chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was found out that she had a Cholesteatoma, which is a tumor in the ear.; On the 3rd day however, she had this dizziness that progressively got worse.; The vertigo made her barely able to walk and as it went on she could feel the room spinning.; The vertigo made her barely able to walk and as it went on she could feel the room spinning.; She wants to know if vertigo or dizziness as well as reports of inflammation a common side effect of the vaccine.; She mentioned that she had soreness on her neck and felt bad for 2 days; She mentioned that she had soreness on her neck and felt bad for 2 days; This is a spontaneous report from contactable consumer via Pfizer sponsored program. A female consumer of unspecified age reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 21Jun2021 at unknown dose single for COVID-19 immunization. She was not pregnant at time of vaccination. Medical history includes ear disorder. No concomitant medication reported. She had a pretty bad reaction from first dose on 21Jun2021. Patient mentioned that she had soreness on her neck and felt bad for 2 days. On the 3rd day however, she had this dizziness that progressively got worse. The vertigo made her barely able to walk and as it went on she could feel the room spinning. She felt it while standing up, moving, and even while laying down. She was not able to function and not able to do anything. She mentioned that it is a lot less worse that what she felt earlier and is progressively better. She mentioned that it was the 1st day that she was able to drive. She mentioned that she consulted with her ENT and family doctor. She had a history of ear problems and had a CT done yesterday. It was found out that she had a Cholesteatoma, which was a tumor in the ear. She mentioned that no one she knows had this problem and she was concerned about getting the 2nd shot. Caller stated she didn't know if it was necessary to file a report. She needed to find out if what happened was a normal reaction and give her some more information. She was debating if she should get the second shot. The pharmacy said to call and get her questions answered. The outcome for Event neck pain was recovered on an unspecified date in 2021 and for vertigo was recovering. The outcome of others Events was unknown.   Information on the lot/batch number has been requested.
Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced pain at the injection site for a couple of days. The reporter did not consent to follow up. The reporter was unable to obtain additional information. For tolerance of 2nd dose, refer case US2019101618.
Blisters/cuts on gums; Blisters/cuts on gums; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medication included fluticasone (FLUTICASONE NASAL SPRAY). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced blisters/cuts on gums. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event blisters/cuts on gums was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Golf ball size knot within 2 hours as well as slight fever in arm. After acetaminophen and an ice pack overnight, fever increased in arm and large red mark. ***TYPE OF INFLUENZA VACCINE NOT KNOWN.
Hospitalization for COVID symptoms on dates 6/1/2021- 6/4/2022.  Treated with ascorbic acid 1000mg PO daily, cholecalciferol 25mcg PO daily, zinc sulfate 50mg PO daily
Patient tested COVID positive on 3/15/21, after completing her vaccination series on 1/13/21.  She states she began having symptoms 3/11/21 the same day she attended a work lunch with 6-7 employees (some vaccinated, some not vaccinated).  Contact tracing is being performed.
Gardisil is not indicated for administration to patients beyond age26 unless it is determined to be necessary in shared decision making process with MD and patient. Patient was advised of rationale for immunization and consented to receive it. However, it had not been ordered to be administered by the provider seeing the patient. It was administered to patient in error, was meant for a patient with a very similar name.
Pt received vaccine on 7/13/01 about 09:00 without incident. At 14:00 on 7/13/01, the pt had a sudden onset of headache, cheeks became red, hot and had a burning sensation. No complaint of difficulty swallowing, no rash or hives, no complaint of increased SOB or wheezing and no chest pain.
covered in hives throughout the body besides face, hands, and feet. Feeling under the weather,
1AM screamed-convuls, eyes rolled back, unconscious, no involuntary excrement; taken to hosp by EMs; combative on way to hosp;
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. It was reported that an unspecified number of unspecified patients received an unspecified number of improperly stored doses of RECOMBIVAX HB (intramuscularly, dose, frequency and lot # not reported) since an unspecified date in December 2014. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Patient was administered FLUVIRIN on 10-29-12. Patient's mother contacted pharmacy on 4-5-13 stating that from the administration date until present, her daughter complains of pain and soreness in the arm near injection site. Patient has sought medical attention and used SALONPAS patches with no relief.
Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 20 year old adult male patient who received a 0.25ml dose of vaccine FLUZONE QUADRIVALENT (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date. The patient's past medical history included Crohn's disease. Concomitant medications included REMICADE for Crohn's disease. It was a case of actual medication error due to underdose. It was reported that due to the REMICADE, the patient's mother does not want him to receive a whole 0.5ml dose. He received a 0.25ml dose previously, at his "college campus". It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for Blood pressure and Thyroiditis, unspecified, Zanax for Product used for unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Blood pressure and Thyroiditis medicines.  Treatment medications were not used   This case was linked to MOD21-073436 (E2B Linked Report).; Sender's Comments:  MOD21-073436:
Felt warm, clingy, out of character, would not eat, laid on floor in hallway. Would not sleep, stayed up until 3 am in the morning. Tiredness for the next few days.
Rash at vaccination site, red, burning, itchy, size approximately 3 inches x 5 inches, 10 days after vaccination.
Patient received 2nd dose of moderna vaccine. Felt increased in knee pain and soreness after for several days. Similar symptoms occurred after first dose in resolved shortly after.
Faulty syringe. Full dose not administered so second shot administered after faulty syringe to ensure full dose given
While injecting, the syringe came loose from the needle and  a large amount of the vaccine did not get injected.  Another full dose was drawn up & administered to the pt without incident
Fever 102 degrees F Sore throat Weight loss Anorexia Red eyes Lethargy Crying Irritability
she received her 1st and 2nd Pfizer vaccine doses she was "a little headachy.; This is a spontaneous report from a contactable consumer (Patient). 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date single for covid-19 immunisation. Medical history included neoplasm malignant, white blood cell count decreased. The patient's concomitant medications were not reported. The patient previously took chemotherapy nos. She received Pfizer covid vaccine both 1st and 2nd doses with no problem. She stated when she received her 1st and 2nd Pfizer vaccine doses she was "a little headachy. The reason she received her 3rd dose was she had "cancer last year and she had chemo and she still have low WBCs." Is this a normal side effect? and will it go away? The patient underwent lab tests and procedures which included white blood cell count: low. The outcome of event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Soreness at injection site; tiredness; achiness; slight fever 99.2 degrees; This is a spontaneous report from a contactable consumer(patient) . A 72-year-old male patient received the second dose of BNT162B2 (lot number: EL9262), via an unspecified route of administration in left arm, on 05Feb2021 15:00 at single dose for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient had previously received the 1st dose of BNT162B2(Lot number: EL3246) on 15Jan2021 03:00 PM in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. No known allergies. No other vaccines were received within 4 weeks. The patient experienced soreness at injection site, tiredness, achiness, slight fever 99.2 degrees on 06Feb2021. No treatment was received for the event. The patient underwent lab test included body temperature: 99.2 degrees on 06Feb2021. The outcome of the events was recovering.
numbness in my leg; pins and needles in my legs from the knees down; had something neurological migraine; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself. A 76-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 10Apr2021 as dose 2, single for COVID-19 immunisation. Medical history included psoriasis she has a history of psoriasis, stroke from Feb2016 to an unknown date. She was placed on warfarin daily because she has atrial fibrillation. Concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, after the vaccination she developed pins and needles in my legs from the knees down, it got bad for a while. Caller asked because of insurance, if is there a specific type of doctor she should go to. It was reported that I still had the numbness in my leg and had something neurological migraine. I had pins and needles, never had this experience before, I had this second shot. My first shot does not gave me any of that but when I had my second shot I live with this, its not constant but right now it's been going on since 3:30 pm and I still had the numbness in my leg. Just merely strong pins of needles feeling in my leg and I had never called to let anyone know that happened it was right after the shot I had it. Now that's been several months now, and I still get it like I thought it will go away, but it is still, every other day several times a week it comes back to me. So, I dont know I am on blood thinners. Somebody said something about maybe it's a prerequisite to stroke that I already had a stroke in the past that didn't had anything like that. I had something neurological, migraine. I dont know if this is affecting my blood vessels in my legs so I am having this experience all the time and asked what she do to prevent it. I do take Warfarin so because of my stroke and I had AFib but that this is totally different. The clinical outcome of the event numbness in my leg, pins and needles in my legs from the knees down was not resolved and the event had something neurological migraine was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101050574 same reporter/drug/AE with different patient(s).
tested positive for COVID; body ache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID) and MYALGIA (body ache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (tested positive for COVID) and MYALGIA (body ache). The patient was treated with IBUPROFEN at an unspecified dose and frequency; AZITHROMYCIN (ZITHROMAX Z-PAK) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID) and MYALGIA (body ache) 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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.
