only made things worse. Today, March 29th - I went to my dentist, still in pain, and wondering if a tooth infection. My teeth were fine and he felt it was neurological, possibly connected to the vaccine. He prescribed me some Norco, told me to go to the hospital tomorrow if I'm still in this much pain.  Today - eyes blurry, face hurts to touch, lymph nodes swollen, tongue tastes metallic, ear hurts, head hurts, fatigue.
The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023; No adverse event; 5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 20-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023).    Concomitant medication was not provided.  Vial size was reported as 2.5 ml. The vial was initially stored in the refrigerator on 16-Mar-2023. Vial did not undergo any temperature excursions. No treatment information was provided This case contains information for the 4th patient out of 5 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720516 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720516:1st patient case (Master case)
APDT given LAT 10/05/06, parents noticed induration, redness 10/10/06 measuring 2.5cm x 1cm. Brought in for visit 10/13/06 no signs infections.
Pt recv vax on 3/17/98; approx 6-8 hr post vax pt exp urticaria rash & redness x 48 hr
Numbness in the face; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 13Mar2021 at 00:15 (reported as 12:15 AM) (at the age of 52 years old) as first dose, single for COVID-19 immunisation in a Public Health Clinic/Veterans Administration facility. Patient has known allergies with Penicillin from an unknown date. The patient was not pregnant at the time of vaccination and prior to vaccine the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in  4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. The patient experienced numbness in the face on 13Mar2021 at 12:45 (reported as 12:45 PM). No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Patient is a 62-year-old female with PMHx significant for BOLT 2013 2/2 bronchiectasis and COPD, GERD, HPLD, DM, RA, who was found to be COVID-19 positive 01/06/2022 who originally presented to Hospital on 01/13/2022 with the chief complaint of intractable nausea and vomiting and inability to tolerate p.o. intake. She tested positive for COVID-19 on 01/06/2022 and again on 01/14/2022. She is vaccinated x 2 with Pfizer + booster. She was transferred to hospital given hx of lung transplant following along with Dr. She arrives to the ICU on NiPPV 50% and appears comfortable. Her course at hospital was uncomplicated and she is currently being treated with Remdesivir, Decadron, and Baricitinib.
Myalgias, exhaustion, achey eyes, cough and wheezing. Most of the symptoms went away by the next day, but the cough and wheezing have persisted for 5 weeks, still not abating. There is some slimey thin watery phlegm that tastes bitter and salty, frequently requires spittingit out, and rarely a metallic taste of blood in the early mornings. No fever, no mucus, but sometimes the cough is so severe it makes me gag. I feels like a reactivation of a bronchitis I had for 8 weeks last fall, 6 months previously. But not like a typical bronchitis, more on an interstitial level. I am truly worried about long lasting lung damage. Some shortness of breath.
Client  received the 1st COVID vaccine (Pfizer Lot #EW0185 expiration 05/22/2021) at 1503. At 1515 client alerted EMT  that she was feeling nauseas and asked for him to take her blood pressure. Nurse responded. Client stated that she was feeling nervous about receiving the vaccine prior to receiving it. Client offered water and she accepted and drank some. She also stated that she normally has high blood pressure and takes Lisinopril for it, and she took her medication this morning at her scheduled time. Client was alert and oriented, skin was appropriate to skin tone, and warm to the touch. EMT unable to obtain blood pressure. Nurse and EMT escorted client to the zero gravity chair. Vital signs taken by nurse at 1524 (blood pressure 120/88, heart rate 76, oxygen 98%). Client vocalized that she did not want to stay and wanted to go home, and that the nausea was gone. Nurse advised the client of the recommended 30 minute observation period, and client deferred. Client insisted on going home. Nurse provided education to the client to call emergency services if life threatening symptoms appear and what those symptoms are, and to follow up with primary care provider. Client has high blood pressure, is taking Lisinopril, and stated that she has no allergies. Client left with her husband unassisted with a steady gait at 1527.
Inconsolable screaming lasting 3 hours. Fever 102 degrees Fahrenheit. Rash. As reported by parent.
Pt recvd vax & 4 hrs p/vax 6OCT92 devel nausea & vomited once;
Patient developed a large rash at injection site on the back or her upper right arm which she thought was cellulitis.
Patient reported she has arm pain after receiving flu shot on 8/26/19. She reproted on 11/5/2019
Employee complained of visual disturbances and lightheartedness. Employee blood pressure was 126/75 pulse 89 Temp at onset of symptoms was 98.6. Respiration at 20. Employee was advised to sit and relax. Symptoms lasted 20 mins in total. Employee now states she feels normal.
This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA433A, expiry date 31st October 2021) for prophylaxis.   On 3rd December 2021, the patient received Menveo. On 3rd December 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 6 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261523:Same reporter US-GLAXOSMITHKLINE-US2021261533:Same reporter US-GLAXOSMITHKLINE-US2021261528:Same reporter US-GLAXOSMITHKLINE-US2021261529:Same reporter US-GLAXOSMITHKLINE-US2021261531:Same reporter
received dose 1 / in late 2020, specific date not known / say he was beyond the recommended 6 month window; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in late 2020).   On an unknown date, the patient 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 details were provided as follows: This case was reported by the patient himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose shingrix which led to incomplete course of vaccination. The patient did not wish to provide any demographics, just wanted his question answered. The reporter did not consent to follow up.
pt recvd MMR vax on 17JUN91; 3 hrs p/vax devel a joint pain in hips; next day devel pain, swelling, & heat @ inject site which progressively worsened; no further details were provided;
sore arm; fatigue; nausea; headache; This is a spontaneous report from a contactable pharmacist (patient) received via a sales representative.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced sore arm, fatigue, nausea, and headache on an unspecified date in Jun2021. Adverse events resolved within 24-48 hours. This adverse event was reported within the 24 hour time frame. Reporter reported as, "I found out about it late afternoon on 08Jun2021 and reported very early morning on 09Jun2021". Outcome of all the events were recovered on an unspecified date in Jun2021.  Information about batch/Lot number has been requested.
