chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain became more intense; Decreased mobility in arm has worsened; Decreased mobility in arm that received Td; Injection looked like it was administered in the wrong place, 2 inches below the deltoid; Arm pain in arm that received Td; Numbness in left hand and fingers; Macular swelling in eye that received cataract surgery; Blurry vision in eye that received cataract surgery; A 69-year-old female received MassBiologics' Td vaccine (Lot # A116A2) in her left arm on 10/15/19 at an urgent care facility for wound prophylaxis.  On the same day post vaccination, the patient experienced arm pain and decreased mobility in her left arm with worsening pain and mobility four (4) days post vaccination.  On 10/20/19 the patient sought treatment for the adverse reactions at a different urgent care facility.  During the 10/20 visit, the physician indicated the Td vaccination site may have been approximately two (2) inches below the deltoid (labeled administration site).  Patient did not receive any treatment for the reaction.  The patient reported the event on 11/4/2019 at which time the worsening pain and mobility had resolved but the patient had reported the addition of numbness in her left hand and fingers.  The patient went on to state that she had undergone cataract surgery in one eye during the week prior to receiving the Td vaccination and subsequent cataract surgery in the other eye one week post vaccination.  When reporting of the event, the patient indicated she had experienced macular swelling / inflammation which resulted in blurry vision, but only in the pre-vaccination eye, which lead the patient to feel the events were related to the Td vaccination.  The patient sought treatment and her ophthalmologist prescribed Prolensa and Invetys for the eye condition but did not report any findings from the ophthalmologist regarding a relation between the eye events and Td vaccine.  During follow-up on 12/19/2019, the patient indicated that all reported events had resolved within 6 weeks post Td vaccination.; Sender's Comments: All events were assessed as non-serious.
I got the shingrix and prevnar20 shots at around 5:30PM Friday evening.  On Saturday morning, about 12-14 hours after the shots, I woke up groggy, achey, and feeling feverish.  At 7AM my temp was 100.2, and by 10AM it was 102.1.  I had a fever that responded briefly to tylenol (for about 2 hours) but came back and ranged from 101-102 for the rest of the day and night.  The fever broke around 3AM the following night (almost 36 hours after receiving the vaccines).  With the fever was brain fog, full body aches, extreme fatigue, anorexia, and some nausea.  I slept all day and was essentially incapacitated, unable to do activities of daily living.  The symptoms mostly resolved by Sunday morning, with some residual fatigue that faded through the day.
Early in the morning on 2/16/21, she has palpitations off and on, but her heart was racing, and she just couldn't figure out what was going on as it was 3 days after the vaccine.  It went on all day long, went to bed that night and as she was lying there she questioned whether she was having a reaction to the vaccine or not.  She continued to have the racing heart beat since then and still has them, but the periods of having these are getting shorter and shorter.
No symptoms until onset of chills and on/off severe sweating at 10 pm EST. By midnight, I had a fever of 100.2, nausea, intense headache (specifically around the eyes) and overall significant discomfort. The fever lasted overnight. Vomiting occurred on several occasions shortly after midnight for a few hours and again around 6 am. The following day, my fever did go down yet I maintained a headache and some nausea. After 3 days, adverse events were resolved. Treatment consisted of tylenol and fluids. I did not contact my a physician, so no medical tests/lab work was completed. For background, I have never experienced a serious event with a vaccine, besides general fatigue.
