chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose 1 given 25Aug2021; Dose 2 01Nov2021; Severe hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 16:00 (Lot number: 33026BD) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing), notes: Chronic pain due to botched surgery; "botched surgery" (unspecified if ongoing), notes: Chronic pain due to botched surgery; "allergies: sulfa drugs" (unspecified if ongoing), notes: known_allergies: Pain meds, sulfur drugs. Concomitant medication(s) included: FLU, administration date Oct2021; XOLAIR; METHADONE; PAMELOR; ATIVAN. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: FC3138, Location of injection: Arm Left, Vaccine Administration Time: 16:00), administration date: 25Aug2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Nov2021, outcome "unknown", described as "Dose 1 given 25Aug2021; Dose 2 01Nov2021"; ALOPECIA (non-serious) with onset Nov2021, outcome "not recovered", described as "Severe hair loss". Therapeutic measures were not taken as a result of alopecia.  Additional information: Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient had not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2015US019165, is an initial spontaneous report received from a consumer on 24 Sep 2015. This case report refers to 63 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 174268), intramuscularly on 16 Sep 2015. On 23 Sep 2015, he experienced bronchitis. The seriousness, outcome and causality of the event were not reported. The seriousness of the event was upgraded to serious (medically significant) based on the NVS IME list.
Pain limiting movement in arm day following injection, no medicines used, problem resolved by Monday 9/22/14. Patient just wants us to know.
UrticariaPruiritus Narrative: Developed urticaria on arms and pruritus of face 2.5 hours after vaccination 2/26. No angioedema/respiratory sx. Symptoms resolved a few hours later without intervention. Urticaria returned on arms on 2/28 though was milder, resolved without intervention several hours later.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient developed an unspecified reaction to penicillin on an unspecified date. The patient did not have none pertinent medical history. On 10-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX at dose: 0.65 ml injected subcutaneously in the right arm (lot # K003599, expiry date: 13-MAR-2015); therapy reason for use reported as "age appropriate". Concomitant therapies included metformin, ZYRTEC and estradiol (manufacturer unspecified). The reporter stated that the patient called him on 12-SEP-2014 to sought medical attention: she stated over the phone that she had a reddish, warm area the size of an orange which was slightly swollen and itchy at the site of administration on her right arm (developed in September 2014, exact date unkonwn). No treatment was given for the experienced events and no laboratory test were performed. The outcome of the events was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Pt got blisters on tongue same day vaccine was administered. Pt states he is unsure whether the vaccine was the cause or not...States he did not have anything corrosive (spicy,hot,fried) to eat.  And doesn't believe he injured his tongue. Started with one blister and now has 3 blisters... pt came back to pharmacy 4 days later to show adverse effect.
She developed a fever the next day of 102.0 F. She had headaches, back pain, neck pain, and chills. Left arm was swollen and tender at injection site. When she presented to me three days after receiving injection her symptoms were improving. She was noted to have erythema, warmth, and tenderness at er left posterior arm. It appears that the injection was given mistakenly subcutaneous versus the intended intramuscular route.
Headache began yesterday 1/14 evening, through the night severe body aches, chills and fever of 102
redness reaction; pain; localized injection swelling; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in May2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset May2023, 1 week after the suspect product(s) administration, outcome "not recovered", described as "localized injection swelling"; PAIN (non-serious) with onset May2023, 1 week after the suspect product(s) administration, outcome "not recovered"; ERYTHEMA (non-serious) with onset May2023, 1 week after the suspect product(s) administration, outcome "not recovered", described as "redness reaction". Additional information: Patient received the shot about a week ago and got localized injection swelling with redness and pain which is still there, caller can see it, so calling to see if Pfizer has any data on how long that would last?   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a healthcare worker (medical assistant) refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that PROQUAD had been transported for the past six months to a sister clinic that was about 15 minutes down the road. The healthcare worker was unable to provide the temperature that the PROQUAD was exposed to or exact time frame. One box of PROQUAD was transported an unspecified amount of times. She reported that the lot # and expiration date for the PROQUAD (Merck) was H020854 and expiration: 26-MAY-2014. She reported that the PROQUAD had been administered but she was unable to provide the dates of administration for the PROQUAD. She did not have patient details or the amount of patients that the PROQUAD were administered to at the time of the call. She did not have physician demographics at the time of the call either. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Began having a blotchy, red rash on my upper back between my left shoulder blade and my shoulder joint. Began early November. About 3 or 4 patches 1 inch in diameter each. It itches. Pointed it out to my dermatologist during my normal 6-month checkup Nov 30.  I have had all 3 types of skin cancer in the past and see him every 6 months for an evaluation. I asked if it could be Eczema. His response was it looked more like Psoriasis, and he asked if I ever had that. I said no. He prescribed Betamethasone Dipropionate cream to use twice a day to see if it would clear. It has started clearing.
