chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reddening and itching at injection site; Reddening and itching at injection site; Fatigue; This is a spontaneous report from a non-contactable consumer. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 18Dec2020 in the left arm at a single dose for COVID-19 immunization. The patient's medical history included shellfish allergy. The patient is not pregnant at the time of vaccination. Concomitant medication included spironolactone (ALDACTONE), dextrin (BENEFIBER), folic acid, atorvastatin (LIPITOR), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC), famotidine (PEPCID), and estradiol (VIVELLE DOT); patient also received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Dec2020, the patient experienced reddening and itching at injection site and fatigue at 2 days post-inoculation. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovered. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.  No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
This spontaneous report was received from a licensed practice nurse refers to multiple patients of unknown age. On an unknown date, the patients may have been vaccinated with an improperly stored doses of GARDASIL. No adverse effects reported. Temperature 1.7 degree centigrade, time frame 19 minutes. This is one of the two reports received from the same reporter. Additional information has been requested.
Flu symptoms after a few days-diarrhea developed.  Saw Dr.  Stool test came back negative.  Given Pepto Bismol then put on Imodium.
Feeling of bugs crawling all over body. Itching all over body & in groin area.
Mom noticed several red bumps on child's trunk anterior and posterior. Also on both arms and legs.
Noticed ringing in my ears (Tinnitus) 2-3 days after second injection. Did not and has not gone away as of todays date., 11/15/2023.
Severe pain in left shoulder and left arm.  It felt like I had ripped a muscle or tendon and would hurt constantly. Pain scale of 7-9 all day and night for a week. Daly?s 6& 7 the pain did subside slightly and remain d light pain for two more days
Headache, Myalgia, "a little rundown, shivering, up and down all night, experiencing body aches, chills, headache and fatigue"  Narrative:
Itchy palms and feet and ears followed by hives.  Total body soreness.  Vomiting.  Very tired.
Patient received Covid booster early.  Patient reports that she experienced same side effects of the first two doses.
On Sunday, 2/21 both forearms, wrists, and thumbs began swelling and experiencing stiffness, tension, and pain (6/10) that was both burning/nerve pain and achy muscle pain. Previously, my DeQuervein's had been steadily improving through occupational therapy, home exercise, reduced tech use (scrolling/typing), and splinting.  By Tuesday, 2/23, range of motion on the Left hand, wrist, and thumb was reduced to almost 0 and the pain reached an steady 9/10 on both arms. As of writing this, the stiffness, swelling, nerve pain, and tension remain at a level higher than the initial level that drove me to seek out occupational therapy back in January.  Basically, I went from being close to being discharged to worse than I started. Overall the left side was worse than the right but both sides were impacted.  Occupational therapy (ultrasound, fascial release, and assisted stretching) splinting, stretches, and ice were used as treatments. NSAIDs are contraindicated due to Crohn's disease.   As of writing this at 16:04 on Thursday, 2/25 none of this has resolved. Pain is a 7/10 on both sides. Range of motion and ability to complete daily care tasks (e.g. dressing, showering, cooking and eating) is nonexistent to minimal.
severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; hair loss; headaches; Anaphylaxis; hives; itching breathing, lips, throat impacted; itching breathing, lips, throat impacted; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 23Feb2021 at 01:00 PM (at age of 54-year-old) as SINGLE DOSE for covid-19 immunisation, Lot Number: EN6198. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 03Feb2021 in Left arm for COVID-19 immunisation, Lot number: EL8982. Medical history was not reported. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 23Feb2021 within 20 mins patient experienced anaphylaxis, hives, itching breathing, lips, throat impacted. On 23Feb2021 at 02:00 PM (also reported as over next week) patient experienced severe fatigued; red eyes; fever; darkened skin in face; subsequent results, Itchy scalp and subsequent hair; seeing hair loss continuing and fatigue, headaches ongoing thus far. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatments received included Anaphylaxis medicine, intravenous (Iv) administration; prescript. Patient had not recovered from the events, at the time of the report.
This spontaneous report was retrieved from a social network via Pfizer (assigned manufacturer control number: 2015420009) and was originally reported by the uncle of a male patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient started therapy with TYLENOL and MOTRIN (for both therapies indication, dose, frequency, route of administration, lot number and expiration date were not provided). Subsequently, the patient was vaccinated with M-M-R II (dose, dose number, route of administration, lot number and expiration date were not provided). Other suspect therapies included SARA (indication, dose, frequency, route of administration, lot number and expiration date were not provided). Concomitant medication was not reported. According to the reporter, on an unknown date, SARA and M-M-R II "killed" his nephew. The reporter stated that he was life flighted to hospital and died. It was also reported that the patient was alive and flew to a county hospital and died. It was unknown if an autopsy was performed. The cause of death was also unknown. Additional information is not expected, since the reporter's details were not provided.
