chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at injection site - started 5 hours after vaccination and as of 4/9/2021 still ongoing; Headache - started 7 hours after vaccination and lasted until 11pm on 4/8/2021; Fever and chills - started 7 hours after vaccination and lasted until 11pm on 4/8/2021; Body aches and fatigue - started 7 hours after vaccination and as of 4/9/2021 still ongoing; Swollen lymph node in left collar bone area - discovered on 4/9/2021 Treatment - 2 Tylenol every 4-6 hours starting 10pm on 4/7/2021 through 10pm on 4/8/2021
Pt called reporting swelling and a nickel sized red circle surrounding the injection site 2-3 days after. Patient used one dose of BENADRYL and reported that her symptoms then resolved.
Information has been received from a physician concerning an approximately 13 year old female who on 07-NOV-2007 was vaccinated with her first dose of Gardasil (Lot # 659435/1265U. Concomitant therapy included MENACTRA. On 07-NOV-2007 the patient experienced a headache, sore arm and nausea. "About 2 weeks after the shot", the patient recovered from the headache, sore arm and nausea. The patient sought unspecified medical attention. Additional information has been requested.
Severe muscle aches all over, muscle weakness in legs and numbness in legs and arms, pain with weight-bearing.
arm warm; arm with a fever; arm red; arm welted up; sore arm; a little sore in the area of injection; arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen), FEELING HOT (arm warm), PYREXIA (arm with a fever), ERYTHEMA (arm red) and URTICARIA (arm welted up) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced PERIPHERAL SWELLING (arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen). On 12-Jul-2021, the patient experienced VACCINATION SITE PAIN (a little sore in the area of injection). On an unknown date, the patient experienced FEELING HOT (arm warm), PYREXIA (arm with a fever), ERYTHEMA (arm red), URTICARIA (arm welted up) and MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 09-Jul-2021 at a dose of UNK dosage form. On 11-Jul-2021, PERIPHERAL SWELLING (arm was already swollen but during the week it got worse and it ended up being 3/4 of patient's left arm swollen) had resolved. At the time of the report, FEELING HOT (arm warm), PYREXIA (arm with a fever), ERYTHEMA (arm red), URTICARIA (arm welted up), MYALGIA (sore arm) and VACCINATION SITE PAIN (a little sore in the area of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        treatment also includes: patient applied warm compresses and a soft massage.
Severe headache, backache all over body aches  Nausea Fever Chills Fatigue   Site of injection 2 days after:  red, hot, swollen and itching
Following vax pt began crying following vax cried x 24 hrs, unable to console; mom took pt to MD who evaluated pt; MD reassured mom pt should be fine w/in 24 hrs, advised to give APAP; take to ER if devel fever, vomiting, lethargy;
I had swollen lymph glands in my left arm from the 1st dosage and it went on for weeks (felt like my arm was going to fall off). When I had the 2nd shot, it was in the right arm without any symptoms. My lymph nodes in my arm and necks was very painful. The symptoms that I was experiencing from the 1st dosage carried over into the 2nd dosage (left side of my body is puffy). I ended up going to the ER because the pain was so intense. He ordered an MRI to find out why I was in so much pain and I'm still going through the severe pain on the left side of my body.
Fever, chills, muscle aches, joint pain, headache for approximately 10 hours.
This spontaneous report as received from a pharmacy technician refers to a 56 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 11-JUN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
FEVER 105F; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced fever 105f. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 105 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever 105f was not reported. This report was non-serious.
Pt complaining of "tingling feeling in her lips and slight tightness in her throat." Advised to take Benadryl and to go to the ER if she worsened at all. Pt went to ER on 04/12/2002 and was treated with IV medication for an allergic reaction and was also given medication to take over the weekend. Pt stated that she is now doing well and has had no further problems.
Day after receiving booster, I had a 104 temperature with flu like symptoms. Symptoms lessened on day two but a severe headache continued for two days. On 3/15 my right arm started to have raised red bumps that only got worse each day following. By 3/20 the rash had spread to both arms and chest. Advice prescribed Zyrtec. No relief from Zyrtec and on 3/21 the rash had spread to my stomach. As of today, 3/24 the rash continues to itch and is all over my body. Advice prescribed a med but  it take it because i am allergic to steroids!
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-OCT-2012, the patient was inoculated with ZOSTAVAX at physician's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 02-JUN-2013, the patient was treated at the same physician's office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. She was prescribed VALTREX and hydrocodone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported for two patients. This is the second of two reports. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 07Aug2017 at single dose for immunization and MENACTRA, via an unspecified route of administration on 07Aug2017 at unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced severe headache on an unspecified date. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017360779 same reporter/product, different patient/event.