Information has been received from a registered nurse concerning a 4-year-old male with no pertinent medical history and no drug reactions/allergies on 29-AUG-2002 was vaccinated with a 0.5mL dose of Varivax (Lot # 641157/0079M). It was unknown if there was an illness at the time of vaccination. Concomitant therapy included a dose of MMR II (Lot # 643499/0538M). There was no other concomitant medication. On 10-JUN-2006 the patient experienced about 30 vesicular lesions, mostly on his trunk. No other symptoms were noted. No other information was available. The outcome was reported as recovering. Unspecified medical attention was sought. There was no product quality complaint involved. There were no relevant diagnostic tests or laboratory data. Follow-up information indicated that on 12-JUN-2006, the patient developed a rash without fever or other symptoms. Approximately 30-35 papules were noted. The outcome was recovered. No additional information is expected.
its positive effect and it would be great if this vaccine works for IBS people; started feeling better; I thought I would be very sick after vaccine; my bloating went away for 2 to 3 days; my diarrhea went away for 2 to 3 days; my stomach pain went away for 2 to 3 days; My IBS problem completely gone for 2 and 3 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling better), ILLNESS (I thought I would be very sick after vaccine), ABDOMINAL DISTENSION (my bloating went away for 2 to 3 days), DIARRHEA (my diarrhea went away for 2 to 3 days) and ABDOMINAL PAIN UPPER (my stomach pain went away for 2 to 3 days) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome and Hysterectomy (I had hysterectomy couple of years ago). Concomitant products included MOMETASONE FUROATE (NASONEX), CETIRIZINE, OMEPRAZOLE, METOPROLOL, DICYCLOMINE [DICYCLOVERINE], FLUOXETINE and ALPRAZOLAM (XANAX) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 30-Apr-2021, the patient experienced FEELING ABNORMAL (started feeling better), ILLNESS (I thought I would be very sick after vaccine), ABDOMINAL DISTENSION (my bloating went away for 2 to 3 days), DIARRHEA (my diarrhea went away for 2 to 3 days), ABDOMINAL PAIN UPPER (my stomach pain went away for 2 to 3 days) and IRRITABLE BOWEL SYNDROME (My IBS problem completely gone for 2 and 3 days). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (its positive effect and it would be great if this vaccine works for IBS people). At the time of the report, FEELING ABNORMAL (started feeling better), ILLNESS (I thought I would be very sick after vaccine), ABDOMINAL DISTENSION (my bloating went away for 2 to 3 days), DIARRHEA (my diarrhea went away for 2 to 3 days), ABDOMINAL PAIN UPPER (my stomach pain went away for 2 to 3 days), IRRITABLE BOWEL SYNDROME (My IBS problem completely gone for 2 and 3 days) and IRRITABLE BOWEL SYNDROME (its positive effect and it would be great if this vaccine works for IBS people) outcome was unknown.            Treatment information was not provided.
affected the movement of muscles in neck, back, shoulder and all the left side of her body; awful; This case was reported by a consumer via other manufacturer and described the occurrence of movements reduced in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced movements reduced and feels awful. On an unknown date, the outcome of the movements reduced and feels awful were recovered/resolved.   It was unknown if the reporter considered the movements reduced and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received the Shingrix vaccine and had an awful adverse reaction.  It affected the movement of muscles in neck, back, shoulder and all the left side of her body and while it lasted some weeks. The patient did not want to go through that experience again so wanted to wanted to know the full list of ingredients of the Covid vaccine. The consent to contact HCP was requested.
Information has been received from a female consumer who 14 days ago, on 13-OCT-2009 was vaccinated with dose of MMR II. The reporter mentioned that on 23-OCT-2009 she developed "painful lumps under her ear lobe and on the back of her head" after getting the vaccination. The reporter also stated that she experienced nausea and weakness "for a couple of days" after she received the MMR II. It was mentioned that "last night" on 26-OCT-2009 she developed a rash on one of her cheeks, which "spread to her other cheek today" on 27-OCT-2009. It was unknown if the patient sought medical attention. No further information was available.
Janssen on 7/19. Positive on 8/4 admitted on 8/11-current
Fever; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jun2021 (Lot number: EW0186) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, First Covid vaccine: , Date: 07May2021, NDC/expiration: unknown, Lot: EW0173, Site: left arm), administration date: 07May2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
05jul90 pt vax hepta B. 06jul90 pt devel h/a sore throat and myalgia.  12jul90 pt devel fever.
