chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she experienced swelling in left arm,; she has redness in the upper arm at injection site and down where arm bends and red around the inside of the arm.; The arm feels hot around the area touch.; a rash, it was itchy, red,; a rash, it was itchy, red,; she has redness in the upper arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (she experienced swelling in left arm,), ERYTHEMA (she has redness in the upper arm at injection site and down where arm bends and red around the inside of the arm.), FEELING HOT (The arm feels hot around the area touch.), RASH ERYTHEMATOUS (a rash, it was itchy, red,) and RASH PRURITIC (a rash, it was itchy, red,) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3835E) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymph node excision (Patient had surgery to remove lymph node in 2021 in the left arm) in 2021 and Radiation therapy.    On 03-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 03-Oct-2023, the patient experienced PERIPHERAL SWELLING (she experienced swelling in left arm,), ERYTHEMA (she has redness in the upper arm at injection site and down where arm bends and red around the inside of the arm.), FEELING HOT (The arm feels hot around the area touch.), RASH ERYTHEMATOUS (a rash, it was itchy, red,), RASH PRURITIC (a rash, it was itchy, red,) and VACCINATION SITE ERYTHEMA (she has redness in the upper arm at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (she experienced swelling in left arm,), ERYTHEMA (she has redness in the upper arm at injection site and down where arm bends and red around the inside of the arm.), FEELING HOT (The arm feels hot around the area touch.), RASH ERYTHEMATOUS (a rash, it was itchy, red,), RASH PRURITIC (a rash, it was itchy, red,) and VACCINATION SITE ERYTHEMA (she has redness in the upper arm at injection site) had not resolved.            No relevant concomitant medications were reported. Patient reported that she received Spikevax on 03Oct2023, and during the night she experienced swelling in left arm, a rash, it was itchy, red, she has redness in the upper arm at injection site and down where arm bends and red around the inside of the arm. The arm felt hot around the area touch. Treatment included allergy medication, and cream for rash.   This case was linked to US-MODERNATX, INC.-MOD-2023-744296 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744296:Monovalent dose
Employee had vaccine on 3/2 today 3/3 started having headache and chills with body aches.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/13/2021 SYNCOPE R09.02 HYPOXEMIA 10/10/2021 SYNCOPE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/13/2021 PULMONARY ARTERY HTN R09.02 HYPOXEMIA 10/10/2021 PULMONARY ARTERY HTN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/13/2021 PALLIATIVE CARE R09.02 HYPOXEMIA 10/10/2021 PALLIATIVE CARE
Extreme tiredness, fatigue, weakness. No energy, only wanted to sleep. Lasted for three days.  Pain in shot area, lasted one day.  Muscle aches, lasted two days.
There were NO ADVERSE REACTIONS.  We gave it thinking he was 18 as his parents were discussing his senior year and getting him ready for college.  We realized the error  when he went to get his second shot and that office questioned why he was getting it  before the next age group had been approved.
Complained of knot and redness, fever, dizziness, soreness in arm.  Observed on 11/26/2003-redness, warmth and knot app. 16 mil in size.
Dizziness, Headache,  left arm soreness, left arm and hand swelled, lower back pain, left side of neck glands swelled, had to clear my throat often Narrative:
On July 6 I woke up with ringing in both ears especially louder in right ear. I went to audiologist stated that I had no hearing loss. The doctor informed me she has several patients that have came in since vaccine withe the same symptoms. My husband experienced the same exact adverse events after Dose 2 as well.
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Additional Details: 911 was called patient refused treatment.
SORENESS IN  ARM (BACK SIDE OF LEFT ARM) AND ACHE IN THE ARM; INJECTION SITE SORENESS; ON AND OFF FLU LIKE SYMPTOMS; HOT FLASHES; FEELING SICK; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause, and cigarette smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the drug abuse or illicit drug usage was unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination.  Concomitant medications included sertraline hydrochloride.  On MAR-2021, the subject experienced feeling sick. On 25-MAR-2021, the subject experienced on and off flu like symptoms. On 25-MAR-2021, the subject experienced hot flashes. On 25-MAR-2021, the subject experienced injection site soreness. On 02-APR-2021, the subject experienced soreness in arm (back side of left arm) and ache in the arm. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling sick, and injection site soreness, was recovering from on and off flu like symptoms, had not recovered from soreness in arm (back side of left arm) and ache in the arm, and the outcome of hot flashes was not reported. This report was non-serious.