Increasing weakness, diarrhea, urinary incontinence - tried antidiarrheal, fluid boluses, offered hospitalization (refused)
Pt developed eczema herpeticum below left eye.  Spread to face.  Hospitalized for 48 hours.  Recovered on acyclovir. Fever, eyes: itching, sore. Ear pain, swollen glands and swollen cracked lips.  Pt is a 12 month old female sent by a dermatologist for diagnosis of eczema herpeticum.  Pt's mother states pt had runny nose, cough and fever for 6 days, developed a single lesion that looked red-based and fluid filled on 12/07.  On 12/10 pt was seen by PMD for fever and swollen glands and was diagnosed with a tear duct infection.  On (12/11), child awoke with swollen, cracked and bleeding lips.  Child soon developed 1-2 blisters around lips. Mom states that more lesions appeared in a short period of time both around mouth and left eye but has been stable since the lesions developed earlier today.  Mom has also noticed the pt rubbing her eyes and stated that the child was screaming and crying more than usual last night.  Cough and rhinorrhea have improved per mom, and fevers have been controlled with Motrin whenever mom thought the child was febrile to touch. Mom has never noticed dry skin or other skin problems on child. Pt received influenza and varicella vaccines 2 weeks ago and notes that one of her friends also has a child who received a varicella vaccine and then developed a perioral and periorbital lesion.  The children played together on 12/06 after the friend had developed the lesions; pt developed cough/fever on 12/07 and first lesions on the 12/08.  Pt was given IV acyclovir along with ancef and started getting better.  Viral PCR came back positive for HSV 1. Nurse follow up on 05/18/04 states: Unable to walk, paresthesias, urinary retention.  Remove:anuria.
chills, sweating, severe body aches (comparable to birth contractions), joint pains, lethargy. started at 12:30 am 1/19/21 until 3:00pm that day. Then just the body aches continued with a low grade temp of a 100 until 10:30 pm that night.
Adverse Event as a result of the Menactra vaccine.  Arm pain and swelling that got worse over 4 days.  Hives on trunk and rash on shoulder in area of vaccine administration.  Prophylactic antibiotics prescribed, and Benadryl and Advil given to try to reduce pain and swelling.  Symptoms decreased after 4 days, but still not resolved after 7 days.  Some swelling and pain remains.
day 1 PV pain at injection site and body aches; day 1 PV pain at injection site and body aches; 4 days PV bump on R neck; 8 days PV R collarbone and R lower jaw; This is a spontaneous report from a contactable physician. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown), via unspecified route of administration, on an unknown date (Age at the time of vaccination was 43-year-old), as dose 2, single for COVID-19 Immunization. Medical history included hypertension. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 1, single for COVID-19 immunization. On an unknown date (reported as Day 1), the patient experienced pain at injection site and body aches, 4 days PV bump on R neck, 8 days PV R collarbone and R lower jaw. The patient was treated with valacyclovir and terras I ll shingles cream. The outcome of the events were unknown.   Information about Lot/Batch number has been requested.
Mom called on 9/14/15. She reported that her son developed fever of 104 on 8/1/15 in the event she administered Ibuprofen Q6 hrs x 4 for 24 hours. His fever reduced to 100 after medication given. Fever resolved in 24 hours.
Possible GUILLAIN BARRE Syndrome. Symptoms started approximately 6 weeks post-vaccination. Went to hospital -neurologist. Started on pheresis and gabapentin.
Presented to ED on 7/24/21 for fever. Notes indicate Sx onset 7/18/21 felt shaky, sweaty, body aches, chills & nausea. Lost sense of smell on 7/24.
Drowsiness; This is a spontaneous report from a contactable pharmacist reported for self. This 43-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 23Dec2020 14:15 on Arm left at single dose for covid-19 immunisation. Medical history included Seasonal allergy. No allergies to medications, food, or other products. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient experienced drowsiness on 23Dec2020 16:30. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatments were received for the event. Outcome of the event was Not recovered.  Information about lot/batch number has been requested.
On and Off tingling sensation on left side of body. Left calve/leg  highly sensitive and tingly for a few hours; comes and goes.
Patient recieved a dose of Moderna Bivalent that was outside the Use by date of 01/10/2023
Patient became symptomatic on 8/14/07. Fever to 102 deg; followed by hives overall. Patient received vaccine-ProQuad 8/9/07. Followed up on 8/20/07 for patient status. Much improved only few hives remain.
Red mark approximately 2.5in below the injection site (mark was small, approximately 1.5in x .5in and bright red ) Outbreak of cold sores on lip. One sore appeared the morning after the vaccine and quickly spread to a min of 20 sores clustered across the bottom lip. I have a history of getting cold sores(either from exposure, stress, illness/immune system compromise, or sunburn), however I have never had an outbreak of cold sores anywhere near this extreme.