Burning from shot site to elbow, tingling from elbow to fingers. Burning from injection site into neck area. Seems to be more painful with movement. Symptoms mild last evening, seem more pronounced today. Took 3 Advil this am-4:30am.
pt recv vax 11OCT95 & pt devel inj site rxn characterized by pain,warmth,swelling & redness;this is on of nine patients from this site who exp above rxn p/vax;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (lot number, expiration date, route of administration and strength were not reported). Then on an unspecified date, the patient was vaccinated with a second dose of ZOSTAVAX (lot number, expiration date, route of administration and strength were not reported) (extra dose administered). There were not adverse effects reported. Additional information has been requested.
Development of Bell's palsy  (patient had Bell's palsy approximately 10 years ago)
VAGINA BLEEDING; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibroids, penicillin allergic, smoker, post-menopause, and anal cancer. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-APR-2021, the subject experienced vagina bleeding. Laboratory data (dates unspecified) included: Complete blood count (NR: not provided) Unspecified. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from vagina bleeding. This report was non-serious.
Tinnitus (ongoing), hearing loss right ear (ongoing), headache, fatigue, muscle and joint pain, dizziness, sinus and head congestion (ongoing).
This study case was received from the investigator on 27 August 2012. A 48-year-old male subject (with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 15 October 2009 (also with a reported date of 19 October 2009) an elevated central laboratory Troponin level of 0.44 ng/ml and on 20 October 2009 a central laboratory Troponin level of <0.10 ng/ml. The date of recovery was reported as 20 October 2009. The subject had a rapid Troponin I level on 15 October 2009 that was within normal limits (negative). On 20 October 2009, the subject had an "abnormal:NCS" ECG reading (per medical records, the ECG reading was documented as normal). There was no other reported visit. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was recovered. According to the Investigator, the event of elevated central lab Troponin was considered an other important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
pt recv vax & facial skin color was white, skin dry, eyes closed; oriented to person only; pt felt nauseated & asked to lie down; pt fainted a/reaching room; BP 70/30; c/o tingling in lt hand & arm; tingling in rt hand, lips deep red color
This case was reported by a nurse and described the occurrence of fever in a 19 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 9/9/03, the patient received an injection of Infanrix. Later that day, at an unspecified time post immunization, the patient's parent telephoned the physician to report that the patient was experiencing fever, malaise, and an injection site reaction characterized by redness, swelling and induration. The events resolved on an unspecified date prior to 9/17/03.
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 23-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
This spontaneous case reported by a consumer, describes the occurrence of decreased heart rate (her pulse has been low more often), oral herpes (9 cold sores since the vaccine) and fatigue in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006M20A) for COVID-19 immunization. No medical history provided. On Feb 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. February 2021, patient experienced ORAL HERPES (9 cold sores since the vaccine). On an unknown date, patient experienced decreased heart rate (her pulse has been low more often) and fatigue. At the time of the report, decreased heart rate (her pulse has been low more often), oral herpes (9 cold sores since the vaccine) and fatigue: not resolved/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The patient reported wearing an event monitor from Mar 9, 2021 to Mar 23, 2021. Concomitant medication and treatment information not provided.
Localized reaction at the injection site on right deltoid; redness; slight rash; moderate itching; swelling
Redness, swelling, warmth distal to vaccine administration site, Right deltoid.  symptomatic treatment, antibiotic for unrelated problem.
Information has been received from a registered nurse concerning a patient who on 09-NOV-1999 was vaccinated with a dose of Varivax. Subsequently, on 18-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Hands and feet became very reddened; burning and itching; took Benadryl 25 mg every 4-5 hours for several days, until symptoms relieved
The day of vaccine she had no problems.  The following wee her arm was red, swollen and hot at the top.  That reaction slowly went down and it's just above her elbow, she's 95 and it is kind of filled up with a hard mass in that area.  Her arm looks like a sunburn with two different shades of skin, on the back side of her arm where it is red.   She still has it on her arms today, 2/11/21.  She has not taken anything for it or put anything on it.  Her doctor told her to call us to see what we said she should do.  There is no pain, but it just looks bad and she is concerned.
Patient called later in the day, stating he had lip swelling and itching 1 hour after getting pneumonia shot. Started taking BENADRYL every 4-6 hrs. which seems to help symptoms.
SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. 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 case, involving the same patient is linked to 20221222848.
two female patients fainted and had seizures; two female patients fainted and had seizures; This initial spontaneous report was received from a Henry Schein refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 19-MAY-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot/ batch number and expiry date were not reported) for prophylaxis. On 19-MAY-2020 (also reported as "after being injected with vaccination), the patient fainted (syncope) and experienced seizures. The outcome of syncope and seizure was unknown. Causality assessment was not provided.  Upon internal review, the events syncope and seizure were determined to be medically significant.  This is one of the two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA008420: