chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm became incredibly sore within an hour. I woke up in the middle of the night aching like I had the flu. The body aches were so intense I couldn?t dress myself in the morning. All of my lymph nodes in my neck, ribs, and collar bones were incredibly swollen and hurt when touched. I rotated Tylenol and Advil with no relief. My fatigue was like no other. My headache wouldn?t go away either. 48 hours after the vaccine, I still had body aches and swollen lymph nodes in my neck to the point of pain when turning my neck.
The initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 20-JAN-2016, the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot # K011004 with expiration date 07-NOV-2015; dose and route were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
pt recv vax 11NOV98 & devel an inj site rxn characterized by a 25 cent area of induration, warmth, & itching;
Fever (6-7 hours), chills (8-9 hours), body aches in lower back and extremities (9-10 hours), and headache (15+ hours)
Flu like symptoms ie: body aches, chills, leg and feet cramps, lethargic, no appetite in the middle of the night, early morning between 2-5am
While adm. 6 mo. shots to baby I gave her Tdap instead of DTaP. I spoke to doctor who said give next DTaP booster at 12 mo. instead of 18 mo
"Pfizer-BioNTech COVID-19 Vaccine EUA" Patient was discovered deceased this morning by her family members.
I am diabetic so symtoms are like low blood sugar..I PASS OUT, SWEAT, COLD, DIZZY, MUSCLE PAINS, CONFUSED, VERY SLEEPY, PAIN IN EUSTACHIAN TUBE , HEADACHE, TOE PAIN,
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since April 2016, the patients were vaccinated with the improperly stored doses of M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. The digital logger was involved. M-M-R II also underwent previous temperature excursion. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA003831:
Vasovagal syncope? decreased blood pressure, passed out, stopped breathing, small convulsions.
He received .5mg H1N1 at 2:00pm. Within 5min of of returning to waiting room developed the following: heart racing, flushed face/neck with hives and felt like he was going to collapse-staff assisted him to exam table. Vitals taken, EMS called 02 44min nc administered and 25mg Benadryl IM given.
Painful lump in neck right besides clavicle bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 16:00 (Lot number: Ew0180) at the age of 32 years as dose number unknown, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NECK MASS (non-serious) with onset 13Jun2021 06:00, outcome "not recovered", described as "Painful lump in neck right besides clavicle bone". Therapeutic measures were not taken as a result of neck mass. Additional information: Patient had no known allergies. Patient reported had not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. The facility type vaccine: Pharmacy or drug store. The adverse event did not results in any seriousness criteria.  Follow-up attempts are completed. No further information expected.
Gave vial that was open on the 27th  at 2:00pm to the patient on the 28th at 9:20am. Patient was fine after the 15 minute observation, no reaction.
This child had inconsolable crying for 12 hours. He napped when tired, crying while awake. The doctor recommended Advil and Tylenol to the mother (per mom) the child is to be seen if no improvement.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-FEB-2019, the patient was vaccinated with one improperly stored dose of VARIVAX, lot # R023502, expiry date: 16-AUG-2020 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose of vaccine was reconstituted with improperly stored sterile diluent, lot # R034106, expiry date: 22-JUN-2021 (dose, route of administration, anatomical location and indication were not provided). The reporter did not know temperature and time frame of excursion. There was no previous temperature excursion. It was not reported if digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1903USA005458: US-009507513-1903USA005457: US-009507513-1903USA005459.
pt recv vax 18APR97 & 30APR97 visited ER w/rash, joint pain, malaise, stiffness & fever x 2d;rx w/cortisone & encouraged to see MD;
Patient received 2nd dose of SHINGRIX vaccine on 7/3/18. Patient had reaction to 1st dose of SHINGRIX and went to her doctor to be seen after the 1 dose. When she came to pharmacy to get 2nd dose, she filled medications (VISTARIL and CLARITIN) which were prescribed by her doctor and she was told to take these when receiving her 2nd dose of SHINGRIX. Patient called on 7/4/18 to let us know that she is having a reaction to the 2nd dose of SHINGRIX. She is experiencing sore arm, pain from armpit to breast area. No visible swelling or redness. Told patient to call her doctor and let them know about reaction and to seek medical treatment if symptoms get worse. Told patient to follow up with us and we would call her.
Tiredness; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received the first dose of bnt162b2 (also reported as COVID 19 vaccine, lot number and expiry date were unknown), via an unspecified route of administration on 16Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension and hypercholesterolaemia; both were diagnosed more than 10 years ago and ongoing. There were no concomitant medications. The patient received his first dose of bnt162b2 on 16Dec2020. He doesn't have the lot number for that one. With his first dose he experienced tiredness on unspecified date, but the second dose was worse. The hospital staff get the vaccine. He is always in contact with patients with COVID. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
We brought our happy healthy 4 month old to his 4 month well baby checkup. And We decided to go along with our Doctors recommendation to Fully Vaccinate him. We did the full 7 shots in one visit! I saw after his administration of all of them his eyes Rolled into his head immediately and his whole body turned red. Something "left" my Son that Day sir!! And I'm mad about it! He had a clouded veil cast apon him after these Vaccines.. its heartbreaking. And My Son will NEVER BE THE SAME!!
