chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 5th October 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information received as follows: The pharmacist stated that till the reporting time, the patient was complaining of injection site soreness or injection site pain that was persisting. The reporter consented to follow up.
24JUN96 pt recv vax & 25JUN96 urticaria-also had apple juice on 24JUN;
Dx: Hives. Developed face - neck - torso rash starting evening of day of injection - gradually worse until seek medical care: treated with Benadryl, Loratadine and Kenalog injection.
Day # 1. Wed 06/05/19 received vaccination, slight swelling upper left arm. 2. Thursday 06/06/2019 swelling increased to size of a fist increased pain and slight itching sensation, slight fatigue, restless nights sleep with periods of leg shaking. 3. Friday 06-07 increased fatigue resltessness nights sleep with periods of arm shaking(no leg shaking) slight soreness on left side of throat. 4. Saturday 06/08 continued fatigue daytime sleep, in bed by 8 pm sore throat worsens making it painful to swallow and sleep. Legs and arms calm at night. 5. Sunday 06/09 morning nosebleed, sore throat on left side continues difficult to swallow, tongue feels swollen making it hard to speak. Slight fatigue and drowsiness continues. Went to emergency room and was examined and tested for strep throat, results neg. O2 level 94. Given oxygen breathing treatment and zpack. ekg normal. started antibiotic that evening. 6. monday 06/10 arm swelling subsided slight soreness in throat and voice terurned to normal. Started steroids in am starting to feel normal. Noticed a small floater in left eye w/ ocasional flash. 7. Tue 06/11 feeling normal and slept well. Floater in left eye has gotten bigger with ocassional flash. 8. Wed 06/12 floaters have increased affecting 75% of the eye, center of eye ok. Called primary for course of action. Instructed to notify if condition worsens or go to ER if needed. 9- Thursday 06/13 minor change additional cloudiness left eye- not severe. Primary physician contacted. (pa, A1C 6.2, follow up eye exam, referred to otptometrist for examination and further evaluation.  10- Friday 06/14 Optometrist evaluation, no diabetes related changes, some hemorrhaging of concern, large detached vitreous. Reffered to retinal diagnostic centaer, for further deep examination and diagnosis.
joint pain; Stiff neck; This non-serious case was reported by a consumer and described the occurrence of joint pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 22-SEP-2023, the patient received RSV vaccine. On 23-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced joint pain (Verbatim: joint pain) and stiff neck (Verbatim: Stiff neck). The outcome of the joint pain and stiff neck were not resolved.   It was unknown if the reporter considered the joint pain and stiff neck to be related to RSV vaccine.     It was unknown if the company considered the joint pain and stiff neck to be related to RSV vaccine.   Additional Information: GSK receipt date: 30-OCT-2023 The patient had stiff neck and joint pain. The reporter requested to follow up.
received a Tenivac injection by mistake when a shingles vaccine was intended with no adverse event; Initial information received on 03-Nov-2020 regarding an unsolicited valid non-serious case from  a nurse.  This case involves a 65-year-old male patient who received a diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] injection by mistake when a shingles vaccine was intended (wrong product administered) on 29-Oct-2020 (lot: U6669AA; expiry date 15-May-2022) at a dose of 0.5 ml once via intramuscular route to the right arm  for prophylactic vaccination.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included influenza vaccine (Flu vaccine).  This was an actual medication error case due to the event wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1st dose 1-7-2021 lot# 027L20A I woke up and sat-up. My dizziness slammed be back to the bed. I could not get up; I was dizzy and vomiting. I went to er and was diagnosed with vertigo. That helped and I was referred to an ENT. He ordered a MRI and ear canal that came back as negative. It took weeks for me to recover. I could hardly walk, and I could not work. ER visit. 2nd dose 2-11-2021 right arm lot# 013M20A. Basically the 3rd day it happened again but not as severe. I still couldn't walk. I knew what to do. I did not go to the doctor. I got better after a couple weeks. 3rd dose 12/6/2021 lot # 031H219 right arm. It happened again, but not as severe. I can not put my head back at the hairdresser or the dentist. I am having right ear pain. I have gone to an ear doctor and chiropractor. I cannot drive. I keep getting theses shooting pains in my head. When I lean my head back, I am so dizzy I can not walk. I am on multiple medications. This has changed my quality of life. I now walk with a cane. I have to driver; I must have assistance walking. I am seeing a chiropractor in March 2022 and trying to get this under control. This has disabled my life.
On 03/15/2000, the pt developed cold symptoms, a rash with 15 lesions, a low grade temperature, and no appetite.  The pt subsequently recovered. No further information is available.
Patient with 2 Moderna vaccinations who admitted with COVID detected test.  Provider d/c summary below:  "Patient is a 55 year old female with a history of anemia, anxiety, depression, DM type II, memory loss, DVT of RLE recently on Eliquis, and seizures who presents to the ED after a GLF. Patient reports her health has been deteriorating since April. She states she falls multiple times a week. Reports she is seeing a neurologist and was diagnosed with seizures a week ago. She was placed on Depakote and has had increased falling since. She reports she always remembers falling and reports unsteadiness on her feet. Today she reports she knew she was going to fall forward and landed in between her bed rail and mattress. She was uncertain if she fainted. States she had an episode of incontinence because she could no longer hold in hre urine. She does state she has urinary urgency and her urine has been more dark with a foul odor lately. Reports she has been confused off and on for months and ""not herself anymore."" Patients son has covid and was tested today. He is symptomatic with diarrhea. Patient reports no symptoms and states she is vaccinated but not boosted against the virus. Reports a dry cough that has been ongoing for months. Admits to diarrhea for months.  Denies ETOH use. Reports she is now down to a couple cigarettes daily. She denies chest pain, dyspnea, abdominal pain, sore throat, nasal congestion, lower extremity edema, or fever.             In the ED, patient was mildly hypotensive otherwise hemodynamically stable. She became hypoxic in the ED with a good waveform. Lab work revealed chronic leukopenia and anemia in which she follow with heme onc. Xray of right shoulder unremarkable. Chest xray unremarkable. CT cervical spine and CT head unremarkable. Valproic Acid sub therapeutic. Covid positive. She was given steroids. Patient was also given Ceftriaxone for presumed UTI. Due to patient having presumed breakthrough seizure, she was transferred to hospital for tele neurology consult. (HPI per NP)   Hospital Course: No notes on file Patient is a 55yr old female with a history of DM, Seizures who presented following a fall and was found to have COVID. She says she has been sick for about a year which was just complicated by covid. She was to be discharged on 07/11 but was too weak so rehab was considered. However rehab placement was a challenge due to covid status but she continued to improve and now feels strong enough to go home.   COVID infection - no respiratory symptom at this time, saturating well on room air. Improving clinically. PT initially recommended SNF, but she is now strong enough to go home. She was positive 7/5 so out of isolation today 7/15. On dexamethasone day#8. Plan is for discharge home today."
New worsening symptoms in hands (I am existing Reynaud's patient). Intense sensitivity to touch preventing me from doing daily activities like driving, chores, and cooking. Burning sensation on parts of hands. Intense itching with hives like bumps on hands, especially triggered by heat or stress distracting me from doing activities and focusing in my daily life. New blood test results positive for more autoimmune markers. I believe getting the mRNA vaccine (pfizer) triggered my existing autoimmune disease and caused progression that effects my quality of life. Even though these symptoms may die down over time, it's unpredictable and poorly understood how bad they will be for people with an autoimmune condition and specifically for mine. It's not fair for the CDC to not recognize these severe effects daily life and symptom progression for people with autoimmune conditions. Someone near their end of life with an autoimmune condition die from a flare up. The mRNA vaccines should not be recommended for people with autoimmune conditions.
Began experiencing tachycardia approximately 11-14 days after 2nd booster along with low blood pressure with spikes of high blood pressure.  Electrocardiologist believes it is POTS syndrome.  I believe I could have had this for a few years but symptoms were made worse after the booster.  Blood pressure drops very low and tachycardia begins within 10 minutes of standing.
I got head congestion; cough and tiredness lasting 10 days and I took PAXLOVID and felt better. I tested negative COVID 19 on 08/11/2022.
Sleepiness-12/10/18-12/16/18 slept more than usual. No bowel movement-poop 12/10/18-12/16/18 Death, SIDS 7:32am on December 16th 2018.
headache; no apetite; fell like puking; shivering; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2020, the patient received the 2nd dose of Shingrix. On 18th June 2020, less than a day after receiving Shingrix, the patient experienced chills. On 19th June 2020, the patient experienced headache, appetite lost and nausea. On an unknown date, the outcome of the chills, headache and appetite lost were not recovered/not resolved and the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the chills, headache, appetite lost and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix yesterday and was shivering last night (from the day of reporting) and had a headache, no appetite and felt like puking (on the day of reporting). The reporter asked how long would the side effects last and the patient wanted to know would he had fever.
Temp x2d x102.6-103, 4-5 red "bites" on trunk and inside of thighs.
Severe pain was felt immediately during injection. It felt as if the vaccine was given too deep and into my shoulder joint as opposed to my deltoid muscle.  Pain in my arm increased throughout the week and I went to an orthopedic urgent care, followed by a regular worker's comp doctor who diagnosed me with SIRVA (shoulder injury related to vaccine administration).  I was prescribed physical therapy and told to take advil/motrin for the pain.  I have completed 12 sessions of physical therapy with no improvements. The pain is sharp and starts at the top of my shoulder and shoots down my arm (halfway to the elbow) when I move my arm out to the side or above my head.  Other treatments have included arnica (Penetrex cream), ice, heat, rest, TENS machine, lidocaine cream, stretching, and 2 sessions of acupuncture.  Nothing has helped with the pain so far.  It has been about 6 weeks since my injection.
