chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports that se awoke on 5/1 & area on left arm where she received varicella vaccine was red, swollen, & warm to touch with some itching.  Applied cool compresses & took anti-inflammatory OTC med & Benadryl.  Continued on Sat. 5/2/15, then improved.  No hives or difficulty breathing.  Discovered also that she had chickenpox disease in 1990.
pt recvd vax 22OCT92 c/o redness, pain & swelling @ site & surrounding area next day; tx for 3-4 days w/warm compresses to MD 30OCT92; recvd inject & po meds; area still red & warm to touch today;
He had chills, congestion, since I had tested positive for COVID-19 we tested him with a home COVID-19 test. The first test came back negative, we tested him again on the nest day because he was extremely congested. I called his doctor who asked that we go to the hospital to have a PCR Rapid COIVD-19 test done, this test came back positive. He was prescribed the antiviral Lagevrio that he started taking today.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a medical clinic 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. In 2015, the patient was treated at the same medical clinic for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. 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.
Pt states she began to have pain in her right arm, along with pain in the axillary lymph nodes, neck pain, pain in her head and right ear.
4/16/2021 rough achy and worn out stuffy when I laid down 4/17/2021 exhausted and stuffy 4/18/2021 tired did nothing all day stuffy at bed time. 11:30 could not get my breath. Husband called 911. Ents gave me oxygen and took me to the Hospital Emergency Room by ambulance. ER gave me oxygen took xrays did CT-scan. Not sure of meds given.no one cared that I had the second dose on4/15/2021
Patient contraindicated for influenza vaccine. Patient only 4 months. Child monitored, no injury noted.
This serious case was received on 20 April 2009 from another manufacturer whose initial reporter was a consumer. A male patient (age not provided) received Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib vaccine. The manufacturer and lot number were not known. Post vaccination, the patient experienced a febrile seizure (date not provided). Recovery status and details regarding the event were not provided. No further information was reported. List of documents held by sender: none.
Fever, chills, body aches starting 10 hrs after injection lasting 24 hrs. Racing heartbeat, fatigue starting 48 hrs after injection
mom described deep sleep during noc p/vax, head lurching up & shaking & 1min later happened again;no further problems;
Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified ) was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.
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 35-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Feb2021, stop date: 20Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details: The patient received Paxlovid for COVID 19 treatment from 10Aug2022 to 14Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MEDI-00068085 is not serious spontaneous case from a consumer involving sore throat. The reporter causality is not provided to FluMist. An 36 year old female office manager in a physician's office reported that she and 3 other office staff experienced headache and sore throat 2 days after receiving FluMist vaccine on 26Oct05. This patient recovered from the headache but sore throat continued. The reporter causality is not provided. A 36 year old female officer manager in a physician's office reported that she and 1 other staff experienced headache and sore throat 2 days after receiving FLUMIST vaccine on 26Oct05. SHe took TYLENOL and MOTRIN. She recovered from the headache but sore throat continued. The reporter causality is not provided. 12April2006: Additional information obtained: Patient's date of Birth.
AM 11/4/05 called had swelling under eyes - no disenbration, no other facial or extremity swelling. Deltoid resp symptoms - stated felt fine except under eyes swelling which decrease during the day - had vaccine and d1st oral typhoid pill 11/3/05 - followup call 11/7/05 no swelling after 2nd typhoid pill.
losing clumps of her hair on Saturday; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing clumps of her hair on Saturday) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21A and 084J21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 11-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2022, the patient experienced ALOPECIA (losing clumps of her hair on Saturday). At the time of the report, ALOPECIA (losing clumps of her hair on Saturday) outcome was unknown.            No medical history was provided by the reporter. Weight of the patient was reported as 210. No treatment medication was reported.
I don't have the sense of smell; Cold; This is a spontaneous report from a contactable consumer (patient).  This female patient with unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 16Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 17Jan2021, she doesn't have the sense of smell. She thinks she has a cold too. Outcome was unknown. Information on the lot/batch number has been requested.
Left arm was sore; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Adverse event.    No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm was sore). At the time of the report, PAIN IN EXTREMITY (Left arm was sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-029836 (Patient Link).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-year-old male patient received BNT162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 11May2023 to 15May2023 as a treatment for the events. He received Multiple vitamins from Jan2023 to May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortly after vaccine, upper respiratory issue started.  Fatigue, falling, soiling bed sheets and pants regularly. Then went to hospital on june 7th with abdominal pain. Low bloid pressure and hight white blood count.  Had blood clot.  Urinary Infection   Possible sepsis.  Still in hospital.