Pt came in on 5/4/00 to have PPD read and mom concerned about left thigh being red and inflammed, more today than yesterday. Pt not being very active today but says "it's sore". Doctor in office today, took a look at it and prescribed Benadryl with follow-up appointment in 1 week unless needed to be seen earlier. Area is also warm to touch.
pt felt lightheaded then fainted after receiving vaccine. pt monitored for 15 minutes vitals stable
Patient said her arm started extremely hurting around 3:30pm after time went on patient couldn't move the arm the injection was administered in and went to the VA the next morning on 10/8/2010 when the soreness did not ease up.She was treated with a couple of shots in the hip (probably steroid according to the patient) she also received pain medication and a steroid dose pak.
I had a sore arm after the vaccine for a couple of days and it went away.  Then 8 days later the injection site swelled up turned red was itching and hurt a little inside my arm.
This spontaneous report as received from a pharmacist via the field employee refers to a female patient of unknown age. No medical history, concurrent condition and concomitant medication was reported. On an unknown date in December 2014, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (lot number, dose, unit and route was not reported). On the same day of vaccination, later she noticed her lips were tingling. Patient sought medical attention and contacted the pharmacist. The patient was treated with BENADRYL. A few days later (approximately in December 2014), the patient recovered. No product quality complaint involved. Additional information has been requested.
cough; High fever; had trouble getting out of bed; Chills; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOVEMENT DISORDER (had trouble getting out of bed), COUGH (cough), CHILLS (Chills), FATIGUE (fatigue) and PYREXIA (High fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first 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) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (Chills) and FATIGUE (fatigue). On 25-Jan-2021, the patient experienced MOVEMENT DISORDER (had trouble getting out of bed). On 26-Jan-2021, the patient experienced COUGH (cough) and PYREXIA (High fever). On 25-Jan-2021, MOVEMENT DISORDER (had trouble getting out of bed) had resolved. On 01-Feb-2021, COUGH (cough) had resolved. At the time of the report, CHILLS (Chills), FATIGUE (fatigue) and PYREXIA (High fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 104.6 (abnormal) high fever of 104.6. On an unknown date, Influenza virus test: (Negative) Negative. On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  It was reported that the patient went to visit his HCP who did a rapid Covid-19 test that came back negative .He was sent to the Emergency Room there they did a complete work-up and 3 more Covid-19 tests.They concluded he may have had a virus but were not sure and he had a negative test for influenza.They sent him home and would not answer whether he should receive second vaccine.
This spontaneous report was received from a physician concerning a male patient of unknown age. On unknown dates, the patient was vaccinated with the first and second doses of GARDASIL (lot number, expiry date, dose and route unspecified) after he had turned 26 years of age. A third dose of GARDASIL was not administered to the patient. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  Headache, body aches,  fever, chills, sweaty, nausea, diarrhea, dehydration
leg weakness became worse; This is a spontaneous report received from a contactable consumer. This is the second of 2 reports. A 71-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) via an unspecified route of administration in right arm on 19Feb2021 at age of 71-year-old at single dose for COVID-19 immunisation. Relevant medical history included COVID-19 from Nov2020 (Was in hospital with COVID in November. Did well in December and January). Other medical history reported as "none". No known allergies. Concomitant medications (received within 2 weeks of vaccination) included bupropion taken for an unspecified indication from an unspecified date; clonazepam taken for an unspecified indication from an unspecified date and "Celebs" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9262) via an unspecified route of administration in left arm on 30Jan2021 at age of 71-year-old at single dose for COVID-19 immunisation and experienced "after first shot began experiencing weakness in legs" and "fell several times" on 01Feb2021. It reported after second shot leg weakness became worse. The event onset date after second shot was not reported. "Steroids" was considered as treatment for the event. CT scans of entire spine and brain with unknown result. The event resulted in Doctor or other healthcare professional office/clinic visit, Hospitalization (for 23 days), Disability or permanent damage. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476453 same patient/reporter/drug, different AE in separated time
Onset of localized swelling, chills/fever and myalgias within 2 hours of receiving PNEUMOVAX vaccine/ZOSTAVAX/TDaP. Swelling/redness at site of PNEUMOVAX only.
Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This case was reported by a physician via sales rep and described the occurrence of tiredness in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced tiredness and fatigue. On an unknown date, the outcome of the tiredness and fatigue were unknown. It was unknown if the reporter considered the tiredness and fatigue to be related to BEXSERO. Additional details were provided as follows: The age at the vaccination was not applicable for this report. The physician reported some patients were tired and fatigued after receiving BEXSERO. The reporter said he was not sure if it was vaccine related.
Pt c/o soreness (eveining of injection date), next day swelling, hard knot and redness at site-size of baseball. Pt c/o sweating, irritable, hot and didn't feel herself starting the next am (5/8/03), lasting couple days. Today 5/13/03 (1st office visit) firm nodule 1cm x 0.5cm under skin, no warmth or redness, no treatment f/u one week.
Subject received his first JEV vaccine, along with a typhoid vaccine on 8/31/06.  He denies any unusual local reactions at vaccine sites except he experienced almost constant itching at his JEV vaccine site.  He denies any systemic symptoms.  He received his second JEV vaccine on 9/7/06 and experienced itching again at his JEV vaccine site on his left arm.  On Monday, 9/11/06, he woke up with hives on his left shoulder and neck area.  Later, he noted hives under his eyes and on his back.  He continued to experience intermittent hives since Monday, usually on his chest or back, but also on his left leg on am of 9/15/06.  He took BENADRL with relief, but noted recurrence of hives as mediation wore off.  If he does not take BENADRYL, the hives usually go away after about 2 hours.  He denies problems with angioedema, itchy or tight throat, or dyspnea. Follow-up Information filed 31 October 2006: An initial VAERS was filed on behalf of this patient by the Vaccine Healthcare Centers Network in September 2006 after patient experienced delayed onset urticaria following his second JEV vaccine. On 10/14/06, patient was given a JEV challenge. He received a total 1 ml JEV subcutaneously in divided doses (.1, .2, .3, .4 ml) with only 1 hive noted after receipt of final increment. At that time, he was given IM BENADRYL 50mg. He remained in clinic under observation for another 1 hour without any additional symptoms or hives. He was prescribed daily Allegra 180 mg. The patient was contacted weekly through 25 October without any further urticaria reported.
48 hours, post vax, pt presented to ER with redness and pain at site of injection, that was extending up towards her neck.
Headache, Myalgia, Tachypnea, Tingling in fingertips, low grade fever, weakness, SOB, "feels like legs will go out" Narrative: Much improved by Sunday, 3/21
Received an expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that they had received the vaccine on 18-Oct-2021 and on the same day, the vial was stored in the refrigerator. The reporter did not realize that the vial was expired 07-Nov-2021. The reporter also reported that, it was unknown if this was the patient's first, second or booster doses. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
I am tired; feeling yucky; Sinus and chest congestion; Body aches; Sinus and chest congestion; Feeling ill; Sinuses were so bad. Had lots of mucus. More mucus than normal. Had lots of mucus. More mucus than normal.; She has allergies; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 14Dec2021 14:30 (Lot number: FJ8757, Expiration Date: 28Feb2022) at the age of 71 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Allergies" (ongoing), notes: Verbatim: Allergies; "Sinus problems" (ongoing), notes: Verbatim: Sinus problems; "Aches and pains" (ongoing), notes: Verbatim: Aches and pains; "Neuropathy" (unspecified if ongoing), notes: Verbatim: Neuropathy. Concomitant medication(s) included: FLU, administration date 22Nov2021. Vaccination history included: Bnt162b2 (First dose: , LOT: EN6200, NDC: Unknown , EXP: 20Jun2021, Dose: Unknown , Route: left shoulder/arm , Formulation: injection), administration date: 23Feb2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "Was a little achy"; Bnt162b2 (Second dose:, LOT: EN6207; It's not identified as the lot number. , NDC: Unknown, EXP: 31Jul2021, Dose: Unknown , Route: left shoulder, Formulation: injection), administration date: 16Mar2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 15Dec2021, outcome "recovering", described as "I am tired"; FEELING ABNORMAL (non-serious) with onset 15Dec2021, outcome "recovering", described as "feeling yucky"; SINUS CONGESTION (non-serious), RESPIRATORY TRACT CONGESTION (non-serious) all with onset 15Dec2021, outcome "recovering" and all described as "Sinus and chest congestion"; PAIN (non-serious) with onset 15Dec2021, outcome "recovering", described as "Body aches"; MALAISE (non-serious) with onset 15Dec2021, outcome "recovering", described as "Feeling ill"; SECRETION DISCHARGE (non-serious) with onset 15Dec2021, outcome "recovering", described as "Sinuses were so bad. Had lots of mucus. More mucus than normal. Had lots of mucus. More mucus than normal."; HYPERSENSITIVITY (non-serious) with onset 15Dec2021, outcome "recovering", described as "She has allergies". Therapeutic measures were not taken as a result of fatigue, feeling abnormal, sinus congestion, pain, respiratory tract congestion, malaise, secretion discharge, hypersensitivity.  No follow-up attempts are required. No further information is expected.
no adverse effects; patient inadvertently received an expired dose of properly stored pneumovax 23; This spontaneous report as received from a medical assistant refers to a 69-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-SEP-2019, the patient was inadvertently vaccinated with an expired, properly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # N024384, expiration date 18-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse event reported.
Patient was diagnosed with shingles on 10-6-18. Symptoms were rash with blisters on back and right buttocks and groin. Treatment was to continue betamethasone cream and start Valacyclovir 1 gram tid.
Patient called to pharmacy about 40 mins after vaccination complaining that she felt her throat swelling a little about 20 mins after the injection. Advised patient to take BENADRYL or go to the ER if symptoms worsened.
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a 36-month-old male. Neither relevant medical history nor concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.