The same day of the vaccine (2nd dose on 11/2/21) I had itchy palms and itchy feet for a few hours which is unusual for me. The following day I had body aches, a headache, swollen lymph nodes, and nausea.  I also experienced lethargy. The nausea & lethargy lasted for a few days afterward. The lymph node under my ear, next to my jaw on the left side has been swollen since the first vaccine and rock hard. It has not decreased still (a month later).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "known allergies: NSAIDS" (unspecified if ongoing), notes: known allergies: NSAIDS. Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Aspirin, reaction(s): "known allergies:Aspirin", notes: known allergies:Aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) positive; (17Jan2023) Negative, notes: Rebound of COVID 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Jan2023 to 14Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient fainted several minutes after vaccine was given. She was stiff and unresponsive for a few seconds. Pharmacy staff called 911, she was transported by EMS to ER and event was determined to be a BRUE (brief, resolved, unexplained event) by ER doctor.
Left upper arm with reddish purple swollen area with knot for about 3 weeks. Fever to 103 starting 7-8 days after vaccines, despite Tylenol and Motrin. Rash started 10 days after vaccine diffuse, Maculo papular erythematous. Erythema of conjunctiva. No vesicles seen.
Narrative: COVID infection following COVID vaccine series 03/17 , Pfizer, dose #1 (non-facility) 04/07, Pfizer, dose #2 (non-facility) 08/11 pt reports positive exposure on 08/11/2021. 08/20 COVID swab, result: detected 08/22 pt cc: chills, fever, headache, congestion, loss of taste or smell exposure; unknown
Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 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 immunization, reaction(s): "no adverse event". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms".".  Additional information: Caller says he got the Pfizer shot. After the 1st shot, he nor his wife had any adverse effects. After their 2nd shot, his wife had flu-like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported) via an unspecified route of administration, administered in the left arm on 06Apr2021 00:45 (at the age of 25 years old) as dose 1, single for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included buspirone and fluoxetine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 10:30, the patient experienced nausea and diarrhea. The events resulted in Emergency room/department or urgent care. The patient was treated with IV and prescription of 15 tablets of ondansetron. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
swelling in the arm; tenderness; Moderna red rash\started experiencing a red rash on my arm; soreness; still experiencing pain at the injection site.; redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch; iitching on hand ,tching on arm,itching on leg,itching on foot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot), RASH ERYTHEMATOUS (Moderna red rash\started experiencing a red rash on my arm) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The medical history was not provided by the reporter.  Concomitant products included IBUPROFEN for Headache, PARACETAMOL (TYLENOL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch). On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), RASH ERYTHEMATOUS (Moderna red rash\started experiencing a red rash on my arm), MYALGIA (soreness) and VACCINATION SITE PAIN (still experiencing pain at the injection site.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), MYALGIA (soreness) and VACCINATION SITE PAIN (still experiencing pain at the injection site.) had not resolved, PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch) had resolved and RASH ERYTHEMATOUS (Moderna red rash\started experiencing a red rash on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes ice patch patient states that she was scheduled to receive her second vaccine on 08Sept2021 and does not know if she should based on the symptoms that she experienced with the first.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Event outcome & additional event is added
Information has been received from a physician concerning a male who was vaccinated with a dose of Zostavax. In approximately October 2006, the patient developed shingles. Unspecified medical attention was sough. There was no product quality complaint involved.  No additional information is expected.
No additional AE's.; A medical assistant reported that a patient received a dose of MMR II on 1/16/2018 and on 5/9/2022.  The same patient received a dose of PROQUAD on 7/12/2022.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JAN-2018 and on 09-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dosage regimen, lot #, expiry date, anatomical location and route of administration were not provided), administered as prophylaxis.   On 12-JUL-2022, the patient received a dose of mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human Albumin (rHA) used as directed to prevent measles, mumps, rubella and varicella infection, lot # W007748, expiration date: 04-SEP-2023, (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (extra dose administered). Lot # W007748 has been verified to be a valid lot number for mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  No additional adverse events were reported.
Initial report received on 07 September 2007 from a health care provider.  A patient (age not specified) had received an injection of Menactra, lot number U2386BA, on an "unknown" date.  Route and site of administration were not provided.  At an unspecified time post-vaccination, the patient experienced fever, muscle weakness, and severe lower extremity weakness and tingling which resolved in three days.  Additional medically relevant information was not provided.  Recovery status was not reported.  The reporter in this case is the same as in case 2007-03056.