Hives (itchy, small round bumps) appeared at upper inner thigh area. Each day for the next four days more hives appeared, spreading down legs past the knees and up the torso to waist line, with a few single bumps appearing on upper arms, ankles, arm pits, and shoulder blades. Hives are still present, but being controlled by Claritin (AM), Benadryl (PM), and Betamethasone Dipropionate cream (.05%) because I cannot take Prednisone.  Also taking Cephalexin 25 MG as some appear to be infected.
Within approximately 2 minutes of getting the shot I started to feel clammy and warm. Then started to sweat heavily. This lasted for about 5 minutes. 7 days after my shot I developed a red itchy bump at the injection site.
Pt states that she experienced headaches off and on from 03/26/21-04/09/21. Pt states she went to hospital 04/09/21 and was diagnosed with TIA. Pt states that she is now showing signs of improvement with no more headaches (04/21/2021).
FLU LIKE SIDE EFFECTS; This spontaneous report received from a consumer 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 not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced flu like side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like side effects was not reported. This report was non-serious.
1 week ( 7/6/2018) after the SHINGRIX injection ( 29/18) given at a pharmacy, patient noted "lumps under her skin", in and around area where she received the injection. Skin rash noted- described as reddish, then bacsme  blister-like. pus-like discharge when lesion opened up. Rash spread to opposite arm, upper chest, face and few on lower extremities. Lesions are sore.  Pt reports " rash reminded her of chicken pox". Pt was seen in office 7/16/2018, then 7/19/2019.   She reported scratchy throat ,sorethroat and hoarseness , dry cough with chest congestion for 3 days . Pt reports (+)  exposure  to family members dx of parainfluenza Type 3. Parainfluenza  Virus 3 titer was done 7/19/2018 and came back (+). Same time urine culture grew (+) E. coli pansensitive to antibiotics. Pt reports continuing to have new rashes.
No adverse event; received an expired dose of VAQTA; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On 13-FEB-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R024008, expiration date 15-NOV-2019 (dose, route of administration and anatomical location of administration were not reported) for prophylaxis. No adverse events were reported.
PT recieved 2nd dose of vaccine Pt stateed she felt lighteheaded and had same reaction to first vaccine Pts vitals were taken and were normal and pt left with no issue
day following vaccination reports having headache and nausea. following day had doctor appointment and was prescribed anti-emetic.
no additional AE; patient over the age of 45 years of age was administered a dose of GARDASIL 9 approximately 1 month ago; This spontaneous report was received from a nurse prescribed and refers to a patient of unknown age (reported as over 45-year-old) and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date approximately in June 2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 time dose, lot # 1659422, expiration date 04-SEP-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (inappropriate age at vaccine administration). There was no additional adverse event reported. 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.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Transverse myelitis in the thoracic cord. Symptom onset 1 week after 2nd vaccine dose. Sensory change in the left leg and increased reflexes/clonus
Returned to site after being released post-vaccine, went to car then noted rash to chest area and face, +itchiness/warmth to upper extremities. On assessment well appearing, NAD airway intact/denied SOB throat irritation-visible rash (raised/reddened) to ant chest and upper back, warmth to arms bilaterally. Pt requested Benadryl, consultant with on duty Pharmacists who recommended Benadryl-Benadryl 50mg PO give, pt observed x 30 more minutes, all sx's resolved, well appearing. VSAFE hand-out given for self-reporting
At home on day of immunization pt stiffened and turned purple for about 1 min. Pt slept for eight hours woke up fine. Pt has had one more episode over next four weeks.
9/30- itching; 10/1- spotty rash on arms; 10/2- hives covering entire upper body.
I am responding due to a follow-up call left on my voice mail.  I am traveling and unable to respond by phone. I developed congestion and a dry cough in early December. I home tested twice for COVID and was negative both times. I did not have a fever or body aches. Prior to travel, I consulted by phone with my primary doc. He said he?d been seeing a lot of cases with my symptoms. Possibly RSV?? Based on the severity of my symptoms, and the fact I was improving, he prescribed a regimen of antibiotics and felt it was safe for mr to travel.