This spontaneous report was received from a nurse practitioner and refers to a 22-year-old female patient. The patient had no pertinent medical history, concomitant medications or drug reactions and allergies. On 28-JUN-2010, the patient was vaccinated with the first dose of GARDASIL intramuscularly (exact dose, site of administration, lot# and expiration date were not reported) for prophylaxis. On 17-SEP-2010, the patient received the second dose and on 11-JUN-2011, the third dose of GARDASIL intramuscularly (exact doses, site of administration, lot# and expiration dates were not reported). On 10-JAN-2019, the reporter performed a papanicolaou test which revealed the patient was positive for high risk human papillomavirus (HPV) types 16 and 18. The patient did not sought medical attention. No treatment was given for the event. The outcome of the event was reported as not recovered. The relatedness between the event and GARDASIL was not reported.
1 day after vaccine infant developed irritability, stopped babbling, cooing inconsolable. Symptoms suddenly stopped  day 11 after vaccine.
Patient received PENTACEL, hep B & PREVANR 13 at clinic. That evening she had fever, chills & became lethargic.
Patient states she woke up on 11/08/2022 at 2am with hives on her abdomen and left arm and lower facial and lip swelling. Patient states she took benadryl and fell asleep about 15 minutes later. When the patient woke up at 8am her mother noticed facial swelling and told her to go straight to urgent care. Patient was seen at Urgent Care at 8:40 am. Patient states she was given a prescription for a 24 hour antihistamine called cetirizine and was told to start premedicate with benadryl 24 hours before her 2nd rabies vaccine.
Patient was in on Friday, 4/27/18 for routine 11 year old vaccines. Received HPV in right arm and Tdap and MENACTRA in Left arm. On Saturday late morning, noticed his left arm had a dime sized red, warm to touch, circle where the vaccines were given. By Saturday night, it was quarter sized. Sunday it was about a 2 1/2" diameter circle and it is still that size on Monday. Mom noted that he has had a sensitivity and reaction to the flu vaccine in the past. She has given him TYLENOL, MOTRIN, 3 doses of BENADRYL, and pt has been icing the arm. Denies fever, trouble breathing, headache, etc.
Patient experienced discomfort with immunization, deltoid muscle twitching was observed as needle was placed in muscle and also throughout injecting contents. Patient shook arm and clenched fist of right hand. Patient left on own accord with no symptoms or signs of adverse effects.
Just notified today by mom that pt, one day after shot, complained of itching on leg but never was checked. The next day, had approximately 6" in diameter hard, red spot that itched a lot. No dyspnea. No rash any other area.
Raised circle around vaccine site, roughly 4 inches. Red hives/rash, warm to touch and hardness. Itchy at times.
Hospitalized with covid 19 diagnosed 1/26/2022. generalized fatigue, chest pain,  and myalgias, vomiting and diarrhea.
severe stomach cramps for 5hr, temp of 103-104, limp, not alert;occurred evening of 17SEP97;ER visit resulted in admission;multiple tests run, WBC inc, IV administered;everything but vax rxn r/o;released 1-2 days later;recovered fully
This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 11-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            This case was linked to MOD-2021-044803, MOD-2021-044803 (Patient Link).
Patient felt diaphoretic, pre-syncopal, placed in trendelburg position and hydrated
experienced swelling after Shingrix /.....I am swollen; This case was reported by a consumer via call center representative and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced swelling after Shingrix. The patient did not consent to follow up.
redness at injection site is not going away; Injection site itching ongoing; Injection site itching ongoing and little swelling; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Apr2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. It was unknown whether the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 10Apr2021, the patient experienced  redness at injection site, which was not going away, injection site itching ongoing and little swelling. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site redness, injection site itching and little swelling was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient felt light headed, thought he was going to throw up...passed out and had a seizure!