Pt c/o tongue swelling.  NP evaluation:  No SOB; No Chest Pain; No Aphagia; VS Stable & WNL.  Benadryl 50 mg PO @ 1604.  Pt state felt better @ 1610.  Advised to say additional 30 minutes post Benadryl.  Pt advised to f/;u with ER if s/s return or worsen.  Pt left department @ 1615.   Stated VS no longer swollen and s/s had resolved
Patient is 14 days out from his first Moderna injection. No issues after receiving the injection.
12 y.o. male patient with history of developmental delay, seizure disorder who presented to the emergency department today with acute encephalopathy, unresponsive with bradycardia,  V-tach requiring defibrillation, and acute respiratory failure requiring intubation.  The family had been traveling and vacationing with extended family members and recently returned Saturday night. No sick contacts during the trip and he recently received his second COVID-19 vaccine on June 5th.  On Sunday, June 20th, he had cold symptoms with stuffy nose, sneezing and minimal oral intake. Mother gave him 10ml of a multi-symptom OTC cold medication that evening.  Unsure what is in the medication or if it contains Benadryl.  This morning, he had an 11am swim lesion and then came back and slept on the couch.  Still minimal oral intake and was resting all day long but awake most of the time.  This evening at 5:43pm per mother, he received another 10ml of the multi-symptom cold medication. He was given his Vimpat and Valproic Acid medications around 7:30pm.  Around 8:20/8:25pm, he was asleep and had an emesis and was not responding In the ED, he was unresponsive and poor respiratory effort with episodes of apnea and was incontient of stool during the exam.  He was brought to the resuscitation room, PIV placed x2.  Placed on oxygen initially. Ativan given once for possible seizure. Epinephrine given for bradycardia.  Noted V-tach on rhythm.  Second Epi given, started Epinephrine infusion and Shock given 2J/kg.  Cardiology at bedside.   Rocuronium and Etomidate given for intubation.  He was intubated on the second attempt with 6.0c ETT.
This spontaneous report has been received from a medical assistant referring to a 13 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent condition, drug and allergy history. On 15-AUG-2016, the patient was vaccinated with an unspecified dose of PROQUAD, lot number L050907 with expiration date 14-JUN-2017, for prophylaxis (dose, frequency, route of administration and anatomical location were not reported). Concomitant medications included sterile diluent (manufacturer unknown, lot number and expiration date were not reported). No adverse effects were reported.
12/7/2021--Client received 2nd dose of Moderna, first dose received 11/9/2021.  Client reported feeling "extremely" dizzy, slight SOB, rapid onset of migraine HA 15 minutes after vaccine administered.  VSS--BP= 144/82.  HR=86, Resp=20, Sats= 98% on RA.  Client took Tylenol 400 mg PO, Benadryl 25 mg PO given.  Continued to monitor client for additional 30 minutes.  VS remained stable,  lungs clear--denied any further SOB.  Client continued to report extreme dizziness & HA.  Reported to Dr, MD--for Clinic.  Client transported to Clinic by her son @ 1510 for further evaluation.  Escorted client to her vehicle with stand-by assist due to dizziness.   12/8/2021--Phoned client.  Reported body aches, HA, slight dizziness.  Stated that, PA examined her at the clinic with no further medical interventions provided.  Client was advised to not receive any COVID vaccinations in the future.  Reaction reported in System & VAERS report completed.
I did not have a period in over a year, and the day after the first and second vaccination I had my period; More than 35 days between first and second shot; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (I did not have a period in over a year, and the day after the first and second vaccination I had my period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05392114 and 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), TESTOSTERONE and ARIPIPRAZOLE (ABILIFY) for an unknown indication.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot). On 17-Aug-2021, the patient experienced MENSTRUAL DISORDER (I did not have a period in over a year, and the day after the first and second vaccination I had my period). On 16-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot) had resolved. At the time of the report, MENSTRUAL DISORDER (I did not have a period in over a year, and the day after the first and second vaccination I had my period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient says she takes testosterone as her body does not produce Estrogen and that she never has a period. treatment information was not provided   This case was linked to MOD-2021-291006 (Patient Link).