Patient's mother states that patient was unable to walk after recieveing  vaccines but states it occured two weeks after vaccination. Patient recieved a consult with Dr. and was referred to a Neurologist, Urologist, and Physical Therapy.
This was an administration error.  The patient did not have an adverse event.  Varivax was drawn up with the intent to be given subcutaneously but was given in the upper left arm with a 5/8 inch needle, instead of subcutaneously.
No additional AE reported; Pharmacist reported that an adult patient received MMR II on 8/27/2023, and then two weeks later received VARIVAX on 9/10/2023. Whenever patient filled out vaccine paperwork, she selected no that she has not received any vaccines lately. However, aft; This spontaneous report has been received form a pharmacist, regarding a female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 27-AUG-2023, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported).  Then two weeks after, on 10-SEP-2023, she was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, as prophylaxis as well (lot number: W011622, which was determined to be valid, with an expiration date on 06-APR-2024) (strength, dose, scheme, route and anatomical location of administration were not reported) (Inappropriate schedule of product administration).  It was reported that whenever patient filled out vaccine paperwork, she selected that she did not received any vaccines lately. However, the pharmacist was reviewing records and noticed patient received the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) two weeks before.   Pharmacist also asked if varicella virus vaccine live (Oka/Merck) (VARIVAX) could be administered both intramuscular and subcutaneous route.  No additional adverse event was reported.   This is one of two cases from the same reporter.
Swelling and thigh 7x8 cm, crying, site of Prevnar and Acthib. Same day as received. Treatment: Benedryl 1/2 tsp q 6h and Advil 1.25mg and ice prn.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 12:00 as dose 1, single (Lot number: EL9264), in right arm, on 19Feb2021 at 12:00 as dose 2, single (Lot number: EL9266), in right arm and on 13Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3181) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies:Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Additional information: If vaccine received Yes. other medication in 2weeks No. anti viral details: product: COVID 19 Treatment, brand: pfizer, treatment start date: 02May2022, treatment stop date: 07May2022, lot number: unknown, indication: Treatment of COVID-19. Did you/the patient previously receive a COVID-19 Vaccine reported as yes.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & 5 days later exp rash on limbs & trunk & itching;
Pt had temp of 104.4 & febrile seizures.  Went to ER for treatment.
Arm was sore and difficult to move, and got worse over course of three days.  Fever began the day after vaccination and was 102 the first day, 101 the second day, and 100 the third day.  On the third day, he played in a football scrimmage and had discomfort in his chest and trouble breathing during activity.  On the fourth day, he woke complaining of chest pain that would not go away or change with movement or pressure.  At the ER, he had an EKG that showed rhythms of a heart attack, and that was confirmed by his troponins and an emergency heart cath.  He was diagnosed with myocarditis.  He was kept in ICU for two days and treated with pain medications and captopril and metoprolol.  After he was stable, he was released and still takes the medications and is on restricted activity.  The doctors also ran multiple tests to determine if the infection was caused by a virus or bacteria, but could find no cause.
They day after the injection I started having a tingling sensation behind my ear and down my neck. It was a weird sort of feeling. The following Monday, my face going to the side. I had no pain in my chest or arm. I figured I was having a stroke maybe. I was rushed to the ER by my husband and diagnosed with Bell's Palsy. I was told to see my PCP, I was given a week worth of antibiotics from the ER doctor prednisone and VALTREX, and my PCP gave me three more days of the pill VALTREX. I have not recovered I feel that it is getting worse. The reason why is because I am feeling trying to affect the other side of face. Right now, it's all the side of my right face, when drinking and trying to eat it is worsening pain in my jaw. My eye does not close, just today I am feeling the same numbness in the other eyes. My eyes are both watering now as we speak. I think it's traveling, from pressure in my jaw and ear and down to my neck. I cannot chew food it is hard for me to eat I have to drink liquids and even swallow my pills.
Patient develop "rash" on upper left arm, few days after vaccination. She used NEOSPORIN on it  but did not seek medical advice until 11/24/17. She went back to Dr. who diagnosed it as shingles.
Client moved arm when vaccinator was giving the vaccine in the left arm.  The majority of the vaccine dripped out.   Client revaccinated in the right arm.  Small scratch noted on left arm from the needle above the puncture site.  Client tolerated it well.
Chills, tingling in legs, flushed face, pt stated face felt like it was on fire from 5:00pm on 12/1/10 & still experiencing sx at 10:45 am 12/2/10. Pt went to er on 12/1/10 at 5pm for evaluation.  Was told sx due to neurontin. Pt called HD at 10:45 am on 12/2/10 with complaints.  Was told to contact doctor who prescribed neurontin.  Pt called back at 1:20pm & stated her doctor told her symptoms not due to neurontin & he instructed her to take Benadryl TID & if not better by 12/6/10, to call him back.  I instructed pt not to hesitate to call 911 if symptoms worsen or if she feels any distress.
Early in the morning Hours, I stopped playing Video games due to annoyance and an Elevated Heart Rate. Started to watch TV, 3-4 mins into a show I started Shivering and Shaking uncontrolably for over an Hour. When I first started shaking i figured i was just cold but my throat started to swell up and my chest felt like it was being squeezed, i was having a very hard time just walking or talking for that matter. when i was laying down with my girlfriend toying to get warm, my hand feel went numb on and off for a while. i did eventually fall asleep. when i woke up to use the bathroom, on my way back peeing, i blacked out in the hallway to my bedroom and fell. i woke up feeling better but i do not feel great.