Patient required hospitalization due to breakthrough infection. He received the Pfizer vaccine (2nd dose in series) on 04/14/21. Patient was hospitalized from 07/31/21 - 08/31/21. Below is copied from discharge summary:   Discharged Condition: deceased   Hospital Course:  Patient is a 82 y.o. male with a PMH of recurrent UTIs, BPH, COPD, bicytopenia (leukopenia and erythropenia), DDM2, HTN, and HLD who presented to the ED on 7/31 for AMS. He was found down by family and EMS was called. SpO2 was 68% and pt was placed on NRB. He was brought to the ED and was COVID + (despite previous Pfizer vaccination on 3/24 & 4/14). CT C/A/P showed bilateral opacities. He also had a brief episode of afib RVR treated w/ metoprolol w/ subsequent hypotension requiring levophed gtt. He later was intubated d/t hypercapnic respiratory failure and admitted to the MICU. His course was complicated by hypernatremia elevated CK, AKI, PSAR UTI and enterococcus bacteremia. Abx were de-escalated to levoflaxacin and ampicillin.Of note he did not receive Remdesivir or Toclilizumab d/t bacteremia. He completed a 7 day course of solumedrol. He was extubated to HFNC on 8/6 and was transferred to the floor on 8/8 and only requiring 5L NC at the time. While on the floor pt had increased lethargy. On the evening of 8/11 pt was noted to have tachypnea and use of accessory muscles. Pt was placed on a VM and on the morning of 8/12 placed on BIPAP.CTH was obtained and showed new bilateral SDH/hygromas. IM team spoke with team and they recommended MRI brain stroke protocol.  Patient continued to have respiratory decline remain on ventilator his symptoms continue to escalate was shortness of breath desaturation to patient was ventrally placed on 100 percent was on flow land saturation still remains low family meeting with palliative Care patient was made DNR with no escalation.
Vertigo, body aches, fatigue, nausea: began two days post vaccination. Vertigo and related nausea persist 4 days post vaccine.
Pt reports dizziness started and increasing blood sugars after receiving second dose.  Pt had ER visit related to dizziness
POTENTIAL UNDER DOSING OF 3 PATIENTS; OFF LABEL USE; This spontaneous report received from a pharmacist concerned multiple patients. 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced potential under dosing of 3 subjects. On 06-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential under dosing of 3 patients and off label use was not reported. This report was non-serious. This report was associated with product quality compliant: 90000175482
Patient c/o tingling in hands a few minutes after vaccine. Was found to be hyperventilating. No airway compromise, SOB, CP, or dizziness. Transported to ED from vaccine clinic.
I was immediately sent to the ER and my arms and my chest and all over the back of my neck got covered in hives, my throat swelled and it was hard to breath I've been severely allergic since a child and was told never to receive another one. I had 2 other pregnancies where I never received the DTaP due to my anaphylactic allergy to it both my kids were full term. My due date for my 3rd pregnancy was Christmas Eve 2017 and I delivered prematurely on November 20th 2017 to a 4 pound baby girl. She was in distress after the DTaP shot and I was given steroids to help mature her lungs.
Patient reported continued arm pain at site of Flublok immunization from on December 17, 2019.  Other symptoms include difficulty sleeping on that side of arm AND completing yard work, and possible putting away groceries.   She's a new patient to our pharmacy and only just got a flu shot.  She reports that she receives the flu vaccine every year, and have never gotten this reaction before.  It was difficult getting a complete medical history from her other than the sphinter of oddi dysfunction?   I recommended that she gets her arm examined ASAP by her primary care provider, Dr.   I  would follow up with her in a few weeks because the holidays may prevent her from seeing Dr..
Patien fainted after receiving all 3 vaccines, Hit his head (R) side. 1st time experience this with the patient. Tdap HPV MCV4
The patient reported noticing a blushed red skin on the left arm with no bumps, descending from the site of the injection approximately 4 inches, halfway to the elbow. This area was warm but did not itch. This lasted for 3 days before it was gone. Patient did also have itchy rash behind knees that a provider attributed to the ciprofloxacin.
C/o "bump" on leg - initially was bruised, then a rash started Tuesday 9/28/10. Same area as vaccination. Red, erythema, blanching. Papular rash with halo red 1.5 x 3 " after 8 days - BENADRYL, cool compress.
