chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm was sore at the injection site; My arm was red at the injection site; My arm was swollen at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20RT) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.   This case was linked to MOD-2021-422610 (Patient Link).   Reporter did not allow further contact
No additional AE or PQC reported; patient was administered expired MMR II; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 19-MAR-2022, the patient was administered expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) dose of 0.5 mL, lot number: T007233, expiry date: 27-FEB-2022 (strength, frequency, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event (AE) or product quality complaint (PQC) reported (no adverse event). The reporter confirmed the measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) did not have any temperature excursions.
This is a spontaneous report from a contactable consumer. This consumer reported similar events two patients. The is the second of two reports. This consumer reported for her sister that a female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The consumer reported she had an infection after getting the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The physician's assistant looked at her arm that was swollen and red telling the caller it's cellulitis and said had to get antibiotics because her arm blew up (swollen) and turned red. The consumer (therapist) said the same thing happened to their sister when she got the pneumococcal vaccine. The outcome of the events was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018463224 same reporter, similar drug/event, different patients.
Shot was administered at 8AM on 4/7, symptoms started around 4PM on 4/7.  I am currently 29 weeks pregnant with a due date of June 22nd. I am 5ft1in and currently weighing 130lbs.  List of symptoms: -Chills/Shakes -Fever (up to 101 F) -Extreme muscle weakness -Extreme Fatigue -Finger tips turning blue/purple -Nausea  At 7:30PM, I took 3 Tylenol (500mg) and went to bed. Woke up at 8AM the next morning, with only feeling a bit of weakness, which was gone after I ate breakfast that morning.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received a dose of improperly stored RECOMBIVAX HB injection (lot # M001578, expiration date 21-NOV-2018; dose unknown), intramuscularly. No adverse effects were reported. The vaccines were stored under temperature 35 Fahrenheit degree for 1 hours. Additional information has been requested.
Rash like a circle at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (Rash like a circle at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash like a circle at the injection site). At the time of the report, VACCINATION SITE RASH (Rash like a circle at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case concerns a 43-year-old female who experienced nonserious expected event of vaccination site rash.  Event onset occurred day 10 after the first dose of mRNA-1273. Treatment not reported. Events ongoing. Based on 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.; Reporter's Comments: This case concerns a 43-year-old female who experienced nonserious expected event of vaccination site rash.  Event onset occurred day 10 after the first dose of mRNA-1273. Treatment not reported. Events ongoing. Based on 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.
Axillary swelling, fatigue, sore throat progressing to vomiting, diarrhea, splenomegally, rash over whole body and off work for 5 weeks with relapsing fatigue and headache.
After 48 hours from DTaP vaccine, Right deltoid area red/swollen 5.5cm. Treated with Benadryl and Tylenol.
Product storage error; No adverse event on patient; This spontaneous report was received from Other and refers to a 13-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1775811, expiration date: 07-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1775827, expiration date: 27-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U032681, expiration date: 26-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1780876, expiration date: 09-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided); and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W009829, expiration date: 19-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced Product storage error, the patient experienced No adverse event on patient. ; Sender's Comments:  US-009507513-2304USA002221:
pt recvd vax & devel local rxn w/in min just below inject 50mm; 3mm wheal around inject site; mom instructed to watch child & notify PMD w/any problems
itchy; hives; rash on my lower body from hips to ankles.; This is a spontaneous report from a contactable consumer. This 49-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) (Lot number& Expiry date not reported) via unspecified route of administration in Left arm on 04Feb2021 9:00 (at age of 49-years-old) as single dose for COVID-19 Immunization. Patient medical history include type 2 diabetes, seasonal allergies. Patient concomitant medication includes Metformin, dulaglutide (TRULICITY), Losartan, cetirizine hydrochloride (ZYRTEC) used for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as single dose for COVID-19 Immunization. On 08Feb2021 at 6:30 (4 days after vaccination), patient reported it has been 4 days since my 2nd dose of the Pfizer vaccine. This morning I woke up with itchy hives/rash on my lower body from hips to ankles. No treatment received for events. The outcome of events was not recovered.  Information on Lot/Batch number has been requested.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
extreme fatigue/tiredness; body soreness; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration in Left Arm on 03Apr2021 (Lot Number: Ew0120) as Dose 2, Single (age at vaccination: 26-years-old) for Covid-19 immunisation. Medical history included testis cancer (History of testicular cancer) and known allergies: Sulfa. Concomitant medication(s) included famotidine, lysine and calcium carbonate (TUMS [CALCIUM CARBONATE]). Historical vaccine included bnt162b2 (PFIZER-(BIONTECH COVID -19 VACCINE, formulation: solution for injection, via an unspecified route of administration in Left Arm on 09Mar2021 (Lot Number: EN6199) as Dose 1, Single at the age of 26-years-old for Covid-19 immunisation and experienced Alopecia areata, and Sudden hair loss in patches on scalp and beard. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had received other medications within 2 weeks prior to the vaccination includes Famotidine, lysine, tums. The patient was not diagnosed with covid-19 before and tested post vaccination. On 04Apr2021 (1 day after the vaccination), the patient experienced extreme fatigue/tiredness, and body soreness. On 20Apr2021 the patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: Negative. The events resulted in emergency room visit/ Physician office visit. Therapeutic measures were taken as a result of extreme fatigue/tiredness, and body soreness includes steroid cream. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; No further information is expected.
Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA
Patient had administration of Tdap (Adacel) on 7/18/07 then began that evening to have right arm pain and soreness.  This progressed on 7/19/07 to generalized myalgias, headache, fevers (documented at home as 102.2F oral), and chills.  He was seen in my office 7/20/07 with persistent headache, generalized myalgias, and malaise.  He treated himself on 7/19/07 with OTC Tylenol PM Flu.  I prescribed symptomatic treatment with tylenol 500 - 1000mg q 8 hours prn, ibuprofen 600 - 800mg q 6-8 hours prn fever, pain, and benadryl 25 - 50mg q 6 hours prn.
pt recv vax 6JUN95 130PM & in the evening of 6JUN95 pt exp a fever; 7JUN95 temp was 104.6; pt was treated w/cool water tub bath & children's ibuprofen; No further details were provided;
pt came down w/chickenpox w/in 10 days;no fever, some irritability, 12 pox so far;
Posterior headache, nape and upper back pain  Low grade fever for about 18 hrs  Armpit tenderness on the side of injection
Patient described large swollen area, redness and warmth at injection site. She was counseled at time of reporting adverse reaction to take ibuprofen (if not contraindicated for any reason), apply a cold pack to the area and see a doctor if she felt is was appropriate or if the symptoms continued to worsen. We will contact her the next day to check on her and follow-up.
Fever , headaches, pain at injection site, and body aches.   Have developed ?itch? on chest.
localized itching, red circular rash to left arm Benadryl 25mg given Monitored for additional 20 minutes
After receiving the vaccination her husband met with his son.  He reported that his dad did not know anything.  His wife told the son to bring him to Hospital.  They brought him to the hospital and got there and his son said that he had called the daughter and he did not know the day, month, his grandson's name, like he wasn't there.  He had a funny look on his face that he was "out of it".  Asked simple questions about pet at home, favorite and could not remember the name of the cat.  He then came out and said that he was fine. They ran tests for a mini-stroke, CT scan, blood work.  They had a consult with Neurology, virtual.  The neurologist did some questioning, and by 3:00 they felt that it was like a mini-stroke, and she said that she felt it was from the vaccination as it occurred right after the vaccine.  She took him home, and told him to take a nap.  By 4:30 PM she woke him up and said that they were going to eat, she was getting things ready.  He was sitting on the couch about 5:00 PM and had that blank stare again.  He went walking through the house walking aimlessly and started fumbling through papers .  She called 9-1-1 and within 10 minutes they took him to the ER.  It took her an hour to get to the hospital, his daughter met them at the ER.  He told them that he was fine, and they knew that he was not.  By 7:00 PM they were going to do an MRI and wanted to admit him to the hospital.  All of a sudden at 9:00 he was having another episode.  She got the nurse and they watched him and decided that he was having a seizure, (agitation, not making sense.).  The entire episode lasts for about 30 minutes.  They did an MRI and an EEG, which she does not have the results of.   On 2/11/21 she talked to the neurologist who insisted it was due to the vaccine.  He has now settled down and has not had another seizure since 9:00 PM the night before.   He was discharged yesterday at around 1:00 PM, he slept, got up and is fine this morning.  He was diagnosed with seizures, and to FU with Dr. in Epilepsy clinic, and prescribed Keppra, which he has not taken as he feels it was due to the vaccination..   He does not remember the events that took place.