They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd. I went into anaphalactic shock admitted to the ER, given an epinephrine drip, I was given iv bolises, chest xray, vitals were taken and blood was drawn. ABGs and chest xray and lactic acid tests were administered. I have to carry a epi pen and need to see a pulmonologist, I have triggers now where I need an emergency inhalor and was put on a course of steroids and my heartbeat is 20 beats higher than usual. I was really tired and having abdominal pain .
consumer received Imogam/Imovax on 25-May-2020 and received second dose on 04-Jun-2020, no AE.; Initial information received on 08-Jun-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 31 years old male patient who was vaccinated with first and second dose of suspect RABIES VACCINE [IMOVAX RABIES] (lot number and other dosing details were not reported) via unknown route in unknown administration site on 25-May-2020  and 04-Jun-2020 respectively as prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate schedule of vaccine administration.  The pharmacist had reported that the consumer had a delayed dose on the second injection of suspect imovax rabies. it was informed that the patient had begun on day zero on 25-May-2020 and had a second dose on 04-Jun-2020, also pharmacist informed that the patient has been behaving erratically described as making trips to the emergency room for other things (unspecified) and not telling the staff that he was there for his follow up Imovax Rabies doses.  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Other medication was received in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Rebound of symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound of symptoms and positive test was experienced on 18Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First dose was administered on the afternoon of May 6, 2021. Onset of cardiac symptoms began approximately 72 hours after first dose, on the evening of May 9, 2021. Severe angina and heart palpitations.  Pain, discomfort, and heartbeat irregularity continued for months. Call with public health nurse advised to take ibuprofen, which produced no alleviation of symptoms. Following no resolution by over the counter anti-inflammatory, urgent care was sought on August 12, 2021. Initial ECG reflected:  * Abnormal sinus arrhythmia, extensive ST elevation suggestive of pericarditis.  Evaluation has involved multiple cardiologists since August, 2021. Multiple echocardiogram studies reflect inflammation of the pericardial sac and heart muscle. Inflammation may be responsive to a combination of colchicine, very high dose aspirin to prevent heart attack, and steroidal anti-inflammatories. Irregular heartbeat only seems to alleviate to some degree with administration of loratadine (antihistamine), which has yet to be fully explained and is awaiting further analysis by a rheumatologist (preliminary suspicion of immune modulating affect upon eosinophils and/or other cells).
The rectal bleeding is not that much; Bleeding with a lot of clots; she started to bleed vaginally; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 50 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the rectal bleeding on an unspecified date with outcome of unknown, bleeding with a lot of clots leading to thrombosis on an unspecified date with outcome of unknown also she started to bleed vaginally leading to vaginal haemorrhage on an unspecified date with outcome of unknown.  No follow-up attempts are possible. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
My mother had the flue shot and the pneumonia shot at the same time... She  started to itch on 10/09/2019  and then on 10/10/2019 she broke out in hives on her arms, back and hips, and legs..  she started taking Benadryl and it helped with the itch , today is the 10/14/2019 and she still has the hives but they are not as red as they were. She is convinced she is doing better, but I am not sure she is.  I am not sure which shot she got, I would have to check with her doctor for the exact ones... she just told me the flue and pneumonia shot.  If need be and there is a follow up I will get this information.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-SEP-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. 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.
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026c21a and 007c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 06-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.     Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-426170 (Patient Link).
Information has been received from a consumer concerning her 15 month old female child who on 11-DEC-2007 was vaccinated with a dose of PedvaxHIB lot # 657385/0677U. Concomitant therapy included other vaccination (unspecified). The reporter reported that within hours after receiving the vaccine her daughter's injection site was really red, hot, bruised, had a rash, and was swollen. She also reported that the child had a low grade fever around 101 degrees, was fussy and she was not eating right. It was reported that within a couple days swelling went from her behind to her leg in a round circle. She still had a knot at the injection site. The reporter mentioned that the child was taken to the physician, and the physician put her on unspecified antimicrobial therapy. She was recovering. Additional information has been requested. Follow-up information received 4/15/08. The concomitant therapy has been changed from study vaccination (unspecified) to therapy unspecified (other unspecified vaccination). Additional information has been requested.
Information has been received on 09/26/2001 from a medical assistant concerning a pt who was vaccinated with a dose of varicella vaccine. The mother of the pt reported that about a week after being vaccinated, her child developed a small red, itchy bump at the site of immunization. The pt sought unspecified medical attention.  It was also noted that there were several other reports with topical type of reactions. Additional info has been requested.
Slight itching and irritation of skin on entire body began day of vaccination then intensified.   Day 3-4 symptoms got worse-severely dry skin, scaly spots on face/eyes, flaky scalp, burning sensation all over skin.  I felt my body temperature was normal, maybe colder than normal, but my skin was hot to the touch.  Itching continued in spots on body for several days.  On Day 10 my left arm, site of injection, became red, swollen and very irritated, itched really bad. The redness traveled up from my arm to my neck and ears causing them to be bright red and very hot to the touch.  While at a regularly scheduled OB/GYN appointment the same day the doctor observed the symptoms and gave me a steroid shot and recommended starting a daily antihistamine.  The itching has subsided but hasn't gone away completely on day 11, some redness remains.
very sleepy; nausea; severe headache; chills; fever; soreness at the injection site; swelling at the injection site; A spontaneous report  was received from a consumer concerning a female patient of 69 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events nausea,severe headache, chills, fever, felt very sleepy ,injection site sore (vaccination site pain ) and swelling at injection site  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 26 feb 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 013A21A) vaccine intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 feb 2021,one day after vaccination, patient experienced nausea, a severe headache, chills, fever and felt very sleepy.patient also started having soreness and swelling at the injection site, which lasted for the next 3 days. Treatment for the event included Tylenol.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, nausea, severe headache, chills, fever, felt very sleepy were considered resolved on 01 Mar 2021.  The outcome of the events, injection site sore and swelling at injection site were considered resolved on 02 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning a 42 year old female patient with no pertinent medical history and no drug reactions or allergies who in 1987 was vaccinated with a dose of MMR II (Lot # not reported). Concomitant therapy included NEXIUM, hydrochlorothiazide (manufacturer unknown) and naproxen. In 2009 rubella titer was performed and was negative. No adverse effects were reported. Follow-up information received from the registered nurse reported that the patient "was not given" a dose of MMR II. The nurse reported that she was asking "if a patient had received 2 doses of MMR II should they receive more dose if the rubella titer was negative". No further information was provided at this time. Additional information is not expected.
Round red area where shot was given, slightly swollen, warm, and sore. Some tingling in arm and hand.
awakened with racing heartbeat-lasted for a few hours, headache-ongoing after 8 hours (Heart racing stopped) headache lessened some by tylenol
Case number PHEH2015US021423, is an initial spontaneous report received from a healthcare professional on 20 Oct 2015. This report refers to a 52 years old female patient. Historical condition and concomitant medication were not provided. It was reported that FLUVIRIN (batch number: 157602) stored at 48 degree F for 8 hours was administered to the patient intramuscularly on 20 Oct 2015. No adverse event was reported following this maladministration.
Pruritic rash starting in extremities and spreading to trunk/total body.  50mg diphenhydramine was taken and patient noted resolution upon waking the following morning.
Patient received expired dose of fluarix; Patient DOB: 13-SEP-2021; This case was reported by a other health professional and described the occurrence of expired vaccine used in a 7-day-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number HS75G, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 20th September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, the patient received expired dose of fluarix, which led to expired vaccine used. The patient received Fluarix at the age of 7 days old, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter
Information has been received from a nurse concerning a 64 year old male with diabetes, low back pain, knee pain and hypertension and no allergies who in 2003 was vaccinated with the first dose of PNEUMOVAX, 0.5 ml IM. On 17-SEP-2008, the patient was vaccinated with a second dose of PNEUMOVAX (lot no. 661899/0519X) 0.5 ml, IM. Concomitant therapy included VIAGRA, Aspirin, MOTRIN, LOTREL, GLUCOVANCE, ACTOS, FLEXERIL, hydrochlorothiazide, simvastatin, nystatin and FLUZONE. In 2003 the patient experienced quite a reaction. On 17-SEP-2008 the patient experienced redness, swelling and warmth on the right upper arm, the patient was diagnosed with cellulitis and was given KEFLEX. The patient recovered from both events. The patient sought medical attention as he was seen. Additional information has been requested.