Initial and follow-up information has been received from a mother and a licensed practical nurse for the Merck Pregnancy Registry for GARDASIL concerning her 17 year old daughter with no previous pregnancies who on approximately 07-JAN-2008 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL. The mother was calling to report that her daughter was pregnant after receiving the vaccine. Therapy was discontinued. The patient's mother reported that "they had no physician information because they have not found an OB/GYN in their area." The patient's mother advised that "once a doctor has been found they would call with the information." Medical attention was not sought. The patient's mother requested prescribing information. No product quality complaint was involved. On 29-JAN-2008 the patient was placed on therapy with ZITHROMAX (250mg once) for the treatment of chlamydia. Other medications taken during pregnancy included ZOFRAN and pre-natal vitamins. On 29-MAY-2008, the ultrasound was performed for rule out abruption and the result was normal. On 05-MAR-2008 the serum alpha fetoprotein test was performed as routine screen with negative result. On 09-AUG-2008 the patient delivered a normal female baby weighing 7 pounds 6 ounces at 38.5 weeks. There were no complications during pregnancy and labor/delivery. There were no congenital anomalies, other complications or abnormalities. Additional information has been requested.
Woke up the morning after IZ on 5/29/13 with stiffness and pain in the R. arm, breast, underarm and neck. 5/30/13 a little better.  Since the IZ 5/28/13 I have weakness with my R arm.  Pain is worse at night better during the day.  I have not seen my primary care giver as I hope each day it will get better. OTC anti-inflammatory gives no relief nor does heat or ice. ... wondering if IZ was given too high above deltoid and hit a nerve ?
This initial spontaneous report was received from a medical assistant referring to an unknown number of patients of unspecified ages and genders. There was no pertinent medical history or drug allergies/drug reactions. The reporter stated that on unspecified dates, the patients were inadvertently administered with improperly stored VARIVAX (Merck) (Lot# L012038, expiration date 07-APR-2017, dose and route not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Rash size of "Large Band-Aid". No fever or excessive swelling. Still present when patient called on Tues. following her vaccine on Saturday.
complete loss of vision, ringing in ears and hearing loss for 30-60seconds;  fever > 101,  elevated HR
Headache, emotional lability, body aches, difficulty breathing/shortness of breath. Headache began within hours of receiving vaccine. Emotional lability began the next day (4/2/21). Body aches and shortness of breath began 4/5/21.
Initial unsolicited report received from nurse on 03 October 2016. This case involves patient (age and gender not reported) who was vaccinated with a single dose of Fluzone Quadrivalent Syringes (Batch number: U1683AA, expiration date, site and route of administration was not reported) on an unspecified date. Patient's medical history and concomitant medication were not reported. On unspecified date, about three hours following vaccination patient experienced loss of consciousness (suspected severe reaction to vaccine). On an unspecified date patient was hospitalized. Lab data and corrective treatment were not reported. Outcome of event was not reported. On an unspecified date, the patient was discharged from hospital. List of documents held by sender: none. Sender's Comments: Patient had loss of consciousness following FLUZONE QUADRIVALENT. This is a poorly documented case as time to onset is unknown and additionally information regarding patient medical history, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assess.
Two days following vaccination,  I woke with severe pain/cramping in hip joints - no history of joint pain of any kind.  The pain got increasingly worse and prevented my ability to transit the stairs in my home.  I have days that movement is difficult due the the hip pain.  I am almost three months post vaccination and the pain is still very present and will often keep me awake at night.
She added that her arm felt the soreness when the hcp administered the pink vaccine (2nd dose) to her.; The color of the 1st dose of that was administered to her was white and the 2nd dose was pink.; The color of the 1st dose of that was administered to her was white and the 2nd dose was pink.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She added that her arm felt the soreness when the hcp administered the pink vaccine (2nd dose) to her."; PRODUCT COLOUR ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "The color of the 1st dose of that was administered to her was white and the 2nd dose was pink.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
- gradually worsening and disabling shoulder pain with most, even slight,  movements - motrin with some improvement - now 10 weeks out with continued severe pain and severe impairment