This spontaneous prospective pregnancy report as received from a certified medical assistant (C.M.A.) refers to a 37 year old female patient with no pertinent medical history or drug reactions/allergies. On an unspecified date in August 2013, the patient was vaccinated with her first dose of GARDASIL inj (dose, route and lot number not provided). On an unspecified date in October 2013 or November 2013, the patient was vaccinated with her second dose of GARDASIL (dose, route and lot number not provided). No co-suspect therapy was reported. There was no concomitant medication. The reporter stated that the patient became pregnant with last menstrual period (LMP) of 17-FEB-2014 and Estimated Due Date (EDD) of 24-NOV-2014. The vaccine exposure was during the first trimester. The pregnancy outcome was pending and the fetal outcome was unknown. The outcome of vaccine exposure during pregnancy was unknown. The reporter stated that the patient received the first and second doses of GARDASIL from another unspecified facility. No treatment was given for the adverse event. No lab diagnostics studies were performed. The patient sought medical attention by visiting the office. Additional information has been requested.
No symptomatic side effects reported during time of call. No additional AE details or PQC.; a patient was administered VARIVAX intramuscularly instead of subcutaneously; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.  On 14-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous Injection with sterile diluent (strength, dose, frequency, lot# and expiration date were not provided) intramuscularly instead of subcutaneously for prophylaxis (incorrect route of product administration). No symptomatic side effects reported during time of call. No additional adverse event (AE) details or product quality complaint (PQC).
Information has been received from a pharmacist referring to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # L030591, expiration date 10-FEB-2017; dose and route were unknown). No adverse effects were reported. The temperature excursion included 30 Minutes at -11.6 Celsius degree, 2 Hours and 30 Minutes at -8.7 Celsius degree, 1 Hour and 30 Minutes at -9.2 Celsius degree, 1 Hour and 15 Minutes at -9.8 Celsius degree. Data logger was involved. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
7.18.21: patient had unwitnessed fall at ALF 2 days prior. has weakness so EMS called. Found to be COVID 19 positive. Patient has previous history of receiving the COVID-19 Pfizer vaccine on 1/16/2021 and 2/6/2021.  diagnosed with AMS, generalized weakness, COVID-19 infection, acute hypoxia from tracheobronchitis. 7/27/21: discharged
Patient is 17 years old. He will turn 18 on April 28, 2021.
got her first vaccine on 26Feb. She got the second dose yesterday (15Mar).; Chills; Bad headache; Very bad muscle pain; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: She mentioned that she has fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMIN-ISTRATION (non-serious), outcome "unknown", described as "got her first vaccine on 26Feb. She got the second dose yesterday (15Mar)."; CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Bad headache"; MYALGIA (non-serious), outcome "unknown", described as "Very bad muscle pain"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional Information: The patient stated that she wanted to know if she can take some Ibuprofen. The patient had her second dose of COVID vaccine of Pfizer yesterday afternoon. She had chills most of the night and woke up with a bad headache. The patient had some very bad muscle pain and nausea.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), PYREXIA (fever) and MYALGIA (very bad muscle aches and spasms in her back.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (soreness), PYREXIA (fever) and MYALGIA (very bad muscle aches and spasms in her back.). On 30-Mar-2021, PYREXIA (fever) had resolved. At the time of the report, PAIN (soreness) and MYALGIA (very bad muscle aches and spasms in her back.) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
I have started to have palpitations and heart fluttering.; 3rd shot booster and being a reported side effect; I have started to have palpitations and heart fluttering.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 06Dec2021 17:00 (Batch/Lot number: unknown) at the age of 61 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "allergy to Trace dye" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; VIT D [COLECALCIFEROL]; KRILL OIL; VIT B COMPLEX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. , Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 23Apr2021, when the patient was 60 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 06Apr2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: CARDIAC FLUTTER (medically significant), PALPITATIONS (non-serious) all with onset 07Dec2021, outcome "not recovered" and all described as "I have started to have palpitations and heart fluttering."; IMMUNISATION (non-serious) with onset 07Dec2021, outcome "not recovered", described as "3rd shot booster and being a reported side effect". Therapeutic measures were not taken as a result of cardiac flutter, palpitations. Clinical course: 'I have started to have palpitations and heart fluttering. This was a familiar feeling as it occurred every so often maybe once or twice, throughout adulthood. But that quickly went away. Now it has started and has been 3 days now and has continued throughout the day. As I have been willing to let it take it's course, it just dawned on me the connection to possibly a recent 3rd shot booster and being a reported side effect'. No covid prior vaccination. No covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt received all 3 vax After her second vax on 3/31/2021 Pt said she had massive hair loss  Pt said she had hair loss after the first vax but the second and third vax made hair loss worse
Ever since my shot my arm has ached (most severe at night). Mainly my upper arm and shoulder. At times extending into my neck. At times it also feels slightly numb. Also when performing certain movements with my arm or hand I have weakness and discomfort.