Patient has large (approximately 4 in diameter) raised surface with bright red ring around vaccination site. Skin was elevated ~1/2 in above surface was taunt/ inflamed. Patient reported that reaction was not painful. She also reported no difficulty breathing, hives, or other indications of allergic reaction.  She called her PCP the day after the vaccination clinic (04/23/21), they determined no emergent response was necessary. Watchful waiting was adapted.  Upon return for second vaccine dose no sign of ADE was present. Vaccinating pharmacist was made aware of the ADE for the first time at second dose clinic (05/20/21). Patient declined second dose of vaccine.
After injection, there was swelling and pain/soreness at the injection site. Later, she developed a rash up and down both arms.
felt funny when left clinic, fainted and lost consciousness on ride down on elavator from pedi clinic.  IZ given at 1215pm and had not eaten since the night before.  Juice and crackers given, monitored vitals
I am on a blood thinner and after reading the brochure that's, there is a precaution of not to take it; muscle soreness; headache; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not reported) via an unspecified route of administration on 25Feb2021 (at the age of 77-year-old) as a DOSE 1, SINGLE for COVID-19 immunisation; received rosuvastatin calcium (CRESTOR), via an unspecified route of administration on an unspecified date as dose Unknown use for blood thinner. The patient medical history and concomitant medications were not reported. The patient reported that he received 1st Pfizer Covid Vaccine 3 weeks ago from the day of report and was set to take 2nd dose next day on 18Mar2021. He was experienced muscle soreness and headache for the last week and a half. The patient also reported that he took a blood thinner (Crestor) and was concerned if it would cause any problems. He was on a blood thinner and after reading the brochure there was a precaution of not to take it. The patient was okay and just wanted to make sure that that was okay to take the second shot which was on next day. Outcome of the events was unknown.  The lot and batch number for the vaccine BNT162B2 was not provided and will be requested during follow up.
12cm x 8cm area of erythema and induration to upper arm at site of injection
Patient contacted informed pediatric dose given on 12/14/18 and needs to return for adult dose administration.
Had three vaccinations; soreness in his arm; Tenderness in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   Vaccination history included: Bnt162b2 (Dose 1, his father reported he has had three vaccinations and the only thing that happened to him was soreness and tenderness in his arm), for COVID-19 Immunization, reaction(s): "Soreness in his arm", "Tenderness in his arm"; Bnt162b2 (Dose 2, his father reported he has had three vaccinations and the only thing that happened to him was soreness and tenderness in his arm), for COVID-19 Immunization, reaction(s): "Soreness in his arm", "Tenderness in his arm".  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Had three vaccinations"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in his arm"; TENDERNESS (non-serious), outcome "unknown", described as "Tenderness in his arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccine received 12/31. Arm pain persisted x3 days. On 01/07 large itchy welts broke out on injection site. over time welts went away and whole area became red, swollen, and hot to touch. Arm also became sore again. Cortisone applied twice with minimal relief.
Resident became rigid with eyes crossing and rolling back in her head.  She was unresponsive and became limp.  Pulse Ox decreased to low 80's.  She came to and then was agitated throughout the day.
I usually have pain (aching) at the site of my flu vaccine (left upper arm); it usually goes away in maybe 3 days. (I usually carry on with whatever I have to do). This year was diffferent. My upper left arm, the site of the flu vaccine, ached and then the aches spread down my arm, even into the joint between my thumb and index finger. It hurt! It was so bad that for 2 or 3 days I could not lift my arm by myself to put on or take off clothes. I needed help to do that. I did not seek medical care because my husband said, "It will get better." The pain did not go entirely away. I was told that this flu vaccine had 4 parts.
back pain; This case was reported by a other health professional via interactive digital media and described the occurrence of back pain 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 back pain. On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had back pain.
pt recvd vax w/a booster dose of MMR then devel meningitis; pt's exp was considered life-threatening; addtl info has been requested;
Acute tonsillitis approximately 1-2 hours after administration, sought care at PCP?s office and was treated with prednisone over 5 days. Subsequent swelling never completely whet away and an appointment with an ENT specialist was scheduled for Tuesday, April 20th. The decision was made to remove the swollen tonsils and they were surgically removed April 23rd, 2021
Shot was given to the upper left arm. Began feeling dizzy, nausea, chills, headache, and tiredness early morning on 3/16/21. Notified primary doctor and was told I could take tylenol and that the symptoms should be gone in a couple days. The injection site was warm, red, and swollen.  By tuesday night, my head was worse and all I could do was sleep.  Wednesday, 3/17/53 I felt better and tried to start my day. Within a short period of time, I was dizzy and nausea had started again along with the tiredness. The injection site was still warm, red, and swollen.