Red splotches around injection site. Not a bumpy rash. Slight itching. About a 2 1/2 to 3 inch area. Moderna COVID?19 Vaccine EUA
Worst headache; Fevers; Chills; Body aches; DOE; Chest pain; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the right arm on 11Jun2021 at 20:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to seafood, pollen and selected chemicals. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 20Jun2021 at 12:30, the patient experienced worst headache, fevers, chills, body aches, DOE (dyspnea on exertion) and chest pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event worst headache, fevers, chills, body aches, DOE (dyspnea on exertion) and chest pain was not resolved at the time of this report.
feeling numb around the bottom of her face; a little tingling; a little flush around her face; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (feeling numb around the bottom of her face), PARAESTHESIA (a little tingling) and FLUSHING (a little flush around her face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 27-Feb-2021, the patient experienced HYPOAESTHESIA (feeling numb around the bottom of her face), PARAESTHESIA (a little tingling) and FLUSHING (a little flush around her face). On 27-Feb-2021, HYPOAESTHESIA (feeling numb around the bottom of her face), PARAESTHESIA (a little tingling) and FLUSHING (a little flush around her face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Large red swollen golf ball sized lump on leg, followed by full body hives for 7+ days, vomiting, diarrhea. Hard pea sized lump under skin at injection site. Hives in circle also around injection site in addition to the full body hives.
pt c/o gen aching/chills accompanied w/SOB 5hr p/vax awoke next AM w/hives covering entire body;states hx some episode hives related to fever or illness;sx resolved 48-72hr;
In April 2021, soon after the patient's second dose of the COVID-19 (Moderna) vaccine, she started to experience word finding difficulties.  She did not report this to the physician until June 2021. She had additionally been on Trikafta since November 2020. Upon report in June 2021, the dose of Trikafta was decreased to exclude the evening dose. The issue has resolved as of October 2021.
left arm is red where she got the vaccine; left arm is painful where she got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left arm is red where she got the vaccine) and VACCINATION SITE PAIN (left arm is painful where she got the vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm is red where she got the vaccine) and VACCINATION SITE PAIN (left arm is painful where she got the vaccine). At the time of the report, VACCINATION SITE ERYTHEMA (left arm is red where she got the vaccine) and VACCINATION SITE PAIN (left arm is painful where she got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
All of a sudden I could not form words, or think straight. I could not articulate words, my voice was flat lined. Right before I had a real intense pain over my left eye. a TIA and I wore a heart monitor for a month
Narrative:  DEATH FOLLOWING 1 DOSE OF COVID VACCINE 02/12/2021 COVID vaccine dose #1 03/05/2021 Patient died at hospital (no records provided or reason given) Patient did not have reaction immediately following vaccine, did not have prior infection with COVID. Patient was seen in ED a few days prior to receiving covid vaccination (2/8-2/9) and was sent home with possible pneumonia, advised to follow up as outpatient. Received most of his medical care through other sources, saw his PCP once per year, in April. Likely that vaccine did not contribute to death, but was combination of advanced age (72 y/o) and comorbidities.
Acute DVT of right lower extremity, diagnosed via venous duplex of lower extremity. Presented to Emergency Room on 4/5/21 with right leg swelling.
Pt stated "passed out", dizziness, bright vision, ringing in both ears, nausea. Evaluated by EMS-Refusal to transport.
Palpitations, swollen lymph nodes under my left armpit and general malaise the day after the vaccine
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal transplant failure (was on immunosuppressant therapy until June 2018).   On 18th July 2019, the patient received the 1st dose of Shingrix. On 27th July 2019, 9 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The physician on the line reported that the patient received their dose about a week before the reporting date and at the time of reporting had shingles. The reporter consented to follow up. The caller had no information regarding the vaccine given. It was given at a pharmacy, information for pharmacy was unknown.
Localized allergic reaction.  Mild to moderate induration over left deltoid with well circumscribed redness and warmth.  Not tender to touch, no exudative lesion at injection site.