Began to feel shaky on two hours after the shot which was given on 10.29.08 - broke out in hives later that nite and have been breaking out ever since the shot - will be seeing my MD on 11.18.08 as this condition has been ongoing since I received the shot.
she did go to anaphylactic shock; A spontaneous report was received from a consumer concerning a 38-year-old female patient who experienced immediate anaphylactic shock (she did go to anaphylactic shock).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 13-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.    The reporter stated that her daughter had an immediate anaphylactic shock after receiving the vaccine on 13-JAN-2021 in another state.  The reporter's daughter was treated with EpiPen (epinephrine) x 2 and then was transferred to an emergency room (ER) by ambulance where she was observed all day. She reports that her daughter is not allowed to get the second shot.  The second dose of mRNA-1273 was discontinued in response to the event.  The outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
One spot on his face, then mom noticed others. Splotchy, macular erythematous rash on face includes sides of neck and (L) ear. Gave 1 dose of BENADRYL.
Seizures started 3 hours after receiving the first dose of Pfizer injection, body temperature was 99 degrees. This continued for the next 3 days.
Patient is 12 years old and received a dose of the pediatric vaccine instead of the adult dose
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-OCT-2015 12:41, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date; 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 4.5 and -2.5 (14 hours 14 mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
0602This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. On 13-MAY-2013 the patient was vaccinated with second dose of VARIVAX (merck) (lot # 0602AA, expiration date 26-APR-2013) intramuscular (dose and anatomical location unspecified). The physician assistant reported that was administered an expired dose of VARIVAX (merck) on 13-MAY-2013. The physician assistant noted that this was the second dose of VARIVAX (merck) the patient had been administered. It was not known when the first dose of VARIVAX (merck) as administered. No adverse effect reported. At the time of the report the patient's outcome was unknown. Additional information has been requested.
patient reported getting up to go to the bathroom around 1 am and experienced extreme leg soreness and the inability to walk to the bathroom  he said he had to "shuffle".  upon waking the next morning he was still sore and having difficulty moving his lower limbs.  He was able to eat a small amount of toast and have a little bit of coffee but his state was not improving so his wife took him to a hospital and  they kept him overnight due to his hx with multiple myeloma.  They concluded that the myeloma had not progressed and that there were no other reasons he experienced these symptoms than a rare side effect of the shingrix vaccination
About 3/3/21 I had a tiny sore on my  neck like a blister that was not a zit or ingrown hair. In the next couple of days I ended up with 3 larger sores on my neck that ached. The doctor said it was staph and gave me an antibiotic and an ointment. I have never had staph or sores like this in my life. The doctor didn't think it had anything to do with the vaccine but I am not so sure so I'd like to report it.
Information has been received from a physician concerning a 41 yr old male HIV positive who on 07Aug04 was vaccinated with pneumococcal 23v polysaccharide vaccine. The pt was now reporting hair loss. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX (batch number 3393R, expiry date 30th June 2019) for prophylaxis. On 3rd December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient planned to follow up with her physician on an unknown date. The reporter gave consent to follow up.
Small hives by 4:30 PM on 9-27-04. Stomach, legs and ankles.  Fever, judged by mother, 101.
received an expired daptacel with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA225761.  This case involves a 4 years old female patient who received an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR); polio vaccine inact 3V (vero) (IPOL); and varicella zoster vaccine (Varicella Vaccine) all for Prophylactic vaccination.  On 14-Jul-2023, the patient received an expired 0.5 mL dose 5 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: C5893AA; expiry date: 21-Jun-2023) via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.  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.
At 1 am, I felt very cold and started getting severe chills. By 5 am, I had a fever of 102 F and very severe body aches to which I had trouble moving from bed. I sweat profusely (more than I ever have before). I was unable to control my fever/pain with IBU or APAP. These symptoms lasted approximately 36 hours. At about that time, I began experiencing GI upset, where I was throwing up and had no appetite for 48 additional hours.