This spontaneous report was received from a female patient of unknown age referring to herself. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. The patient reported that she experienced redness, swelling, a hard lump, and warmth where the shot was given, after receiving ZOSTAVAX (on an unknown date). The outcome of vaccination site swelling, vaccination site warmth, injection site induration and injection site erythema was unknown. The causality was not reported. Additional information has been requested.
Mild case of shingles.  Scalp tenderness, small rash around eye.  Nerve pain.  Antiviral valocyclovir prescribed 4 days after onset of symptoms.  Cleared up after 2 weeks.
Headache same evening. Fever and diarrhea day 2-3. Symptoms resolved day 4. Fever >101 and diarrhea resumed day 5. Symptoms resolved day 6.
Pt became very fussy approx 7 hrs p/immun & throughout the night was awake every hr; remained very irritable until afternoon of the next day; mom gave APAP entire time & did not think pt had a fever;
About 30 minutes after first dose I felt a rush up my arm straight into my neck then started having neck pain. The pain was very bad for week and a half to where I could hardly turn my neck ( neck very stiff). The real bad pain has eased off but pain still exist today.  About a 1 hour after vaccine very high pitch ear ringing  started the ring was ridiculous the first two weeks and I still to this day have ringing off and on in my ears almost everyday even had stopped up ears ( like a ride to the mountains).  I also had some high up chest pains after the first two shots. The next day after the first shot was nauseous and body aches all over.  I did tell the Guy after first dose about side effects but he did not seem to care
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. On 11th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, muscle pain, general body pain and headache. The patient was treated with KEFLEX and VICODIN. In April 2018, the outcome of the fever, muscle pain, general body pain and headache were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on Wednesday at 4 to 11 about noon. On Wednesday, at 7:00 pm, the patient experienced muscle; all over body aches, very bad headache, fever and pain, swelling and redness (about 4 into 2, 1 by 2 inch) at the site. On Friday afternoon the swelling gone down on arm and was about 3x2 inches. It was unknown redness was caused by an allergy, but might be from the fluid in the injection. If were the actual medication, the patient thought would have hives or a rash all over my body. The patient experienced allergic reactions to KEFLEX and VICODIN and afraid of adverse reactions. The patient went to the emergency room for the KEFLEX reaction. The patient would be receive 2nd dose in 4 months.
1035: Pt rec'd Covid vaccine 1110: Pt c/o dizziness.  Also occurred w/1st vaccine.  This time is a little less severe 1115: BP 102/68 HR 79 RR 16 SpO2 100% 1119: Monitored sat for 45 mins after vaccine. Discharged home w/spouse
Fever, stomach cramps, nausea at first then got local inflammation at site of administration with swelling & soreness. She said her physician diagnosed it was staph infection.
A 71 year old female pt was treated with OncoTICE for bladder cancer. On 07Jul04 after her 4th instillation, she had retained OncoTICE in her bladder four about 10 hours. The pt reported that she experienced facial flushing and a possible fever. She reported that she took Tylenol at the time, and the symptoms resolved after a couple hours.
Vasovagal response, responded to fluids and food. VSS after observe for 30 min. Narrative:
Area around injection site was Red, tender and warm to the touch. The size of the affected area was 10cm X 7cm.
It received vaccines 9-13-17 and developed fevers to 104 within 24 hrs. Fussy, not eating, sleeping all day.
The father of patient refused to have the child vaccinated at their adult dose. Father was educated by the vaccinator and physician's assistant. The father acknowledged understanding but still refused to have the child vaccinated at the adult dose for many reasons. The child recently turned 12 and father explained that the only vaccine he will authorize for the child is a child dose due to age, size of patient and many other factors. The child was administered a child dose of the vaccine. There were no adverse reactions, no medical events or other complications from this vaccine administration.
Information has been received from a physician's assistant concerning an adult male who on an unspecified date (at young age) was vaccinated with a dose of MMR II (dose, route and lot number not reported). It was reported that the patient was tested no immunity to rubella and measles, so the physician gave the patient another dose of the vaccine recently. The patient sought medical attention by contacting the physician's assistant. This is one of several reports from the same source. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number or recovery status. Additional information has been requested.