Fever, inj site pain/swelling; fever 104F, gen weakness Narrative:
Chief Complaint:  Injection site was initially red, with pain/discomfort (unable to sleep on left side.)  Those symptoms were reported through v-safe.  That resolved/improved then Localized Rash presented 8 days after injection.   Warm, red, slight lump/bump .  Redness is over an area approximately 3" x 3" with irregular edges.  Utilized telehealth visit.  Suspected sterile abscess.  Diagnosis: Cellulitis (Bacterial Skin Infection) Vaccine reaction symptom or question Prescription Medication(s): cephalexin 500 mg capsule - 1 cap by mouth 3 times per day for 7 days
Itching of throat, tongue, and scalp. Lasted approx 30-40 minutes and resolved after PO Benadryl administration.
3 hrs /p vaxes exp scratchy,irritated throat unable to clear, red & watery eyes, flush-hot feeling; previous flu vax w/o adverse effects
Immediately experienced intense erratic nerve pulsations along left cheek. Left side of cheek and jaw felt numb and tingly. Jaw felt sore. I could feel the nerve pulsations with my fingertips very strong. The Pulsations continued on and off and subsided but the numbness tightness soreness and tingling feeling on the left side of my face lasted  for about 36 hours until it completely resolved. 72 hours later the left side of my cheek still feels mildly sore or like a little tense at the jar hinge and under the skin. I also experienced dizziness and that lasted for most of the day I had trouble for instance focusing on things up close like washing dishes. I had to look further away. I also experienced an intense headache on the left side of my skull like a hammer pounding ten times at about 9 PM. Then it went away then the pounding came back again so Itook 500 mg Tylenol which seem to help but I still had a little bit of an ache  in my jaw a few hours later so I took another 500 mg and that seem to resolve the headache and jaw pain. The next morning my face was still a little numb tingly and tight all day. It wasn?t until Sunday that it felt like it had finally resolved itself.
Information has been received from a physician concerning a 13 year old male who on 12-MAR-1997 was vaccinated with the first dose of MMR II. On 06-JUL-2000 the patient was vaccinated with the second dose of MMR II. On 02-JAN-2010 the patient experienced mumps. Date of mumps diagnosis was reported as 05-JAN-2010. The patient had bilateral parotitis. The patient was afebrile. On 05-JAN-2010, the first blood work revealed IgM <1:10, IgG 8.59, and serum amylase 347. At the time of this report, the patient's outcome was not reported. No further information is available.
Client states started experiencing chest tightness just on the left side approximately 5 minutes after receiving. Client states this continued through the day and into this day, but is getting better, client states did not go to Dr.
ears started hurting, eyes bloodshot, weakness,dizziness,nausea, unable to get up without help. Call Dr. then 911 and went by ambulance to ER. They gave her meds to counter allergic reation. Observed for several hours at ER and was sent home, with prescription for Epi Pen and Zyrtec, Benedryl.
Pt received vaccine and developed redness and swelling that night. She went to the ER on 11/7/17 after the swelling and redness were becoming concerning to the pt, she also had developed dizziness.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Concomitant medications details were not reported by the reporter.  Patient ID was reported as 7223173.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, In this report the patient was not eligible for vaccine. Breakdown of doses were reported as 51 doses from batch numberAS7140C and  60 doses from Batch number AS7148B.  Treatment details were not reported by the reporter.
Redness with slight induration, swelling and mild tenderness. Swelling 5cm x 5cm on extensor upper left arm surrounding injection site. No fluctuation noted. No streaking. Able to move forarm well. Treatment Augmentin, Benadryl and avoid scratching. ER warnings given. Follow up in 3 days for recheck.
This spontaneous case was reported by a respiratory therapist and describes the occurrence of SWELLING (swelling from armpit to beginning of breast tissue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling from armpit to beginning of breast tissue). At the time of the report, SWELLING (swelling from armpit to beginning of breast tissue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   Reporter did not allow further contact
In June of 2021 my hair began falling out at an increased rate and has continued period of shedding until the present. I have lost about 40% of my hair. I also have elevated cholesterol as proven by bloodwork I had done, despite never having high cholesterol before. I was very sick following both doses of the vaccine with fevers, extreme fatigue/weakness, and a persistent cough that took over a month to get rid of. My period was longer and had increased bleeding after the vaccine.  I did not have Covid prior or during this time.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 31st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 1st June 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms and fever. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the influenza-like symptoms and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose of SHINGRIX. The patient received 1st dose of SHINGRIX on right arm. A day after receiving 1st dose of SHINGRIX, the patient experienced fever and flu like symptoms which lasted for a couple days. It has been over 6 months and till the time of reporting, the patient had not received the second dose of SHINGRIX, which led to incomplete course of vaccination. No further details were provided. The reporter did not consent to follow-up.